Grapefruit USA Inc (GPFT)

[mr_sano]

Well IHUBBERS Here you go: BTW this cost me $50 so anybody wnat to send me a nice bottle of booze pleases feel free:

DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue
Document Mail Center - W066-G609
Silver Spriihg, MD 20993-0002
Mr. Dean Janes
Chairman/CEO
Imaging3T
, Inc.
3200 W. Valhalla Drive
BURBANK CA 91505 orT. 2 Z[hD
Re: K093147
Trade Name: Dominion Vi Scanner
Regulatory Class: III
Product Code: MQB
Dated: July 2, 2010
Received: July 7, 2010

Dear Mr. Janes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above. We have determined the device is not substantially equivalent to devices
marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to any device which has been reclassified into class I (General Controls) or class II (Special Controls), or to another device found to be substantially equivalent through the 510(k)process. This decision is based on the fact that we requested additional information on October 23,2009 and January 5, 2010 and you have failed to adequately respond to our requests.You may resubmit a new 5 10(k) if you have data you believe can show your device to be
substantially equivalent.
Therefore, this device is classified by statute into class III (Premarket Approval), under Section
513(D of the Federal Food, Drug, and Cosmetic Act (Act).
Section 515(a)(2) of the Act requires a class III device to have an approved premarket approval
application (PMA) before it can be legally marketed, unless the device is reclassified.
Any commercial distribution of this device prior to approval of a PMA, or the effective date of any
order by the Food and Drug Administration re-classifying this device into class I or LI, would be a
violation of the Act. Clinical investigations of this device must be conducted in accordance with the
investigational device exemptions (TDE) regulations.
If you wish to pursue the marketing of this device and need information or assistance for preparing
investigational or premarket submissions, please contact the Division of Small
Manufacturers, International and Consumer Assistance at its toll free number [phone] or
[phone], or at its Internet address
Page 2 - Mr. Janes
http://www.fda.gzov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
If you decide to submit a new 5 10(k) you should submit a complete submission which
includes the information identified in Title 21, Code of Federal Regulations (21 CFR),
Section 807.87 and follows the formatting specified in 21 CFR, Section 807.90, and also
refer to our document, titled Guidance for Industry and FDA Staff - Format for Traditional
and Abbreviated 51 0(k)s which is available from the Internet at:
www.fda.gov/Medica]Devices/DeviceRegulationandGuidance/GuidanceDocuments/ucni084365.htm
In addition, please ensure that any new 510(k) includes information that was previously
requested on January 5, 2010 and addresses the following issues:
1. Solid-State X-ray Imager Bench Data: In deficiency 1(a) of our January 5,2010 letter, we
requested that you submit nonclinical information for the solid state detector as
recommended by section VI of "Guidance for Industry and/or for FDA Reviewers/Staff
and/or Compliance: Guidance for the Submission of 51O(k)'s for Solid State X-ray Imaging
Devices", available at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumients/uc
m073780.htm#1 0 vi Nonclinical. Your response did not address this request. Please provide
this information.
2. Clinical Study: In deficiency l(b) of our January 5, 2010 letter, we requested clinical
information as recommended by section VII of "Guidance for Industry and/or for FDA
Reviewers/Staff and/or Compliance: Guidance for the Submission of 51 0(k)'s for Solid State
X-ray Imaging Devices", available at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m073780.htm#17 vii Clinical. The information you have provided in response to this
deficiency is not sufficient.
(a) Sample Images: You provided a CD with images of anatomical phantoms in place of
patients. You said:
"Spine images from the and were downloaded
from their respective websites as access to these devices was extremely difficult to
impossible, especially the These phantoms were selected as to provide the
least burdensomeapproach to acquire images as well as providing the best possible
detail and contrast ranges of imaging devices within a fairly wide range of exposure
values. Providing these images as live would be far too burdensome as most if any
facilities do not own both a and a Also to purchase
or lease these two pieces of equipment would be a financial burden for Imaging3...
The proved to be impossible to have access to, so images from
their website were used. It should also be noted that gaining access to the
was extremely difficult as well, which is why images of the spine had to be
obtained via their website."
In addition to not satisfying the guidance document, such a comparison is
scientifically invalid and useless. The spine web images used were heavily
compressed, in some cases with decorative borders bleeding into the image area.
(b) (4) (b) (4)
(b) (4)
(b) (4) (b) (4)
(b) (4)
(b) (4)
(b) (4)
Page 3 - Mr. Janes
Furthermore, only a hand, skull, and spine phantom were used. No soft-tissue image
evaluations were performed.
(b) Radiologist Report: Moreover, the radiologist report you have provided says,
"3D (three dimensional) and CT (computed tomography) emulation images obtained
using the Dominion Vi Scanner were compared to the images
retrieved from their website. The did not have any relevant images
available on their website for comparison, as 3D and CT functions are not available
for this device. These images were of different anatomy, proiections and 3D
reconstructive technique, therefore direct comparison was not possible. For the
Dominion Vi scanner, 3D fly-through images of the jaw using the skull phantom and
one MIP (maximum intensity projection) image of the CT emulation of the hand
phantom were reviewed. For the
... No technique factors were available for the
3D and CT emulation images retrieved from the website. It was
therefore not possible to compare the technique of these two devices in this mode of
operation. Allowing for difference in imaging anatomy and acquisition technique, the
3D images from the Dominion Vi scanner and were of comparable
quality and resolution."
Therefore, this was not a valid comparison and does not satisfy the recommendations
of the guidance document.
(c) Financial Disclosure: Finally, no financial disclosure information was provided for
the investigators, as requested in "Guidance for Industry: Financial Disclosure by
Clinical Investigators"
(http://www.fda.gov/Regulatorvlnfornation/Guidances/ucm 26832.htm). Please
provide this.
3. CT emulation and real-time 3D reconstruction: In deficiency 2 of our January 5, 2010 letter,
we requested the 3D data sets associated with the sample image loops in the submission, CT
emulation images, and a detailed description of the reconstruction algorithms used to create
the 3D constructs. The information you have provided in response is not sufficient.
(a) You provided the TIFF images that were looped to create the sample image loops
described. These non-DICOM files are not adequate. Please provide DICOM files.
(b) You provided videos of MIP images. In addition, the sponsor has provided the TIFF
source images for these videos. These are not in a DICOM format, so they can't be
loaded into a proper reader. In addition, the window/level settings appear to be off,
with significant data clipping As seen in the representative example below:
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
Page 4 - Mr. Janes
This image, which has been cropped, apparently shows a slice through the jaw but
provides no diagnostically useful information. Without a DICOM image, it's not
possible to determine whether the machine is bad, the acquisition is bad, or the
window/level setting is bad. Please provide these images in DICOM format.
(c) You provided a very broad overview discussion of cone beam reconstruction, not the
detailed description requested by the deficiency. What can be gleaned from the
response is that image data at the center of the reconstructed slice will be
considerably better than data interpolated radially further from the center of the
image. While it may currently be possible to obtain a decent image with between 60
and 100 projected images, using only 36 is likely to result in significant radial
ariifacts or other issues. In fact, the descriptive image of the reconstruction technique
you provided appears to suggest that there will be radial artifacts. Please provide a
more detailed description of your reconstruction technique.
4. Software Documentation: In deficiency 3 of our January 5, 2010 letter, we requested
software documentation at a major level of concern. The software documentation you have
provided in response is not sufficient to determine the safety and effectiveness of the device.
Numerous elements related to the device safety and effectiveness are missing from the
software documentation. For instance, turning the system on/off, entering patient
information, control of the image acquisition, image processing, image storage and
communication, features for service and quality assurance, etc... For more information on
Page 5 - Mr. Janes
software documentation, please review the "Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices".
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m089543.htm
(a) Device Hazard Analysis: The hazard analysis only covers basic issues. The hazard
analysis should include a detailed description of the hazards (including clinical
hazards) presented by this device, the causes and severity of the hazards, the method
of control of the hazards and the testing done to verify the correct implementation of
that method of control, and any residual hazards. This is typically done is a columnar
form, wherein the first column identifies the hazard to the patient, the second column
identifies from where in the system that hazard could be caused, the third column
presents, for software caused hazards, where in the software the hazard could be
caused, and the fourth column provides the specific details of the mitigation
including identifying the enumerated tests. For more information, please review ISO
14971:2000 (Medical devices - Application of risk management to medical devices
and Rationale for requirements).
(b) Software Requirements Specifications (SRS): The submission provides only a high
level description of the system requirements. The list of requirements seems
insufficient and does not cover many aspects related to the safety and effectiveness of
the device. Please provide an acceptable Software Requirements Specification
document, which should clearly document the functional, performance, interface,
design and development requirements in an enumerated fashion.
(c) Software Design Specification (SDS): The software design specifications and
architectural design chart are not considered adequate and do not cover many aspects
related to the safety and effectiveness of the device. Please provide a Software
Design Specification document, which describes how the requirements in the
Software Requirements Specifications (SRS) are implemented. The information
presented in the SDS should be sufficient to ensure that the work performed by the
software engineers who created the software device was clear and unambiguous, with
minimal ad hoc design decisions. The document that you submit should provide
adequate information to allow for the review of the implementation plan for the
software requirements in terms of intended use, functionality, safety and
effectiveness. These should be presented in an enumerated manner, referencing the
associated Software Requirements.
(d) Traceability Analysis: The traceability matrix linked requirements, specifications,
and software testing. However, these items were not enumerated; therefore; it is not
possible to find the exact design specification or test associated with each
requirement in the table. Furthermore, there is no traceability based on the identified
hazards, which are linked to mitigation, requirements, specifications, and testing. The
traceability analysis typically consists of a columnar matrix With line items for
enumerated hazards, enumerated requirements, enumerated specifications, hazard
mitigation, and enumerated tests.
5/
Page 6 - Mr. Janes
(e) Development Environment: The submission contained a basic summary of the
software development life cycle; however, given the issues in the other aspects of the
software documentation, please review the following standards: IEC 62304 edition 1
(2006): Medical device software - Software Life Cycle Processes, and IEC 60601-1-
4: Programmable Electrical Medical Systems.
(f) Verification and Validation Documentation: Please provide a complete description of
the validation and verification activities at the unit, integration and system level.
Please include system level test protocols, including the pass/fail criteria, and the
results of these activities. For more information, please review: "General Principles
of Software Validation; Final Guidance for Industry and FDA Staff'.
http://www.fda.gov/Med icalDevices/DeviceRegulationandGuidance/GuidancefDocu
ments/ucmn085281 .htm
(g) Revision Level History: The submission should include the history of software
revisions generated during the course of product development. This typically takes
the form of aline-item tabulation of the major changes to the software during the
development cycle, including date, version number, and a brief description of the
changes in the version relative to the previous version.
(h) Unresolved Anomalies: The submission should include a list of all unresolved
software anomalies. For each anomaly, please indicate the: problem (including
human factors issues), impact on device performance, any plans for mitigation or
correction.
(i) Off-the-Shelf Software: Please provide basic documentation for off-the-shelf
software used in your device following the "Guidance for Industry, FDA Reviewers
and Compliance on Off-The-Shelf Software Use in Medical Devices".
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guid
anceDocuments/UCM073779.htm
6) DICOM Conformance: The submission mentions DICOM; however, the submission
did not include a DICOM conformance statement or a Standards Data Report Form
(FDA 3654) for DICOM. Please include these items to document your level of
compliance with the DICOM standard.
5. Vibration: In deficiency 4 of our January 5, 2010 letter, we asked for additional information
regarding vibration hazards. In response, you indicated that the device will not be provided
with the second revolution speed rpm) previously described because it is still being
tested. (Please note that a 5 10(k) should not be submitted until the device is in its final state
and device testing and validation have been completed). The device will ship with an
acquisition rate that requires a second revolution speed rpm). This could still cause
significant vibration and affect image quality. It is also possible that the device could
resonate and be damaged. Please describe the measures in place to mitigate these and any
other associated hazards.
6. Overheating: In deficiency 6 of our January 5, 2010 letter, we requested a demonstration that
the device maintains a safe temperature without "extra caution" on the part of the operator
(b)
(4)
(b)
(4)
(b)
(4)
(b)
(4)
Page 7 - Mr. Janes
when draped and used according to its indications. In response, you have indicated that the
instructions indicating that extra caution must be used in such situations to avoid an
overheating scenario where hot oil could cause scalds or burns to the operator, patient, and
others nearby were a misprint. You have included a description of the device cooling
characteristics. You do not appear to have demonstrated through real-wo/ld tests that this
device maintains a safe temperature even when draped and used as it would be in a clinical
environment. Please provide this.
7. Lateral Patient Access: Deficiency 7 of our January 5 2010 letter expressed concern about
the lack of lateral patient access when using your device as opposed to the predicate device.
In response, you reiterated a previous argument that opening feature "creates a
sense of false security as this opening if inoperable or malfunctioned would allow the
operator to connect cables, IV tubes and wires in such a way that they could have to remove
them from the patient prior to removing the patient from the gantry, adding significant time
for removal." In fact, the device can and should be used in exactly the way you
describe your device being used: with all wires, tubes, etc. arranged in such a way that the
patient can be extracted axially without opening the bore. Your device does not encourage or
force a clinician to do this any more than the predicate device does. In an emergency
situation with the predicate device, the clinician has two potential options for removing the
patient: axial patient removal and lateral patient removal. With your device, axial removal
would appear to be the only option. Because your device is and not expected to
operate in an significant care should be taken when
setting up the device in each environment to ensure an acceptable layout for rapid patient
extraction. Please ensure that the device is labeled accordingly.
8. User Sync Detector Mode: Deficiency 9 in our January 5, 2010 letter, noted that the device
operates at frames per second (fps) while the publicly available promotional material
for the detector indicates only that it is capable of frame rates of fps. In response, you
indicated that the device uses the "User Sync" mode of operation of the detector to acquire
images at fps. It is not clear that this is a safe and effective duty cycle. Please provide data
evidence from your supplier of from your own testing that demonstrates that this duty cycle
is safe and effective and will not result in ghosting or other artifacts due to lag.
9. User's Manual: Deficiency 10(g) of our January 5, 2010 letter requested a description of all
post-processing features of this device. You have indicated that there are no post-processing
features. in this system. Based on the sample images provided, it is not clear that this is the
case. Please confirm whether or not there are post processing features in this system. In
addition, deficiency 10(j) requested information about safeguards built into the device to
prevent it from, as described in the original manual, "operating at random on a patient". You
have indicated that the statement has been removed, but have not provided the requested
information about the safeguards in place to prevent the device from operating at random on
a patient. Please provide this information as part of your hazard analysis.
10. Over-the-Counter Use: In response to deficiency 15 of our January 5, 2010.letter, you
indicate that this device is intended for prescription and over-the-counter use. Your predicate
device is not indicated for over-the-counter use: Please identify a predicate device for overthe-
counter use. In addition, please demonstrate that your device meets the requirements of
21 CFR § 801 Subpart B (Labeling Requirements for Oyer-the-Counter Devices).
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b
)
(4
)
(b
)
(4
)
Page 8 - Mr. Janes
11. Use at Physician's Discretion: As noted in deficiency 16 of our January 5, 2010 letter, your
indications for use states that "This system may be used for other imaging applications at the
physician's discretion". It is true that FDA does not regulate the practice of medicine, and a
physician may use cleared devices for uncleared indications at his or her discretion (though a
manufacturer may not market the device for those uses). However, the indications for use
form exists to identify those applications for which FDA has determined the device is
substantially equivalent to the predicate, not all applications for which the device can
conceivably be used. The statement is superfluous and should be removed.
12. Electronic Copy: The electronic copy you provided was not submitted in accordance with the
guidelines at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m084365.htm. In the future, please submit electronic copies in accordance with these
guidelines.
The information requested above represents the issues that we believe need to be resolved before our
review of a new 5 10(k) submission canbe successfully completed. In developing the deficiencies,
we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug,
and Cosmetic Act for determining substantial equivalence.
If you have any questions concerning the additional information that should be submitted in a new
510(k) submission, please contact Brendan O'Leary at 301-796-6898.
Sincerely yours,
A avid .Bon hD
Acting Director
Division of Radiological Devices
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health