Bioelectronics Corp (BIEL)

[seven-up]

Section 5: ActiPatch 510(k) Summary(Found the problem FDA Cleared for OTC LOL Reality FACT)
1. Submitter’s Name:
BioElectronics Corporation
2. Address: 4539 Metropolitan Court
Frederick, MD 21704
United States
Phone: [phone]
Fax: [phone]
Contact Person:
Andrew Whelan
President and Chief Executive Officer
3. Date Prepared:
December 1, 2016
4. Trade Name:
ActiPatch®
5. Common Name
Non-thermal Shortwave Therapy
6. Product Classification:
21 CFR § 890.5290(b)
Product code ILX
7. Predicate Devices:
ActiBand (K022404), Ivivi (K070541), Orthocor (K092044)
8. Description of Device:
The ActiPatch® device is a pulsed shortwave therapy device.
The circuitry consists of low voltage (3 V) digital/analog
electronics that control all timing functions to produce the
therapeutic radiofrequency (RF) field, where the antenna is
placed directly above the therapeutic site. This closed loop
system of the antenna, low energy signal generator circuit, and
battery power supply, transfers the RF energy to the target tissue
as a localized therapy with no far field effects.
9. Intended Use:
Adjunctive treatment of musculoskeletal pain related to: (1) plantar
fasciitis of the heel; and (2) osteoarthritis of the knee.
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10.Standards:
ISO 13485:2003 Quality System Standard
ISO 13485:2012 Medical Devices: Quality Management Systems
ISO 14155 Clinical investigation of medical devices for human
subjects.
ISO 14971: 2012 Risk Management
ISO 10993-6:2009 Part 6 Evaluations of Medical Devices
SOR/ 98-282 G D 207 & GD 210 Canadian MDR Quality Systems
93/42/EEC 2012/47/EC Council Directive
BS EN ISO 15223-1:2012 Labeling of Medical Devices
EN 1041:2008 Information Supplied with Medical Devices
EN 60601-1-2:2012 Electromagnetic Compatibility Requirements &
Tests
EN 60601-1-11: 2010 Home Health Care Environment
EN 60601 -1: 2006 Medical Electrical Equipment Requirements and
Tests
EN 60601-2-3: 2012 Short-Wave Therapy Equipment
EN 60601-2-10: 2001 Safety of Nerve and Muscle Stimulators
MEDDEV 2.7.1 Rev. 3 Clinical Evaluation
MEDDEV 2.12-1 Rev.8 Vigilance System in Europe
MEDDEV 2.12/2 rev. 2 Post Market Clinical Follow-Up Studies
MEDDEV 12.2-2 Rev. 2 Post Market Surveillance
11.Summary of technological characteristics:
The ActiPatch® device has the following technological
characteristics (TABLE 1). The ActiPatch operates at
27.12MHz shortwave frequency, pulsing at a 1000 pulses per
second with a pulse width of 100µsecs. The duty cycle is
therefore 10%. The power source is a 3V battery (CR 2032),
producing a peak spatial power density of 73 microWatts/cm2
.
Table 1. Technological characteristics of the ActiPatch® Shortwave
Therapy Device
Carrier frequency 27.12MHz
Peak spatial power density 73 microwatts/ cm²
Pulse rate 1000 pulses per second
Pulsed on duration 100 micro seconds
Power source Battery CR2032
Antenna size 12cm or 6cm
Treatment area 110cm2 or 30cm2
Weight 9.5 grams
Operation time (lifetime of battery) 720 hours
Recommended Treatment Time Minimum of 12 hours per day
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12.Substantial Equivalence:
Substantial Equivalence Comparison Table
BioElectronics
ActiPatch®
ActiBand
(K022404)
Ivivi
(K070541)
Orthocor
(K092044)
Indication for
Use
Adjunctive
treatment of
musculoskeletal
pain related
to: (1) plantar
fasciitis of the
heel; and (2)
osteoarthritis of
the knee
Treatment of edema
Following
Blepharoplasty
Adjunctive use
in the palliative
treatment of
post-operative
pain and edema
in superficial
soft tissue.
Adjunctive use in
the palliative
treatment of
postoperative
pain and
edema in
superficial soft
tissue.
Temporary relief of
minor muscular and
joint aches and
pains associated
with over-exertion,
strains, sprains,
and arthritis.
Technology
Pulsed
Shortwave
Therapy (Nonthermal

Diathermy)
Pulsed
Shortwave
Therapy (Nonthermal
Diathermy)
Pulsed
Shortwave
Therapy (Nonthermal

Diathermy)
Pulsed Shortwave
Therapy (Nonthermal
Diathermy)
Product Code ILX ILX ILX ILX
IMD
Regulation 21 CFR
890.5290(b) 21 CFR 890.5290(b) 21 CFR
890.5290(b)
21 CFR
890.5290(b)
21 CFR 890.5710
Classification
Name
Shortwave
diathermy Shortwave diathermy Shortwave
diathermy Shortwave diathermy
Anatomical sites Superficial soft
tissue
Superficial soft
tissue
Superficial soft
tissue Superficial soft tissue
How energy is
coupled Induction coil Induction coil Induction coil Induction coil
Carrier
Frequency 27.1 MHz 27.1 MHz 27.1 MHz 27.1 MHz
Pulse duration 100 µsecs 100 µsecs 2 ms 2 ms
Pulse rate 1000 Hz 1000 Hz 2 Hz 2 Hz
Duty cycle 10% 10% 0.4% 0.4%
Power source
3V DC
(1 X CR2032
Lithium Battery)
3V DC (Battery)
6V DC
(2 X CR2032
Lithium Battery)
(or) Mains
3V – 4.2V DC
(Battery)
Antenna size
(treatment area)
110 cm2 65 cm2 285 cm2 Undisclosed by
manufacturer
Averagespatial
power
density (RMS)
4.4 µWatts/cm2 4.4 µWatts/cm2 4.4 µWatts/cm2 4.4 µWatts/cm2
Specific
absorption rate
(W/kg) (Peak)
0.0007 W/kg 0.0007 W/kg Undisclosed by
manufacturer
Undisclosed by
manufacturer
Operation time 720 hours 720 hours Undisclosed by Undisclosed by
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(battery lifetime) manufacturer manufacturer
Recommended
treatment
duration (use
time) based on
clinical evidence
Minimum of 12
hours per day, up
to 24 hours per
day
Minimum of 12 hours
per day, up to 24
hours per day
Undisclosed by
manufacturer
Undisclosed by
manufacturer
The table above compares the indication for use and technological
characteristics of the ActiPatch with those of the predicate
devices.
ActiPatch’s technological features are almost identical to those of
the ActiBand, with only slight differences that do not affect the
technological performance of the device, such as the adoption of
an ASIC microchip, compared to larger, discrete circuitry
components (both active and passive) in the ActiBand, and a
slightly larger antenna in the ActiPatch. The therapeutic effects of
ActiBand® and ActiPatch® are due to the pulsed shortwave signal
that is identical between the two devices.
ActiPatch’s technological characteristics are also similar to those
of the other predicates, for example, ActiPatch has the same
carrier frequency as the Ivivi SofPulse device (K070541) and the
OrthoCor Knee System (K092044), with only slight technological
differences, for example in the pulse duration, pulse rate and duty
cycle.
The minor differences in the antenna size between ActiPatch and
the predicate devices do not affect the average spatial power
density levels. The performance data submitted in the premarket
notification, including the electrical safety, electromagnetic safety,
biocompatibility, and clinical data described in Section 13 below,
show that any differences in technology do not adversely affect
the safety and effectiveness of the ActiPatch compared to the
predicates, and that the ActiPatch is at least as safe and effective
as the predicates.
ActiPatch has the same intended use as the predicate devices,
i.e., the application of electromagnetic energy to non-thermally
treat pain. The difference in indications between the predicate
products and ActiPatch, including the OTC use, does not result in
a new intended use, and the available data on ActiPatch show
that it is as safe and effective as the predicates.
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13.Testing:
Non-Clinical/Performance Data:
Electrical safety, electromagnetic safety, biocompatibility testing,
and testing in accordance with the special controls of the October
13, 2015 Final Reclassification Order for Non-thermal Shortwave
Therapy devices was performed for the ActiPatch®.
The ActiPatch was tested for conformity to the following standards
and was determined to conform to these standards:
a. General Safety and Requirements – Medical Equipment- IEC/EN
60601-1-2:2012
b. General Safety and Requirements – Medical Equipment- IEC
60601-1:2005+A1:2012
c. General Safety and Requirements – Medical EquipmentEN
60601-1:2006
Biocompatibility testing was conducted for the ActiPatch. The skin
sensitization test performed in accordance with ISO 10993-
10:2010 showed no evidence of an ActiPatch extract causing skin
sensitization in guinea pigs. The skin irritation test conducted in
accordance with ISO 10993-10:2010 demonstrated that gauze
material saturated with extract from the ActiPatch showed no
evidence of causing skin irritation in New Zealand white rabbits.
The cytotoxicity test performed in accordance with ISO 10993-
5:2009 showed that no observable in vitro cytotoxicity in L- 929
mouse fibroblast cells that were placed in contact with an extract
prepared from ActiPatch.
The testing that was conducted in accordance with the special
controls of the October 13, 2015 Final Reclassification Order
demonstrated that the ActiPatch performs as intended under
anticipated conditions of use. The testing determined and
considered the peak output power; the pulse width; the pulse
frequency; the duty cycle; the average measured output powered
into the RF antenna/applicator; the specific absorption rates in a
saline gel test load; the characterization of the electrical and
magnetic fields in saline gel test load for each RF antenna and
prescribed RF antenna orientation/position; and the
characterization of the deposited energy density in saline gel test
load.
Clinical Data:
Two IRB approved double blind and placebo controlled
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randomized controlled trials were conducted in support of this
premarket notification. Usability testing was conducted to support
the OTC use of the device.
d. The osteoarthritis of the knee study was a double blind
randomized controlled study in 66 intent-to-treat patients, out
of which 60 patients completed the four-week study. The
primary effectiveness endpoints were improvements in pain
level over the four weeks as measured by the before and after
VAS score and WOMAC scores, and the primary safety
endpoint was all treatment-related adverse events during the
study. 36% of the treatment group reported a clinically
significant decrease in VAS pain, defined as a >30% decrease
in pain, compared to 9% for the placebo group, and 18% of
the treatment group reported a clinically significant decrease
in total WOMAC pain, defined as a >30% decrease in pain,
compared to 3% for the placebo group. In the treatment
group, 26% stopped pharmacological therapy whereas in the
placebo group 33% started a new pharmacological therapy
during the study. No adverse events were recorded.
e. The plantar fasciitis study was a double-blind, multicenter,
randomized, placebo-controlled study to evaluate the safety
and effectiveness of the ActiPatch to reduce the pain level of
patients diagnosed with plantar fasciitis. A total of 70 patients
completed the study. The primary effectiveness endpoint was
the daily morning (AM) VAS score, and the primary safety
endpoint was all treatment-related adverse events during the
7-day study. The results showed that the average reported
pain reduction between the first day’s AM pain score and the
7th day’s AM pain score for the treatment group was 40%
compared to 7% for the control group.
f. Usability testing was conducted on 46 men and women over
the age of 17 with a wide range of education levels. These
subjects demonstrated use of the ActiPatch on either the
knee, lower back, or shoulder. The testing showed that lay
users understand the indications for use and when not to use
the device. In addition, the study showed that users
understand how to turn the device on, place it correctly on the
right part of the body, and how long to use the device.
Conclusion: The non-clinical and clinical data demonstrate that
the ActiPatch is at least as safe and effective as its predicate
devices, and can be used as an over-the-counter device.
https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152432.pdf