Quote, "What's the problem with biel?" BIEL does not have FDA approval, BIEL does not advertise, BIEL does not sell to retail, Without FDA approval BIEL does not advertise so retail is not aware of the product. ONE VICIOUS CIRCLE JMHO
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: 301-874-4890 Fax: 301-874-6935 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. 12 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 13 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) 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 14 (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. 15 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 16 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