Feb 3, 2017 — BioElectronics Corporation. Andrew Whelan. President. 4539 Metropolitan Court. Frederick, Maryland 21704. Re: K152432.
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DEPARTMENT OF HEAL TH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002 BioElectronics Corporation Andrew Whelan President 4539 Metropolitan Court Frederick, Maryland 21704 Re:K152432 Trade/Device Name:ActiPatch® Regulation Number: 21 CFR 890.5290 Regulation Name:Shortwave Diathermy Regulatory Class: Class II Product Code: PQY Dated: December 2, 2016 Received: December 2, 2016 Dear Mr.Whelan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally mark eted predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassi fied in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not requireapproval of a premarke t approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evalua te information related to contract liability warranties. We remind you, however, that device labeling must be truthf ul and not misleading. If your device is classified (see above) into eith er class II (Special Cont rols) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federa l Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA’s issuance of a subs tantial equivalence dete rmination does not mean that FDA has made a determination that your de vice complies with other requirements of the Act or any Federal statutes and regulations administe red by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part807); labeling (21 CF R Part 801); medical device reportin g (reporting of medical device- related adverse events) (21 CFR 803); good manuf acturing practice requirements as set forth in February3,2017
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-Andrew Whelan Page 2 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Secti ons 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Res ourcesforYou/Industry/default.htm . Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Sa fety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on yourresponsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Res ourcesforYou/Industry/default.htm .Sincerely yours, Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health EnclosureforMichael J. Hoffmann -S
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FORM FDA 3881 (8/14)Page 1 of 1PSC Publishing Services (301) 443-6740 EFDEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationIndications for UseForm Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.510(k) Number (if known)K152432Device NameActiPatch®Indications for Use (Describe)Adjunctive treatment of musculoskeletal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the kneeType of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”
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11 Section 5: ActiPatch 510(k) Summary 1. Name: BioElectronics Corporation 2. Addres s: 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 N ame: 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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12 10. Standards: I SO 13 485:2003 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 GD 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 100 µ secs. The duty cycle is therefore 10%. The power source is a 3V battery (CR 2032), producing a peak spatial power density of 73 microWatts/cm 2 . 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 6 cm Treatment area 1 1 0cm 2 or 3 0cm 2 Weight 9.5 grams Operation time ( lifetime of battery ) 720 hours Recommended Treatment Time Minimum of 12 hours per day
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13 12. S ubstantial Equivalence: S ubstantial 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 (Non – thermal Diathermy) Pulsed Shortwave Therapy (Non – thermal Diathermy) Pulsed Shortwave Therapy (Non – thermal Diathermy) Pulsed Shortwave Therapy (Non – thermal 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 cm 2 65 cm 2 285 cm 2 Undisclosed by manufacturer Average s patial power density ( RMS ) 4.4 µ Watts/cm 2 4 .4 µ Watts/cm 2 4 .4 µ Watts/cm 2 4 .4 µ Watts/cm 2 S pecific absorption rate (W/kg) ( Peak ) 0. 000 7 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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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 Equipment – EN 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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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, compare d 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 AM pain score and the 7th 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 : T he 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.
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