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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ActiPatch® device. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the information provided focuses on comparative performance and safety rather than establishing acceptance criteria as would be seen for a new medical device. The document does not explicitly state "acceptance criteria" but rather presents clinical study results as evidence of comparable safety and effectiveness to predicate devices.

Here's an attempt to extract and organize the requested information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't define explicit "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents clinical study results to demonstrate effectiveness and safety comparable to predicate devices. The "reported device performance" below summarizes these clinical findings.

Criterion Type (Implicit)	Acceptance Criteria (Not explicitly stated, but implied by study results)	Reported Device Performance (ActiPatch®)
Effectiveness - Knee OA	Improvement in pain levels (VAS and WOMAC scores) comparable to or better than placebo/no treatment, and potentially supporting reduction in pharmacological therapy for osteoarthritis of the knee.	Osteoarthritis of the knee study: - 36% of the treatment group reported a >30% decrease in VAS pain, compared to 9% for the placebo group. - 18% of the treatment group reported a >30% decrease in total WOMAC pain, compared to 3% for the placebo group. - 26% of the treatment group stopped pharmacological therapy, whereas 33% of the placebo group started new pharmacological therapy.
Effectiveness - Plantar Fasciitis	Reduction in pain levels (daily morning VAS score) comparable to or better than placebo/no treatment for plantar fasciitis.	Plantar fasciitis study: - Average reported pain reduction (day 1 AM to day 7 AM VAS) for the treatment group was 40%, compared to 7% for the control group.
Safety	No significant adverse events related to the device.	Osteoarthritis of the knee study: No adverse events were recorded. Plantar fasciitis study: Primary safety endpoint was all treatment-related adverse events; the document does not explicitly state if any were recorded but implies a positive safety profile through the "safe and effective as its predicate devices" conclusion.
Usability (OTC Use)	Lay users must understand how to use the device safely and effectively for pain relief in the specified indications.	Usability testing: - 46 men and women (age >17, wide education levels) demonstrated understanding of indications for use, contraindications, how to turn on, correct placement, and duration of use.
Non-Clinical Performance	Conformity to relevant electrical safety, electromagnetic compatibility, and biocompatibility standards. Performance as intended under anticipated conditions of use regarding output power, pulse characteristics, absorption rates, and electromagnetic fields.	Non-Clinical/Performance Data: - Conformed to IEC/EN 60601-1-2:2012, IEC 60601-1:2005+A1:2012, EN 60601-1:2006. - Biocompatibility testing (ISO 10993-10:2010 for sensitization and irritation, ISO 10993-5:2009 for cytotoxicity) showed no evidence of sensitization, irritation, or in vitro cytotoxicity. - Special controls testing (per October 13, 2015 Final Reclassification Order) demonstrated intended performance, characterizing peak output power, pulse characteristics, duty cycle, average output power, specific absorption rates, and electrical/magnetic fields in a saline gel test load.

2. Sample Size Used for the Test Set and the Data Provenance

Osteoarthritis of the knee study:
- Sample size: 66 intent-to-treat patients, with 60 patients completing the four-week study.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific locations), but described as "double-blind randomized controlled study" implying a prospective design.
Plantar fasciitis study:
- Sample size: 70 patients completed the study.
- Data Provenance: Described as "double-blind, multicenter, randomized, placebo-controlled study," implying a prospective design. Country of origin not specified.
Usability testing:
- Sample size: 46 men and women.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but the description ("These subjects demonstrated use...") implies a prospective, interactive study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of image interpretation or diagnostic accuracy studies. The clinical studies evaluated patient-reported outcomes (VAS and WOMAC scores) and adverse events, which are direct measures from the participants themselves, rather than interpretations by experts.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document describes the clinical studies as "double-blind and placebo-controlled randomized controlled trials." This implies that blinding was used for both participants and researchers/assessors regarding treatment allocation. However, it does not specify an adjudication method for outcome measures like VAS or WOMAC scores, which typically do not require such adjudication as they are direct patient responses. For adverse events, it states "No adverse events were recorded" for the knee study; the method for reviewing or adjudicating AEs in the plantar fasciitis study is not detailed beyond "primary safety endpoint was all treatment-related adverse events."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The ActiPatch® is a physical medical device for pain relief, not an AI or imaging interpretation device that would typically involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The ActiPatch® is a physical device, not an algorithm. Its performance is inherent in its physical and electrical characteristics and its interaction with the patient's body. The clinical studies evaluate the device's effect directly on patients.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" was primarily based on patient-reported outcomes:

Pain levels: Measured using validated scales like the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
Adverse events: Self-reported by patients or observed during the study.

For usability testing, the "ground truth" was established by observing lay user comprehension and ability to perform tasks (turn on, place correctly, understand indications/contraindications).

For non-clinical testing, the "ground truth" was conformance to established engineering and biological standards (e.g., IEC, ISO standards for electrical safety, biocompatibility, and specific power output measurements).

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" as it would for an algorithm or AI model development. The clinical studies described are for evaluating the final device's performance, not for training a model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was explicitly mentioned or used in the context of algorithm development. The document describes clinical trials and usability studies of a physical medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2017

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 marketed 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 reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket 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 evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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/ResourcesforYou/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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152432

Device Name ActiPatch®

Indications for Use (Describe)

Adjunctive treatment of musculosketal pain related to: (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5: ActiPatch 510(k) Summary

1. Submitter's Name:
  BioElectronics Corporation
1. 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

1. Date Prepared:
  December 1, 2016
1. Trade Name:
  ActiPatch®

5. Common Name

Non-thermal Shortwave Therapy

1. Product Classification: 21 CFR § 890.5290(b) Product code ILX

7. Predicate Devices:

ActiBand (K022404), Ivivi (K070541), Orthocor (K092044)

8. Description of Device:

9. Intended Use:

Adiunctive 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 subiects.

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 100psecs. 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:

	BioElectronicsActiPatch®	ActiBand(K022404)	Ivivi(K070541)	Orthocor(K092044)
Indication forUse	Adjunctivetreatment ofmusculoskeletalpain relatedto: (1) plantarfasciitis of theheel; and (2)osteoarthritis ofthe knee	Treatment of edemaFollowingBlepharoplasty	Adjunctive usein the palliativetreatment ofpost-operativepain and edemain superficialsoft tissue.	Adjunctive use inthe palliativetreatment ofpostoperativepain andedema insuperficial softtissue.Temporary relief ofminor muscular andjoint aches andpains associatedwith over-exertion,strains, sprains,and arthritis.
Technology	PulsedShortwaveTherapy (Non-thermalDiathermy)	PulsedShortwaveTherapy (Non-thermal Diathermy)	PulsedShortwaveTherapy (Non-thermalDiathermy)	Pulsed ShortwaveTherapy (Non-thermal Diathermy)
Product Code	ILX	ILX	ILX	ILXIMD
Regulation	21 CFR890.5290(b)	21 CFR 890.5290(b)	21 CFR890.5290(b)	21 CFR890.5290(b)21 CFR 890.5710
ClassificationName	Shortwavediathermy	Shortwave diathermy	Shortwavediathermy	Shortwave diathermy
Anatomical sites	Superficial softtissue	Superficial softtissue	Superficial softtissue	Superficial soft tissue
How energy iscoupled	Induction coil	Induction coil	Induction coil	Induction coil
CarrierFrequency	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 CR2032Lithium Battery)	3V DC (Battery)	6V DC(2 X CR2032Lithium Battery)(or) Mains	3V - 4.2V DC(Battery)
Antenna size(treatment area)	110 cm²	65 cm²	285 cm²	Undisclosed bymanufacturer
Averagespatialpowerdensity (RMS)	4.4 µWatts/cm²	4.4 µWatts/cm²	4.4 µWatts/cm²	4.4 µWatts/cm²
Specificabsorption rate(W/kg) (Peak)	0.0007 W/kg	0.0007 W/kg	Undisclosed bymanufacturer	Undisclosed bymanufacturer
Operation time	720 hours	720 hours	Undisclosed by	Undisclosed by
(battery lifetime)			manufacturer	manufacturer
Recommendedtreatmentduration (usetime) based onclinical evidence	Minimum of 12hours per day, upto 24 hours perday	Minimum of 12 hoursper day, up to 24hours per day	Undisclosed bymanufacturer	Undisclosed bymanufacturer

Substantial Equivalence Comparison Table

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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 cvcle.

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 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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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. TThe 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.

Regulation Number and Section

§ 890.5290 Shortwave diathermy.

(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.