ActiPatch
Device Facts
| Record ID | K192234 |
|---|---|
| Device Name | ActiPatch |
| Applicant | Bioelectronics Corporation |
| Product Code | PQY · Physical Medicine |
| Decision Date | Jan 31, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5290 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K192234 · Jan 31, 2020 | ActiPatch | Bioelectronics Corporation | Real-world registry data | The sponsor cites extensive real-world registry data as part of the evidence base to demonstrate that the ActiPatch is at least as safe and effective as the predicate device for the adjunctive treatment of musculoskeletal pain. | registry data; real-world registry |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Real-world registry data; Registry | — | Not applicable for this study | Safety and effectiveness |
Indications for Use
Adjunctive treatment of musculoskeletal pain
Device Story
ActiPatch is a pulsed shortwave therapy device for musculoskeletal pain. It consists of a 3V battery-powered low-energy signal generator, a control circuit, and an antenna. The device operates by generating a localized radiofrequency (RF) field (27.12 MHz) via the antenna, which is placed directly over the therapeutic site. It is an over-the-counter (OTC) device intended for patient self-use, applied to superficial soft tissue for 12 to 24 hours daily. The device functions as a closed-loop system with no far-field effects. By delivering non-thermal electromagnetic energy, it aims to reduce pain levels. Clinical evidence supports its efficacy in reducing pain associated with conditions like cervical osteoarthritis, knee osteoarthritis, and plantar fasciitis. Users operate the device via an on/off switch or continuous-use switch.
Clinical Evidence
Evidence includes three randomized controlled trials (RCTs) and usability testing. 1) Cervical osteoarthritis (n=200): ActiPatch vs. NSAID; significant pain reduction (p<0.05). 2) Knee osteoarthritis (n=66): ActiPatch vs. placebo; significant improvement in VAS and WOMAC scores (p<0.05). 3) Plantar fasciitis (n=70): ActiPatch vs. placebo; significant reduction in morning VAS pain (p<0.05). Usability testing (n=46) confirmed lay users can correctly operate the device and understand indications.
Technological Characteristics
Pulsed shortwave therapy device; 27.12 MHz carrier frequency; 1000 Hz pulse rate; 100 microsecond pulse width; 10% duty cycle; 3V DC battery power (CR2032/CR1632/CR1620); induction coil antenna (12cm or 6cm diameter); peak spatial power density 73 microWatts/cm2. Complies with IEC 60601-1, IEC 60601-1-2, EN 60601-2-3, and EN 60601-2-10. Biocompatibility per ISO 10993-5 and ISO 10993-10.
Indications for Use
Indicated for adjunctive treatment of musculoskeletal pain in adults.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ActiPatch (K152432)
Submission Summary (Full Text)
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January 31, 2020
BioElectronics Corporation Sree Koneru, Ph.D. VP, Product Development 4539 Metropolitan Ct Frederick, Maryland 21704
Re: K192234
Trade/Device Name: ActiPatch® Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: PQY Dated: November 1, 2019 Received: November 4, 2019
Dear Dr. Koneru:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K192234
Device Name ActiPatch
Indications for Use (Describe) Adjunctive treatment of musculoskeletal pain
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: 510(k) Summary
| 1. Submitter's Name: | BioElectronics Corporation |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Address: | 4539 Metropolitan Court,<br>Frederick, MD 21704, USA<br>Phone: 301-500-2061<br>Fax 301-874-6935 |
| Contact Person: | Sree N Koneru, Ph.D.<br>VP, Product Development |
| 3. Date Prepared: | January 3, 2020 |
| 4. Trade Name: | ActiPatch® |
| 5. Common Name | Nonthermal Shortwave Therapy |
| 6. Product Classification: | 21 CFR 890.5290 (b)<br>Product Code: PQY |
| 7. Predicate Devices: | Primary Predicate: ActiPatch (K152432) |
| 8. Description of Device: | The ActiPatch® device is a pulsed shortwave therapy<br>device. The circuitry consists of low voltage (3 V)<br>digital/analog electronics that control all timing functions<br>to produce the therapeutic radiofrequency (RF) field, where<br>the antenna is placed directly above the therapeutic site.<br>This closed loop system of the antenna, low energy signal<br>generator circuit, and battery power supply, transfers the<br>RF energy to the target tissue as a localized therapy with no<br>far field effects. |
| 9. Intended Use: | Adjunctive treatment of musculoskeletal pain |
| 10. Standards | BS EN 980: 2003 Graphical Symbols For Use In The<br>Labeling of Medical Devices<br>ISO 13485:2012 Medical Devices: Quality<br>Management Systems<br>ISO 14971: 2012 Risk Management |
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IEC 60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety and Essential Performance
IEC 60601 -1-2: 2007 Medical Electrical Equipment --Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
EN 60601-2-3: 2014 Short-Wave Therapy Equipment
EN 60601-2-10: 2015 Safety of Nerve and Muscle Stimulators
MEDDEV 2.7.1 Rev. 4 Clinical Evaluation
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 a carrier frequency of 27.12MHz, with a pulse frequency of 1000 Hz and a pulse width of 100 microseconds. The duty cycle is therefore 10%. The devices uses a 3v battery as the power source (CR 2032 or CR1632 or CR1620) and produces 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 or CR1632 or CR1620 |
| Antenna size | 12cm or 6 cm diameter |
| Treatment area | 110cm² or 30cm² |
| Weight | 9.5 grams |
| Operation time (lifetime of<br>battery) | 720 hours or 360 hours or 168 hours |
| User Control | On/Off switch or On-only (continuous use)<br>switch |
| Recommended Treatment Time | Minimum of 12 hours per day, up to 24 hours<br>per day |
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### 12.Substantial Equivalence:
ActiPatch has the same intended use as the predicate device, i.e., the application of electromagnetic energy to non-thermally treat pain. The current ActiPatch's technological features are identical to those of the predicate ActiPatch device in K152432 (Table 2). No device modifications have been made to the current ActiPatch, when compared to the predicate ActiPatch device.
The predicate device is indicated for adjunctive treatment of musculoskeletal pain related to: 1) Osteoarthritis of the knee; and 2) Plantar fasciitis of the heel (K152432). 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 there is no difference in technology between the subject and predicate device, and that the subject ActiPatch is at least as safe and effective as the predicate ActiPatch.
| | ActiPatch | Predicate ActiPatch (K152432) |
|-----------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Adjunctive treatment of<br>musculoskeletal pain | Adjunctive treatment of<br>musculoskeletal pain related<br>to: (1) plantar fasciitis of the<br>heel; and (2) osteoarthritis of the<br>knee |
| Technology | Pulsed Shortwave<br>Therapy (Non- thermal<br>Diathermy) | Pulsed Shortwave Therapy<br>(Non- thermal Diathermy) |
| Product code | PQY | PQY |
| Regulation | 21 CFR 890.5290(b) | 21 CFR 890.5290(b) |
| Classification Name | Shortwave Diathermy | Shortwave Diathermy |
| Anatomical Site of<br>application | Superficial soft tissue | Superficial soft tissue |
| How the Energy is<br>coupled | Induction Coil | Induction Coil |
| Carrier Frequency | 27.1 MHz | 27.1 MHz |
Table 2. Technological characteristics of the ActiPatch® and predicate ActiPatch®.
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| Pulse Duration | 100 micro-secs | 100 micro-secs |
|----------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------|
| Pulse rate | 1000 Hz | 1000 Hz |
| Duty cycle | 10% | 10% |
| Power source | 3V DC (1 X CR2032<br>or CR1632 or CR<br>1620 Lithium Battery) | 3V DC (1 X CR2032 Lithium<br>Battery) |
| Antenna Size | 110 cm² or 30 cm² | 110 cm² or 30 cm² |
| Average spatial power<br>density (RMS) | 4.4 µWatts/cm² | 4.4 µWatts/cm² |
| Specific adsorption rate<br>(W/kg) (Peak) | 0.0007 W/kg | 0.0007 W/kg |
| Operation time (battery<br>lifetime) | 720 hours or 360 hours or<br>168 hours | 720 hours |
| Recommended treatment<br>duration (use time) based<br>on clinical evidence | Minimum of 12 hours per<br>day, up to 24 hours per<br>day | Minimum of 12 hours per day, up<br>to 24 hours per day |
# 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 Nonthermal 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:
- General Safety and Requirements - Medical Equipment- IEC/EN 60601-1-2
- 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-
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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:
The clinical data in this 510(k) includes results from three IRB approved, randomized, controlled studies. Additionally, usability testing was conducted to support the OTC use of the device.
- A randomized, controlled trial on chronic cervical osteoarthritis (neck pain): This was a randomized, active-treatment controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with cervical osteoarthritis. The active-treatment control was an NSAID of the Cox-2inhibitor family. There were 200 intent-to-treat patients, out of which 197 completed the four-week study. There were 142 women (71%) and 58 (29%) men in the study, with an average age of 45 years. The primary endpoint for efficacy was reduction in pain (VAS score) while at rest and being active, over four weeks, when compared to the beginning of the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with COA in the device treatment group, and that the treatment differences between device-treatment and NSAID-treatment groups was significant (p<0.05).
- A randomized controlled trial on osteoarthritis of the knee: The osteoarthritis of the knee study was a double-blinded, randomized, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with knee osteoarthritis. The placebo treatment was a device that was identical to ActiPatch but did not produce an
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electromagnetic field when turned on. There were 66 intent-to-treat patients, out of which 60 patients completed the four-week study. There were 43 women (71.6%) and 17 (16.4%) men in the study, with the following average demographics at baseline: 68 years of age, BMI of 27.4 and disease duration of 12.1 years. 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. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with KOA in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
- A randomized controlled trial on plantar fasciitis (heel pain): This was a randomized, double-blinded, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with plantar fasciitis. The placebo treatment was a device that was identical to ActiPatch but did not produce an electromagnetic field when turned on. A total of 70 patients were recruited into the study, and all 70 completed the study. There were 52 women (74.4%) and 18 (25.6%) men in the study, with the following average demographics at baseline: 51.5 years of age, BMI of 31.8 and disease duration of 1.1 years. 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 indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with PF in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
- Usability testing was conducted in 46 men and women over the age of 18 with a wide range of education levels who used the RecoveryRx on 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 data, clinical data, and extensive real-world registry data demonstrate that the ActiPatch is at least as safe and effective
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as the predicate device and can be used as an over-the-counter device for adjunctive treatment of musculoskeletal pain.
Note: Treatment effects of device use were clinically assessed for up to 4 weeks.
