RecoveryRx

K190251 · Bioelectronics Corporation · ILX · Jun 28, 2019 · Physical Medicine

Device Facts

• Record ID: K190251
• Device Name: RecoveryRx
• Applicant: Bioelectronics Corporation
• Product Code: ILX · Physical Medicine
• Decision Date: Jun 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Adjunctive treatment of postoperative pain

Device Story

RecoveryRx is a pulsed shortwave therapy device for adjunctive treatment of postoperative pain. It consists of a low-voltage (3V) battery-powered signal generator and an antenna placed over the therapeutic site. The device generates a localized, non-thermal radiofrequency (RF) field at 27.12 MHz (1000 Hz pulse rate, 100 µs pulse width, 10% duty cycle). It is intended for use by patients as prescribed, with recommended treatment times of 12 to 24 hours per day. The device provides non-thermal electromagnetic energy to superficial soft tissue, which is intended to reduce postoperative pain. The device is a closed-loop system with no far-field effects.

Clinical Evidence

Evidence includes two randomized, double-blinded, placebo-controlled studies. Study 1 (n=18, breast augmentation) and Study 2 (n=96, cesarean section) evaluated postoperative pain reduction using a 0-10 visual analog scale. Both studies reported a statistically significant reduction in postoperative pain for the active treatment group compared to placebo (p<0.05).

Technological Characteristics

Pulsed shortwave therapy device; 27.12 MHz carrier frequency; 1000 Hz pulse rate; 100 µs pulse width; 10% duty cycle; 3V battery power (CR2032/CR1632/CR1620); peak spatial power density 73 µW/cm². Standards: IEC 60601-1, IEC 60601-1-2, EN 60601-2-3, EN 60601-2-10, ISO 10993 (biocompatibility). ASIC-based circuitry. Non-networked.

Indications for Use

Indicated for adjunctive treatment of postoperative pain in patients undergoing surgical procedures.

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

• ActiBand (K022404)
• Ivivi (K070541)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

June 28, 2019

BioElectronics Corporation Sree Koneru, PhD VP. Product Development 4539 Metropolitan Ct Frederick, Maryland 21704

Re: K190251

Trade/Device Name: RecoveryRx® Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: ILX Dated: May 30, 2019 Received: May 31, 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.

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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 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek Pinto, Ph.D. Assistant 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) K190251

Device Name RecoveryRx®

Indications for Use (Describe) Adjunctive treatment of postoperative pain

| Type 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)

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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: [phone]<br>Fax [phone] |
| | Contact Person: | Sree N Koneru, Ph.D.<br>VP, Product Development |
| 3. | Date Prepared: | June 27, 2019 |
| 4. | Trade Name: | RecoveryRx® (K190251) |
| 5. | Common Name | Nonthermal Shortwave Therapy |
| 6. | Product Classification: | 21 CFR 890.5290 (b)<br>Product Code: ILX |
| 7. | Predicate Devices: | Primary Predicate: ActiBand (K022404)<br>Secondary Predicate: Ivivi (K070541) |
| 8. | Description of Device: | The RecoveryRx® 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 postoperative 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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BS EN ISO 15223-1:2012 Labeling of Medical Devices

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 RecoveryRx® device has the following technological characteristics (Table 1.) The RecoveryRx 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 RecoveryRx® 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 battery) | 720 hours or 360 hours or 168 hours |
| User Control | On/Off switch or On-only (continuous<br>use) switch |
| Recommended Treatment Time | Minimum of 12 hours per day, up to 24<br>hours per day |

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## 12.Substantial Equivalence:

RecoveryRx has the same intended use as the predicate device, i.e., the application of electromagnetic energy to non-thermally treat pain. The current RecoveryRx's technological features are similar to those of the predicate devices, ActiBand (K022404) and Ivivi (K070541) as shown in the table below. No modifications have been made to the signal parameters of the RecoveryRx device when compared to the ActiBand predicate device.

RecoveryRx's technological features are 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 RecoveryRx. The therapeutic effects of ActiBand® and RecoveryRx are due to the pulsed shortwave signal that is identical between the two devices.

The predicate devices are indicated for treating postoperative conditions (K022404-treatment of edema following blepharoplasty; K070541adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue). The subject RecoveryRx is identical to the primary predicate and differs from the secondary predicate only in antenna size/pulse rate (Table 2), but does 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 RecoveryRx compared to the predicates, and that the RecoveryRx is at least as safe and effective as the predicates.

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| | RecoveryRx | Predicate ActiBand<br>(K022404) | Predicate<br>Ivivi (K070541) |
|-------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Adjunctive treatment<br>of postoperative pain | For the treatment of<br>edema following<br>Blepharoplasty | Adjunctive use in the<br>palliative treatment of<br>post-operative pain and<br>edema in superficial<br>soft tissue. |
| Technology | Pulsed Shortwave<br>Therapy (Non-<br>thermal Diathermy) | Pulsed Shortwave<br>Therapy (Non-<br>thermal Diathermy) | Pulsed Shortwave<br>Therapy (Non-<br>thermal Diathermy) |
| Product code | ILX | ILX | ILX |
| Regulation | 21 CFR 890.5290(b) | 21 CFR 890.5290(b) | 21 CFR 890.5290(b) |
| Classification Name | Shortwave Diathermy | Shortwave Diathermy | Shortwave Diathermy |
| Anatomical Sites | Superficial soft tissue | Superficial soft tissue | Superficial soft tissue |
| How the Energy is<br>coupled | Induction Coil | Induction Coil | Induction coil |
| Carrier Frequency | 27.1 MHz | 27.1 MHz | 27.1 MHz |
| Pulse Duration | 100 µsec | 100 µsec | 2 msec |
| Pulse rate | 1000 Hz | 1000 Hz | Undisclosed on public<br>510(k) database |
| Duty cycle | 10% | 10% | 0.4%1 |
| Power source | 3V DC (1 X<br>CR2032 Lithium<br>Battery) | 6V DC (2 X<br>CR2032 Lithium<br>Battery | 2x CR2032 batteries |
| Antenna Size | 110 cm2 | 110 cm2 | 285 cm2 |
| Average spatial<br>power density<br>(RMS) | 4.4 µWatts/cm2 | 4.4 µWatts/cm2 | Undisclosed on public<br>510(k) database |
| Specific adsorption<br>rate (W/kg) (Peak) | 0.0007 W/kg | 0.0007 W/kg | Undisclosed on public<br>510(k) database |
| Operation time<br>(battery lifetime) | 720 hours | 720 hours | Undisclosed on public<br>510(k) database |
| Recommended<br>treatment duration<br>(use time) based on<br>clinical evidence | Minimum of 12 hours<br>per day, up to 24<br>hours per day | Minimum of 12 hours<br>per day, up to 24 hours<br>per day | Undisclosed on public<br>510(k) database |

Table 2. Technological characteristics of the RecoveryRx® and predicate devices.

¹ Duty cycle for Ivivi was calculated by BioElectronics Corporation available from clinical publications.

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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 Nonthermal Shortwave Therapy devices was performed for the RecoveryRx.

The RecoveryRx 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 RecoveryRx. The skin sensitization test performed in accordance with ISO 10993-10:2010 showed no evidence of an RecoveryRx 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 RecoveryRx 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 RecoveryRx.

The testing that was conducted in accordance with the special controls of the October 13, 2015 Final Reclassification Order demonstrated that the RecoveryRx 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.

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### Clinical Data:

The clinical data in this 510(k) includes results two randomized, doubleblinded, placebo-controlled studies:

- A randomized, controlled, double-blinded study that investigated the ● effectiveness of RecoveryRx in treating postoperative pain in 18 women who underwent breast augmentation surgery. These women presented with the following average baseline demographics: 31.6 years of age, weight of 134 lbs and height of 5.52 ft. The primary outcome was a difference in daily pain, measured on a 0-10 visual analog pain scale. The results indicate that the effect of active treatment with RecoveryRx provides a statistically significant treatment effect (reduction in postoperative pain), when compared to placebo (p<0.05).
- A randomized, controlled, double-blinded study that investigated the ● effectiveness of RecoveryRx in treating postoperative pain in 96 woman who underwent cesarean section surgery. These women presented with the following average baseline demographics: 27.1 years of age, gestation period of 38.7 weeks and 2 prior cesarean section surgeries. The primary outcome measure was differences in postoperative pain as assessed on a 0-10 visual analog scale. The results indicate that the effect of active treatment with RecoveryRx provides a statistically significant treatment effect (reduction in postoperative pain), when compared to placebo (p<0.05).

Conclusion: The non-clinical data and clinical data demonstrate that the RecoveryRx is at least as safe and effective as the predicate devices and can be used as a prescription device for the adjunctive treatment of postoperative pain.