PROVANT THERAPY SYSTEM

K131979 · Regenesis Biomedical, Inc. · ILX · Dec 13, 2013 · Physical Medicine

Device Facts

• Record ID: K131979
• Device Name: PROVANT THERAPY SYSTEM
• Applicant: Regenesis Biomedical, Inc.
• Product Code: ILX · Physical Medicine
• Decision Date: Dec 13, 2013
• 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
K131979 · Dec 13, 2013	PROVANT THERAPY SYSTEM	Regenesis Biomedical, Inc.	FDA MDR/MAUDE database; Industry complaint data; Clinical literature	Retrospective analysis of postmarket surveillance data (MDR/MAUDE and industry complaints) and clinical literature was used to demonstrate that heating from implanted metal is a theoretical risk with no reported adverse events, supporting the removal of a contraindication.	Postmarket surveillance; MDR/MAUDE; Safety analysis; Retrospective analysis

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis of adverse event data; Retrospective analysis	Patients treated with the Provant system (over 175,000 patients); Sample Size: 175,000+ patients; 3,000,000+ treatments	Not applicable for this study	Incidence of adverse events related to metal implants

Indications for Use

The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Device Story

Provant Therapy System is a nonthermal shortwave diathermy device; delivers pulsed radiofrequency energy at 27.12 MHz. System comprises a control unit and a treatment applicator; disposable applicator covers with RFID tags prevent reuse. Device is placed directly over the treatment area. Operates via 115V, 60Hz AC power. Intended for clinical use to provide palliative relief for postoperative pain and edema. No contraindication for patients with metal implants. Safety validated via tissue phantom testing and retrospective analysis of over 3 million treatments; no clinically significant heating of metal implants observed. Benefits include non-invasive pain and edema management.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing using a validated tissue phantom with various metal implants under worst-case conditions (no heat dissipation) and a retrospective analysis of FDA MDR/MAUDE databases, manufacturer complaint data (175,000+ patients, 3,000,000+ treatments), and medical literature.

Technological Characteristics

Shortwave radiofrequency energy at 27.12 MHz (ISM band). Pulsed output: 1 kHz, 42µsec pulse width, 4% duty cycle. Electrical field strength: 591 V/m at 5cm. Average RF power: 1.9 Watts. VSWR: 1.3:1 or less. Control unit housed in UL-compliant high-impact ABS plastic case. Disposable applicator covers include RFID tags for usage tracking. Power: 115V, 60Hz AC.

Indications for Use

Indicated for adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.

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

• Provant System, Model 4201 (K091791)

Submission Summary (Full Text)

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A final order reclassifying shortwave diathermy (SWD) 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, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-

diathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K131979 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

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Image /page/1/Picture/0 description: The image shows a logo with text and a symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around a symbol. The symbol consists of three curved lines that resemble a stylized caduceus or a representation of human figures.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service .

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

December 13, 2013

Regenesis Biomedical, Inc. Richard Isenberg, MD 5301 North Pima Road, Suite 150 Scottsdale, Arizona 85250

Re: K131979

Trade/Device Name: Provant Therapy System, Model 4201 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class III Product Code: ILX Dated: November 8, 2013 Received: November 12. 2013

Dear Dr. Isenberg:

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

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Page 2 - Dr. Richard Isenberg

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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): K131979

Device Name: Provant Therapy System

Indications For Use:

The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Prescription Use __ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

<PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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#### K131979 · 510(k) Summary

| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Regenesis Biomedical, Inc. |
| Contact Person | Richard Isenberg<br>5301 North Pima Road, Suite 150<br>Scottsdale, AZ 85275<br>[phone] |
| Date Prepared | 27 June 2013 |
| Product Name | Provant Therapy System |
| Common Name | Nonthermal shortwave diathermy device |
| Device<br>Classification | Class III |
| Product Code | ILX |
| Predicate<br>Device(s) | Provant System, Model 4201 (K091791) |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act. |
| Indications for<br>Use | The Provant Therapy System is indicated for adjunctive use in the palliative<br>treatment of postoperative pain and edema in superficial soft tissue. |
| Device<br>Description | The Provant Therapy System is nearly identical to the previously cleared<br>Provant System Model 4201 (cleared under K091791), except for the device<br>labeling. Specifically, unlike the Provant System Model.4201, the Provant<br>Therapy System does not include a contraindication for use in patients with<br>metal implants. The device includes a Control Unit and Treatment<br>Applicator. Disposable Applicator Covers are provided for the Treatment<br>Applicator for infection control and to provide appropriate contact surfaces<br>for the patient. The Control Unit for the Provant Therapy System is housed |
| | in a UL-compliant injection-molded case made of high-impact ABS plastic.<br>The case contains a lockable hinge to prevent accidental closure of the lid.<br>Upon opening the Provant Therapy case, the user sees the control panel of<br>the Control Unit. The main electronics of the Control Unit are housed<br>beneath its control panel. The device also includes a Treatment Applicator<br>that is attached to the Control Unit. When not in use, the Treatment<br>Applicator is stored inside the carrying case. The Treatment Applicator is<br>removed from the case prior to administration of therapy, inserted into a<br>Disposable Applicator Cover, and placed directly over the area to be treated.<br>Device labeling is also located inside the case cover. Four pre-drilled holes<br>in the underside of the case allow for attachment of the device to the<br>optional roller stand (sold separately). |
| | The Disposable Applicator Covers of the Provant Therapy System are<br>single-use-only and are intended to minimize contagion and help protect the<br>Treatment Applicator from biological contamination. The Disposable<br>Applicator Covers contain a Radio Frequency Identification Device (RFID)<br>tag which guards against reuse of used Disposable Applicator Covers. |
| Technological<br>Characteristics | Both the Provant Therapy System and the predicate device use shortwave<br>radiofrequency energy in the FCC-approved ISM (Industrial, Scientific and<br>Medical) frequency of 27.12MHz to provide treatment. The proposed<br>Provant Therapy System has the same features and technological<br>characteristics as the predicate Provant System Model 4201. Specifically,<br>both the Provant Therapy System and the predicate device: |
| | • Emit pulsed radiofrequency energy at 1 kHz with a pulse width of<br>42µsec, resulting in a 4% duty cycle. |
| | • Emit an Electrical Field strength of 591 V/m at 5cm above the<br>Treatment Applicator. |
| | • Provide an average RF Generator power of 1.9Watts |
| | • Utilize an identical 115V, 60Hz AC power source |
| | • Have a Voltage Standing Wave Ratio (VSWR) of 1.3:1 or less |
| Nonclinical<br>Performance | The Provant Therapy System was tested using a validated tissue phantom<br>with a variety of metal implants of different sizes, shapes and materials<br>under worst case conditions (no dissipation of heat from circulation). No<br>clinically significant rise in temperature of metal implants was noted. |
| | Retrospective analysis of the FDA MDR/MAUDE database, Regenesis and<br>other industry complaint data from over 175,000 patients and over |
| | 3,000,000 treatments, and the medical literature demonstrates that heating<br>from implanted metal is a theoretical risk with no actual reported adverse<br>events. This information further supports removal of the metal implant<br>contraindication and that use of the Provant Therapy without this<br>contraindication is as safe and as effective as use of the predicate Provant<br>System Model 4201. |
| Conclusion | The Provant Therapy System and its predicate device have the same<br>intended use, similar indications for use, and the same technological<br>characteristics. The results of the analysis of the adverse event data, clinical<br>literature and bench testing provide evidence that removal of the<br>contraindication for use in patients with implanted metal in the area of<br>treatment does not raise any new questions of safety and effectiveness as<br>compared to the predicate device. Thus, the Provant Therapy System is<br>substantially equivalent to its predicate device. |

Confidential

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