The Provant Therapy System is nearly identical to the previously cleared Provant System Model 4201 (cleared under K091791), except for the device labeling. Specifically, unlike the Provant System Model.4201, the Provant Therapy System does not include a contraindication for use in patients with metal implants. The device includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces 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. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into a Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant Therapy System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.

AI/ML Overview

This document describes the Provant Therapy System, a nonthermal shortwave diathermy (SWT) device, and its substantial equivalence to a predicate device. The information provided is primarily focused on reclassification and regulatory clearance rather than a typical AI/ML device study. Therefore, some of the requested categories for AI/ML device studies may not be directly applicable or fully detailed in the provided text.

Here's an analysis based on the given information:

Acceptance Criteria and Reported Device Performance

The device, Provant Therapy System, was cleared based on substantial equivalence to a predicate device (Provant System, Model 4201). The primary "acceptance criteria" here relate to demonstrating that the updated device (Provant Therapy System) is as safe and effective as the predicate, specifically with the removal of a contraindication for patients with metal implants.

Acceptance Criteria (Implied)	Reported Device Performance
Safety with Metal Implants: No clinically significant temperature rise in metal implants when exposed to the device.	Nonclinical Performance: "The Provant Therapy System was tested using a validated tissue phantom with a variety of metal implants of different sizes, shapes and materials under worst case conditions (no dissipation of heat from circulation). No clinically significant rise in temperature of metal implants was noted."
Effectiveness (Equivalent to Predicate): Maintain the same therapeutic effect despite the change in contraindication.	Retrospective analysis: "Retrospective analysis of the FDA MDR/MAUDE database, Regenesis and other industry complaint data from over 175,000 patients and over 3,000,000 treatments, and the medical literature demonstrates that heating from implanted metal is a theoretical risk with no actual reported adverse events." Conclusion: "The Provant Therapy System and its predicate device have the same intended use, similar indications for use, and the same technological characteristics."
Technological Equivalence: Device characteristics are identical to the predicate.	Technological Characteristics: "Both the Provant Therapy System and the predicate device use shortwave radiofrequency energy in the FCC-approved ISM (Industrial, Scientific and Medical) frequency of 27.12MHz to provide treatment. The proposed Provant Therapy System has the same features and technological characteristics as the predicate Provant System Model 4201."

Study Information

This submission is a 510(k) for a medical device reclassification/modification, not a study of an AI/ML algorithm. Therefore, many of the typical AI/ML study parameters are not applicable.

Sample size used for the test set and the data provenance:
- Test Set: For the nonclinical performance, a "validated tissue phantom with a variety of metal implants" was used. The specific number of implants or types of tests is not detailed beyond "variety."
- Data Provenance (Clinical Data): Retrospective analysis of the FDA MDR/MAUDE database, Regenesis and other industry complaint data (over 175,000 patients and over 3,000,000 treatments), and medical literature. The country of origin for these databases and literature is not specified but generally refers to US FDA data and global medical literature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device and the "ground truth" for the nonclinical testing was based on temperature measurements in a tissue phantom. For the retrospective analysis, the "ground truth" was the absence of reported adverse events related to heating from metal implants, which would be based on medical records and adverse event reporting systems, not expert consensus on specific cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The nonclinical testing involves physical measurements (temperature). The retrospective analysis relies on reported adverse events, not a diagnostic interpretation that would require adjudication.
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:
- Not applicable. This is not an AI/ML device and no MRMC study was performed or required for this 510(k) submission.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device operates independently for therapy delivery.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Nonclinical Test: Physical measurements (temperature rise) in a validated tissue phantom.
- Clinical (Retrospective): Absence of reported adverse events (outcomes data/safety data) related to metal implant heating, extracted from a large database and medical literature.
The sample size for the training set:
- Not applicable. There is no AI/ML algorithm requiring a training set for this device.
How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm requiring a training set for this device.

Summary

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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

Page 1 of _ 1

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K131979 · 510(k) Summary

510(k)Summary	This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R. § 807.92.
Submitter	Regenesis Biomedical, Inc.
Contact Person	Richard Isenberg5301 North Pima Road, Suite 150Scottsdale, AZ 85275(877) 970-4970
Date Prepared	27 June 2013
Product Name	Provant Therapy System
Common Name	Nonthermal shortwave diathermy device
DeviceClassification	Class III
Product Code	ILX
PredicateDevice(s)	Provant System, Model 4201 (K091791)
PerformanceStandards	Performance standards have not been established by the FDA under section514 of the Federal, Food, Drug and Cosmetic Act.
Indications forUse	The Provant Therapy System is indicated for adjunctive use in the palliativetreatment of postoperative pain and edema in superficial soft tissue.
DeviceDescription	The Provant Therapy System is nearly identical to the previously clearedProvant System Model 4201 (cleared under K091791), except for the devicelabeling. Specifically, unlike the Provant System Model.4201, the ProvantTherapy System does not include a contraindication for use in patients withmetal implants. The device includes a Control Unit and TreatmentApplicator. Disposable Applicator Covers are provided for the TreatmentApplicator for infection control and to provide appropriate contact surfacesfor 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.The case contains a lockable hinge to prevent accidental closure of the lid.Upon opening the Provant Therapy case, the user sees the control panel ofthe Control Unit. The main electronics of the Control Unit are housedbeneath its control panel. The device also includes a Treatment Applicatorthat is attached to the Control Unit. When not in use, the TreatmentApplicator is stored inside the carrying case. The Treatment Applicator isremoved from the case prior to administration of therapy, inserted into aDisposable Applicator Cover, and placed directly over the area to be treated.Device labeling is also located inside the case cover. Four pre-drilled holesin the underside of the case allow for attachment of the device to theoptional roller stand (sold separately).
	The Disposable Applicator Covers of the Provant Therapy System aresingle-use-only and are intended to minimize contagion and help protect theTreatment Applicator from biological contamination. The DisposableApplicator Covers contain a Radio Frequency Identification Device (RFID)tag which guards against reuse of used Disposable Applicator Covers.
TechnologicalCharacteristics	Both the Provant Therapy System and the predicate device use shortwaveradiofrequency energy in the FCC-approved ISM (Industrial, Scientific andMedical) frequency of 27.12MHz to provide treatment. The proposedProvant Therapy System has the same features and technologicalcharacteristics as the predicate Provant System Model 4201. Specifically,both the Provant Therapy System and the predicate device:
	• Emit pulsed radiofrequency energy at 1 kHz with a pulse width of42µsec, resulting in a 4% duty cycle.
	• Emit an Electrical Field strength of 591 V/m at 5cm above theTreatment 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
NonclinicalPerformance	The Provant Therapy System was tested using a validated tissue phantomwith a variety of metal implants of different sizes, shapes and materialsunder worst case conditions (no dissipation of heat from circulation). Noclinically significant rise in temperature of metal implants was noted.
	Retrospective analysis of the FDA MDR/MAUDE database, Regenesis andother industry complaint data from over 175,000 patients and over
	3,000,000 treatments, and the medical literature demonstrates that heatingfrom implanted metal is a theoretical risk with no actual reported adverseevents. This information further supports removal of the metal implantcontraindication and that use of the Provant Therapy without thiscontraindication is as safe and as effective as use of the predicate ProvantSystem Model 4201.
Conclusion	The Provant Therapy System and its predicate device have the sameintended use, similar indications for use, and the same technologicalcharacteristics. The results of the analysis of the adverse event data, clinicalliterature and bench testing provide evidence that removal of thecontraindication for use in patients with implanted metal in the area oftreatment does not raise any new questions of safety and effectiveness ascompared to the predicate device. Thus, the Provant Therapy System issubstantially equivalent to its predicate device.

Confidential

. .

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Confidential

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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.