PROVANT SYSTEM, MODEL 4201

K091791 · Regenesis Biomedical, Inc. · ILX · Apr 7, 2010 · Physical Medicine

Device Facts

• Record ID: K091791
• Device Name: PROVANT SYSTEM, MODEL 4201
• Applicant: Regenesis Biomedical, Inc.
• Product Code: ILX · Physical Medicine
• Decision Date: Apr 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Provant System is a shortwave diathermy device; consists of control unit and treatment applicator. Used for palliative treatment of postoperative pain and edema in superficial soft tissue. Operates by delivering shortwave radio frequency energy to target area. Applicator placed directly over treatment site using single-use disposable covers. Covers include RFID tags to prevent reuse and minimize biological contamination. Control unit housed in high-impact ABS plastic case. Intended for clinical use; operated by healthcare professionals. Device provides non-thermal therapy; energy delivery parameters equivalent to predicate. Benefits include adjunctive pain and edema management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and extensive clinical experience with reusable components of the predicate device.

Technological Characteristics

Shortwave radio frequency energy delivery; high-impact ABS plastic enclosure; RFID-enabled disposable applicator covers for infection control; UL-compliant electronics; non-thermal operation.

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

• Regenesis Model 42

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-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K091791 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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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Regenesis Biomedical, Inc. % Mr. William H. Ouirk 755 East Mulberry Avenue Suite 200 San Antonio, TX 78212

Re: K091791

Trade/Device Name: Provant System Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: III Product Code: ILX Dated: April 1, 2010 Received: April 6, 2010

APR 0 7 2010

Dear Mr. Quirk:

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. Iisting 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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## Indications for Use

510(k) Number (if known): K091791

Device Name: Provant System

INDICATIONS FOR USE:

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

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091791

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## 510(k) Summary

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| 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 | William H. Quirk<br>755 E. Mulberry, Suite 200<br>San Antonio, Texas 78212<br>[phone] |
| Date Prepared | 10 June 2009 |
| Product Name | Provant System |
| Common Name | Short-wave diathermy device |
| Device<br>Classification | Class III |
| Predicate<br>Device(s) | Regenesis Model 42 |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act. |
| Device<br>Description | Much like the predicate Regenesis Model 42 device, the new Provant System<br>includes a Control Unit and Treatment Applicator. Disposable Applicator<br>Covers are provided for the Treatment Applicator for infection control and to<br>provide appropriate contact surfaces for the patient. The predicate Provant<br>System contains the same components.<br>The Control Unit for the Provant System is housed in a UL-compliant<br>injection-molded case made of high-impact ABS plastic.<br>The case contains a<br>lockable hinge to prevent accidental closure of the lid. Upon opening the<br>Provant case, the user sees the control panel of the Control Unit. The main<br>electronics of the Control Unit are housed beneath its control panel. The<br>device also includes a Treatment Applicator that is attached to the Control Unit. |
| Device<br>Description<br>(continued) | When not in use, the Treatment Applicator is stored inside the carrying case.<br>The Treatment Applicator is removed from the case prior to administration of<br>therapy, inserted into its Disposable Applicator Cover, and placed directly over<br>the area to be treated. Device labeling is also located inside the case cover.<br>Four pre-drilled holes in the underside of the case allow for attachment of the<br>device to the optional roller stand (sold separately).<br>The Disposable Applicator Covers of the Provant System are single-use-only<br>and are intended to minimize contagion and help protect the Treatment<br>Applicator from biological contamination. The Disposable Applicator Covers<br>contain a Radio Frequency Identification Device (RFID) tag which guards<br>against reuse of used Disposable Applicator Covers. |
| Indications for<br>Use | The Provant System and its predicate are both intended for adjunctive use in<br>the palliative treatment of postoperative pain and edema in superficial soft<br>tissue. |
| Technological<br>Characteristics | Both the Provant System and the predicate device use shortwave radio<br>frequency energy to treat postoperative superficial pain and edema. The<br>proposed Provant System has similar features and<br>technological<br>characteristics as the predicate. |
| Nonclinical<br>Performance | Bench testing data demonstrates that the technological differences between<br>the Provant System and its predicate do not raise new questions of safety or<br>effectiveness. These data also demonstrate that the Provant System delivers<br>the same amount of energy to the subject and is therefore as safe and as<br>effective as its predicate. |
| Clinical Data | Although the reusable portions of the Provant System have extensive clinical<br>experience, this 510(k) Notice does not rely upon clinical data. |
| Conclusion | The Provant System and the predicate device have the same intended use and<br>similar technological characteristics. The results of bench testing further<br>demonstrate that the Provant System does not raise any new questions of<br>safety or effectiveness as compared to its predicate device.<br>Thus. the<br>Provant System is substantially equivalent to its predicate device. |

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