REGENESIS MODEL 42

K972093 · Regenesis Biomedical, Inc. · ILX · Oct 21, 1997 · Physical Medicine

Device Facts

• Record ID: K972093
• Device Name: REGENESIS MODEL 42
• Applicant: Regenesis Biomedical, Inc.
• Product Code: ILX · Physical Medicine
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Regenesis Model 42 is intended to be used in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Device Story

Regenesis Model 42 is a pulsed short-wave diathermy device; consists of a main control console connected to a treatment pad via cable. Pad is waterproof and bacterial resistant; designed for placement directly on patient or over standard dressings. Device operates via solid-state design to deliver short-wave energy for palliative treatment of postoperative pain and edema. Used in clinical settings; operated by healthcare providers. Output is non-thermal short-wave therapy; intended to provide symptomatic relief of pain and edema in superficial soft tissue. Device lacks microprocessor and software.

Clinical Evidence

Bench testing only. Testing conducted by Amethyst Technologies addressed electrical safety, electromagnetic compatibility, stray radiation, and applicator field patterns to support substantial equivalence.

Technological Characteristics

Pulsed short-wave diathermy device; solid-state design. Includes main control console and cable-connected treatment pad. Pad is waterproof and bacterial resistant. No software or microprocessor.

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

• MRT® sofPulse™ shortwave diathermy device (K903675)

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 K972093 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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• **UNITS AFFECTED:** 100%

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1997

T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh Associates, Inc. Representing Regenesis Biomedical, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re : K972093 Regenesis Model 42 Trade Name: III Regulatory Class: ITX Product Code: Dated: June 3, 1997 ...... - -Received: June 4, 1997

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with General the Good Manufacturing Practice for Medical Devices: (GMP) regulation (21 CFR Part 820) and that, through periodic

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Page 2 - T. Whit Athey, Ph.D.

GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/demamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Regenesis Model 42 Device Name:

Indications For Use:

The Regenesis Model 42 is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tocolef

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K972083

**Prescription Use**
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ____________

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# 510(k) Summary

K972093
Oct.21,1997

# Regenesis Model 42

Common/Classification Name: Shortwave Diathermy 21 CFR 890.5290(b), Class III

> Regenesis Biomedical, Inc. 1435 North Hayden Road Scottsdale, AZ 85257-3773

Contact: Mary C. Ritz, Ph.D.

Tel: [phone] FAX: [phone]

Prepared: May 21, 1997

## LEGALLY MARKETED PREDICATE DEVICES A.

The Regenesis Model 42 is substantially equivalent to the MRT® sofPulse™ shortwave diathermy device made by ElectroPharmacology (K903675), which was cleared on January 17, 1991.

### DEVICE DESCRIPTION B.

The Regenesis Model 42 device is a pulsed short-wave diathermy device. The device has a solid state design that is very simple. It has no microprocessor and therefore no software.

The Regenesis Model 42 unit consists of a main control console connected by cable to a treatment pad. The pad and cable are a single unit which is connected or disconnected easily from the console. The pad surface is water proof, bacterial resistant and designed to be placed directly on the patient or on top of any standard dressings used over the area to be treated.

#### C. INTENDED USE

The Regenesis Model 42 is intended to be used in the palliative treatment of postoperative pain and edema in superficial soft tissue.

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### SUBSTANTIAL EQUIVALENCE SUMMARY D.

The new device has the same indications statement as the predicate device and it has the same technological characteristics. Some of the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, in addition to a side-by-side comparison of the descriptive characteristics of the Regenesis Model 42 and the predicate device, performance data were presented which assure equivalence. The 510(k) decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.

### TECHNOLOGICAL CHARACTERISTICS E.

See Section B, above.

#### u TESTING

Amethyst Technologies carried out testing on the Regenesis Model 42 to address the following issues: (1) electrical safety; (2) electromagnetic compatibility, (3) stray radiation, (4) and applicator field patterns. The results of all these tests support the substantial equivalence of the device.

#### CONCLUSIONS G.

Regenesis Biomedical has demonstrated through its comparison of characteristics with the predicate device and comparison of performance testing with the predicate device that the Regenesis Model 42 is substantially equivalent to the predicate devices.

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