MODEL PMT850

K070931 · Promedtek, Inc. · ILX · May 24, 2007 · Physical Medicine

Device Facts

• Record ID: K070931
• Device Name: MODEL PMT850
• Applicant: Promedtek, Inc.
• Product Code: ILX · Physical Medicine
• Decision Date: May 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model PMT850 is indicated for adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.

Device Story

Model PMT850 is a pulsed shortwave diathermy device; consists of a generating unit connected via cable to a treatment applicator. Operates by delivering pulsed shortwave radiofrequency (27.12 MHz) energy to superficial soft tissue. Used in clinical settings; operated by healthcare providers. Provider places applicator over standard dressing on treatment area; selects one of 36 combinations of 6 pulse frequencies and 6 power settings via generating unit dials. Device provides non-thermal energy to assist in pain and edema management. Benefits include adjunctive palliative care for postoperative patients. Performance verified via applicator field measurements and output energy comparisons against predicate.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including applicator field measurements and output energy comparisons against the predicate device to demonstrate equivalent performance. Biocompatibility testing (ISO 10993-5) performed on applicator foam material.

Technological Characteristics

Pulsed shortwave diathermy; 27.12 MHz operating frequency; 50 Ohm RF output impedance; 65 µsec pulse width; 27 MHz sine wave envelope. Power: 110 VAC, 60 Hz. Applicator covering: high-grade polyethylene foam. Electrical safety: UL 60601-1. EMC: IEC 60601-1-2. Packaging: ASTM D4169-05. Timer: 0-30 minutes.

Indications for Use

Indicated for adjunctive palliative treatment of postoperative edema and pain 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 K070931 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ProMedTek, Inc. % The Weinberg Group, Inc. Diane Mandell, Ph.D., RAC Senior Consultant 1220 Nineteenth St NW, Suite 300 Washington, District of Columbia 20036

MAY 2 4 2007

Re: K070931

Trade/Device Name: Model PMT850 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class III Product Code: ILX Dated: April 3, 2007 Received: April 3, 2007

Dear Dr. Mandell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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## Page 2 - Dr. Diane Mandell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated. The PDF intembly sification 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), please n you uchie specific acriviance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milhem

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(K) Number (if known): K070 931

Device Name: Model PMT850

Indications for Use:

The Model PMT850 is indicated for adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use 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)

Mark N. Millhusan

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

**510(k) Number** K07 093

Page 1 of 1

ProMedTek Premarket Notification Model PMT850

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# 510(k) Summary

# Model PMT850

MAY 2 4 2007

| Name of Device: | Model PMT850 |
|-----------------------|------------------------------------------------------------------------------------|
| Common Name: | Shortwave Diathermy |
| Classification Name: | 21 CFR 890.5290(b), Class III |
| Product Code: | ILX |
| Classification Panel: | Physical Medicines Devices Panel |
| Sponsor: | ProMedTek, Inc.<br>7272 East Indian School Road, Suite 102<br>Scottsdale, AZ 85251 |
| Contact: | Daniel R. Puchek |
| Tele: | 480-385-2468 |
| Fax: | 480-385-2499 |
| Date Prepared: | May 14, 2007 |

#### LEGALLY MARKETED PREDICATE DEVICE A.

K903675. MRT sofPulse shortwave diathermy device, ElectroPharmacology, Inc.

#### DEVICE DESCRIPTION B.

The Model PMT850 device is a pulsed shortwave diathermy device. The Model PMT850 system consists of a Generating Unit connected by a cable to the Treatment Applicator. The Treatment Applicator and cable are a single unit which is connected or disconnected easily from the Generating Unit. The Generating Unit connects to a standard AC electrical outlet by a grounded 3-prong UL/CSA approved, medically rated electric cord.

Treatment with the Model PMT850 requires placing the Treatment Applicator on top of any standard dressing over the area to be treated, setting the dials on the Generating Unit, and turning the device on. There are 6 possible pulse frequency and 6 possible power control settings on the generating unit of the Model PMT850, providing 36 setting options for treatment. Suggested treatment settings are discussed in the Operating Manual for the Model PMT850.

#### INTENDED USE ்.

The Model PMT850 is indicated for adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.

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#### SUBSTANTIAL EQUIVALENCE SUMMARY D.

The Model PMT850 has the same intended use and indications for use statement as the predicate device. The Model PMT850 has the same technological characteristics as the predicate device, with the exception of the lower power required from the Generating Unit to provide an equivalent amount of Peak Power from the Treatment Applicator, which does not affect safety or effectiveness. In addition to a side-by-side comparison of the descriptive characteristics of the Model PMT850 and the predicate presented below, performance studies were conducted to ensure equivalent performance compared with the predicate: Applicator Field Measurements, and Output Energy Comparison. The decision algorithm brings us to a determination of device substantial equivalence with the predicate.

#### TECHNOLOGICAL CHARACTERISTICS ប៉

The general technological characteristics of the Model PMT850 and the predicate are equivalent. This includes: power supply, operating principle, energy transfer mechanism, treatment applicator, device physical conformation (weight and size), and packaging.

The following technical specifications are also found equivalent between the Model PMT850 and the predicate: power required, fuse protection, operating frequency, RF Output Impedance, RF Pulse Width, RF Pulse waveform, pulse frequency, pulse duty cycle, pulse control accuracy, peak RF applicator power, average RF applicator output power, exposure timer, and timer accuracy (see Table 1 below). The only technical specification that differs is the lower peak RF generator power required for the Model PMT850 Generating Unit to provide an equivalent amount of Peak Power as the predicate from the Treatment Applicator for each of the six power settings.

| | ProMedTek Inc.<br>MODEL PMT850 | Predicate Device<br>MRT sofPulse |
|------------------------|------------------------------------|------------------------------------|
| Power required | 110 VAC, 60 Hz | 110 VAC, 60 Hz |
| Fuse protection | AC: 1 Amp, 250 V | AC: 1 Amp, 250 V |
| Operating frequency | Short Wave RF<br>27.12 MHz ± 0.05% | Short Wave RF<br>27.12 MHz ± 0.05% |
| RF Output Impedance | 50 Ohms | 50 Ohms |
| RF Pulse width | 65 µsec | 65 µsec |
| RF Pulse waveform | 27 MHz Sine Wave Envelope | 27 MHz Sine Wave Envelope |
| Pulse control accuracy | 0.0025% | Not reported |
| Exposure timer | 0 - 30 minutes | 0 - 30 minutes |
| Timer accuracy | 0.001% | 1% |

## Table 1. COMPARISON OF TECHNICAL SPECIFICTIONS

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#### г. TESTING

## Substantial Equivalence

Applicator Field Measurements and Output Energy Comparison testing was conducted by two independent laboratories to determine equivalence in device performance of the Model PMT850 and the predicate device. The results of these tests support the substantial equivalence of the Model PMT850 with the predicate device.

### Conformance to Standards

Prior to marketing, the Model PMT850 will comply with all standard requirements listed by an NRTL and also will conform to electrical safety (UL 60601-1), electromagnetic compatibility (IEC 60601-1-2) and packaging guidelines (ASTM D4169-05).

Biocompatibility testing was determined not to be required because the device does not contact patient skin. However, it should be noted that the treatment applicator covering is made of a high-grade polyethylene foam, which has passed biocompatibility tests for cytotoxicity/irritancy (ISO 10993-5).

#### CONCLUSIONS G.

ProMedTek, Inc. has demonstrated through the comparison of characteristics and comparison of performance testing, that the Model PMT850 is substantially equivalent to the predicate, MRT sofPulse shortwave diathermy device.