ProMedTek Model C1400 Shortwave Diathermy Device

K162240 · Promedtek, Inc. · IMJ · Nov 17, 2016 · Physical Medicine

Device Facts

• Record ID: K162240
• Device Name: ProMedTek Model C1400 Shortwave Diathermy Device
• Applicant: Promedtek, Inc.
• Product Code: IMJ · Physical Medicine
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as: 1. Relieving pain 2. Reducing muscle spasm 3. Increasing range of motion of contracted joints using heat and stretch techniques. 4. Increasing blood flow to tissues in the treatment area.

Device Story

Device delivers 27.12 MHz radio frequency energy for deep tissue heating; utilizes inductive drum or soft-rubber electrodes. Operated by clinicians in clinical settings; mounted on a mobile cart with locking wheels. User interface features LCD touch screen for setup and parameter selection (continuous/pulsed modes, pulse rates 10-400 Hz, pulse widths 65-400 μs). Includes patient safety pull-cord to terminate output. Output provides therapeutic heat to treat pain, muscle spasms, joint contractures, and blood flow deficits. Benefits include non-invasive deep tissue thermal therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes software verification and validation (moderate level of concern) and compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-3).

Technological Characteristics

Shortwave diathermy device operating at 27.12 MHz. Components: mobile cart, arm, inductive drum applicator, soft-rubber electrodes. Power: 100-240 VAC, 50-60 Hz. Output: 100 W average (continuous), 200 W peak (pulsed). Modes: Inductive and capacitive. Software-controlled via LCD touch screen. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-3.

Indications for Use

Indicated for patients requiring deep tissue heating to relieve pain, reduce muscle spasm, increase range of motion of contracted joints, or increase blood flow to tissues.

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

• Auto Therm 390, Model ME 390 (K042554)

Submission Summary (Full Text)

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

November 17, 2016

ProMedTek Inc. % Diane Horwitz President Mandell Horwitz Consultants LLC 2995 Steven Martin Dr. Fairfax, Virginia 22031

Re: K162240

Trade/Device Name: ProMedTek Model C1400 Shortwave Diathermy Device Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: October 14, 2016 Received: October 15, 2016

Dear Ms. Horwitz:

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 device

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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS 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) K162440

Device Name

ProMedTek Model C1400 Shortwave Diathermy Device

Indications for Use (Describe)

The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

- 1. Relieving pain
- 2. Reducing muscle spasm
- 3. Increasing range of motion of contracted joints using heat and stretch techniques
- 4. Increasing blood flow to tissues in the treatment area

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for PROMEDTEK. The logo features the company name in gray, with a stylized figure above the "M" and a globe in orange replacing the "O". The font is sans-serif and appears to be a modern design.

# 510(k) SUMMARY

#### GENERAL INFORMATION 1.

#### 1.1 Submitter and 510(k) Owner

Dan Puchek, President and CEO ProMedTek Inc. 4110 N Scottsdale Road, Suite 270 Scottsdale AZ 85251

#### 1.2 Official Correspondent

Diane Horwitz, Ph.D., RAC, Regulatory Consultant 2995 Steven Martin Dr. Fairfax, VA 22031

Telephone: [phone] Fax: [phone] Email: [e-mail]

#### 1.3 Date of Preparation

November 15, 2016

#### 2. NAME OF THE DEVICE

#### 2.1.1 Trade/Proprietary Name

ProMedTek Model C1400 Shortwave Diathermy

#### 2.1.2 Common/Usual Name

Diathermy, Shortwave, for use in Applying Therapeutic Deep Heat

#### 2.1.3 Classification Information

| Classification Name: | Shortwave diathermy |
|----------------------------|---------------------|
| Classification Regulation: | 21 CFR 890.5290 |
| Class: | II |
| Product Code: | IMJ |
| Panel: | Physical Medicine |

#### 3. PREDICATE DEVICE

The predicate device is Auto Therm 390, Model ME 390 (Mettler Electronics Corp., K042554).

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Image /page/4/Picture/0 description: The image shows the logo for PROMEDTEK. The logo is in gray and orange. The letters are in gray, and there is an orange globe in the middle of the logo.

#### 4. DESCRIPTION OF THE DEVICE

The ProMedTek C1400 shortwave diathermy device operates at 27.12 MHz. It provides traditional shortwave diathermy using an inductive drum or soft-rubber electrodes. The unit offers both continuous or pulsed modes of operation with a variety of frequencies and pulse widths to choose from. An easy-to-use LCD Touch Screen guides the user through setup. A Patient Safety Pull-Cord allows the patient to stop all output. The base of the ProMedTek C1400 is a sturdy cart with large locking wheels that allows the ProMedTek C1400 to be moved easily around the clinic and supports the arm and drum applicator during treatment.

#### 5. INTENDED USE

The intended use / indications for use for the Model C1400 Shortwave Diathermy is as follows:

"The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

- 1. Relieving pain
- 2. Reducing muscle spasm
- 3. Increasing range of motion of contracted joints using heat and stretch techniques.
- 4. Increasing blood flow to tissues in the treatment area."

#### SUBSTANTIAL EQUIVALENCE COMPARISON 6.

The Model C1400 Shortwave Diathermy and the predicate device share intended use and technological features. The intended use and indications for use statements are almost identical. There are no differences in technology between the two devices. A comparison of the characteristics to the predicate device follows.

| Characteristic | ProMedTek Model C1400<br>Shortwave Diathermy<br>New device | Predicate (K042554)<br>AutoTherm 390<br>Mettler Electronics Corp. |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE / INDICATIONS FOR USE STATEMENT | | |
| Statement | The ProMedTek Model C1400<br>Shortwave Diathermy device delivers<br>energy in the radio band of 27.12<br>MHz to provide deep heating<br>therapeutic effects to body tissues.<br>When shortwave diathermy is<br>delivered to the body at intensities<br>capable of generating a deep tissue<br>temperature increase, it can be used to<br>treat selected medical conditions such<br>as:<br>1. Relieving pain<br>2. Reducing muscle spasm | Shortwave diathermy delivers<br>energy in the radio band of 27.12<br>MHz to provide deep heating<br>therapeutic effects to body<br>tissues. When shortwave<br>diathermy is delivered to the<br>body at intensities capable of<br>generating a deep tissue<br>temperature increase, it can be<br>used to treat selected medical<br>conditions such as:<br>1. Relieving pain<br>2. Reducing muscle spasm |
| Characteristic | ProMedTek Model C1400<br>Shortwave Diathermy | Predicate (K042554)<br>AutoTherm 390 |
| | New device | Mettler Electronics Corp. |
| | 3. Increasing range of motion of<br>contracted joints using heat and<br>stretch techniques.<br>4. Increasing blood flow to tissues in<br>the treatment area. | 3. Increasing range of motion of<br>contracted joints using heat and<br>stretch techniques.<br>4. Increasing blood flow to<br>tissues in the treatment area. |
| TECHNOLOGY | | |
| System Components | Unit with Cart and Arm for Inductive<br>Drum Applicator | Same |
| Applicator Components | Inductive Drum Applicator<br>Soft-Rubber Applicators (2) | Same |
| Accessories | Felt spacers for Soft-Rubber<br>Applicators (6)<br>Cloth cover for Soft-Rubber<br>Applicators (2)<br>Velcro Receptive Elastic Straps (2) | Same |
| Input | 100-240 VAC, 50-60 Hz | Same |
| Frequency | 27.12 MHz | Same |
| Output Types | Continuous<br>Pulsed | Same |
| HF Output Continuous | 100 W Average Power | Same |
| HF Output Pulsed | 200 W Peak Power | Same |
| Pulse Rate Settings | 10Hz, 20 Hz, 50 Hz, 100 Hz, 400 Hz | Same |
| Pulse Width Settings | 65 μs, 100 μs, 200 μs, 300 μs, 400 μs | Same |
| Modes | Inductive<br>Capacitive | Same |
| Treatment Time | 1-30 minutes | Same |
| Software controlled | Yes | Same |
| User Display and<br>Interface | LCD Touch Screen displays<br>interactive instructions and indicators | Similar<br>User interface has tactile<br>selection buttons and LED<br>indicators |

## TECHNOLOGY OF THE MODEL C1400 SHORTWAVE DIATHERMY AND THE PREDICATE DEVICE

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Image /page/5/Picture/0 description: The image shows the logo for PROMEDTEK. The logo features the company name in a bold, sans-serif font, with the letters in gray. Above the letters 'OM' is a stylized graphic of a person with their arms raised above their head, and the letter 'O' is replaced with an orange globe.

#### PERFORMANCE TESTING 7.

The 510(k) submission provided performance data to establish the substantial equivalence of the ProMedTek Model C1400 to the predicate device. A summary of these performance tests is provided below.

Software verification and validation testing: Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and

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Image /page/6/Picture/0 description: The image shows the logo for PROMEDTEK. The logo is in gray, except for the globe in the middle of the logo, which is orange. The logo also includes a figure above the globe.

FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Electrical safety and electromagnetic compatibility: The Model C1400 complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-3 and was found to meet all applicable requirements.

#### 8. CONCLUSIONS

This 510(k) submission demonstrates that the ProMedTek Model C1400 is substantially equivalent to the predicate device.