CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000

K033358 · Surgitech, Inc. · LIH · Nov 14, 2003 · Neurology

Device Facts

• Record ID: K033358
• Device Name: CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
• Applicant: Surgitech, Inc.
• Product Code: LIH · Neurology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended uses of the Chronic Pain Suppressor are: Symptomatic relief of chronic intractable pain - Adjunctive treatment for the management of post-traumatic or post-surgical pain .

Device Story

Chronic Pain Suppressor CPS-2000 is a rechargeable battery-operated interferential current therapy device. It generates symmetric monophasic sine or square electrical waveforms delivered via patient cables and electrodes placed on the skin. The device is physician-programmed to deliver electrical stimulation to underlying nerves for pain management. It features a 'Patient-Lock' mechanism that restricts patient interaction to starting/stopping treatment, adjusting intensity, and viewing a session countdown timer, while preventing alteration of physician-prescribed parameters. Used in clinical or home settings under physician prescription to provide symptomatic relief of chronic intractable pain and adjunctive management of post-traumatic or post-surgical pain.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive characteristics and conformance to voluntary safety and electromagnetic compatibility standards (UL 60601-1, IEC 60601-1-2, AAMI/ANSI NS4:1986/(R)2002).

Technological Characteristics

Rechargeable battery-operated interferential current therapy device. Generates symmetric monophasic sine or square waveforms. Includes patient cable and skin electrodes. Conforms to UL 60601-1, IEC 60601-1-2, and AAMI/ANSI NS4:1986/(R)2002 standards. Features a 'Patient-Lock' function for parameter security.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain and as adjunctive treatment for management of post-traumatic or post-surgical pain.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• SD-730 (K992652)
• HMP 4000 (K924961)

Submission Summary (Full Text)

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# NOV 1 4 2003

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#### 8.0 Chronic Pain Suppressor CPS-2000 510(k) Summary (as required by section 807.92(c))

| Submitter's Name: | SurgiTech, Inc.<br>2424 Vista Way, Suite 300<br>Oceanside, CA 92054 |
|------------------------------------|---------------------------------------------------------------------|
| Contact Person: | Chris Crowell<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | October 10, 2003 |
| Trade or Proprietary Name: | Chronic Pain Suppressor |
| Common or Usual Name: | Interferential Current Therapy |
| SurgiTech Model Number: | CPS-2000 |
| Establishment Registration Number: | 2032724 |
| Device Class: | II |
| Classification Name: | Interferential Current Therapy |
| CFR #: | Unclassified |
| Product Code: | LIH |

# Description of Device:

The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

#### Intended Use:

The intended uses of the Chronic Pain Suppressor are:

- Symptomatic relief of chronic intractable pain
- Adjunctive treatment for the management of post-traumatic or post-surgical pain .

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# Predicate Device Information:

| Device | Applicant | 510(k) # |
|----------|----------------|----------|
| SD-730 | Skylark Device | K992652 |
| HMP 4000 | HMP 4000, Inc. | K924961 |

## Substantial Equivalence:

The Chronic Pain Suppressor CPS-2000 is equivalent in basic form and function to almost any other Class II Interferential Current Therapy device. A difference to the legally marketed predicate devices is the "Patient-Lock" feature. This difference in no way affects the safety or effectiveness of the device. Ultimately, the safety is raised as the prescribed treatment parameters programmed by the physician are protected from alteration. The patient may only initiate and stop treatment at designated time intervals, adjust the intensity, and view the session countdown timer for the next treatment.

# Performance Data:

The descriptive characteristics presented are thorough to ensure the substantial equivalence of the Chronic Pain Suppressor CPS-2000 to the legally marketed predicate devices. The descriptive characteristics include the data provided in the Substantial Equivalence Comparison Table within this premarket notification submission.

## Conformance to Voluntary Standards:

- UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for . Safety
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- AAMI/ANSI NS4:1986/(R)2002 Transcutaneous Electrical Nerve Stimulators -● specifically items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2

#### Conclusion:

The Chronic Pain Suppressor CPS-2000 is as safe and effective, and performs as well as the predicate devices.

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NOV 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Crowell Ouality Assurance Manager SurgiTech, Inc. 2424 Vista Way, Suite 300 Oceanside, California 92054

Re: K033358

Trade/Device Name: Chronic Pain Suppressor CPS-2000 Regulatory Class: Unclassified Product Code: LIH Dated: October 10, 2003 Received: October 20, 2003

Dear Mr. Crowell:

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 - Mr. Christopher Crowell

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 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), please contact the Office of Compliance 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milliken

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of of

510(k) Number:

Device Name: ___ Chronic Pain Suppressor CPS-2000

Indications for Use:

- Symptomatic relief of chronic intractable pain. ●
- Adjunctive treatment for the management of post-traumatic or post-. surgical pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark N. Milkerson

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

510(k) Number K033358
K033358

(Optional Format 3-10-98)