CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)

K041908 · Medoc Ltd. Advanced Medical Systems · NTU · Feb 25, 2005 · Neurology

Device Facts

• Record ID: K041908
• Device Name: CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
• Applicant: Medoc Ltd. Advanced Medical Systems
• Product Code: NTU · Neurology
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Indications for Use

The Contact Heat-Evoked Potential Stimulator (CHEPS) is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.

Device Story

CHEPS is a computerized thermal stimulator for evaluating pain reception and sensory pathways. System components include control unit, external cooling unit, 27mm thermode probe, cables, and software. Device delivers rapid thermal stimuli (70°C/sec) from baseline to 55°C in 250ms. Operated by clinicians using an external IBM-compatible computer. Output consists of controlled heat pulses to evoke potentials for clinical assessment of sensory nerve function. Optional MRI-safe thermode and cart available. Benefits include objective assessment of pain pathways.

Clinical Evidence

No clinical data. Device underwent mechanical, physical, and biocompatibility bench testing. Results were successful, confirming the device performed as designed and met or exceeded all product specifications.

Technological Characteristics

Computerized thermal stimulator; 27mm diameter thermode probe; heating rate 70°C/sec; max temperature 55°C; requires external IBM-compatible PC; optional MRI-safe components; software-controlled.

Indications for Use

Indicated for evaluating human pain reception and sensory pathway transmission functionality.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• GSA Genito Sensory Analyzer (K010981)
• TSA-2001 Thermal Sensory Analyzer (K922052)

Submission Summary (Full Text)

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# SUMMARY AND CERTIFICATION

FEB 2 5 2005

### 510(k) Summary A.

| Submitter: | Medoc Ltd. Advanced Medical Systems | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Alquest, Inc<br>Tracy Gray RN, BS, RAC<br>Sr. Consultant and Consultant to Medoc<br>4050 Olson Memorial Hwy      Suite 350<br>Minneapolis, MN 55422. | |
| Date Prepared: | February 2, 2005 | |
| Trade Name: | Contact Heat-Evoked Potential Stimulator (CHEPS) | |
| Classification, Name<br>and Number: | Class II<br>No assigned classification number, as with the predicate devices<br>21 CFR 882 | |
| Product Code: | LQW/LLN | |
| Predicate Device(s): | The subject device is substantially equivalent to the following device(s):<br>GSA Genito<br>Sensory Analyzer<br>(K010981),<br>manufactured by<br>Medoc Ltd.<br>Advanced Medical<br>Systems. TSA-2001<br>Thermal<br>Sensory<br>Analyzer<br>(K922052),<br>manufactured by<br>Medoc Ltd.<br>Advanced<br>Medical<br>Systems. | |

Device Description: The Contact Heat-Evoked Potential Stimulator (CHEPS) is a computerized thermal stimulator that produces a heating stimulation in rate of 70°C/sec, enabling delivery of painful stimuli from a baseline to 55℃ in 250 milliseconds. The system consists of the CHEPS control unit, external cooling unit, 27mm diameter thermode probe, thermode cables, and software. The software program requires the use of an IBM compatible notebook or desktop computer, which is not supplied. Also, the following are optional components: MRI-safe thermode and cables and cart.

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K041908 2/2

・

| Intended Use: | The Contact Heat-Evoked Potential Stimulator (CHEPS) is<br>indicated for the use in evaluating the functionality of human pain<br>reception and transmission of sensory pathways. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and<br>Safety Testing: | The device underwent mechanical, physical, and biocompatibility<br>testing as described in Section 6 and Section 7 of this submission.<br>The results of testing were successful. The device performed as<br>designed and met, or exceed, all product specifications. |
| Conclusion : | Medoc Ltd. Advanced Medical Systems considers the Contact<br>Heat-Evoked Potential Stimulator (CHEPS) equivalent to the<br>predicate devices listed above. This conclusion is based upon the<br>devices' similarities in function, design, materials, and indication<br>for use. |

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like extensions.

Public Health Service

FEB 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medoc Ltd. Advanced Medical Systems c/o Ms. Tracy Gray, RN, BS, RAC Alquest, Inc. 4050 Olson Memorial Highway, Suite 350 Minneapolis, Minnesota 55422

Re: K041908

Trade/Device Name: Contact Heat-Evoked Potential Stimulator (CHEPS) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: NTU Dated: January 17, 2005 Received: January 21, 2005

Dear Ms. Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regars actment date of the Medical Device Amendments, or to conninered pror to they 2011 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Act ( rece) that the device, subject to the general controls provisions of the Act. The r ou may, mererers, mains of the Act include requirements for annual registration, listing of general controls profice, 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 rr your device is elabilitional controls. Existing major regulations affecting your device can may oc subject to adential Regulations, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be acrised and I bring that your device complies with other requirements of the Act that I DT has made a aond regulations administered by other Federal agencies. You must of any I edetal states and seegirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 8077, moening (21 CS) regulation (21 CFR Part 820); and if applicable. the clectronic form in the quant) of the stations (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Tracy Gray, RN, BS, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally prematicated predicated on "The 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 if you desire specific acrioliance 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 golfirers, International 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,

Miriam C Provost

Celia M. Witten, Ph.D., M.D. 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): Pending

Device Name: Contact Heat-Evoked Potential Stimulator (CHEPS)

### Indications For Use:

The Contact Heat-Evoked Potential Stimulator (CHEPS) is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.

Prescription Use ___X________ AND/OR 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use ______________ (Part

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Meriam C. Provost

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

**510(k) Number** K041908