PATHWAY - ATS/CHEPS

K052357 · Medoc Ltd. Advanced Medical Systems · NTU · Jan 19, 2006 · Neurology

Device Facts

• Record ID: K052357
• Device Name: PATHWAY - ATS/CHEPS
• Applicant: Medoc Ltd. Advanced Medical Systems
• Product Code: NTU · Neurology
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Indications for Use

The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.

Device Story

PATHWAY- ATS/CHEPS is a computerized thermal stimulator for pain research and sensory nerve fiber stimulation. Device delivers non-invasive thermal stimuli to skin; induces sensation and pain responses. Operated by clinicians in research or clinical settings. System utilizes thermodes to apply controlled heat/cold stimuli; enables evaluation of sensory pathway functionality. Output consists of controlled thermal stimulation; healthcare providers observe patient response to assess nerve transmission. Benefits include objective assessment of pain reception pathways.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Computerized thermal stimulator; utilizes thermodes for heat/cold delivery. Capable of reaching lower temperatures than predicate. Non-invasive. Software-controlled stimulation parameters.

Indications for Use

Indicated for evaluating human pain reception and sensory pathway transmission functionality in patients requiring neurological assessment.

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

• Modified Contact Heat-Evoked Potential Stimulator (K051448)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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FEB - 2 2006

Medoc, Ltd., Advanced Medical Systems c/o Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K052357

Trade/Device Name: Pathway - ATS/CHEPS Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: NTU Dated: December 20, 2005 Received: December 22, 2005

Dear Mr. Hattub:

This letter corrects our substantially equivalent letter of January 19, 2006.

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 (PMA). You mav. 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 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 mav 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

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## Page 2 - Mr. Hattub

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.

This letter will allow you to continue 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" (21 CFR 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,

Кавале Внешко

Mark N. Melkerson Acting 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):

Device Name: PATHWAY- ATS/CHEPS

Indications For Use: The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buckland A. McKie
(Division Signee)

Division of General, Restorative and Neurological Devices

Page 1 of 1

510(k) Number K052357

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| K052357 | 1/1 (1 of 1)

## JAN 1 9 2006

## 510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. (a) | Submitter<br>Address: | MedicSense, Ltd.<br>Galdani Bldg<br>58b Amal St.<br>Kiriat Arie, Petach Tikya, Israel 47103<br>www.medicsense.com |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer<br>Address: | Medoc, Ltd., Advanced Medical Systems<br>Ha' oren St. 45<br>Ramat Yishai, Israel 30095 |
| | Mfg. Phone: | 972-4-9830751 |
| | Contact Person: | Udi Gafni, President |
| | Date: | August 26, 2005 |
| 2. | Device &<br>Classification<br>Name: | Evoked response thermal stimulator, Class 2, Product Code NTU,<br>21 CFR 882.1870- Trade-name of device: PATHWAY- ATS/CHEPS |
| 3. | Predicate Device: | Modified Contact Heat-Evoked Potential Stimulator K051448 |
| 4. | Description: | The PATHWAY- ATS/CHEPS is an advanced, computerized thermal<br>stimulator designed for advanced pain research. This non-invasive device<br>can be used as a stimulator for creating sensation and pain stimuli, in the<br>sensory nerves fibers. |
| 5. | Intended Use: | The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the<br>functionality of human pain reception and transmission of sensory pathways |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology, the PATHWAY- ATS/CHEPS is substantially<br>equivalent to its predicate device which is the Modified Contact Heat-Evoked<br>Potential Stimulator (CHEPS). The primary differences between the devices<br>is the ability of one of its thermodes to provide lower temperatures |