(27 days)
The Modified Contact Heat-Evoked Potential (CHEPS) is indicated finaloations in evaluating the functionality of human pain reception and transmission of sensory pathways.
The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.
This document is a 510(k) summary for a medical device called the "Modified Contact Heat-Evoked Potential Stimulator (CHEPS)". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics for the device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies against specific criteria.
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Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K051448". The characters are written in a simple, slightly irregular style, suggesting they were written quickly or casually. The number appears to be a serial number or identification code.
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | MedicSense, Ltd.Galdani Bldg58b Amal St.Kiriat Arie, Petach Tikya, Israel 47103www.medicsense.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | Medoc, Ltd., Advanced Medical SystemsHa' oren St. 45Ramat Yishai, Israel 30095 |
| Mfg. Phone: | 972-4-9830751 | |
| Contact Person: | Udi Gafni, President | |
| Date: | May 31, 2005 | |
| 2. | Device &ClassificationName: | Evoked response thermal stimulator, Class 2, Product Code NTU,21 CFR 882.1870- Modified Contact Heat-Evoked Potential Stimulator(CHEPS) |
| 3. | Predicate Device: | Contact Heat-Evoked Potential Stimulator K041908 |
| 4. | Description: | The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) is anadvanced, computerized thermal stimulator designed for advanced painresearch. This non-invasive device can be used as a stimulator for creatingsensation and pain stimuli, in the sensory nerves fibers. |
| 5. | Intended Use: | The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) isindicated for the use in evaluating the functionality of human pain receptionand transmission of sensory pathways |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology, the Modified Contact Heat-Evoked PotentialStimulator (CHEPS) is substantially equivalent to its predicate device whichis the Original Contact Heat-Evoked Potential Stimulator (CHEPS). Theprimary differences between the devices are the enclosure, the addition of athermode, the Ramp & Hold option, and optional languages. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread, with three curved lines representing the wings and two curved lines representing the tail feathers. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Medoc, Ltd. Advanced Medical Systems C/o Mr. George J. Hattub, RAC & CQE Medicsense 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K051448
Trade/Device Name: Modified 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: May 31, 2005 Received: June 3, 2005
Dear Mr. Hattub:
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. George J. Hattub, RAC & CQE
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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. 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): 1 051448
Device Name: Modified Contact Heat-Evoked Potential Stimulator (CHEPS)
Indications For Use: The Modified Contact Heat-Evoked Potential (CHEPS) is indicated finaloations 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)
Rula Rha
sion Sign-
of Ge. 1 Restorative
آٽان ناديندي والي رياني ريالي سان
§ 882.1870 Evoked response electrical stimulator.
(a)
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.(b)
Classification. Class II (performance standards).