(143 days)
Not Found
No
The summary describes a thermal stimulator for pain research and does not mention any AI or ML components or functionalities.
No
Explanation: The device is described as a stimulator for creating sensation and pain stimuli for evaluating functionality of pain reception and transmission, indicating a diagnostic or research purpose, not a therapeutic one.
Yes
The device is indicated for "evaluating the functionality of human pain reception and transmission of sensory pathways," which is a diagnostic purpose.
No
The device description explicitly states it is a "computerized thermal stimulator," indicating it includes hardware components for generating thermal stimuli.
Based on the provided information, the PATHWAY- ATS/CHEPS is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The PATHWAY- ATS/CHEPS is described as a "computerized thermal stimulator" that is "non-invasive" and used to "create sensation and pain stimuli, in the sensory nerves fibers." This involves applying a stimulus to the body, not analyzing a specimen taken from the body.
- Intended Use: The intended use is "evaluating the functionality of human pain reception and transmission of sensory pathways." This is achieved by stimulating the body and observing the response, not by analyzing a biological sample.
Therefore, the PATHWAY- ATS/CHEPS falls under the category of a medical device that interacts with the body directly, rather than an IVD that analyzes samples from the body.
N/A
Intended Use / 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
Product codes
NTU
Device Description
The PATHWAY- ATS/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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a simple, modern design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
No text detected in this image.
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
1
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
2
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
3
| 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
Address: | MedicSense, Ltd.
Galdani Bldg
58b Amal St.
Kiriat Arie, Petach Tikya, Israel 47103
www.medicsense.com |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | Medoc, Ltd., Advanced Medical Systems
Ha' oren St. 45
Ramat Yishai, Israel 30095 |
| | Mfg. Phone: | 972-4-9830751 |
| | Contact Person: | Udi Gafni, President |
| | Date: | August 26, 2005 |
| 2. | Device &
Classification
Name: | Evoked response thermal stimulator, Class 2, Product Code NTU,
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
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. |
| 5. | Intended Use: | The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the
functionality of human pain reception and transmission of sensory pathways |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology, the PATHWAY- ATS/CHEPS is substantially
equivalent to its predicate device which is the Modified Contact Heat-Evoked
Potential Stimulator (CHEPS). The primary differences between the devices
is the ability of one of its thermodes to provide lower temperatures |