(225 days)
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No
The document describes a thermal stimulator and its components, focusing on hardware and basic software control for delivering stimuli. There is no mention of AI, ML, or any learning or adaptive algorithms.
No
The device is used for evaluating the functionality of pain reception and transmission pathways, not for treating or providing therapy for a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device "is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways," which aligns with the definition of a diagnostic device that assesses physiological function.
No
The device description explicitly lists hardware components such as the control unit, cooling unit, thermode probe, and cables, in addition to the software.
Based on the provided information, the Contact Heat-Evoked Potential Stimulator (CHEPS) is not an In Vitro Diagnostic (IVD) device.
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 for diagnosis, monitoring, or screening.
- CHEPS Function: The CHEPS device directly stimulates the human body (skin) to evoke a physiological response (pain reception and transmission) that is then measured. It does not analyze samples taken from the body.
- Intended Use: The intended use is to evaluate the functionality of human pain reception and transmission pathways, which is a direct assessment of a physiological process within the body, not an analysis of a biological sample.
- Device Description: The description details components for applying thermal stimulation to the skin and a control unit, not components for handling or analyzing biological specimens.
Therefore, the CHEPS device falls under the category of a therapeutic or diagnostic device that interacts directly with the patient, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LQW/LLN, NTU
Device Description
The Contact Heat-Evoked Potential Stimulator (CHEPS) is a computerized thermal stimulator that produces a heating stimulation in rate of 70 degrees C/sec, enabling delivery of painful stimuli from a baseline to 55 degrees C 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device underwent mechanical, physical, and biocompatibility testing as described in Section 6 and Section 7 of this submission. The results of testing were successful. The device performed as designed and met, or exceed, all product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
SUMMARY AND CERTIFICATION
FEB 2 5 2005
510(k) Summary A.
| Submitter: | Medoc Ltd. Advanced Medical Systems | |
|---|---|---|
| Contact Person: | Alquest, Inc | |
| Tracy Gray RN, BS, RAC | ||
| Sr. Consultant and Consultant to Medoc | ||
| 4050 Olson Memorial Hwy Suite 350 | ||
| Minneapolis, MN 55422. | ||
| Date Prepared: | February 2, 2005 | |
| Trade Name: | Contact Heat-Evoked Potential Stimulator (CHEPS) | |
| Classification, Name | ||
| and Number: | Class II | |
| No assigned classification number, as with the predicate devices | ||
| 21 CFR 882 | ||
| Product Code: | LQW/LLN | |
| Predicate Device(s): | The subject device is substantially equivalent to the following device(s): | |
| GSA Genito | ||
| Sensory Analyzer | ||
| (K010981), | ||
| manufactured by | ||
| Medoc Ltd. | ||
| Advanced Medical | ||
| Systems. TSA-2001 | ||
| Thermal | ||
| Sensory | ||
| Analyzer | ||
| (K922052), | ||
| manufactured by | ||
| Medoc Ltd. | ||
| Advanced | ||
| Medical | ||
| 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.
1
K041908 2/2
・
| Intended 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. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and
Safety Testing: | The device underwent mechanical, physical, and biocompatibility
testing as described in Section 6 and Section 7 of this submission.
The results of testing were successful. The device performed as
designed and met, or exceed, all product specifications. |
| Conclusion : | Medoc Ltd. Advanced Medical Systems considers the Contact
Heat-Evoked Potential Stimulator (CHEPS) equivalent to the
predicate devices listed above. This conclusion is based upon the
devices' similarities in function, design, materials, and indication
for use. |
:
2
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.
3
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 (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 other golfirers, 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,
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
4
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