(225 days)
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.
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.
The Contact Heat-Evoked Potential Stimulator (CHEPS) is a computerized thermal stimulator that produces a heating stimulation, enabling the delivery of painful stimuli from a baseline to 55℃ in 250 milliseconds at a rate of 70°C/sec.
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:
The provided document specifies the device underwent functional and safety testing. However, it does not detail specific quantitative acceptance criteria or corresponding reported performance metrics for the device's primary function of evaluating pain reception and transmission. Instead, it offers a general statement regarding the successful completion of tests.
| Acceptance Criterion | Reported Device Performance | Type of Ground Truth |
|---|---|---|
| Functional Testing | "The device performed as designed and met, or exceeded, all product specifications." | Device Specifications (internal, not detailed) |
| Safety Testing | "The results of testing were successful." | Safety standards/protocols (not detailed) |
| Mechanical Testing | "The device underwent mechanical...testing...The results of testing were successful." | Device Specifications/Engineering Standards (not detailed) |
| Physical Testing | "The device underwent...physical...testing...The results of testing were successful." | Device Specifications/Engineering Standards (not detailed) |
| Biocompatibility Testing | "The device underwent...biocompatibility testing...The results of testing were successful." | Biocompatibility standards (not detailed) |
The ground truth for these evaluations appears to be based on internal product specifications, design requirements, and possibly established safety/biocompatibility standards, rather than clinical outcomes or expert consensus on human pain perception.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific "test set" in the context of clinical or performance data. The device underwent "mechanical, physical, and biocompatibility testing," but details on the sample sizes for these engineering-focused tests are not given. There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Since no clinical "test set" and associated ground truth based on expert assessment are described, this information is not available in the provided document. The "ground truth" for the device's engineering and safety performance was likely internal product specifications and compliance with relevant standards, rather than expert clinical judgment.
4. Adjudication Method for the Test Set:
As no clinical "test set" requiring expert adjudication is described, this information is not available in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on substantial equivalence to predicate devices based on function, design, materials, and indication for use, not on demonstrating an improvement in human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The CHEPS device is a thermal stimulator intended for "evaluating the functionality of human pain reception and transmission of sensory pathways." It is a diagnostic tool that interacts directly with a human; therefore, the concept of "algorithm only without human-in-the-loop performance" as typically applied to image analysis or AI diagnostics does not directly apply in the same way. The device's performance is inherently tied to its interaction with a human subject. No standalone algorithm performance is described.
8. The Sample Size for the Training Set:
The document does not describe a "training set" for an algorithm or AI. The CHEPS device is a hardware and software system for thermal stimulation, not a machine learning model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
As no "training set" is described, this information is not applicable and not available regarding how ground truth for it would have been established.
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SUMMARY AND CERTIFICATION
FEB 2 5 2005
510(k) Summary A.
| Submitter: | Medoc Ltd. Advanced Medical Systems | |
|---|---|---|
| Contact Person: | Alquest, IncTracy Gray RN, BS, RACSr. Consultant and Consultant to Medoc4050 Olson Memorial Hwy Suite 350Minneapolis, MN 55422. | |
| Date Prepared: | February 2, 2005 | |
| Trade Name: | Contact Heat-Evoked Potential Stimulator (CHEPS) | |
| Classification, Nameand Number: | Class IINo assigned classification number, as with the predicate devices21 CFR 882 | |
| Product Code: | LQW/LLN | |
| Predicate Device(s): | The subject device is substantially equivalent to the following device(s):GSA GenitoSensory Analyzer(K010981),manufactured byMedoc Ltd.Advanced MedicalSystems. TSA-2001ThermalSensoryAnalyzer(K922052),manufactured byMedoc Ltd.AdvancedMedicalSystems. |
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) isindicated for the use in evaluating the functionality of human painreception and transmission of sensory pathways. |
|---|---|
| Functional andSafety Testing: | The device underwent mechanical, physical, and biocompatibilitytesting as described in Section 6 and Section 7 of this submission.The results of testing were successful. The device performed asdesigned and met, or exceed, all product specifications. |
| Conclusion : | Medoc Ltd. Advanced Medical Systems considers the ContactHeat-Evoked Potential Stimulator (CHEPS) equivalent to thepredicate devices listed above. This conclusion is based upon thedevices' similarities in function, design, materials, and indicationfor 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 (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
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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
§ 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).