TempStat" is a daily activity assist device that is intended to assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. TempStat" will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. TempStat™ is intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

Device Description

The Visual Footcare Technologies TempStat® device is a daily activity assist designed to make the examination of the plantar surface of the foot simple and easy to accomplish. It consists of a plastic pancl that has a 2X convex mirror in the center third scction, with two polycarbonate plastic pads on either side of the mirror. The plastic pads are contructed primarily of liquid crystallinc cholesteric esters that react to skin surface temperature and change to a specific color relative to that level of temperature. With this device, the patient can visually examine his foot and also see a graphical representation of the heat pattern on the plantar solc of his foot. The device is designed to sit on the floor in front of the patient, who is seated in a chair. The patient leans over and raises his foot to see the bottom of his foot in the mirror, and then places them on the polycarbonate pads. After 60 seconds, the patient can remove his feet and can visualize the pattern of skin tempcrature from the plantar surface of his foot.

AI/ML Overview

The Visual Footcare Technologies, LLC TempStat™ device, as described in the 510(k) summary, includes performance testing centered on the accuracy of its liquid crystal pads and its ability to assist patients in visualizing their foot's plantar surface. Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Liquid Crystal Pad Temperature Accuracy: The liquid crystal pads must accurately reflect skin surface temperature changes. (Implicitly, the device should provide reliable temperature indications for detecting signs of inflammation).	The TempStat™ liquid crystal pads are accurate within 1ºF with respect to color changes, as assessed following Section 5.2 of the ASTM E 1061-01 Standard.
Patient Assistance in Visualization: The device should effectively assist subjects in visualizing the plantar surface of their feet. (Implicitly, users should find the device helpful for self-examination).	All study subjects in a patient preference study felt that the TempStat™ device enhanced their ability to visualize the plantar surface of their feet.

Detailed Study Information

The provided 510(k) summary offers limited detail on the specific study methodologies for each criterion. Based on the available information:

Sample size used for the test set and the data provenance:
- Temperature Accuracy Study: Not explicitly stated. The study references ASTM E 1061-01 Standard, which might specify sample sizes for such tests, but this detail is not present in the 510(k).
- Patient Preference Study: Not explicitly stated. The text says "All study subjects felt...", which implies a sample was used, but the number is not provided.
- Data Provenance: Not explicitly stated, but given it's for a US regulatory submission, it's highly likely to be US data, and given the nature of the device, likely prospective studies (i.e., experiments designed to test the device).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Temperature Accuracy Study: No experts were mentioned for establishing ground truth for the temperature accuracy. The ground truth would likely be established by a calibrated reference thermometer or laboratory equipment against which the device's color changes are compared, as per ASTM E 1061-01.
- Patient Preference Study: No experts were described as establishing ground truth. This type of study relies on direct feedback from the "study subjects" themselves regarding their perception of the device's utility in visualization, rather than an expert's assessment of their visualization ability.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified for either study.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies focused on functional accuracy and user preference rather than reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Temperature Accuracy Study: This would be considered a standalone performance test of the device's physical components (liquid crystal pads) to accurately reflect temperature. It assesses the intrinsic accuracy of the temperature display mechanism.
- Patient Preference Study: This involved human interaction ("study subjects" viewing their feet), so it was not standalone in the sense of "algorithm only."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Temperature Accuracy Study: The ground truth was likely established by reference to a calibrated temperature standard (e.g., a precise thermometer) as implied by the ASTM E 1061-01 standard.
- Patient Preference Study: The "ground truth" was the self-reported perception of the study subjects regarding the device's assistance in visualization.
The sample size for the training set: Not applicable, as this device does not use machine learning algorithms that would require a training set. Its functionality is based on physical properties of liquid crystals and mirror optics.
How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

Summary

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510(k) Summary for the Visual Footcare Technologies, LLC TempStat™

JUN 2 4 2008

SUBMITTER/510(K) HOLDER 1.

Visual Footcare Technologies, LLC 23 Split Rock Road Pound Ridge, NY 10576

Contact Person: Scott R. Kantro, DPM (914) 588-8808 Telephone: skantro@visualfootcare.com Email:

June 2, 2008 Date Prepared:

2. DEVICE NAME

Proprietary Name:	Visual Footcare Technologies, LLC TempStatT
Common/Usual Name:	Examination Mirror
Classification Name:	Daily activity assist device

PREDICATE DEVICES 3.

890.5050 Daily Activity Assist Device Class I (General Controls) .
The Fred Sammons Extend-A-Mirror (K760293, Product Code ILW). .
880.2200 Liquid Crystal Forehead Temperature Strip Class II (Spccial Controls) . LCR-Hallcrest FeverScan™ Forehead Strip Thermometer

DEVICE DESCRIPTION 4.

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to sit on the floor in front of the patient, who is seated in a chair. The patient leans over and raises his foot to see the bottom of his foot in the mirror, and then places them on the polycarbonate pads. After 60 seconds, the patient can remove his feet and can visualize the pattern of skin tempcrature from the plantar surface of his foot.

5. INTENDED USE

TempStat" is a daily activity assist device that is intended to assist a patient to visualize the image and condition of the soles of their feet in connection with a daily selfexamination for signs of inflammation on the sole of the foot. TempStat™ will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. TempStat™ is intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health carc professional and used under the direction of a health care professional and does not diagnose any specific disease state.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Visual Footcare Tcchnologies TempStat™ device is similar in design and method of operation to the Fred Sammons, Inc. Extend-A-Mirror (K760293). Both devices use a mirror to allow the user to visualize the plantar surface of their feet.

The TempStat™ device is also similar in design and method of operation to the LCR-Hallcrest FeverScan™ Forchead Strip Thermometer. Both devices employ liquid crystals encased within polycarbonate plastic. The liquid crystals change color corresponding to the skin temperature they are in contact with. In fact, the manufacturer of the LCR-Hallcrest FeverScan™ also manufactures the pads used in the TempStat® device.

PERFORMANCE TESTING 7.

The temperature accuracy of the TempStat™ device was assessed as specified in Section 5.2 of the ASTM E 1061-01 Standard. The results demonstrated that the TempStat ™ liquid crystal pads are accurate within 1ºF with respect to color changes.

Visual Footcarc Technologies, LLC, conducted a patient preference study to assess the ability of the TempStat™ device to provide assistance to the subject in visualizing the plantar surface of his foot. All study subjects felt that the TempStat™ device enhanced their ability to visualize the plantar surface of their feet.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2008

Mr. Andrew Singer President Visual Footcare Technologics, LLC P.O. Box 760 South Salem, New York 10590

Re: K080816

Trade/Device Name: Visual Footcare Technologies, LLC, TempStat™ Device Regulation Number: 21 CFR 890.5050 Regulation Name: Daily Activity Assist Device Regulatory Class: I Product Code: OIZ Dated: June 2, 2008 Received: June 3, 2008

Dear Ms. Singer:

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.

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Page 2 - Ms. Singer

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.

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours.

Susan Barnes

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K080816

Visual Footcare Technologies, LLC, TempStat™ Device Device Name:

Indications for Use:

× Prescription Use (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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k<489516

June 2, 2008

Regulation Number and Section

§ 890.5050 Daily activity assist device.

Link to an amendment published at 90 FR 55995, Dec. 4, 2025. (a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.