The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric.

Device Description

Stav Fresh Skin Fold Management Textile is a non-sterile skin protectant indicated for management of skin folds and other skin-to-skin contact areas, such as extremities, and is offered as a 25.4 cm x 365.8 cm fabric piece (other sizes may also be available). The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Stay Fresh Skin Fold Management Textile is a single patient use product that is custom cut from a multiuse package. Polyester fabrics are well known to wick moisture away from skin as well as provide a low friction surface.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device (Stay Fresh Skin Fold Management Textile) and associated FDA correspondence. However, it does not contain the detailed information requested regarding specific acceptance criteria, a study proving those criteria were met, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based device study.

The document states that the device was subjected to "extensive testing to assess the biocompatibility and the performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties." This is a general statement and does not provide the specifics of a study suitable for answering the questions.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of specific quantitative thresholds for properties like moisture management or bacterial reduction.
Reported Device Performance: The text generally states the device "was shown to provide moisture management and antimicrobial properties." No specific metrics or values are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not mentioned.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable as this is a textile product, not an AI/diagnostic device requiring expert ground truth in that sense. The "testing" mentioned doesn't involve medical image interpretation or similar.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for this type of device and testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, this is not an AI/algorithm-based diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not an AI/algorithm-based diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "moisture management and antimicrobial properties" testing, the ground truth would likely be based on established laboratory methods and standards for measuring these properties (e.g., absorbency tests, microbiological assays). However, the specific methods are not detailed.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI/machine learning model.

Summary Table (with available information):

Criterion/Information	Description from Provided Text
1. Acceptance Criteria & Reported Device Performance	Acceptance Criteria: Not explicitly stated as quantitative thresholds.Reported Performance: "The performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties." (No specific metrics or quantitative results provided).
2. Test Set Sample Size & Data Provenance	Sample Size: Not mentioned.Data Provenance: Not mentioned.
3. Number of Experts & Qualifications (for ground truth)	Not applicable (not an AI/diagnostic device requiring expert ground truth).
4. Adjudication Method (for test set)	Not applicable (not an AI/diagnostic study).
5. MRMC Comparative Effectiveness Study	No, not an AI/algorithm-based diagnostic device.
6. Standalone Algorithm Performance Study	No, not an AI/algorithm-based diagnostic device.
7. Type of Ground Truth Used (for performance claims)	Likely established laboratory methods for moisture management (e.g., absorbency) and antimicrobial properties (e.g., microbiological assays). Specifics not provided.
8. Training Set Sample Size	Not applicable (not an AI/machine learning model).
9. How Ground Truth for Training Set Was Established	Not applicable (not an AI/machine learning model).

Summary

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K121898

510(k) Summary for the Quick-Med Technologies, Inc. Stay Fresh Skin Fold Management Textile

MAY 2 4 2013

1. SUBMITTER/510(K) HOLDER

Quick-Med Technologies, Inc. 902 NW 4th Street Gainesville, FL 32601 352-379-0611 352-379-1099 (fax)

Contact Person: Susan Leander Telephone: 352-379-0611

Date Prepared: May 24, 2013

2. DEVICE NAME

Proprietary Name:	Stay Fresh™ Skin Fold Management Textile
Common/Usual Name:	Skin Protectant
Classification Name:	Medical absorbent fiber
Classification Regulation:	21 CFR 880.5300
Product Code:	FRL

3. PREDICATE DEVICES

· Milliken Interdry Textile with Silver subject of K110715, K061615
· ConvaTec SurePress® Absorbent Padding which is listed with the FDA by Convatec

4. DEVICE DESCRIPTION

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5. INTENDED USE

The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin-to-skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Stay Fresh Skin Fold Management Textile is substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use.

7. PERFORMANCE TESTING

The Stay Fresh Skin Fold Management Textile has been subjected to extensive testing to assess the biocompatibility and the performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties.

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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 consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2013

Quick-Med Technologies, Incorporated Ms. Susan E. Leander, M.S. Regulatory Affairs Coordinator 902 North West, 4th Street GAINESVILLE, FL 32601

Re: K121898

Trade/Device Name: Stay Fresh Skin Fold Management Textile (SFMT) Regulation Number: 21 CFR 880.5300 Regulation Name: Medical Absorbent Fiber Regulatory Class: I Product Code: FRL Dated: May 15, 2013 Received: May 17, 2013

Dear Ms. Leander:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Leander

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Image /page/3/Picture/7 description: The image shows a signature and some text. The text includes the phrase "Sincerely yours," followed by a signature that is difficult to read. To the right of the signature, the text "Tejashri" and "Clinical D" are visible, along with the word "DAGRID".

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

Anthony D. Watson, B.S., M.S., M.B.A. . Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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QMT K121898

Indications for Use

510(k) Number (if known): K121898

Device Name: Stay Fresh Skin Fold Management Textile (SFMT)

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

. AND/OR

Over-The-Counter Use X (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) ·
	Date:

Division Sign-Off) livision of Anesthesiology, General Hospital infection Control, Dental Devices

. 2013.05.24 13:20:56 -04'00'

510(k) Number: KI21898

Regulation Number and Section

§ 880.5300 Medical absorbent fiber.

(a)
Identification. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.(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 § 880.9. If the device is not labeled or otherwise represented as sterile, it 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.