(329 days)
Not Found
No
The device description and intended use focus on the physical properties of the textile (moisture management, friction reduction, antimicrobial properties) and do not mention any computational or algorithmic functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a skin protectant intended for moisture management and friction reduction, not for diagnosing, treating, or preventing disease. While it reduces bacterial populations in the fabric and has "antimicrobial properties," its primary stated function is managing the skin environment rather than directly treating a medical condition of the skin.
No
Explanation: A diagnostic device is used to diagnose a condition or disease. This device is described as a "skin protectant" for "moisture management and reduce friction" and "reduces bacterial populations in the fabric," which are all therapeutic or preventative functions, not diagnostic ones.
No
The device is a textile product, which is a physical material, not software. The description clearly outlines its composition and physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. This is a direct interaction with the body surface, not the examination of specimens derived from the human body.
- Device Description: The device is a textile used as a skin protectant. It manages moisture and reduces friction on the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide medical information. This device is a topical application for skin management.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin folds and other skin-to-skin contact areas, such as extremities
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
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
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.
1
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.
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 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.
3
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
4
QMT K121898
Indications for Use
510(k) Number (if known): K121898
Device Name: Stay Fresh Skin Fold Management Textile (SFMT)
Indications for Use:
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.
| 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