(234 days)
K061615, 21 CFR 880.5300
Not Found
No
The summary describes a textile with antimicrobial properties and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is a skin protectant fabric designed to manage skin folds and reduce microbial colonization, which falls under general wound care rather than a high-level therapeutic intervention.
No.
The device description and intended use focus on protecting skin and reducing microbial colonization, not on diagnosing medical conditions.
No
The device description clearly states it is a "non-sterile skin protectant fabric with an antimicrobial silver complex," indicating it is a physical textile product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect skin in skin folds and other skin-to-skin contact areas and reduce microbial colonization in the fabric. This is a topical application for managing skin conditions, not for diagnosing a disease or condition based on testing samples taken from the body.
- Device Description: It's described as a "skin protectant fabric." This aligns with a topical medical device, not an IVD which typically involves reagents, instruments, and software for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, InterDry Textile is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
InterDry is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry reduces microbial colonization in the fabric.
Product codes (comma separated list FDA assigned to the subject device)
FRL
Device Description
InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.
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
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)
Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use.
Antimicrobial effectiveness testing was performed which showed that InterDry reduces microbial colonization within the device itself.
Physical property testing was performed, including absorption, wicking, friction and silver release. Results of the physical testing indicate that the physical properties of the InterDry are substantially equivalent to the SurePress Absorbent Padding and that the InterDry is suitable for its intended use.
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.
K061615, 21 CFR 880.5300
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
K110715 page 1 of 2
NOV - 4 2011
ﻟﻤﺴﺘﺒ
510(K) SUMMARY for InterDry
1. SPONSOR Milliken Healthcare Products, LLC
920 Milliken Road Spartanburg, SC 29303 Telephone: 864-503-1323 Facsimile: 864-504-6800
Primary Contact: Brian J Lindsay (864-503-1323) Secondary Contact: Peter Kang (864-503-6452)
Date Prepared: March 11, 2011
2. DEVICE NAME
| Proprietary Name: | InterDry |
|---|---|
| Common/Usual Name: | Skin Protectant |
| Classification Name: | Fiber, Medical, Absorbent (21 CFR 880.5300, Product Code FRL) |
3. PREDICATE DEVICE
- InterDry Textile with Silver (K061615, Milliken Healthcare Products, LLC) .
- SurePress Absorbent Padding (21 CFR 880.5300, Convatec, Inc.) .
4. DEVICE DESCRIPTION
InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.
5. INDICATIONS FOR USE
InterDry is a skin protectant indicated for management of skin folds and other skin-toskin contact areas. InterDry reduces microbial colonization in the fabric.
1
K110715 page 2 of 2
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The InterDry is identical to the previously cleared InterDry Textile with Silver (K061615).
The technological characteristics of InterDry and the predicate products are substantially equivalent in that they are devices designed for moisture (fluid) absorption and are suitable for use on skin.
InterDry is substantially equivalent in material, design, performance and indications for use to the original InterDry Textile with Silver (K061615), which is indicated for prescription use only. The InterDry is substantially equivalent in design, function and intended use to the SurePress™ Absorbent Padding from ConvaTec which is indicated for over-the-counter use.
7. PERFORMANCE TESTING
Biocompatibility testing was performed in accordance with the International Organization for Standardization recommendations. Results of the biocompatibility tests demonstrate that the device is suitable for its intended use.
Antimicrobial effectiveness testing was performed which showed that InterDry reduces microbial colonization within the device itself.
Physical property testing was performed, including absorption, wicking, friction and silver release. Results of the physical testing indicate that the physical properties of the InterDry are substantially equivalent to the SurePress Absorbent Padding and that the InterDry is suitable for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
Mr. Brian J. Lindsay Quality & Regulatory Manager Milliken Healthcare Products, LLC 920 Milliken Road Spartanburg, South Carolina 29303
Re: K110715
Trade/Device Name: InterDry Regulation Number: 21 CFR 880.5300 Regulation Name: Medical Absorbent Fiber Regulatory Class: I Product Code: FRL Dated: May 19, 2011 Received: June 3, 2011
Dear Mr. Lindsay:
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 - Mr. Lindsay
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Industry/default.htm.
Sincerely yours,
Anthony D. Aus
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): __ _ _ K110715
Device Name: _ _ InterDry
Indications for Use:
InterDry Textile is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile reduces microbial colonization in the fabric.
Prescription Use AND/OR Over-the-Counter Use X (Part 21 CFR 801 Subpart D) (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)
Richard C. Chopra 11/3/4
(Division Sign. Off.)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: