InterDry Textile with Silver is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile with Silver reduces microbial colonization in the fabric.

Device Description

Interdry Textile with Silver is a non-sterile skin protectant comprised of polyester knit textile substrate indicated for management of skin folds and other skin-to-skin contact areas and is offered as a 25.4 cm x 365.8 cm fabric piece, although other sizes may be available. The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Interdry Textile with Silver is a single patient use product that is custom cut from a multiuse package.

AI/ML Overview

The provided text describes a 510(k) summary for the "Interdry Textile with Silver" device, which is a skin protectant. The performance testing section mentions "Biocompatibility testing" and "Antimicrobial testing". However, it does not provide detailed acceptance criteria with specific numerical targets, nor does it present a detailed study with a defined sample size, ground truth, or statistical analysis in the way typically expected for an AI/ML device.

It's important to note that K061615 is for a medical textile, not an AI/ML device. Therefore, the questions about AI/ML specific criteria (e.g., test set sample size, experts for ground truth, MRMC study, training set size) are not applicable to this submission. The "study" mentioned here refers to standard biocompatibility and antimicrobial efficacy tests for a medical textile.

Here's an attempt to answer the questions based on the available information, noting the limitations due to the nature of the device:

Acceptance Criteria and Device Performance for Interdry Textile with Silver (K061615)

This 510(k) submission is for a medical textile, not an AI/ML device. Therefore, many of the requested details, particularly those related to machine learning model evaluation, are not applicable. The reported performance relates to the physical and biological characteristics of the textile.

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

Acceptance Criteria Category	Specific Test/Attribute	Acceptance Criteria (Implied/General)	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Irritation (typical for ISO 10993)	Suitable for intended use without adverse biological reactions	"Results of the Organization for biocompatibility tests demonstrate that the device is suitable for its intended use."
Antimicrobial Efficacy (Device itself)	Reduction of microbial colonization within the fabric	Effective microbial barrier to the device itself	"Antimicrobial testing was performed which showed that Interdry Textile with Silver provides an effective microbial barrier to the device itself."
Material Equivalence/Comparison to Predicate	Design, Function, Intended Use	Substantially equivalent to predicate in design, function, and intended use; additional feature does not affect safety/effectiveness.	"Substantially equivalent in design, function and intended use to the SurePress device." "The additional antimicrobial feature... does not affect the safety and effectiveness of the device."
Physical Properties	Moisture management, low coefficient of friction	Provides moisture management to keep skin dry; reduces skin-to-skin friction.	"The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction." (Describes device function, not a specific test result here)

Note: Specific numerical acceptance criteria for biocompatibility and antimicrobial tests are not provided in this summary. These would typically be detailed in the full submission, referencing standards like ISO 10993 for biocompatibility and specific microbiological test standards.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. For biocompatibility tests, sample sizes are dictated by the specific ISO 10993 test methods (e.g., animal tests, in-vitro cell cultures). For antimicrobial testing, sample sizes are typically small, involving various microbial strains and replicates.
Data Provenance: Not explicitly stated but inferred to be laboratory-generated data from testing performed to industry standards. This is likely prospective testing conducted in controlled environments. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of device. "Ground truth" in the context of biocompatibility and antimicrobial testing is established by standard laboratory protocols and expert interpretation of results, not by a consensus of medical experts reviewing patient data. The "experts" would be the scientists and toxicologists performing and interpreting the laboratory tests according to established scientific principles and standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical outcome or image interpretation studies. For laboratory tests, results are interpreted based on predefined criteria in the test standard, often without external adjudication beyond internal quality control and peer review of results.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Ground Truth for Biocompatibility: Established by adherence to standardized testing protocols (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and comparison against established biological reactivity scales. The "truth" is whether the material elicits a harmful biological response above acceptable thresholds.
Ground Truth for Antimicrobial Efficacy: Established by quantitative microbiological assays that measure the reduction in microbial counts when in contact with the material, compared to control samples. The "truth" is the measured inhibition or kill rate of specific microorganisms.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

Summary

{0}------------------------------------------------

K061615

510(k) Summary for Interdry Textile with Silver

DEC 2 2 2006

1. SPONSOR

Milliken Chemical 920 Milliken Rd. PO Box 1927, M-209 Spartanburg, SC 29304

John D. Bruhnke, Ph.D. Contact Person: Telephone: 864-503-2844

June 8, 2006 Date Prepared:

2. DEVICE NAME

Proprietary Name:	Interdry Textile with Silver
Common/Usual Name:	Skin Protectant
Classification Name:	Fiber, Medical, Absorbent

3. PREDICATE DEVICE

. SurePress Absorbent Padding (21 CFR 880.5300)

4. DEVICE DFSCRIPTION

Interdry Textile with Silver is a non-sterile skin protectant comprised of polyester knit textile substrate indicated for management of skin folds and other skin-toskin contact areas and is offered as a 25.4 cm x 365.8 cm fabric piece, although other sizes may be available. The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Interdry Textile with Silver is a single patient use product that is custom cut from a multiuse package.

{1}------------------------------------------------

ડ. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Technological characteristics of Interdry Textile with Silver and the predicate product are substantially equivalent in that they are devices designed for moisture (fluid) absorption and are suitable for use on skin. The Interdry Textile with Silver is manufactured from a knitted polyester fabric containing a polyurethane coating (with AlphaSan RC-500) whereas the predicate, SurePress™ Absorbent padding, is a nonwoven fabric made from a blend of viscose/bicomponent with superabsorbent fibers (88:12). The only significant difference between the Interdry Textile with Silver and the predicate device is that Interdry Textile with Silver contains a small amount of a silver-based antimicrobial in a polyurethane coating for odor control. This additional function of Interdry Textile with Silver is minor and does not affect the safety or effectiveness of the device, as demonstrated by the biocompatibility and physical property tests that were performed and compared with the predicate device, SurePress™M Absorbent Padding.

7. PERFORMANCE TESTING

Biocompatibility testing was performed in accordance with the International Standardization recommendations. Results of the Organization for biocompatibility tests demonstrate that the device is suitable for its intended use. Antimicrobial testing was performed which showed that Interdry Textile with Silver provides an effective microbial barrier to the device itself. Milliken believes that the data included in this submission including the technical characteristics and physical properties demonstrate that Interdry Textile with Silver is substantially equivalent in design, function and intended use to the SurePress device. The additional antimicrobial feature of Interdry Textile with Silver does not affect the safety and effectiveness of the device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2007

Milliken Chemical C/O Mary McNamara-Cullinane Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K061615

Trade/Device Name: Interdry Textile with Silver Regulation Number: 21 CFR 880.5300 Regulation Name: Medical Absorbent Fiber Regulatory Class: I Product Code: FRL Dated: December 18, 2006 Received: December 19, 2006

Dear Ms. McNamara-Cullinane:

This letter corrects our substantially equivalent letter of December 22, 2006.

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.

{3}------------------------------------------------

Page 2 - Ms. McNamara-Cullinane

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 (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suíte Y. Michael Oud.

Chiu-Lin, Ph.D.

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K061615

Device Name: Interdry Textile with Silver

Indications for Use:

Prescription Use X (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)

Cun V

ra Intogy, Ganeral Hospila I,

96161s

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.