Biatain Ag Foam Adhesive & Non-Adhesive Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions. Biatain Ag Foam Non-Adhesive Dressings are additionally indicated for diabetic foot ulcers. Biatain Ag Foam Cavity Dressings are indicated for deep wounds with moderate to high amounts of exudate. Biatain Ag Foam Cavity Dressings are indicated for stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.

Device Description

Biatain Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria, or where there is a risk of infection. Biatain Ag Foam Dressings consist of soft, absorbing polyurethane (PU) foam pads with a moisture-permeable PU topfilm on one side and a smooth, wound-contact surface on the other side. The foam is directly on the topfilm, except for Biatain Ag Cavity which has no topfilm. The foams contain silver, which is released upon contact with wound exudate. The dressings are available in different sizes and shapes, including squares and rectangles, with rounded corners. Biatain Ag Non-Adhesive Foam Dressings also have bevelled edges. Foam thicknesses are 3 mm or 4.4 mm. The dressings are individually-packed in a pouch. All dressings are sterile and are for single use only.

AI/ML Overview

The provided text describes a 510(k) summary for Biatain Ag Foam Dressings and indicates that substantial equivalency is supported by bench testing and biocompatibility testing. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance metrics such as sensitivity, specificity, or reader studies.

The document is a regulatory submission for a medical device (wound dressing) and its focus is on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. Such submissions typically do not include detailed performance studies with acceptance criteria in the way an AI/software device would.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be extracted based on the document:

A table of acceptance criteria and the reported device performance
- Not applicable / Information not provided. The document states "Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device." It does not present specific acceptance criteria or performance metrics (like sensitivity, specificity, agreement rates) in a tabular format typically seen for algorithm performance. The "performance" here refers to the overall product functionality and safety, not AI-driven diagnostic accuracy.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Information not provided. This document does not describe a clinical performance study with a test set. The "bench testing" mentioned generally involves laboratory tests, not patient data in the sense of a clinical trial for AI performance.
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 / Information not provided. This information pertains to studies where ground truth needs to be established through expert review, typically for AI or diagnostic devices. This document describes a physical wound dressing, not a diagnostic tool requiring expert ground truth for performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Information not provided. As there's no clinical performance test set or expert ground truth process described, adjudication methods are not relevant here.
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 / Information not provided. This document describes a physical medical device (wound dressing), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Information not provided. The device is a physical wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Information not provided. For "bench testing" and "biocompatibility testing," ground truth refers to established laboratory standards and test methodologies, not clinical ground truth like pathology or expert consensus for AI performance.
The sample size for the training set
- Not applicable / Information not provided. This document is not about an AI device, so there is no concept of a "training set."
How the ground truth for the training set was established
- Not applicable / Information not provided. As above, there is no AI training set.

Summary

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510(k) Summary

Biatain Ag Foam Dressings

The assigned 510(k) number is: K100218

510(k) Owner's Name: Coloplast A/S

Contact Person: Rebeka A. Stoltman
Manager, Regulatory Affairs
Coloplast Corp.
1601 West River Road North
Minneapolis, MN 55411

Telephone: (612) 302-4997
Facsimile: (612) 287-4138
Email: usrst@coloplast.com

Date Prepared: January 22, 2010

FEB 17 2010

Device Name and Classification

Trade Name:	Biatain Ag Foam Dressings
Common Name:	Topical Wound Dressing
Classification:	Unclassified; 21 CFR § 878.4020
Classification Name:	Dressing, Wound, Drug
Product Code:	FRO

Manufacturer

Coloplast A/S Holtedam 1 3050 Humlebaek, Denmark

ﺮ ﻟﻤ Establishment Registration: 9610694 Owner/Operator: 8010144

Biatain Ag Foam Dressings

Confidential -

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Device Description

The dressings are available in different sizes and shapes, including squares and rectangles, with rounded corners. Biatain Ag Non-Adhesive Foam Dressings also have bevelled edges. Foam thicknesses are 3 mm or 4.4 mm.

The dressings are individually-packed in a pouch. All dressings are sterile and are for single use only.

Substantial Equivalence Claim

The modified Coloplast Biatain Ag Foam Dressings are substantially equivalent in performance, indications, design and materials to Coloplast's currently marketed Contreet Adhesive and Non-Adhesive Foam Dressings and Contreet Cavity Foam Dressings, which were cleared under 510(k)s K022416 & K033869, respectively.

Indications for Use

Biatain Ag Foam Cavity Dressings are indicated for deep wounds with moderate to high amounts of exudate. Biatain Ag Foam Cavity Dressings are indicated for stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.

Summary & Conclusions of the Nonclinical Tests Submitted

Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device.

Biatain Ag Foam Dressings

Confidential -

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

FEB 1 7 2010

Coloplast A/S % Coloplast Corporation Ms. Rebeka A. Stoltman 1601 West River Road North Minneapolis, Minnesota 55411

Re: K100218

Trade/Device Name: Biatain Ag Foam Adhesive & Non-Adhesive, & Cavity Regulatory Class: Unclassified Product Code: FRO Dated: January 22, 2010 Received: January 26, 2010

Dear Ms. Stoltman:

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.

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.

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Page 2 - Ms. Rebeka A. Stoltman

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.html 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/Reportal?roblem/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 tolloffree 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,

Mark N. Mallonee

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Biatain Ag Foam Adhesive & Non-Adhesive, & Cavity

Biatain Ag Foam Non-Adhesive Dressings are additionally indicated for diabetic foot ulcers.

Biatain Ag Foam Cavity Dressings are indicated for deep wounds with moderate to high amounts of exudate.

Biatain Ag Foam Cavity Dressings are indicated for stage II, III and IV pressure ulcers, leg

ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.

Daniel Keene for MXM
Sign-Off

Division of Surgical, Orthopedic, and Restorative Devic

510(k) Number K100218

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

N/A