The Contreet Foam is 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. Contreet Foam Nonadhesive is additionally indicated for diabetic foot ulcers.

Device Description

Contreet Foam Dressing is a wound dressing with silver as the active component. The dressing provides an optimal moist wound healing environment, combining an effective antibacterial barrier activity with exudates management.

Contreet Foam Non-adhesive is suitable for use on fragile skin due to the absence of adhesive. The film backing is waterproof and semi permeable.

Contreet Foam Adhesive has a hydrocolloid adhesive border and a central absorbent foam pad containing silver. The film backing is waterproof and semi permeable.

The dressing demonstrates in-vitro antibacterial activity for up to 7 days in certain strains known to be detrimental to wound healing such as Pseudomonas aeruginosa, Staphylococcus aureus, B-haemolytic Streptococcus, MRSA and VRE.*

*The list of bacteria that Contreet Foam has demonstrated in-vitro antibacterial activity towards is as follows: Acinetobacter, C. albicans, C. perfringens, E. cloacae, E. faecalis, E. faecium, E. coli, hemolytic Streptococcus Gr.A, MRSA (Methicillin resistant S. aureus), anaerobic Peptostreptococcus , P. mirabilis, P. vulgaris, P. aeruginosa, S. aureus. Coaqulase negative Staphylococcus, S. epidermidis. VREF (Vancomvcin resistant E. faecium).

AI/ML Overview

The provided document is a 510(k) summary for the Contreet Foam Dressing, an antimicrobial wound dressing. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and intended use.

However, the document does not contain information about acceptance criteria, detailed study designs, or performance metrics from clinical trials or comparative effectiveness studies that would allow for a comprehensive description of how the device meets specific acceptance criteria.

The 510(k) submission process primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, often through in-vitro testing and comparison of technological characteristics, rather than extensive clinical efficacy studies with predefined acceptance criteria.

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

Here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (from provided document)
Substantial Equivalence: Demonstrate that the new device is as safe and effective as a legally marketed predicate device, and does not raise different questions of safety and effectiveness.	The Contreet Foam Dressing is substantially equivalent to Biatain Foam Adhesive Dressing (K983173), Biatain Foam Non-adhesive Dressing (K983163), and Acticoat Moisture Control Dressing (K010447).The only difference to Biatain Foam Dressings is the incorporation of silver. Both Contreet Foam and Acticoat Moisture Control Dressing contain silver as an antimicrobial barrier.
In-vitro Antibacterial Activity: Demonstrate effectiveness against relevant wound pathogens.	The dressing demonstrates in-vitro antibacterial activity for up to 7 days against various strains, including: Pseudomonas aeruginosa, Staphylococcus aureus, B-haemolytic Streptococcus, MRSA, VRE, Acinetobacter, C. albicans, C. perfringens, E. cloacae, E. faecalis, E. faecium, E. coli, hemolytic Streptococcus Gr.A, anaerobic Peptostreptococcus, P. mirabilis, P. vulgaris, Coagulase negative Staphylococcus, S. epidermidis, VREF (Vancomvcin resistant E. faecium).
Biocompatibility/Safety Profile: Not explicitly detailed in the summary, but assumed to be acceptable through material selection and predicate equivalence.	Not explicitly detailed in the provided text.
Exudate Management: Ability to manage wound exudates.	Provides an optimal moist wound healing environment, combining an effective antibacterial barrier activity with exudates management. Indicated for exuding wounds, preferably for the management of wounds with moderately to high amounts of exudates.
Adhesive/Non-Adhesive Properties: Functionality of the adhesive border (for adhesive version) and suitability for fragile skin (for non-adhesive version).	Contreet Foam Adhesive: has a hydrocolloid adhesive border and a central absorbent foam pad. Contreet Foam Non-adhesive: suitable for use on fragile skin due to the absence of adhesive.

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

Not provided. The document focuses on in-vitro data and substantial equivalence, not a clinical trial with a defined test set of patients. The antibacterial activity is stated as "in-vitro."

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/Not provided. No clinical "test set" requiring expert ground truth is described in the provided 510(k) summary for performance evaluation.

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

Not applicable/Not provided. No clinical "test set" and associated adjudication is described.

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 such study was mentioned or performed. This device is a wound dressing, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical wound dressing, not an algorithm.

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

For the antibacterial activity, the ground truth was based on laboratory strain identification and quantification in in-vitro tests.
For substantial equivalence, the "ground truth" is regulatory equivalence to predicate devices based on technological characteristics and intended use.

8. The sample size for the training set:

Not applicable/Not provided. This is a physical medical device, not an AI model requiring a training set in the typical sense.

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

Not applicable/Not provided. No training set for an AI model is involved.

Summary of Device Acceptance:

The Contreet Foam Dressing was accepted for market by the FDA based on a 510(k) Premarket Notification, which determined that the device is substantially equivalent to legally marketed predicate devices. The primary "study" proving this was a comparison of its technological characteristics and performance to the predicates, including the demonstration of in-vitro antibacterial activity. There were no clinical trials with specific acceptance criteria outlined in this summary. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means that due to its similarity to already approved devices, no new significant safety or effectiveness questions were raised that would require extensive clinical studies for this particular submission.

Summary

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

Contreet Foam Dressing K022416 January 21, 2003

510(k) Summary

Contreet Foam Dressing

FEB 0 3 2003

Submitters name, address, phone and fax numbers

Coloplast Corporation 1955 West Oak Circle Marietta, GA 30062-2249 USA Phone: 770-281-8400 Fax: 770-345-8960

Contact person at Coloplast Corp

Elizabeth Boots Vice President Quality Assurance 1940 Commerce Drive PO Box 8300 North Mankato, MN 56002-8300 USA Phone: 507-386-4362 Fax: 507-345-3291

Date 510(k) prepared

June 14, 2002

Name of the medical device

Trade name Contreet Foam Dressing, Adhesive and non-adhesive Common name Topical wound dressing Classification name Dressing, wound and burn, occlusive (21CFR878.4020)

Legally marketed device to which substantial equivalence is claimed

Biatain Foam Adhesive Dressing (K983173) Biatain Foam Non-adhesive Dressing (K983163) Acticoat Moisture Control Dressing (K010447)

Description of the device

Contreet Foam Non-adhesive is suitable for use on fragile skin due to the absence of adhesive. The film backing is waterproof and semi permeable.

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

Contreet Foam Dressing K022416 January 21, 2003

Contreet Foam Adhesive has a hydrocolloid adhesive border and a central absorbent foam pad containing silver. The film backing is waterproof and semi permeable.

Intended use of the device

Contreet Foam is an effective barrier to bacterial penetration in wounds.

Contreet Foam is indicated for exuding wounds, preferably for the management of wounds with moderately to high amounts of exudates.

Contreet Foam is indicated for partial and full thickness wounds, leg ulcers and pressure sores. The dressing can also be used for 20d degree burns, donor sites, postoperative wounds and skin abrasions.

Contreet Foam Non-Adhesive dressing is additionally indicated for diabetic foot ulcers.

Contreet Foam can also support reduction of the odor caused by microorganisms from the wound.

Contreet Foam can be used on patients with wound infection at the discretion of the physician.

Contreet Foam is suitable for use where compression bandaging is indicated.

Summary of technological characteristics of subject device compared to predicate

Contreet Foam compared to Biatain Foam Dressings: Biatain Foam Dressings are PUfoam dressings and are the products that Contreet Foam is based on. The only difference is that Contreet Foam has silver incorporated into it. The indications for use that apply to Biatain also apply to Contreet Foam.

Contreet Foam compared to Acticoat Moisture Control Dressing: Both dressings contain silver, which acts as an antimicrobial barrier.

{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 depiction of a human figure in profile, represented by three curved lines that suggest a head and shoulders. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Coloplast Corporation Elizabeth Boots Vice President, Ouality Assurance 1940 Commerce Drive P. O. Box 8300 North Mankato, Minnesota 56002-8300

Re: K022416

Trade/Device Name: Contreet Foam Adhesive/Non-Adhesive Regulation Number: Unclassified Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 11, 2002 Received: November 18, 2002

Dear Ms. Boots:

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.

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

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

Page 2 - Ms. Elizabeth Boots

(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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

fol Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Statement of indications for use

510(k) Number (if known):

K022416

Device Name:

Contreet Foam Adhesive Contreet Foam Non-Adhesive

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109

Over-The-Counter Use

(Optional Format 1-2-96)

Muriam C. Provost

al, Restorative

K622416

Contreet Foam

Regulation Number and Section

N/A