AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as:

Partial thickness (second degree) burns; -
Diabetic foot ulcers, leg ulcers, (venous stasis ulcers and leg ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
Surgical wounds -
Traumatic wounds; -
Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
Abrasions;
Lacerations;
Minor Cuts;
Minor scalds and burns.

Device Description

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is a soft, sterile foam wound dressing comprised of a waterproof outer polyurethane film and a multi-layered absorbent pad, with the adhesive dressing having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of silver Hydrofiber™ (sodium carboxymethylcellulose). The dressing's Hydrofiber™ wound contact layer contains 1.2% w/w ionic silver. The silver in the dressing kills a broad spectrum of wound bacteria held in the dressing. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement) without damaging healthy tissue. The outer film layer provides a waterproof viral and bacterial barrier which protects the wound from external contaminants. The film also helps manage the moisture vapor transmission of the exudates absorbed by the dressing AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive may be used as a primary or secondary dressing. It may be used alone or in combination with other wound care products. The adhesive dressing has a silicone border which provides secure, skin friendly adhesion. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment. The moist wound environment is known to support the body's healing process.

AI/ML Overview

This document describes a medical device, the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and statistical analysis for a device performance study is not present in this submission.

The document primarily focuses on establishing "substantial equivalence" to legally marketed predicate devices, a regulatory pathway where direct clinical performance trials demonstrating specific acceptance criteria are often not required if the new device's technological characteristics and intended use are similar to established predicates.

Here's a breakdown of the available information based on your request, highlighting what is missing due to the nature of this 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission is a 510(k) summary for a wound dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance against quantitative acceptance criteria from a standalone study. The document states:

"The predicate AQUACEL Dressings in clinical studies shown to be successfully used in the management of chronic wounds." (This refers to predicate devices, not the subject device's own study.)
"The subject device's technological characteristics are similar to the other AQUACEL predicate devices."
"The AQUACEL foam devices contain a polyurethane film which on the bench testing is shown to provide bacterial, viral and waterproof properties." (This is a mention of bench testing but no specific acceptance criteria or performance numbers are given).

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

No test set for evaluating the performance of the subject device against specific criteria is described in this document. The submission references past clinical studies on predicate devices but does not detail a test set for the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver.

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

Not applicable as no such test set or ground truth establishment is described for the subject device's performance evaluation.

4. Adjudication method for the test set

Not applicable.

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 a wound dressing, not an AI-powered diagnostic device.

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

Not applicable. This is a wound dressing.

7. The type of ground truth used

Not applicable, as no ground truth for performance evaluation of the subject device is described. The "ground truth" for the 510(k) submission is the pre-existing regulatory clearance and established safety/effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a wound dressing, and no machine learning model or training set is mentioned.

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

Not applicable.

Summary of what is present in the document relevant to its regulatory submission:

The document serves as a 510(k) premarket notification, aiming to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.

Predicate Devices:
- AQUACEL™ Ag Hydrofiber™ Dressing, K080383
- AQUACEL™ Foam Hydrofiber™ Foam Dressing (Adhesive and Non-Adhesive), Exempt, NAC
- Mepilex Border Ag Foam Dressing, K100029
Argument for Substantial Equivalence: The applicant argues that the AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is substantially equivalent due to:
- Similar technological characteristics to other AQUACEL predicate devices.
- The use of a polyurethane film (in AQUACEL foam devices) demonstrated in bench testing to provide bacterial, viral, and waterproof properties.
- Predicate AQUACEL Dressings having been successfully used in clinical studies for chronic wounds.
Intended Use/Indications: The device is indicated for the management of various acute and chronic wounds, including partial thickness burns, diabetic foot ulcers, pressure ulcers, surgical wounds, traumatic wounds, and minor cuts/abrasions. This is consistent with the indications for the predicate devices.

Summary

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

K123481 Page 1/2

SECTION 5: 510(K) SUMMARY

JUN 0 6 2013

Device:	AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive
Applicant:	ConvaTec Inc.
Contact:	Katrina FiedlerAssociate Director, US Regulatory AffairsPhone: 908-904-2541Fax: 908-904-2235Email: katrina.fiedler@convatec.com
Date:	May 30, 2013
Trade Name:	AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive
Classification Name:	Dressing, Wound, Drug
Device Class:	Unclassified
Product Code:	FRO
Predicate Devices:	AQUACEL™ Ag Hydrofiber™ Dressing, K080383,AQUACEL™ Foam Hydrofiber™ Foam Dressing (Adhesive and Non-Adhesive), Exempt, NACMepilex Border Ag Foam Dressing, K100029

Device Description

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

K123481 page 2/2

The film also helps manage the moisture vapor transmission of the exudates absorbed by the dressing

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive may be used as a primary or secondary dressing. It may be used alone or in combination with other wound care products. The adhesive dressing has a silicone border which provides secure, skin friendly adhesion. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment. The moist wound environment is known to support the body's healing process.

Indications For Use

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is indicated for the management of wounds and can be used under the supervision of a healthcare professional. AQUACEL™ Ag Foam Hydrofiber™ Foam Dressings with Silver, Adhesive and Non-Adhesive may be used for the management of both chronic and acute wounds, such as partial thickness (second degree) burns; diabetic foot ulcers( venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores(partial and full thickness), surgical wounds, traumatic wounds, wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites, abrasions, lacerations, minor cuts and minor scalds and burns.

The predicate AQUACEL Dressings in clinical studies shown to be successfully used in the management of chronic wounds. The subject device's technological characteristics are similar to the other AQUACEL predicate devices. The AQUACEL foam devices contain a polyurethane film which on the bench testing is shown to provide bacterial, viral and waterproof properties.

Thus we believe that, AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is substantially equivalent to ConvaTec's previously cleared Hydrofiber™ technology based products ( AQUACEL™ Ag Hydrofiber™ Dressing K080383 and AQUACEL™ Foam Hydrofiber™ Foam Dressing, NAC, Exempt) and Mölnlycke Health Care's Mepilex Border Ag Foam Dressing ( K100029). In addition, we believe that AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive can be used safely and effectively for the management of wounds.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 6. 2013

ConvaTec. Inc. % Ms. Katrina Fiedler Associate Director, US Regulatory Affairs 200 Headquarters Park Drive Skillman, New Jersey 08558

Re: K123481

Trade/Device Name: AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive

Regulatory Class: Unclassified Product Code: FRO Dated: March 22, 2013 Received: March 28, 2013

Dear Ms. Fiedler:

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

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

Page 2 - Ms. Katrina Fiedler

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.zov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm -S

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

Enclosure

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

SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K123481

Device Name: AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive

Under the supervision of a healthcare professional:

AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as:

Partial thickness (second degree) burns; -
Diabetic foot ulcers, leg ulcers, (venous stasis ulcers and leg ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
Surgical wounds -
Traumatic wounds; -
Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
Abrasions;
Lacerations;
Minor Cuts;
Minor scalds and burns.

Prescription Use X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause)-S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123481

Regulation Number and Section

N/A