HA ABSORBENT WOUND DRESSING by CONVATEC, A DIVISION OF E.R. SQUIBB & SONS

For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional, HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.

Device Description

HA Absorbent Wound Dressing is an absorbent fibrous fleece (F) or rope (R), entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HA Absorbent Wound Dressing, based on the provided text:

HA Absorbent Wound Dressing

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the HA Absorbent Wound Dressing and its substantial equivalence to predicate devices, but does not explicitly state quantitative acceptance criteria or provide specific device performance metrics in numerical form (e.g., absorption rate in mL/cm², healing time in days, etc.).

Instead, the "performance" is demonstrated through:

Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) based on composition, function, and intended use.
Biocompatibility Testing: The device passed standard toxicity tests.

Therefore, a direct table of "Acceptance Criteria" and "Reported Device Performance" as typically expected for diagnostic AI/ML devices is not present in this type of submission for a wound dressing. The "acceptance criteria" for clearance in this context are primarily demonstrating substantial equivalence and safety.

Feature/Criterion	Description of "Acceptance"	"Reported Device Performance" / Evidence from Study
Material Composition	Equivalent biopolymer composition to predicate device.	HA Absorbent Wound Dressing (HYAFF 11p757M, a benzyl ester of hyaluronic acid) is "entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid," similar to FIBRACOL Collagen-Alginate Wound Dressing.
Function - Absorbency	Absorb wound exudate and create a moist wound environment.	HA Absorbent Wound Dressing is an "absorbent fibrous fleece (F) or rope (R)." HA Absorbent Wound Dressing-F is equivalent to FIBRACOL Collagen-Alginate Wound Dressing, which also "absorb wound exudate, and create a moist wound environment."
Intended Use (Fleece)	Management of abrasions, lacerations, minor cuts, first-degree burns, leg ulcers, pressure ulcers (I-IV), diabetic ulcers, surgical wounds, second-degree burns, and bleeding-prone wounds.	Indications for Use statement matches predicate device and deemed acceptable by FDA.
Intended Use (Rope)	Management of deep exuding wounds, sinuses, and fistulae.	Indications for Use statement matches predicate device and deemed acceptable by FDA.
Biocompatibility	Non-toxic, non-hemolytic, negligible irritant, non-cytotoxic, 0% sensitization potential.	"The results of this testing show that Hyalofill Absorbent Wound Dressing has passed toxicity tests and is considered to be non-toxic, non-hemolytic, a negligible irritant, non-cytotoxic, and has shown to have 0% sensitization potential."
Contraindications	No known sensitivity to the dressing or its components.	Standard contraindication listed, consistent with similar medical devices.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not describe a "test set" in the context of an algorithm or AI system evaluation. This submission is for a physical medical device (wound dressing), and its clearance is based on substantial equivalence to predicate devices and biocompatibility testing, not on clinical performance data in a "test set" as understood for AI/ML devices. Therefore, these categories are not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. As above, there is no "test set" or "ground truth" establishment for an algorithm in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

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

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

Not applicable in the context of an algorithm. For the physical device, the "ground truth" or basis for acceptance relies on:

Predicate Device Equivalence: The established safety and effectiveness of the legally marketed predicate devices.
Biocompatibility Standards: Pre-defined standards for biological safety testing of medical devices.

8. Sample Size for the Training Set:

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

9. How the Ground Truth for the Training Set Was Established:

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

Summary for the HA Absorbent Wound Dressing (K984388):

This submission is for a physical medical device (a wound dressing), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and "study" as typically applied to AI performance (e.g., sensitivity, specificity, F1-score on a test set) is not directly applicable.

The "study" in this context refers to biocompatibility testing and the comparison to predicate devices to demonstrate substantial equivalence and safety. The acceptance criteria for clearance were primarily based on:

Demonstrating the HA Absorbent Wound Dressing is substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) in terms of materials, intended use, and fundamental function.
Passing a series of biocompatibility tests to ensure the material is safe for its intended use (non-toxic, non-hemolytic, negligible irritant, non-cytotoxic, 0% sensitization potential).

The FDA's decision letter (K984388) confirms the device's substantial equivalence and outlines specific labeling limitations, which effectively become part of the modified acceptance criteria for its marketing.

Summary

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K9843888

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant:	ConvaTec, A Division of E.R. Squibb and Sons, Inc.100 Headquarters Park Drive, Skillman, NJ 08558
Contact:	Adrienne McNally, Director, Regulatory Affairs(908) 904-2630
Device:	HA Absorbent Wound Dressing
SubstantiallyEquivalent Device	FIBRACOL Collagen-Alginate Wound DressingKnitted Wound Dressing

The purpose of this 510(k) Premarket Notification is to request clearance to market HA Absorbent Wound Dressing.

HA Absorbent Wound Dressing is an absorbent fibrous fleece (F) or rope (R), entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid.

For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional. HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.

HA Absorbent Wound Dressing is contraindicated for use on patients with known sensitivity to the dressing or its components.

HA Absorbent Wound Dressing is substantially equivalent to FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing (Ribbon). HA Absorbent Wound Dressing-F is equivalent to FIBRACOL Collagen-Alginate Wound Dressing where both are of a biopolymer composition, absorb wound exudate, and create a moist wound environment supportive of the healing process.

HA Absorbent Wound Dressing-R (Rope) is equivalent to Knitted Wound Dressing (Ribbon) where both are indicated for deep exuding wounds, sinuses and fistulae.

HA Absorbent Wound Dressing has been subject to biocompatibility testing. The results of this testing show that Hyalofill Absorbent Wound Dressing has passed toxicity tests and is considered to be non-toxic, non-hemolytic, a negligible irritant, non-cytotoxic, and has shown to have 0% sensitization potential.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Ms. Adrienne McNally Director, Regulatory Affairs ConvaTec 100 Headquarters Park Drive Skillman, New Jersey 08558

Re: K984388
Trade Name: HA Absorbent Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: December 4, 1998 Received: December 8, 1998

Dear Ms. McNally:

This letter corrects our substantially equivalent letter of March 3, 1999.

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 (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 and the following limitations:

This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 - Ms. Adrienne McNally

This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

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); 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 continue 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.

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Page 3 - Ms. Adrienne McNally

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/dsma/dsmamain.html

Sincerely yours,

Kol Melkerson

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

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INDICATIONS FOR USE STATEMENT

1984388 510(k) Number (if known): Not Hot Hown

Device Name: HA Absorbent Wound Dressing

Indications for Use:

HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984388

Prescription Use_X (Per 21 CFR 801.109) Over-the-Counter Use X (Optimal Formate 1-2-96)

Regulation Number and Section

N/A