HA ABSORBENT WOUND DRESSING

K984388 · Convatec, A Division of E.R. Squibb & Sons · KGN · Mar 3, 1999 · SU

Device Facts

• Record ID: K984388
• Device Name: HA ABSORBENT WOUND DRESSING
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: KGN · SU
• Decision Date: Mar 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

Absorbent wound dressing composed of HYAFF 11p757M (benzyl ester of hyaluronic acid). Available as fibrous fleece (F) or rope (R). Applied topically to wounds by patients (OTC) or healthcare professionals. Functions as passive dressing to absorb exudate and maintain moist wound environment. Supports healing process; manages bleeding in debrided or traumatic wounds. No active electronic components or software.

Clinical Evidence

Bench testing only. Biocompatibility testing performed; results indicate device is non-toxic, non-hemolytic, non-cytotoxic, negligible irritant, and has 0% sensitization potential.

Technological Characteristics

Material: HYAFF 11p757M (benzyl ester of hyaluronic acid). Form factor: Fibrous fleece or rope. Mechanism: Passive absorption of wound exudate to maintain moist environment. No energy source, connectivity, or software.

Indications for Use

Indicated for OTC use on abrasions, lacerations, minor cuts, 1st-degree burns. Professional use for leg/pressure (stages I-IV)/diabetic ulcers, surgical/traumatic wounds, donor sites, 2nd-degree burns, and bleeding wounds. Rope form indicated for deep exuding wounds, sinuses, and fistulae. Contraindicated for patients with sensitivity to dressing components.

Predicate Devices

• FIBRACOL Collagen-Alginate Wound Dressing
• Knitted Wound Dressing

Submission Summary (Full Text)

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K9843888

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, Inc.<br>100 Headquarters Park Drive, Skillman, NJ 08558 |
|------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact: | Adrienne McNally, Director, Regulatory Affairs<br>[phone] |
| Device: | HA Absorbent Wound Dressing |
| Substantially<br>Equivalent Device | FIBRACOL Collagen-Alginate Wound Dressing<br>Knitted 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:

1. This device may not be labeled for use on third degree burns.

2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.

3. 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

4. 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 [phone]. 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 [phone] or [phone] 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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Ro

(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)