WOUND DRESSING/ABD PAD, MODEL #10810

K990861 · Hospital Specialty Co. · NAD · Apr 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990861
• Device Name: WOUND DRESSING/ABD PAD, MODEL #10810
• Applicant: Hospital Specialty Co.
• Product Code: NAD · General, Plastic Surgery
• Decision Date: Apr 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4020
• Device Class: Class 1

Intended Use

The pad is used to cover wounds.

Device Story

The Hospeco ABD wound dressing is a pad designed to cover wounds. It consists of a non-woven outer-wrap and internal absorbent material. The device is used in clinical or home settings to provide a protective barrier over wounds. It is not indicated for third-degree burns, nor is it intended to accelerate wound healing, act as artificial skin, or serve as a treatment/cure for wounds. The device is sterilized via gamma irradiation. Healthcare providers or patients apply the dressing to the wound site to protect the area from external contaminants.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (Intensified Shelasnski Repeated Insult Patch Test) and microbiological validation of gamma irradiation sterilization per AAMI Method 1 to achieve a sterility assurance level of 10^-6.

Technological Characteristics

Non-woven wax-cured polyester barrier/wrap; absorbent pad construction. Sterilization: Gamma irradiation (AAMI Method 1). Biocompatibility: Tested per Intensified Shelasnski Repeated Insult Patch Test. No software or electronic components.

Indications for Use

Indicated for covering wounds in patients requiring wound dressing.

Regulatory Classification

Identification

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

• Kendall's Tendersorb ABD pad

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a black and white logo with the word "HOSPECO" stacked vertically in the center of a cross shape. The cross is white, and the background is black. The entire logo is enclosed in a circle. There is a number "4" in the upper right corner of the image.

Devi

## lospital Specialty Company

Personal Care Division of the Tranzonic Companies 7501 Carnegie Avenue • Cleveland, Ohio 44103-4896 P.O. Box 94763 • Cleveland, Ohio 44101-4763 [phone] • [phone] • (800) B-AT-EASE FAX [phone] e-mail [e-mail]

K 990861

## 510(k) Summarv

Hospeco

| _Contact: | John Quigley | |
|------------|------------------------------------------|----------|
| _Company: | Hospital Specialty | |
| Address: | 7501 Carnegie Ave<br>Cleveland, OH 44103 | |
| telephone: | 216-361-1230 x 371 | |
| fax: | 216-361-0829 | |
| ice Name: | Classification name: | dressing |
| | Trade/Common name: | ABD pad |

Predicate Device: Kendall's Tendersorb ABD pad

Proprietary name:

Device Description: The pad is composed of the same type of materials as the predicate device. The non-woven outer-wrap has been tested according to the Intensified Shelasnski Repeated Insult Patch Test and is neither a skin irritant nor a skin sensitizer. The pads are available in the same sizes and similar weights.

Intended Use: The pad is used to cover wounds.

Technological Characteristics: Non-woven wax-cured polyester is used as a barrier and to wrap the pad instead of non-woven polypropylene.

Supporting Data and Conclusions: The wound dressing is made of similar materials and in a similar manor as the previously cleared device. The finished device has been evaluated using the AAMI Method 1 for microbiological validation of gamma irradiation sterilization. The bioburden has been established and the minimum irradiation dose has been determined and tested for providing a sterility assurance level of 10°. A quarterly dose audit will be performed on the product. Based upon this evidence, the wound dressing is substantially equivalent to the existing legally marketed device.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three lines forming its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 1999

Mr. John Quigley Quality Assurance Manager Hospital Specialty Co. 7501 Carnegie Avenue Cleveland, Ohio 44103

Re: K990861 Trade Name: Hospeco ABD Wound Dressing Regulatory Class: Unclassifed Product Code: FRO Dated: March 15, 1999 Received: March 16, 1999

Dear Mr. Quigley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. 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 2. 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.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.

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).

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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

Page 2 - Mr. John Quigley

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

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

Enclosure

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

Page_1_of_1

K990861

510(k) Number (if known):

Hospeco ABD wound dressing Device Name:

# #

Indications For Use:

The pad is used to cover wounds

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Signature

(Division Sign-Off)
Division of General Restorative Devices K990861
510(k) Number***_***__