HYDRASORB STERILE DRESSING

K973260 · Avitar, Inc. · MGP · Oct 21, 1997 · SU

Device Facts

• Record ID: K973260
• Device Name: HYDRASORB STERILE DRESSING
• Applicant: Avitar, Inc.
• Product Code: MGP · SU
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moiest healing environment, manage exudate, and protect the wound from contamination. Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds. Hydrasorb Sterile Dressing -Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment. is an ideal dressing in the local management of exudate that may occur at surgically induced body drainage sites such as a tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump In generallit can be used anywhere there is a need to manage drain. the surrounding skin due to potential skin irritation or maceration.

Device Story

Hydrasorb Sterile Dressing is a wound care product designed to manage exudate and maintain a moist healing environment. It functions as a physical barrier to protect wounds from contamination. The device is applied topically to the wound site by clinicians or patients. It absorbs fluid, particularly in the fenestrated version used around surgical drainage sites (e.g., tracheostomy, G-tubes). The dressing does not accelerate healing, nor is it a permanent skin substitute or treatment/cure for wounds. It serves as a protective cover for various external wounds, including ulcers and surgical incisions, helping to prevent skin maceration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Hydrophilic polyurethane foam dressing. Designed for fluid absorption and moisture management. Fenestrated configuration available for drainage sites. Non-implantable, external use only.

Indications for Use

Indicated for local management of external wounds including post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, trauma-induced wounds, and as a secondary/cover dressing for packed wounds. Fenestrated version indicated for management of exudate at surgical drainage sites (tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, sump drain) to prevent skin irritation/maceration. Contraindicated for third-degree burns.

Predicate Devices

• Lyofoam Sterile Dressings (Acme United Corporation)
• Epi-Lock Wound Dressings (Calgon Vestal Laboratories)
• Allevyn Hydrophilic Polyurethane Foam (Smith & Nephew, Inc.)

Submission Summary (Full Text)

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## APPENDIX A

K973260

## SUMMARY OF SAFETY AND EFFECTIVENESS

Avitar Technologies, Inc. Hydrasorb™ Sterile Dressings are comparable in their effectiveness to Lyofoam Sterile Dressings manufactured by Acme United Corporation, Epi-Lock Wound Dressings manufactured by Calgon Vestal Laboratories, Allevyn Hydrophilic Polyurethane Foam manufactured by Smith & Nephew, Inc. and is the same product as Hydrasorb Sterile Dressings distributed by Calgon Vestal. It has been previously determined by FDA that these products are substantially equivalent to other products that have been introduced into interstate commerce prior to May 28, 1976. These products are currently marketed in the United States.

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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 symbol resembling a person embracing another, with flowing lines suggesting movement or support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Paul H. Patrone .V.P. Regulatory Affairs and Quality Assurance AVITAR, Inc. 65 Dan Road Canton, Massachusetts 02021

OCT 2 1 1997

Re: K973260 HYDRASORB™ Sterile Dressing Regulatory Class: Unclassified Product Code: MGP Dated: August 13, 1997 Received: August 29, 1997

Dear Mr. Patrone:

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:

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

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## Page 2 - Mr. Paul H. Patrone

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.

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

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Page / of / / _

510(k) Number (if known): 长973260

Device Name: Hy OKA SORIS STERILE DRESS; NQ

Indications For Use:

.

Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moiest healing environment, manage exudate, and protect the wound from contamination.

Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds.

Hydrasorb Sterile Dressing -Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment. is an ideal dressing in the local management of exudate that may occur at surgically induced body drainage sites such as a tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump In generallit can be used anywhere there is a need to manage drain. the surrounding skin due to potential skin irritation or maceration.

O.A. J
9/9/97

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | <div align="center"> <img alt="signature" src="signature.png" width="200"/> </div> |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K973260 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
| | (Optional Format 1-2-96) |