3M TEGASORB HYDROCOLLOID DRESSING

K982893 · 3M Company · KMF · Oct 26, 1998 · General Hospital

Device Facts

• Record ID: K982893
• Device Name: 3M TEGASORB HYDROCOLLOID DRESSING
• Applicant: 3M Company
• Product Code: KMF · General Hospital
• Decision Date: Oct 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

3M Tegasorb™ Hydrocolloid Dressings are intended for use as a dressing for partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first- and second-degree burns, and donor sites.

Device Story

3M Tegasorb™ Hydrocolloid Dressing is a sterile wound dressing consisting of a hypoallergenic hydrocolloid adhesive with an outer clear, moisture-vapor-permeable, and bacteria-impermeable film. The device is applied over a wound site where it interacts with wound fluid to form a soft, semi-transparent absorbent mass. This process maintains a moist wound environment to support healing. The dressing is intended for use by lay persons (for superficial wounds/first-degree burns) or under the supervision of healthcare professionals (for more severe wounds). It is not a treatment or cure for wounds, nor is it intended as artificial skin or a long-term permanent dressing.

Clinical Evidence

No new clinical data provided. Biocompatibility testing results from the predicate device (K940624) are cited to support the safety of the dressing for its intended use.

Technological Characteristics

Sterile hydrocolloid dressing; hypoallergenic hydrocolloid adhesive; outer clear adhesive film; moisture vapor permeable; water and bacteria impermeable. Form factor: dressing. No software or electronic components.

Indications for Use

Indicated for superficial wounds (cuts, lacerations, abrasions) and first-degree burns for OTC use; partial/full thickness dermal ulcers, leg ulcers, second-degree burns, and donor sites for use under healthcare professional supervision. Contraindicated for third-degree burns.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• 3M Tegasorb™ Ulcer Dressing (K940624)

Submission Summary (Full Text)

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OCT 2 6 1998

## 510(k) Summary of Safety and Effectiveness

- Manufacturer: 3M Medical Products 3M Center St. Paul, Minnesota 55144-1000 Anna E. McRight Regulatory Affairs Contact: Regulatory Affairs Specialist 3M Medical Products Resource Division 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144-1000 Telephone: [phone] Date Summarv Prepared: August 13, 1998 3M Tegasorb™ Hydrocolloid Dressing Product Trade Name: Wound Dressing Common Name: Wound Dressing Classification: Predicate Devices: 3M Tegasorb™ Ulcer Dressing (see also, K940624, May 4, 1994, for competitive comparable products). Description: 3M Tegasorb™ [and 3M Tegasorb™ Thin] Hydrocolloid Dressings are sterile wound dressings which consist of a hypoallergenic hydrocolloid adhesive with an outer clear adhesive cover film. The film is moisture vapor permeable and water and bacteria impermeable. The products are not designed, sold or intended for use except as indicated. Over the wound site, 3M Tegasorb [and 3M Tegasorb THIN] Hydrocolloid dressings interact with wound fluid to create a soft, semi-transparent absorbent mass. The dressings maintain a moist wound environment, which has been shown to enhance wound healing. (continued)

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## K982893

| Intended Use: | 3M Tegasorb™ Hydrocolloid Dressings<br>are intended for use as a dressing for<br>partial and full thickness dermal ulcers,<br>leg ulcers, superficial wounds, abrasions,<br>first- and second-degree burns, and<br>donor sites. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence: | This premarket notification was<br>submitted for package insert changes<br>only. The comparative products remain<br>identical to those submitted in the<br>premarket notification, K940624, cleared<br>for marketing by FDA on May 4, 1994. |
| Summary of Testing: | See K940624 which provided<br>biocompatibility test results to support<br>3M Tegasorb™ Hydrocolloid Dressing as<br>acceptable for its intended use. |

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## OCT 2 6 1998

Anna E. McRight. 3M Medical Products Division Building 275 - 3E- 08 St. Paul. Minnesota 55144

Re: K982892 Trade Name: 3M Tegasorb™ Thin Hydrocolloid Dressing K982893 Trade Name: 3M Tegasorb™ Hydrocolloid Dressing Regulatory Class: Unclassifed Product Code: KMF Dated: August 13 and 14, 1998 Received: August 17, 1998

Dear Ms. McRight:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are 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 devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- These devices may not be labeled for use on third degree burns. 1.
- These devices may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- These devices may not be labeled as a long-term, permanent, or no-change dressing, 3. or as an artificial (synthetic) skin.
- These devices 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 devices 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. Anna McRight

If your devices are 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 devices 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

Salie McWitter, Ph.D., M.D.

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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NO. 1883 P. 3

K9182893

3M Tegasorb™ Hydrocolloid Dressing 510(k) for Labeling Changes

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K9P2873

510(k) Number (if known): K940624, May 4, 1994

Device name: 3M Tegasorb™ Hydrocolloid Dressing, Product Number series 90001-90005.

Indications for Use:

The following conditions are considered appropriate for OTC use by the lay person:

Superficial wounds such as cuts, lacerations, or abrasions First-degree burns

The following conditions are considered appropriate for OTC use under the supervision of a health care professional:

Partial or full thickness dermal ulcers Leg ulcers Second-degree burns Donor sites

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|------------------|------------------------------------------------------------------------|
| | OR |
| | Over the Counter Use <span style="text-decoration: overline;">✓</span> |

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K982893 |

(Optional Format 1-2-96)