3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES

K973036 · 3M Healthcare · MGP · Nov 12, 1997 · SU

Device Facts

• Record ID: K973036
• Device Name: 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
• Applicant: 3M Healthcare
• Product Code: MGP · SU
• Decision Date: Nov 12, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

3M Tegaderm™ Transparent Dressings can be used over a variety of IV catheters and other devices, for wound management and as a protective eye covering. Tegaderm HP dressing provides stronger adhesion, particularly in problem areas. The later was designed to stay on even longer and help reduce unscheduled dressing changes in challenging situations, e.g. diaphoretic patients, conditions of high humidity, febrile patients, any high moisture-prone areas for venous catheterization, such as the jugular area, and difficult-to-dress wound areas (sacral).

Device Story

3M Tegaderm Transparent Dressing is a thin polyurethane film backing with hypoallergenic, acrylate, pressure-sensitive adhesive. Device is transparent, permeable to oxygen and moisture vapor, but impermeable to liquids and bacteria. Used in clinical settings for wound management, IV catheter securement, and as a protective eye covering. Applied by clinicians to protect skin, secure devices, or facilitate autolytic debridement in a moist environment. HP version provides enhanced adhesion for diaphoretic, febrile, or high-humidity conditions. No active components; passive barrier function.

Clinical Evidence

No clinical data submitted. The submission relies on existing literature, CDC Guidelines for the Prevention of Intravascular Device-Related Infections, and FDA guidance to support the removal of a labeling warning. Previous 510(k) data remains applicable.

Technological Characteristics

Polyurethane film backing with hypoallergenic, acrylate, pressure-sensitive adhesive. Transparent, moisture vapor and oxygen permeable, liquid and bacteria impermeable. Passive barrier dressing.

Indications for Use

Indicated for covering and protecting catheter sites and wounds, creating a moist environment for healing, secondary dressing, protective cover for at-risk skin, device securement, and protective eye covering. Facilitates autolytic debridement. Applications include IV/intravascular catheters, percutaneous devices, clean closed surgical incisions, skin graft donor sites, Stage I/II pressure ulcers, superficial wounds (abrasions, skin tears, blisters), first/second degree burns, and chafed/moisture-exposed skin.

Predicate Devices

• 3M Tegaderm Transparent Dressings (original)
• Op-Site Transparent Permeable Membrane
• OpSite I.V. 3000
• Bioclusive Transparent Dressing
• Transeal Transparent Dressing
• Conmed Veni-Gard Dressing
• Pro-Clude Transparent Wound Dressing
• Polyskin M.R. Moisture Responsive Transparent Dressing

Submission Summary (Full Text)

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

NOV 1 2 1997

## 510(k) Summary of Safety and Effectiveness

・・

| Manufacturer: | 3M Medical Products Division<br>3M Center<br>St. Paul, Minnesota 55133 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs<br>Contact: | Karen C. Holmen<br>Regulatory Affairs Specialist<br>3M Medical Products Group<br>3M Center 275-3E-08<br>P.O. Box 3275<br>St. Paul, Minnesota 55133-3275 |
| Telephone: | [phone] |
| Date Summary<br>Prepared: | 7/25/97 |
| Product Trade Name: | 3M Tegaderm™ Transparent Dressing (original frame style and<br>easy application frame style)<br>3M Tegaderm™ Transparenet Dressing (First Aid Delivery)<br>3M Tegaderm™ HP Transparent Dressing<br>3M Tegaderm™ Transparent I.V. Dressing |
| Common Name: | Wound dressing, IV Secural dressing |
| Classification: | Intravascular catheter securement device, wound dressings, and/or<br>protective eye covering, Class I. |
| Predicate Devices: | 3M Tegaderm Transparent Dressings mentioned above, Op-SiteR Transparent Permeable Membrane, OpSiteR I.V. 3000<br>Bioclusive™ Transparent Dressing, Transeal™ Transparent<br>Dressing, Conmed Veni-Gard® Dressing, Pro-Clude® Transparent<br>Wound Dressing, Polyskin® M.R. Moisture Responsive<br>Transparent Dressing |
| Description: | 3M Tegaderm™ Transparent Dressing consists of a thin,<br>polyurethane film backing with a hypoallergenic, acrylate, pressure<br>sensitive adhesive. The dressing is transparent and possess good<br>oxygen and moisture vapor permeability and yet is impermeable to<br>liquids and bacteria |
| Intended Use: | 3M Tegaderm™ Transparent Dressings can be used over a variety<br>of IV catheters and other devices, for wound management and as a<br>protective eye covering. Tegaderm HP dressing provides stronger<br>adhesion, particularly in problem areas. The later was designed to<br>stay on even longer and help reduce unscheduled dressing changes<br>in challenging situations, e.g. diaphoretic patients, conditions of<br>high humidity, febrile patients, any high moisture-prone areas for<br>venous catheterization, such as the jugular area, and difficult-to-<br>dress wound areas (sacral). |
| Substantial<br>Equivalence: | This 510(k) proposed to delete a warning on current labeling for<br>3M Tegaderm™ Transparent Dressings, specifically, the warning<br>regarding its use over arterial catheter sites. Neither literature,<br>clinical studies, CDC guidelines for the Prevention of Intravascular<br>Device-Related Infections, nor FDA Device Labeling Guidance re<br>the use of Precautions, Warnings or Contraindications support such<br>a warning. Furthermore, 3M Tegaderm Transparent Dressings are<br>substantially equivalent to other standard transparent dressings on<br>the market, none of which contraindicate or warn against use over<br>arterial catheter sites at this time, as evidenced by labeling<br>presented in this submission.<br><br>Note: The term "substantial equivalence" is used only in the<br>context of 21 CRF Part 807, Subpart E (Premarket Notification<br>Procedures). |
| Summary of Testing: | No product data submitted; this submission is seeking deletion of a<br>contraindication/warning from current labeling and relied on known<br>literature, lack of conclusive clinical studies, CDC Guidelines for<br>Prevention of Intravascular Device-Related Infections, and FDA<br>guidance as support for the proposed deletion. All data supplied in<br>previous 510(k)s are not changed and are applicable to this 510(k). |

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

・・

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 1997

Ms. Karen C. Holmen Regulatory Affairs Specialist 3M Health Care 3M Center 275-3E-08 PO Box 3275 St. Paul, Minnesota 55133-3275

Re: K973036 3M™ Tegaderm™ Transparent Dressing Regulatory Class: Unclassified Product Code: MGP Dated: August 7, 1997 Received: August 14, 1997

Dear Ms. Holmen:

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.
- 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).

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.

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

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

{4}------------------------------------------------

510(k) Number (if Known): _ kg-1303636

3M™ Tegaderm™ Transparent Dressings Device Name:

Indications for Use:

NUV.

3M Tegaderm Transparent Dressings can be used to cover and protect catheter sites and wounds, to create a moist enviroment for wound healing, as a secondary dressing, as a protective cover over at risk skin, to secure devices to the skin and as a protective eye covering. It can also be used to create a moist wound environment to facilitate autolytic debridement. Common applications include: IV catheters, other intravascular catheters and percutaneous devices, clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, superficial wounds such as abrasions, skin tears, and blister, first and second degree burns, chafed skin or skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels, protective eye covering during surgery or for patients with corneal abrasions.

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

Concurrence of CHRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973036 |

| Prescription Use: (Per 21 CFR 801.109) | OR Over-the-Counter Use (Optional Format 1-2-96) |
|----------------------------------------|--------------------------------------------------|
|----------------------------------------|--------------------------------------------------|