3M TEGADERM SILVER

K040890 · 3M Company · FRO · Nov 2, 2004 · SU

Device Facts

• Record ID: K040890
• Device Name: 3M TEGADERM SILVER
• Applicant: 3M Company
• Product Code: FRO · SU
• Decision Date: Nov 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

3M™ Tegaderm™ Silver Nonwoven Dressings are indicated for use as a primary wound dressing over: - abrasions - - ulcers - - trauma wounds - - surgical wounds - - first and second degree burns - - donor sites -

Device Story

3M™ Tegaderm™ Silver Nonwoven Dressing is a cotton nonwoven mesh dressing containing silver oxide; functions as a primary wound dressing. Applied by clinicians to manage various wound types including abrasions, ulcers, trauma, surgical sites, burns, and donor sites. Silver oxide provides antimicrobial properties to the wound environment. Device is a passive physical dressing; no electronic components, software, or algorithms involved. Benefits include protection of the wound site and antimicrobial action to support healing.

Clinical Evidence

No clinical data. Effectiveness established via in vitro reduction studies comparing 3M Tegaderm Silver Dressing to Acticoat Silver Coated Dressing against gram-negative bacteria, gram-positive bacteria, and Candida albicans. Biocompatibility testing included cytotoxicity, intracutaneous irritation in rabbits, and skin sensitization in guinea pigs.

Technological Characteristics

Cotton nonwoven mesh dressing containing silver oxide. Available in various rectangular and square sizes. Passive dressing; no energy source, connectivity, or software.

Indications for Use

Indicated for use as a primary wound dressing for patients with abrasions, ulcers, trauma wounds, surgical wounds, first and second degree burns, and donor sites.

Predicate Devices

• Acticoat™ Silver Coated Dressing (aka Acticoat Burn Antimicrobial Dressing)

Submission Summary (Full Text)

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3MTM Tegaderm™ Silver Dressing K040890 Response to May 18, 2004 Request

### 2 2004

Section 4: Modified 510(k) Summary Page

The indications for use presented in the Premarket Notification Summary of the original 510(k) have been modified. The updated summary pages are presented below:

## Premarket Notification Summary

#### 1. Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

| Contact Person: | Amy E. Short<br>Regulatory Specialist |
|-----------------|---------------------------------------|
| Phone Number: | [phone] |
| FAX Number: | [phone] |

#### 2. Device Name:

| Common or Usual Name: | Silver Nonwoven Dressing |
|-----------------------|--------------------------|
| Proprietary Name: | 3M™ Tegaderm™ Silver |
| Classification Name: | Unclassified |

#### 3. Predicate Device:

Acticoat™ Silver Coated Dressing, aka Acticoat Burn Antimicrobial Dressing, manufactured by Smith & Nephew.

#### র্ব. Description of Device:

3M™ Tegaderm™ Silver Nonwoven Dressing is a cotton nonwoven mesh dressing which contains silver oxide. It is available as rectangle or square dressings of various sizes.

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3M™ Tegaderm™ Silver Dressing K040890 Response to May 18, 2004 Request

K040890

### Indications for Use: ડાં

3MTM Tegaderm™ Silver Nonwoven Dressing is indicated for use as a primary wound dressing over:

- abrasions 1
- ulcers -
- trauma wounds -
- surgical wounds -
- first and second degree burns -
- donor sites 1

### Description of Safety and Substantial Equivalence: ર.

Safety Studies - A standard battery of biocompatibility studies was conducted: Cytotoxicity, Intracutaneous Irritation in rabbits, and Skin Sensitization in guinea pigs. No deleterious effects were observed with Tegaderm Silver Dressing; results were comparable to or better than those reported for Acticoat Silver Coated Dressing.

Effectiveness - 3M Tegaderm Silver Dressing was compared with Acticoat Silver Coated Dressing in in vitro reduction studies against a known number of gram-negative and gram-positive bacteria.. The dressings were also tested against Candida albicans. The results of this study demonstrated that Tegaderm Silver Dressing was equivalent to Acticoat Silver Coated Dressing

Substantial Equivalence - Tegaderm Silver Dressing and Acticoat Silver Coated Dressing (aka, Acticoat Burn Antimicrobial Dressing) provide the same function and have the same indications for use. These characteristics, as well as the results of safety studies and effectiveness show the two products to be substantially equivalent.

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2004

Ms. Amy E. Short Regulatory Specialist 3M Health Care 3M Center Building 275-5W-06 St. Paul, Minnesota 55144

Re: K040890

Trade/Device Name: 3M™ Tegaderm™ Silver Nonwoven Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 30, 2004 Received: August 31, 2004

Dear Ms. Short:

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 application (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with cation. The FDA finding of substantial equivalence of your device to a legally promance noticated 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), please 11 you a 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 vours.

Miriam C. Provost

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

Enclosure

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# Indications for Use

510(k) Number (if known): K040890

3M™ Tegaderm™ Silver Nonwoven Dressing Device Name:

Indications For Use:

3M™ Tegaderm™ Silver Nonwoven Dressings are indicated for use as a primary wound dressing over:

- abrasions -
- ulcers -
- trauma wounds ﮯ
- surgical wounds 1
- first and second degree burns .
- donor sites -

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_4040890

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