MODIFICATION TO 3M TEGADERM CHG DRESSING

K080620 · 3M Company-3M Health Care · FRO · May 19, 2008 · SU

Device Facts

• Record ID: K080620
• Device Name: MODIFICATION TO 3M TEGADERM CHG DRESSING
• Applicant: 3M Company-3M Health Care
• Product Code: FRO · SU
• Decision Date: May 19, 2008
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended Use

3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

Device Story

3M™ Tegaderm™ CHG Dressing is a transparent adhesive dressing with an integrated pad containing Chlorhexidine Gluconate (CHG). The device functions as a waterproof barrier to liquids, bacteria, viruses (≥27 nm), and yeast, while protecting IV sites from external contamination. The integrated pad absorbs up to eight times its weight in fluid. The dressing is transparent to allow for continuous site observation and is breathable to facilitate moisture vapor exchange. It is intended for use by healthcare professionals to cover and protect catheter sites and secure devices to the skin. The antimicrobial properties of the CHG pad provide a barrier against a variety of gram-positive and gram-negative bacteria and yeast, potentially reducing the risk of catheter-related infections.

Clinical Evidence

Bench testing only. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrated antimicrobial effect against gram-positive and gram-negative bacteria and yeast. Viral barrier testing confirmed protection against viruses 27 nm in diameter or larger (e.g., HCV, HBV, HIV) while the dressing remains intact.

Technological Characteristics

Transparent adhesive film dressing with integrated Chlorhexidine Gluconate (CHG) pad. Waterproof, breathable, and antimicrobial. Provides barrier to bacteria, yeast, and viruses (≥27 nm).

Indications for Use

Indicated for covering and protecting catheter sites and securing devices to skin, including IV catheters, other intravascular catheters, and percutaneous devices.

Predicate Devices

• 3M™ Tegaderm™ CHG Dressings (K063458)
• Bioclusive Transparent Film Dressing (K895207)
• Opsite IV 3000 (K895353)
• Tegaderm™ Transparent Film Dressings (K973036)
• SorbaView® Ultimate Window Dressing
• SorbaView® 2000

Submission Summary (Full Text)

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K080620

## Premarket Notification (510(k)) Summary

#### 1. Sponsor Information:

MAY 1 9 2008

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

| Contact Person: | Maria Ruiz<br>Senior Regulatory Affairs Associate |
|------------------|---------------------------------------------------|
| Phone Number: | [phone] |
| FAX Number: | [phone] |
| Date of Summary: | April 18, 2008 |

April 18, 2008

#### 2. Device Name and Classification:

| | Common or Usual Name: | Antimicrobial I.V. Securement Dressing |
|------------------------|----------------------------------------------------------------------------------|----------------------------------------|
| Proprietary Name: | 3M™ Tegaderm™ CHG Dressing<br>(Chlorhexidine Gluconate I.V. Securement Dressing) | |
| Classification Name: | Antimicrobial Dressing, Unclassified | |
| Performance Standards: | None | |

#### Predicate Devices: 3.

- 3M™ Tegaderm™ CHG Dressings (K063458, cleared April 5, 2007) .
- Bioclusive Transparent Film Dressing (K895207, cleared September 28, 1989) .
- Opsite IV 3000 (K895353, cleared December 14, 1989) .
- Tegaderm™ Transparent Film Dressings (K973036, cleared November 12, 1997) .
- SorbaView® Ultimate Window Dressing .
- SorbaView® 2000 .

#### 4. Description of Device:

3M™ Tegaderm™ CHG Dressing, Chlorhexidine Gluconate I.V. Securement Dressing, is used to cover and protect catheter sites and to secure devices to skin. Available in a variety of shapes and sizes to meet the needs of the caregiver.

Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an integrated pad containing Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and viruses* and yeast, and

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protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing. Tegaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

* In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 19 2008

3M Health Care % Ms. Maria Ruiz Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K080620

Trade/Device Name: 3M™ Tegaderm™ CHG Dressing, (Chlorhexidine Gluconate I.V. Securement Dressing) Regulatory Class: Unclassified Product Code: FRO Dated: April 18, 2008 Received: April 22, 2008

Dear Ms. Ruiz:

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 (OS) 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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Page 2 - Ms. Maria Ruiz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to I 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Petmanect Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours,

Mark M. Millican

Mark N. Melkerson 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 Statement

510(k) Number (if known):

Device Name:

3MTM Tegaderm™ CHG Dressing, (Chlorhexidine Gluconate I.V. Securement Dressing)

080620

### Indications for Use:

3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

Prescription Use_ X (Per 21 CFR 801 109)

OR

Over-The-Counter-Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ogle for myn
(Division Sign-Off)

Division of General, Restorative, and Neurological Dexicest 2 - 2

**510(k) Number** K070620