3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

K171908 · 3M Company · SEL · Jul 11, 2017 · SU

Device Facts

• Record ID: K171908
• Device Name: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
• Applicant: 3M Company
• Product Code: SEL · SU
• Decision Date: Jul 11, 2017
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices. Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

Device Story

Transparent adhesive dressing with integrated hydrophilic gel pad containing 2% w/w Chlorhexidine Gluconate (CHG); provides antimicrobial/antifungal activity; acts as barrier to fluids, bacteria, viruses, and yeast. Used in clinical settings to cover/protect catheter sites and secure intravascular catheters/percutaneous devices. Gel pad absorbs fluid; dressing allows site observation and moisture vapor exchange. Single-use; sterile; ethylene oxide sterilized. Healthcare providers apply dressing over catheter site; CHG provides continuous antimicrobial effect to suppress microorganism regrowth and reduce CRBSI risk. Benefits include infection prevention and securement of medical devices.

Clinical Evidence

No clinical data. Non-clinical bench testing performed to verify viral barrier performance at end of shelf-life.

Technological Characteristics

Transparent adhesive film dressing with integrated hydrophilic gel pad containing 2% w/w Chlorhexidine Gluconate (CHG). Provides moisture vapor exchange, fluid absorption, and barrier protection against bacteria, yeast, and viruses (≥27 nm). Sterile, single-use, ethylene oxide sterilization.

Indications for Use

Indicated for patients with central venous or arterial catheters to cover/protect catheter sites, secure devices to skin, and reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI).

Regulatory Classification

Identification

These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI).

Predicate Devices

• 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620, K153410)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2017

3M Company Melissa Forth Regulatory Affairs Specialist 3M Center. 2510 Conwav Ave. Bldg 275-5W-06 St. Paul, Minnesota 55144

Re: K171908

Trade/Device Name: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2017 Received: June 26, 2017

Dear Melissa Forth:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K171908

Device Name

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing

#### Indications for Use (Describe)

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

Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 510(k) Summary

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92.

# I. SUBMITTER

| Applicant Name: | 3M Health Care<br>3M Center<br>2510 Conway Ave, Bldg. 275-5W-06<br>St. Paul, MN 55144-1000 |
|--------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Melissa J. Forth<br>Regulatory Affairs Specialist |
| Phone:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] |
| Date Prepared: | June 22, 2017 |
| II. DEVICE | |
| Trade Name: | 3MTM TegadermTM CHG Chlorhexidine Gluconate<br>I.V. Securement Dressing |
| Common or Usual<br>Name: | Antimicrobial I.V. Securement Dressing |
| Classification: | Unclassified |
| Product Code: | FRO |
| Classification<br>Name: | Dressing, wound, drug |

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#### 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification - Special 510(k): Device Modification

# III. PREDICATE DEVICE

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620, K153410)

No reference devices are used in this submission.

## IV. DEVICE DESCRIPTION

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.

Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria. viruses* and yeast, and protects the IV site.

In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.

*In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage.

Tegaderm™ CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

| Catalog<br>Number | Device Name | Dressing Size | Average Amount of<br>CHG per Dressing<br>(mg based on gel pad size) |
|-------------------|--------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------|
| 1657 | 3M™ Tegaderm™ CHG<br>Chlorhexidine Gluconate I.V.<br>Securement Dressing | 8.5 cm x 11.5 cm<br>(3-1/2 X 4-1/2 in) | 45 mg |
| 1658 | 3M™ Tegaderm™ CHG<br>Chlorhexidine Gluconate I.V.<br>Securement Dressing | 10 cm X 12 cm<br>(4 X 4-3/4 in) | 45 mg |
| 1659 | 3M™ Tegaderm™ CHG<br>Chlorhexidine Gluconate I.V.<br>Securement Dressing | 10 cm x 15.5 cm<br>(4 X 6-1/8 in) | 78 mg |

The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.

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#### 3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification - Special 510(k): Device Modification

| Catalog<br>Number | Device Name | Dressing Size | Average Amount of<br>CHG per Dressing<br>(mg based on gel pad size) |
|-------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------|
| 1660 | 3M™ Tegaderm™ CHG<br>Chlorhexidine Gluconate I.V.<br>Securement Dressing | 7 cm x 8.5 cm<br>(2 3/4 in. x 3 3/8 in.) | 15 mg |
| 1877* | 3M™ PICC / CVC Securement<br>Device + Tegaderm™ CHG<br>Chlorhexidine Gluconate I.V.<br>Securement Dressing | 8.5 cm x 11.5 cm<br>(3 1/2 x 4 1/2 in) | 45 mg |
| 1879* | 3M™ PICC / CVC Securement<br>Device + Tegaderm™ CHG<br>Chlorhexidine Gluconate I.V.<br>Securement Dressing | 10 cm x 15.5 cm<br>(4 x 6 1/8 in) | 78 mg |

* Note: Catalog numbers 1877 and 1879 are convenience kits. The 3M™ PICC / CVC Securement Device portion of the kit is a US Class I device.

# V. INDICATIONS FOR USE

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering I.V. catheters, other intravascular catheters and percutaneous devices.

Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Characteristic | 3M™ Tegaderm™ CHG<br>I.V. Securement Dressing<br>(Submission Subject) | 3M™ Tegaderm™ CHG<br>I.V. Securement Dressing<br>(K063458, K080620, K153410) |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No changes.<br>Same intended use as predicate<br>device. | 3M™ Tegaderm™ CHG Chlorhexidine<br>Gluconate I.V. Securement Dressing can be used<br>to cover and protect catheter sites and to secure<br>devices to skin. |
| Indications for<br>Use | No changes.<br>Same Indications for Use as<br>predicate device. | 3M™ Tegaderm™ CHG Chlorhexidine<br>Gluconate I.V. Securement Dressing can be used<br>to cover and protect catheter sites and to secure<br>devices to skin. Common applications include<br>securing and covering I.V. catheters, other<br>intravascular catheters and percutaneous devices. |
| Characteristic | 3MTM TegadermTM CHG<br>I.V. Securement Dressing | 3MTM TegadermTM CHG<br>I.V. Securement Dressing |
| | (Submission Subject) | (K063458, K080620, K153410) |
| | | TegadermTM CHG I.V. Securement Dressing is<br>intended to reduce vascular catheter colonization<br>and catheter-related bloodstream infections<br>(CRBSI) in patients with central venous or<br>arterial catheters. |
| Operating<br>Principle | No change.<br>Same operating principle as<br>predicate. | Catheter securement device. |
| Antimicrobial<br>agent | No change.<br>Same as predicate device. | CHG Chlorhexidine Gluconate (CHG)<br>Gel pad contains 2% w/w chlorhexidine<br>gluconate (CHG) or 15-78 mg CHG per pad<br>(depending on dressing size). |
| Technology<br>description | No change.<br>Same as predicate device. | The Chlorhexidine Gluconate I.V. Securement<br>Dressing consists of a transparent adhesive<br>dressing and an integrated hydrophilic gel pad<br>containing 2% w/w Chlorhexidine Gluconate<br>(CHG). The gel pad absorbs fluid. |
| Absorbent | No change.<br>Same as predicate device. | Yes |
| Transparent | No change.<br>Same as predicate device. | Yes |
| Breathable | No change.<br>Same as predicate device. | Yes |
| Secures | No change.<br>Same as predicate device. | Yes |
| Broad spectrum,<br>continuous,<br>antimicrobial /<br>Broad spectrum<br>antifungal | No change.<br>Same as predicate device. | <i>In vitro</i> testing (log reduction and barrier testing)<br>demonstrates that the TegadermTM CHG gel pad<br>in the TegadermTM CHG I.V. Securement<br>Dressing has an antimicrobial effect against, and<br>is a barrier to, a variety of gram-positive and<br>gram-negative bacteria, and yeast in the dressing. |
| Suppresses<br>re-growth of<br>microorganisms | No change.<br>Same as predicate device. | Yes |
| Reduces vascular<br>catheter<br>colonization | No change.<br>Same as predicate device. | Yes |
| Reduces catheter-<br>related<br>bloodstream<br>infection (CRBSI) | No change.<br>Same as predicate device. | Yes |

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## 3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification – Special 510(k): Device Modification

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# VII. SUMMARY OF PERFORMANCE (NON-CLINICAL TESTING) DATA

Non-clinical testing of the subject device for viral barrier performance at the end of shelf-life was performed. The device's performance is substantially equivalent to the predicate device. No biocompatibility, animal studies or clinical studies were needed to support this change.