IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER

K112549 · Covalontechnologies, Inc. · FRO · May 4, 2012 · SU

Device Facts

• Record ID: K112549
• Device Name: IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
• Applicant: Covalontechnologies, Inc.
• Product Code: FRO · SU
• Decision Date: May 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.

Device Story

IV Clear is a clear polyurethane film dressing coated with a silicone adhesive containing chlorhexidine and silver salts. It is applied by clinicians to cover and protect percutaneous insertion sites (e.g., IVs, PICCs, catheters, pins) and secure medical devices to the skin. The dressing acts as a physical barrier to prevent external contamination and utilizes the antimicrobial properties of chlorhexidine and silver to inhibit microbial growth within the dressing. It is intended for use in clinical settings where site protection and device securement are required.

Clinical Evidence

Bench testing only. Evidence includes in vitro log reduction studies, biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, sub-chronic toxicity per ISO 10993), a porcine wound healing study, and a human repeat insult patch test.

Technological Characteristics

Clear polyurethane film dressing; silicone adhesive containing chlorhexidine and silver salts. Biocompatibility testing performed per ISO 10993. No electronic or software components.

Indications for Use

Indicated for patients requiring protection of percutaneous insertion sites and securement of medical devices, including IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, and orthopedic pins.

Predicate Devices

• 3M™ Tegaderm™ CHG Dressing (K080620)
• 3M™ Tegaderm™ Transparent Dressing (K973036)
• Arglaes® Film Antimicrobial Barrier Dressing (K990810)
• Mepitac® Soft Silicone Tape (Class I)

Submission Summary (Full Text)

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MAY - 4 2012

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# Premarket Notification (510(k)) Summary

### 1. Sponsor information

Covalon Technologies Inc. 405 Britannia Road East, Suite #106 · Mississauga, Ontario, Canada L4Z 3E6

| Contact person: | Kim Crooks<br>Dir., Customer Operations, QA/RA |
|------------------|------------------------------------------------|
| Phone number: | 1-905-568-8400 |
| Fax number: | 1-905-568-5200 |
| Date of summary: | 26 March 2012 |

## 2. Device name and classification

| Common Name: | Wound Dressing, Antimicrobial |
|------------------------|-------------------------------------------------------------------------------------------|
| Proprietary Name: | IV Clear® Antimicrobial Clear Silicone Adhesive Dressing<br>with Chlorhexidine and Silver |
| Device Classification: | Antimicrobial Dressing, Unclassified |
| Classification Panel: | General and Plastic Surgery |

#### 3. Predicate devices

| Manufacturer | Device | 510(k) number |
|-----------------------|----------------------------------------------|---------------|
| 3M Health Care | 3M™ Tegaderm™ CHG Dressing | K080620 |
| 3M Health Care | 3M™ Tegaderm™ Transparent Dressing | K973036 |
| Maersk Medical, Ltd. | Arglaes® Film Antimicrobial Barrier Dressing | K990810 |
| Molnlycke Health Care | Mepitac® Soft Silicone Tape | Class I |

#### 4. Indications for use

IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.

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K112549

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#### 5. Performance testing

IV Clear® is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts. The following tests were performed on IV Clear®.

- in vitro log reduction -
- Biocompatibility studies, including, cytotoxicity, sensitization, irritation, systemic toxicity and sub-chronic toxicity in accordance with ISO 10993
- Porcine wound healing study -
- Human repeat insult patch test "
- Human regrowth prevention study -

#### e Substantial equivalence

Performance testing confirmed that IV Clear is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).

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#### Public Health Service

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

MAY - 4 2012

Covalon Technologies, Inc. % Ms. Kim Crooks Director, Customer Operations, QA/RA 405 Britannia Road East, Suite #106 Mississauga, Ontario, Canada L4Z 3E6

Re: Ki12549

Trade/Device Name: IV Clear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine and Silver

Regulatory Class: Unclassified Product Code: FRO Dated: March 26, 2012 Received: March 27, 2012

Dear Ms. Crooks:

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

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Page 2 - Ms. Kim Crooks

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Einet Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112549

### Indications for Use

510(k) Number: K112549

Device Name: IV Clear® Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver

Indications for Use:

IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. IV. Olear 13 michaed to 6010. and and and all enous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other Cathelers, epiddral catheters, nemodiaryols outhors, exclude inhibits microbial growth within the dressing and prevents external contamination.

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kramer NKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K112549

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