ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)

K163529 · Avery Dennison Corporation · FRO · Mar 29, 2017 · SU

Device Facts

• Record ID: K163529
• Device Name: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
• Applicant: Avery Dennison Corporation
• Product Code: FRO · SU
• Decision Date: Mar 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires. ReliaTect™ may also be used to cover and secure a primary dressing. ReliaTect™ inhibits microbial growth within the dressing and prevents external contamination.

Device Story

Transparent adhesive wound dressing integrated with Chlorhexidine Gluconate (CHG); provides physical barrier against external contaminants and fluids; inhibits microbial growth within dressing via CHG release. Used in clinical settings to cover percutaneous device sites or secure primary dressings. Applied by healthcare providers. Benefits include protection of percutaneous sites and reduction of microbial colonization within the dressing material.

Clinical Evidence

No human clinical trials performed. Evidence consists of bench testing and an animal study. Bench testing confirmed fluid handling, moisture vapor transmission, adhesion, and antimicrobial effectiveness against various gram-positive/negative bacteria and yeast. Porcine study in Yucatan miniature swine evaluated wound healing impact on full-thickness incisional wounds, demonstrating performance equivalent to the predicate device.

Technological Characteristics

Transparent adhesive film dressing containing Chlorhexidine Gluconate (CHG) as an antimicrobial agent. Features include waterproof barrier, moisture vapor transmission, and fluid absorption capabilities. Device is non-sterile or sterile (implied by post-op use). No software or electronic components.

Indications for Use

Indicated for covering and protecting wounds caused by percutaneous medical devices (drains, chest tubes, orthopedic pins, fixtures, wires) and for securing primary dressings.

Predicate Devices

• Covalon SurgiClear™ (K121819)

Reference Devices

• Avery Dennison Benehold CHG Transparent Film Dressing (K113836)

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

March 29, 2017

Avery Dennison Corporation Ms. Lisa Bartakovics Director of Global Regulatory Affairs 7100 Lindsay Dr., Bldg. 14 Mentor, Ohio 44060

Re: K163529

Trade/Device Name: Reliatect Post-op Dressing With CHG (8cm X 15cm), Reliatect Postop Dressing With CHG (10cm X 25cm)

Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2017 Received: February 23, 2017

Dear Ms. Bartakovics:

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 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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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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EPARTMENT OF HEALTH AND HUMAN SERVIC
Food and Drug Administration

lications for

Expiration Date

ration Date: January 31, 20
PRA Statement below.

Approved: OMB No. 0910-0120

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IS1052

Device Name
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Indications for Use (Describe)

ndication for Use (Describe)
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ReliaTect™ may also be used to cover and secure a primary dress

iiaTect™ inhibits microbial growth within the dressing and prevents external contamin

ype of Use (Select one or both, as applicable

Over-The-Counter Use (21 CFR 801 Subpart ■ Prescription Use (Part 21 CFR 801 Subpart D)

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## 510(k) Summary

Avery Dennison Corporation ReliaTect™ Post-Op Dressing with CHG

#### 1. Submitter Information

| Name: | Avery Dennison Corporation |
|-------------------|------------------------------------------|
| Address: | 7100 Lindsay Drive<br>Mentor, Ohio 44060 |
| Telephone Number: | + 1 [phone] |
| Contact Person: | Lisa Bartakovics |
| Telephone Number: | [phone] |
| Email: | [e-mail] |

#### 2. Device Name

| Trade Name: | ReliaTect™ Post-Op Dressing with CHG |
|----------------------|--------------------------------------|
| Common Name: | Dressing, Wound, Drug |
| Classification Name: | Unclassified |
| Product Code: | FRO |

#### 3. Predicate Device(s)

- Predicate Device- Covalon SurgiClear™ K121819 ●
- Reference Device- Avery Dennison Benehold CHG Transparent Film . Dressing K113836

#### 4. Device Description

The ReliaTect™ Post-Op Dressing with CHG is a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial activity.

In vitro testing (barrier and log reduction) demonstrates the ReliaTect™ Post-Op Dressing with CHG provides an effective barrier against external contamination including fluids (waterproof) and a variety of gram-positive bacteria, gramnegative bacteria, and yeast within the dressing including: Staphylococcus aureus, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Escherichia coli, Pseudomonas aeruginosa,

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Enterobacter aerogenes, Klebsiella pneumonia, and Candid albicans. Reduction in the colonization or microbial growth on the device has not been shown to correlate with a reduction in infections in patients. Clinical studies to evaluate reduction in infection have not been performed.

# 5. Indications for Use

The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.

ReliaTect™ may also be used to cover and secure a primary dressing.

ReliaTect™ inhibits microbial growth within the dressing and prevents external contamination.

## 6. Technological Characteristics and Substantial Equivalence

The ReliaTect™ Post-Op Dressing with CHG is substantially equivalent to the commercially available Covalon SurgiClear™ device (K121819). Bench testing studies, including antimicrobial efficacy, demonstrate the two devices have comparable performance. The Intended Use of the ReliaTect™ is equivalent to the SurgiClear™ device.

# 7. Performance Testing

Performance testing was completed on various characteristics to ensure product requirements were satisfied as well as for comparison aqainst the predicate product. The acceptance criteria were met for all characteristics and comparison against the predicate demonstrated equivalent performance. Performance tests included:

- . Fluid Handling Capacity
- Static Absorption
- . Moisture Vapor Transmission Rate
- Peel Adhesion to Polyethylene .
- . Liner Release
- . Antimicrobial Effectiveness
- Transparency ●
- Peel Adhesion to Sutures .

Antimicrobial effectiveness testing performed demonstrates that the presence of CHG within the dressing inhibits microbial growth within the dressing.

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# 8. Animal Study

The ReliaTect™ Post-Op Dressing with CHG was subjected to a wound healing evaluation through a porcine study. The objective of this study was to evaluate the wound healing impact of the Post-Op dressing with an active antimicrobial agent on full thickness incisional wounds in Yucatan miniature swine. Results of the study demonstrate the ReliaTect™ Post-Op Dressing and the predicate device achieved equivalent performance.

# 9. Conclusion

The ReliaTect™ Post-Op Dressing with CHG is substantially equivalent to the Covalon SurgiClear™ device. Bench and Animal performance testing, including antimicrobial effectiveness, demonstrate the two devices are substantially equivalent for their intended use.