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 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.

AI/ML Overview

The provided document is a 510(k) summary for the ReliaTect™ Post-Op Dressing with CHG. This device is a medical dressing, not an AI/ML powered device, so information typically requested for AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

However, I can extract information related to the acceptance criteria and performance testing that was conducted for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The acceptance criteria were met for all characteristics and comparison against the predicate demonstrated equivalent performance." It also mentions "bench testing studies, including antimicrobial efficacy, demonstrate the two devices have comparable performance."

While specific numerical acceptance criteria values are not provided, the following tests were conducted, and the device met the criteria and showed equivalent performance to the predicate device:

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Fluid Handling Capacity	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device (Covalon SurgiClear™ K121819).
Static Absorption	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device.
Moisture Vapor Transmission Rate	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device.
Peel Adhesion to Polyethylene	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device.
Liner Release	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device.
Antimicrobial Effectiveness	Met established criteria (details not specified, but involved log reduction)	In vitro testing demonstrated an effective barrier against external contamination (waterproof) and a variety of gram-positive bacteria, gram-negative bacteria, and yeast within the dressing, including: Staphylococcus aureus, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Escherichia coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella pneumonia, and Candida albicans. The presence of CHG inhibits microbial growth within the dressing. The device also showed comparable performance to the predicate device. (Note: "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.")
Transparency	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device.
Peel Adhesion to Sutures	Met established criteria (details not specified)	Met acceptance criteria and showed equivalent performance to the predicate device.
Wound Healing Impact (Porcine Study)	Equivalent performance to predicate device	Achieved equivalent performance to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to clinical studies often conducted for AI/ML devices. The testing mentioned (bench testing, in vitro testing, and a porcine study) are laboratory and animal studies, not human clinical trials with specific test sets in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not provided. The device is a physical dressing, and its performance was assessed through laboratory and animal studies rather than expert-derived ground truth as would be used for diagnostic AI/ML systems.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable and not provided for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable and not provided. This is a physical medical device, not an AI-powered diagnostic tool engaging human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable and not provided for the reasons stated above.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance was established through:

Bench Testing: Objective measurements against established physical and chemical standards for properties like fluid handling, adhesion, and moisture transmission.
In vitro Testing: Laboratory culture results for antimicrobial efficacy, demonstrating log reduction against specific microorganisms.
Animal Study: Direct observation and evaluation of wound healing in a porcine model, with performance compared to a predicate device.

8. The sample size for the training set

Not applicable and not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable and not provided for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

IS1052

Device Name
The ReliaTect™ Post-Op Dressing with t

Indications for Use (Describe)

ndication for Use (Describe)
The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous media
levices such as drains, chest tube

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)

ONTINUE ON A SEPARATE PAGE IF NEED

This section applies only to requirements of the Paperwork Reduction Act of 1995.
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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 DriveMentor, Ohio 44060
Telephone Number:	+ 1 (440) 534-6000
Contact Person:	Lisa Bartakovics
Telephone Number:	+1 (312) 206-6159
Email:	Lisa.Bartakovics@averydennison.com

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.

Regulation Number and Section

N/A