The BeneHold CHG Transparent Film Dressing is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices.

Device Description

The BeneHold CHG Transparent Film Dressing is used to cover and protect catheter sites and to secure devices to the skin. The dressing consists of a transparent film with an acrylic adhesive which contains 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 yeast, and protects the IV site from outside contamination. The dressing absorbs between 8 and 21 ml of fluid depending on the dressing size. In vitro testing (barrier, kill time and log reduction) demonstrates that the BeneHold CHG Transparent Film Dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria, yeast and fungus in the dressing. BeneHold CHG Transparent Film Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

AI/ML Overview

The provided 510(k) summary (K113836) for the BeneHold CHG Transparent Film Dressing describes performance testing, but does not provide specific acceptance criteria or detailed study results for all tests. It lists the tests performed but largely states that they demonstrated "conformance to design specifications" or that "testing indicates that the BeneHold CHG Transparent Film Dressing is substantially equivalent."

Therefore, much of the requested information regarding specific acceptance criteria, detailed device performance, sample sizes, ground truth establishment, and expert involvement is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific acceptance criteria and quantitative performance metrics are generally not explicitly stated in this 510(k) summary. The summary broadly states that the device "conforms to design specifications" and demonstrated "antimicrobial effect" and "barrier" properties.

Performance Test	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Summary)
Fluid Handling Capacity	(Not specified)	Absorbs between 8 and 21 ml of fluid depending on dressing size.
Static Absorption	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
Moisture Vapor Transmission Rate	(Not specified)	Breathable, allowing good moisture vapor exchange.
Peel Adhesion	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
Liner Release	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
Finat Tack	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
Seal Strength	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
Die Migration	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
CHG/PCA Content	(Not specified)	(Performed, no specific result mentioned beyond general conformance)
Antimicrobial Effectiveness	(Not specified, but generally means significant reduction of pathogens)	In vitro testing demonstrates an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, yeast and fungus in the dressing.
Bacterial/Viral Barrier	(Not specified)	Barrier to liquid (waterproof), bacteria and yeast, and protects the IV site from outside contamination.
Sterility	(Not specified, but assumed to meet sterility standards)	(Performed, no specific result mentioned beyond general conformance)
Biocompatibility (Irritation)	(Negligible irritation)	Negligible irritation.
Biocompatibility (Cell Lysis/Toxicity)	(No evidence)	No evidence the device causes cell lysis or toxicity.
Biocompatibility (Sensitization)	(No evidence)	No evidence of delayed dermal contact sensitization.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size:
- Test Set: Not specified in the document. The document refers to "in vitro testing" for antimicrobial effects and barrier properties, but the sample sizes (e.g., number of dressings, number of bacterial cultures) are not provided.
- Training Set: Not applicable as this is a physical medical device, not an AI/ML diagnostic device with a training set.
Data Provenance: The studies are described as "in vitro testing." The country of origin of the data is not specified, but the submitter is "Avery Dennison Belgie, BVBA" (Belgium) and the contact person is in the US. The studies are described as performance tests, which are typically conducted in a laboratory setting for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable/Not specified. This is a physical device performance study, not an imaging/diagnostic study requiring expert ground truth establishment in a clinical context. Laboratory testing for physical and chemical properties typically relies on standardized methods and measurements rather than expert consensus on a "ground truth" derived from clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need resolution. This document describes laboratory-based performance testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not mentioned or implied by the described performance testing. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human reader performance is being evaluated with and without assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

In this context, the "ground truth" for the device's performance tests would be established through scientific measurements and standardized laboratory protocols. For example:
- For fluid handling capacity, the ground truth is the measured volume of fluid absorbed.
- For antimicrobial effectiveness, the ground truth is the measured log reduction of microbial population compared to controls based on established microbiological methods.
- For biocompatibility, the ground truth is determined by standardized in vitro or in vivo tests for irritation, cytotoxicity, and sensitization.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML diagnostic device.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is a physical medical device, not an AI/ML diagnostic device.

Summary

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K113836
p1/2

510(k) Summary

Avery Dennison Belgie, BVBA · BeneHold CHG Transparent Film Dressing

1. Submitter Information

Name:	Avery Dennison Belgie, BVBA
Address:	Tieblokkenlaan 1Turnhout, Belgium B-2300
Telephone Number:	1-312-629-4608

Contact Person: Jerzy Wojcik Telephone Number: . 1-312-629-4608 Email: jerzy.wojcik@averydennison.com

Date Prepared:

December 27, 2011

2. Device Name

Trade Name:	BeneHold CHG Transparent Film Dressing
Common Name:	Dressing, Wound, Drug
Classification Name:	Unclassified

3. Predicate Device(s)

K063458, 3M Tegaderm CHG Dressing

বঁ Device Description

Avery Dennison Belgie, BVBA	Section: 5
Traditional 510(k) Submission: BeneHold CHG Transparent Film Dressing	Page: 1 of 2

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K113836
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5. Indications for Use

6. Technological Characteristics and Substantial Equivalence

Both the BeneHold CHG Transparent Film Dressing and 3M Tegaderm CHG Dressing are wound dressings used to cover and protect catheter sites and secure devices to the skin via adhesion of the dressing to the skin.

7. Performance Testing

The BeneHold CHG Transparent Film Dressing was evaluated to assure conformance to design specifications. The following performance tests were performed:

Fluid Handling Capacity �
. Static Absorption
Moisture Vapor Transmission Rate .
. Peel Adhesion
Liner Release ●
Finat Tack .
Seal Strength .
. Die Migration
CHG/PCA Content
Antimicrobial Effectiveness .
Bacterial/Viral Barrier ●
Sterility .

The BeneHold CHG Transparent Film Dressing was also evaluated for safety concerns relative to biocompatibility. The evaluations showed that there irritation is negligible, and that there is no evidence the device causes cell lysis or toxicity, nor is there evidence of delayed dermal contact sensitization.

8. Conclusion

Testing indicates that the BeneHold CHG Transparent Film Dressing is substantially equivalent in terms of both indications for use and technology to the predicate product.

Avery Dennison Belgie, BVBA	Section:	5
Traditional 510(k) Submission: BeneHold CHG Transparent Film Dressing	Page:	2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

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

Avery Dennison Belgie, BVBA % Avery Dennison Corporation Mr. Jerzy Wojcik Manager, Regulatory Affairs 20 North Wacker Drive, Suite 2240 Chicago, Illinois 60606

SEP
24
2012

Re: K113836

Trade/Device Name: BeneHold CHG Transparent Film Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 14, 2012 Received: September 18, 2012

Dear Mr. Wojcik:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Jerzy Wojcik

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.html 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mach H. Millman

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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K113836

Indications for Use

510(k) Number (if known):

Device Name: BeneHold CHG Transparent Film Dressing

Indications for Use:

Prescription Use x
(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)

(Division Sign-Off)
Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number

Regulation Number and Section

N/A