The ChloraShield IV Dressing with CHG Antimicrobial 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 ChloraShield IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing with integrated Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.

AI/ML Overview

The provided text describes a Special 510(k) submission for the "ChloraShield IV Dressing with CHG antimicrobial" due to a change in packaging material. The study reported focuses on verifying that this packaging change does not negatively impact the device's sterility and functionality.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (Original)	10⁻⁶
Sterility Assurance Level (Revised Packaging)	10⁻⁶ (confirmed no impact to sterility)
Seal Strength	Verified (no specific numerical criteria or results given)
Bubble Leak Test	Performed (no specific numerical criteria or results given)

Note: The primary acceptance criterion explicitly stated and tested related to a numerical value is the Sterility Assurance Level. For Seal Strength and Bubble Leak Test, the text only states they were "verified" or "performed" without providing specific target values or quantitative results. The overarching acceptance criterion is that the new packaging "did not negatively impact the sterility assurance level" and that "the performance, functionality and manufacturing methods remain unchanged."

Study Information

The document describes a verification/validation activity rather than a traditional clinical study with a test set of patients.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not explicitly stated for any of the tests (Sterility, Seal Strength, Bubble Leak Test).
Data Provenance: The tests were conducted internally by Avery Dennison Belgie, b.v.b.a. No information on country of origin of data or whether it was retrospective or prospective in a clinical sense. These are laboratory/engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts: Not applicable. Ground truth for sterility or mechanical integrity tests is established by standardized laboratory methods and measurements, not expert consensus in the way a clinical image analysis study might.
Qualifications: Not applicable for this type of testing.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. These are objective laboratory tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

MRMC Study: No, this type of study was not done. The device is a wound dressing, and the study described focuses on the impact of a packaging change on its physical and microbiological properties, not on reader effectiveness.

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

Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI algorithms does not apply. The tests described are for the device's intrinsic properties.

7. The type of ground truth used:

Ground Truth:
- Sterility: Established by microbiology testing to confirm the absence of viable microorganisms, adhering to a defined Sterility Assurance Level (SAL) of 10⁻⁶. This is an objective, laboratory-derived ground truth.
- Seal Strength and Bubble Leak Test: Established through mechanical testing methods, likely comparing results against established engineering specifications or the performance of the original device packaging. This is an objective, laboratory-derived ground truth.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable. As there is no training set.

Summary

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MAR 1 3 2014

K133764 page 1 of 2

Special 510(k) Summary

Avery Dennison Belgie, b.v.b.a. ChloraShield IV Dressing with CHG antimicrobial

1. Submitter Information

Name:	Avery Dennison Belgie, bvba
Address:	Tieblokkenlaan 1Turnhout, Belgium B-2300
Telephone Number:	1-312-629-4608
Contact Person:	Lisa Bartakovics
Telephone Number:	1-312-629-4608
Email:	Lisa.Bartakovics@averydennison.com

December 10, 2013 Date Prepared:

2. Device Name

Trade Name:	ChloraShield IV Dressing with CHG Antimicrobial
Common Name:	Dressing, Wound, Drug
Classification Name:	Unclassified

3. Predicate Device(s)

K113836, Benehold CHG Transparent Film Dressing .

4. Device Description

5. Indications for Use

The ChloraShield IV Dressing with CHG antimicrobial 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.

The Indications for Use have not been altered and are the same as those listed within the original 510(k) application (K113836).

Avery Dennison Belgie, b.v.b.a.
Special 510(k) Submission: ChloraShield IV Dressing with CHG antimicrobial	Page: 1 of 2

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K133764 page 2 of 2

6. Technological Characteristics and Substantial Equivalence

The change in the packaging material does not affect the substantial equivalence of the device per submission K113836. Although the packaging has been modified, the fundamental technology of the finished device has not been altered. The inclusion of CHG as a preservative within the adhesive of the dressing, which is the fundamental scientific technology, is unaffected by the change to the packaging. In addition, the performance, functionality and manufacturing methods remain unchanged.

7. Performance Testing

Sterility testing was conducted to verify the change to the packaging material did not negatively impact the sterility assurance level. The sterility assurance level within the original 510(k) submission was 10 ° and testing confirmed that the revised packaging achieved a sterility assurance level of 10 * thus there was no impact to the sterility. In addition to the sterility testing, the seal strength was verified. In summary, the following performance tests were performed as part of verification/validation activities:

. Seal Strength
Bubble Leak Test
Sterility ●

8. Conclusion

Testing demonstrates that the change in the packaging material does not affect the technological characteristics of the device or the intended use as listed within the original submission (K113836). The method of sterilization, gamma, remains unchanged. Furthermore, there has been no decrease in the sterility assurance level of the ChloraShield IV Dressing with CHG antimicrobial thus the proposed change in the packaging of the device is equivalent to that of the original submission.

Avery Dennison Belgie, b.v.b.a.
Special 510(k) Submission: ChloraShield IV Dressing with CHG antimicrobial	Page:	2 of 2

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Public Health Service

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

March 13, 2014

Avery Dennison Belgie, bvba Ms. Lisa Bartakovics Director of Global Regulatory Affairs Tieblokkenlaan 1 Turnhout, Belgium B-2300

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K133764

Trade/Device Name: ChloraShield IV Dressing with CHG Antimicrobial Regulatory Class: Unclassified Product Code: FRO Dated: February 10, 2014 Received: February 12, 2014

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 10 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 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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Page 2 - Ms. Lisa Bartakovics

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Krause -S

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

Enclosure

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Indications for Use

K133764 510(k) Number (if known):

Device Name: ChloraShield IV Dressing with CHG Antimicrobial

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number

Regulation Number and Section

N/A