BIOPATCH* Antimicrobial Dressing containing Chlorhexidine gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: Vascular Devices IV Catheters Central Venous Lines Arterial Catheters Dialysis Catheters Peripherally Inserted Coronary Catheters Mid-Line Catheters Non-vascular percutaneous devices Drains Chest Tubes Externally Placed Orthopedic Pins Epidural Catheters It is also intended to reduce local infections, catheter related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.

Device Description

BIOPATCH* Antimicrobial Dressing is an absorptive foam with chlorhexidine gluconate, a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity.

AI/ML Overview

The BIOPATCH* Antimicrobial Dressing is an absorptive foam with chlorhexidine gluconate, intended as a hydrophilic wound dressing to absorb exudate and cover wounds caused by vascular and non-vascular percutaneous medical devices. It is also intended to reduce local infections, catheter-related bloodstream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI in patients with central venous or arterial catheters.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Intended Effect)	Reported Device Performance
Reduction in the incidence of local infection	Resulted in a statistically significant 44% reduction in the incidence of local infection (p ≤ 0.0001).
Reduction in the incidence of catheter-related blood stream infections (CRBSI)	Resulted in a statistically significant 60% reduction in the incidence of catheter-related blood stream infections (p = 0.026).
Reduction in skin colonization of microorganisms commonly related to CRBSI	Resulted in statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI (p ≤ 0.05).

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

Sample Size: The clinical trial consisted of 687 subjects with 1699 central venous or arterial catheter insertion sites.
Data Provenance: The study was a prospective controlled, randomized clinical trial conducted at two centers. The country of origin is not explicitly stated in the provided text.

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

This information is not provided in the summary. The study relied on clinical outcomes (incidence of infection, CRBSI, and skin colonization) rather than expert review of images or specific data points requiring a separate ground truth established by experts.

4. Adjudication Method for the Test Set:

This information is not provided in the summary. The study design (controlled, randomized clinical trial) implies direct measurement of clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data (e.g., radiologists reading images) to assess the impact of AI assistance on reader performance. The BIOPATCH study focuses on the direct clinical effectiveness of a physical dressing.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. The BIOPATCH is a physical medical device, not an algorithm. The study directly evaluated the device's performance in a clinical setting with human patients.

7. Type of Ground Truth Used:

The ground truth used was clinical outcomes data. This includes:
- Incidence of local infection
- Incidence of catheter-related bloodstream infections (CRBSI)
- Measurement of skin colonization of microorganisms

8. Sample Size for the Training Set:

This information is not applicable as the BIOPATCH Antimicrobial Dressing is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above.

Summary

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510(k) SUMMARY K003229

Submitter's Name:	Integra LifeSciences Corporation
Submitter's Address:	105 Morgan LanePlainsboro, NJ 08536
Submitter's Phone Number:	(609) 936-2311
Submitter's Fax Number:	(609) 897-0645
Name of Contact Person:	Sergio J. Gadaleta, Ph.D.Johnson & Johnson Wound Management,a Division of ETHICON, Inc.Somerville, N.J.(908) 218-2893
Date of Preparation:	October 18, 2001
Name of Device:
Trade Name:	BIOPATCH* Antimicrobial Dressing
Common Name:	Dressing
Classification Name:	Unclassified
Legally Marketed Device to Which Equivalencyis Being Claimed:	The proposed BIOPATCH* Antimicrobial Dressingis the same (material type, manufacturing methods,sterilization type) as the existing BIOPATCH*Antimicrobial Dressing (K895920).
Description of the Device:	BIOPATCH* Antimicrobial Dressing is anabsorptive foam with chlorhexidine gluconate, awell-known antiseptic agent with broad spectrumantimicrobial and antifungal activity.
Intended Use of the Device:	BIOPATCH* Antimicrobial Dressing containingChlorhexidine gluconate is intended for use as ahydrophilic wound dressing that is used to absorbexudate and to cover a wound caused by the use ofvascular and non-vascular percutaneous medicaldevices such as:Vascular DevicesIV CathetersCentral Venous LinesArterial CathetersDialysis CathetersPeripherally Inserted Coronary CathetersMid-Line CathetersNon-vascular percutaneous devicesDrainsChest TubesExternally Placed Orthopedic PinsEpidural CathetersIt is also intended to reduce local infections,catheter related blood stream infections (CRBSI),and skin colonization of microorganisms commonlyrelated to CRBSI, in patients with central venous orarterial catheters.
Summary of Technological CharacteristicsCompared to the Predicate Device:	The proposed BIOPATCH* Antimicrobial Dressingis the same (material type, manufacturing methods,sterilization type) as the existing BIOPATCH*Antimicrobial Dressing.
Brief Discussion of Nonclinical Tests:	No new nonclinical tests were required to support the change.
Brief Discussion of Clinical Tests:	A controlled, randomized, clinical trial consisting of 687 subjects with 1699 central venous or arterial catheter insertion sites was conducted at two centers. Results of this study demonstrated:use of BIOPATCH Antimicrobial Dressing resulted in a statistically significant 44% reduction in the incidence of local infection (p ≤ 0.0001). use of BIOPATCH Antimicrobial Dressing resulted in a statistically significant 60% reduction in the incidence of catheter related blood stream infections (p = 0.026). use of BIOPATCH Antimicrobial Dressing resulted in statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI (p ≤ 0.05). Patients randomized to the BIOPATCH Antimicrobial Dressing Treatment Group experienced no serious device-related adverse events.
Conclusions Drawn for the Nonclinical and Clinical Tests:	See "Brief Discussion" of Clinical Tests above.
Other Information Deemed Necessary by FDA:	Not Applicable

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Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

OCT 2 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sergio J. Gadaleta, Ph.D. Senior Project Manager, Regulatory Affairs Johnson & Johnson Wound Management A Division of Ethicon Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K003229

Trade/Device Name: BIOPATCH Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 8, 2001 Received: August 10, 2001

Dear Dr. Gadaleta:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Sergio J. Gadaleta, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Wall, is

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOO3229

510(k) Number (if known): K003229

Device Name: BIOPATCH Antimicrobial Dressing

Indications for Use:

BIOPATCH* Antimicrobial Dressing containing Chlorhexidine gluconate is intended for use as BIOPATCH ' Antimicronal Dressing containty our a wound cause and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis cathers, peripherally inserted coronary catherers. It s Venous intel, diverial catherels, charysis duardson pins, and epidural cathers. It is a also intended to reduce local infections, catheter related blood stream infections (CRBS), and also intellection of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.

(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 General, Restorative and Neurological Devices

510(k) Number K003229

Regulation Number and Section

N/A