Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as: A hydrophilic foam patch that is used to absorb exudates and to cover the peri-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.

Device Description

The Medtrade Product Ltd CHG Antibacterial Foam Patch consists of a hydrophilic Polyurethane absorbent foam with chlorhexidine gluconate (CHG) and a thin Polyurethane backing. The foam material absorbs up to eight times its own weight in fluid. The CHG present in the dressing inhibits or kills microorganisms on the surface of the dressing.

AI/ML Overview

The provided documentation describes a 510(k) submission for the Medtrade Products Ltd CHG Antibacterial Foam Patch. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to establish novel performance criteria. Therefore, the device performance is primarily assessed against the predicate device's established uses and through in-vitro and bench testing to show it meets its own specifications and is safe and effective for its intended use.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured/tested for)	Reported Device Performance (Results)
Antibacterial Activity (In-vitro)
Reduces/inhibits microbial colonization in the dressing	Demonstrated
Log 4 reduction of specific organisms over 7 days	Demonstrated for: - Staphylococcus aureus (MRSA) NCTC 13142 - Escherichia coli ATCC 8739 - Pseudomonas aeruginosa ATCC 9027 - Enterococcus faecalis NCTC 12201 - Staphylococcus aureus ATCC 6538
Biocompatibility	In compliance with BS EN ISO 10993-1 (Biological Evaluation of Medical Devices)
Sterilization	Performed in compliance with harmonized standards
Manufacturing Quality	Meets all established specifications; manufactured under GMP; risk analysis (BS EN ISO 14971) performed and controls implemented
Absorption Capacity	Hydrophilic foam absorbs up to eight times its own weight in fluid

Note on "Acceptance Criteria" for a 510(k): For a 510(k) submission like this, the "acceptance criteria" are typically demonstrating that the device is as safe and effective as the predicate device, and that its in-vitro and bench testing results meet its own internal specifications and relevant standards. There isn't a "clinical study" in the traditional sense with specific clinical endpoints and acceptance thresholds for clinical performance in humans, as you might see in a PMA or a more novel device.

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

Sample Size for Test Set: Not explicitly stated for specific tests. The antibacterial data refers to "organisms" which implies laboratory strains, not human patient samples.
Data Provenance: The antibacterial and bench testing are in-vitro (laboratory) and bench studies, meaning they are not derived from human patients or a specific country of origin in a clinical context.

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

This information is not applicable and not provided. The testing described is in-vitro (lab-based antibacterial efficacy) and bench testing (physical properties, biocompatibility, sterilization). These types of tests do not involve human experts establishing a "ground truth" through interpretation (e.g., radiologists reviewing images). Instead, results are determined by laboratory measurements and adherence to specified standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, the testing is in-vitro and bench testing, not clinical with expert review of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with/without AI Assistance

No. This is a medical device (foam patch), not an AI/imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question applies to AI algorithms. This device is a physical medical dressing.

7. The Type of Ground Truth Used

Antibacterial Testing: The "ground truth" would be the direct measurement of microbial reduction (e.g., Log reduction) in laboratory conditions following established microbiological protocols.
Biocompatibility: Adherence to the requirements of the standard BS EN ISO 10993-1.
Sterilization: Compliance with harmonized standards.
Absorption: Direct measurement of fluid absorption capacity.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical product undergoing in-vitro and bench testing.

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

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

Summary

{0}------------------------------------------------

Page 1 of 3

K120930

Section 5 – Traditional 510(k) Notification:- Summary

This Traditional 510(k) notification is to provide substantial equivalence for the Medtrade Products Ltd CHG Antibacterial Foam Patch, which is substantially equivalent to currently marketed devices intended for wound care.

OCT 2 6 2012

Submitted by:-	Medtrade Product LtdElectra House, Crewe Business ParkCrewe, CheshireCW1 6GLUnited Kingdom
Contact:-	Mrs Claire RyanHead of Regulatory & QATelephone: + 44(0)1270 500019Fax:- + 44(0)1270 500045Email: claire.ryan@medtrade.co.uk
Date prepared:-	26th March 2012
Proprietary Name:	CHG Antibacterial Foam Patch
Common Name:-	CHG Antibacterial Foam DressingCHG Antibacterial PatchCHG Antibacterial DressingCHG PatchCHG Dressing
Trade Names:-	Not yet defined
Classification Name:-	Dressing, Wound, Drug
Classification:-	Unclassified
Product Code:-	FRO

Legally marketed device(s) for substantial equivalence comparison:-BIOPATCH, 510(k) # K003229, manufactured by Johnson and Johnson Wound Management.

Device Description :-

{1}------------------------------------------------

posi 2 of 3

CHG Antibacterial Patch is available in the following sizes :-1" DISK (2.5cm) 4.0mm center hole with radial slit. %" DISK (1.9cm) 1.5mm center hole with radial slit. 1" DISK (2.5cm) 7.0mm center hole with radial slit.

CHG Antibacterial Patches are packaged in individual pouches, then into shelf cartons with an instruction for use.

Indications for use:

Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as a hydrophilic foam patch that is used to absorb exudates and to cover the peri-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.

In-vitro Testing :-

In-vitro Antibacterial data has shown that CHG Antibacterial Foam Patch reduces or inhibits microbial colonization in the dressing. In vitro CHG Antibacterial Foam Patch has demonstrated a Log 4 reduction and has been shown to kill the following organisms, over a 7 day period.

Staphylococcus aureus (MRSA) NCTC 13142 – Gram Positive Bacterium Escherichia coli ATCC 8739 - Gram Negative Bacterium Pseudomonas aeruginosa ATCC 9027 - Gram Negative Bacterium Enterococcus faecalis NCTC 12201 – Gram Positive Bacterium Staphylococcus aureus ATCC 6538 - Gram Positive Bacterium

Manufacturing :-

CHG Antibacterial Foam Patch is manufactured according to the product specifications and under good manufacturing practices (GMP). A risk analysis has been performed in accordance with BS EN ISO 14971 to identify possible failure mode during manufacturing and design. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode.

Medtrade Product Ltd. CHG Antibacterial Foam Patch meets all the established specifications prior to release to ensure the device is safe, effective and correctly labeled for its intended use.

{2}------------------------------------------------

Testing: -

Performance data for the CHG Antibacterial Foam Patch have been established using antibacterial and bench testing. The biocompatibility of CHG Antibacterial Foam Patch has demonstrated to be in compliance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). Sterilisation has been performed in compliance with harmonised standards. The biocompatibility and performance testing for the CHG Antibacterial Foam Patch have demonstrated that the device is safe and effective for the indications of use.

Statement of Substantial Equivalence:-

The indication for use, performance testing and antibacterial activity for the CHG Antibacterial Foam Patch are substantially equivalent to the predicate device; BIOPATCH, 510(k) # K003229, cleared October 26, 2001, manufactured by Johnson & Johnson, as both products are absorbent polyurethane foams with the addition of CHG as an antibacterial.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Medtech Products, Limited % Ms. Clare Ryan Head of Regulatory and Quality Affairs Electra House, Crewe Business Cheshire, United Kingdom CWI 6GL

Re: K120930

Trade/Device Name: CHG Antibacterial Foam Patch Regulatory Class: Unclassified Product Code: FRO Dated: October 12, 2012 Received: October 16, 2012

Dear Ms. Ryan:

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.

OCT 26 2012

{4}------------------------------------------------

Page 2 - Ms. Clare Ryan

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: CHG Antibacterial Foam Patch

Indications for Use:

Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as:

A hydrophilic foam patch that is used to absorb exudates and to cover the peri-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

। প্

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for MMM

(Division Sign-Off) Division of Surgical. Orthoped and Restorative Devices

510(k) Number K120930

Regulation Number and Section

N/A