Prontosan™ Wound Gel is intended for moistening and cleansing wounds by maceration of wound coatings and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds, and abrasions.

Device Description

Prontosan™ Wound Gel is a clear, colourless liquid-gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan™ Wound Gel is used for managing and treating wounds by sustaining wound moisture between dressing changes and aiding in the manual removal of wound exudates and encrustations. The gel is aseptically filled using a blow fill seal process into low density polyethylene 30 mL squeeze bottles with screw caps.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Prontosan™ Wound Gel) and does not describe acceptance criteria or a study that rigorously tests the device against such criteria in the way a clinical performance study for an AI/ML device would. Instead, it demonstrates substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety testing.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not applicable to this submission.

However, I can extract the relevant information regarding the stated safety and performance support for the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Documentation	Reported Performance
Biocompatibility	Biocompatibility testing	Supported
Sterility/Purity	USP <51> Antimicrobial Effectiveness Testing	Supported (Implied to meet USP standards)
	USP <85> Bacterial Endotoxin testing	Supported (Implied to meet USP standards)
Material/Product Stability	Shelf life testing	Supported
Clinical Performance	(Not applicable - substantial equivalence based on predicate, not clinical trials for performance metrics)	(Not applicable)

Notes on the "Reported Performance": The document states that these tests were "supported by" or "conducted with" Prontosan™ Wound Gel, implying successful completion and meeting of relevant standards to demonstrate safety and effectiveness.

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

Not applicable. This submission relies on substantial equivalence to a predicate device and direct safety testing, not a clinical "test set" in the context of an AI/ML or diagnostic performance study.
The provenance for the safety tests (biocompatibility, USP <51>, USP <85>, shelf life) is the product itself, as tested by the manufacturer.

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

Not applicable. Ground truth in the context of expert review for a test set is not relevant to this type of device submission. The "ground truth" for safety aspects would be established by the respective test methodologies and their validated standards.

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

Not applicable. There was no "test set" and no expert adjudication process described.

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. This device is a wound gel, not an AI/ML-powered diagnostic or assistive tool.

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

Not applicable. This device is a wound gel, not an algorithm.

7. The type of ground truth used:

For safety: The "ground truth" was established by the outcomes of standard, validated laboratory tests for biocompatibility, antimicrobial effectiveness (per USP <51>), bacterial endotoxin (per USP <85>), and product shelf life. These are objective measures with established pass/fail criteria.
For effectiveness/performance: The "ground truth" for effectiveness is primarily established by substantial equivalence to the predicate device, Prontosan™ Wound Irrigation Solution, which implies similar clinical utility for wound moistening and cleansing based on its known formulation and the presence of minor inactive ingredients (hydroxyethylcellulose and glycerol) that add viscosity and moisturizing properties. No new clinical performance studies proving efficacy were presented, as per the 510(k) pathway.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. Since there is no training set, this question is not relevant.

Summary of Device Substantiation:

The B. Braun Medical, Inc. Prontosan™ Wound Gel received 510(k) clearance based on demonstrating substantial equivalence to a legally marketed predicate device (Prontosan™ Wound Irrigation Solution). The primary evidence for this was:

Similar Intended Use: Both devices are for moistening and cleansing wounds.
Similar Technological Characteristics: The core active ingredients and mechanism of action are similar. The gel formulation adds inactive ingredients (hydroxyethylcellulose and glycerol) for viscosity and moisturizing, which are described as not raising new questions of safety or effectiveness.
Safety Testing: Biocompatibility testing, USP <51> Antimicrobial Effectiveness Testing, USP <85> Bacterial Endotoxin Testing, and shelf life testing were conducted to demonstrate the safety of the specific gel formulation. The document states these tests "supported" the safety and effectiveness, implying acceptable results.

The 510(k) pathway (especially for Class II devices without special controls or Class I unclassified devices like this one) does not typically require extensive clinical trials or performance studies that would utilize concepts like "acceptance criteria" against clinical performance metrics, expert adjudication, MRMC studies, or AI training/test sets. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Summary

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March 12, 2009

B. Braun Medical, Inc. 510(k) Premarket Notification

MAR 1 7 2009

5. 510(k) SUMMARY

SUBMITTER:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500

Contact: Lisa Giaquinto, Sr. Regulatory Affairs Analyst Phone: (610) 596-2536 Fax: (610) 266-4962 E-mail: Lisa.Giaquinto@bbraun.com

DEVICE NAME:

Prontosan™ Wound Gel

COMMON OR USUAL NAME:

Wound Cleanser, Wound Dressing

DEVICECLASSIFICATION:	Class II, Product Code FRO, Unclassified
---------------------------	------------------------------------------

PREDICATE DEVICES: Prontosan™ Wound Irrigation Solution B. Braun Medical, Inc. Regulatory Class: Unclassified, Product Code: FRO 510(k) K072876, June 19, 2008

Prontosan™ Wound Gel is a clear, colourless liquid-gel DESCRIPTION: containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified organide, gryseron, Wound Gel is used for managing and water. Tromods by sustaining wound moisture between dressing changes and aiding in the manual removal of wound exudates and encrustations. The gel is aseptically filled using a blow fill seal process into low density polyethylene 30 mL squeeze bottles with screw caps.

Prontosan™ Wound Gel is intended for moistening and INTENDED USE: cleansing wounds by maceration of wound coatings and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds, and abrasions.

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March 12, 2009

B. Braun Medical, Inc. 510(k) Premarket Notification

SUBSTANTIAL EQUIVALENCE:

The proposed device and the predicate device are both intended for the cleansing and moistening of wounds. Both Intended to: the croationing and Prontosan The Wound Irrigation I follesan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - formulation by the presence of the inactive ingredients: hydroxyethylcellulose and glycerol, which have been added frydroxyothyrose of providing viscosity and moisturizing properties to the formulation.

The safety and effectiveness of Prontosan™ Wound Gel is supported by biocompatibility testing, USP <51> supported by orocompaness Testing, USP <85> Bacterial Andotoxin testing, and shelf life testing. Biocompatibility Endotoxin toonce testing conducted with Prontosan TM and performance that there are no new issues of safety or effectiveness for the proposed device.

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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 features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAR 1 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

B. Braun Medical, Inc. % Ms. Lisa Giaquinto, RAC Regulatory Affairs Analyst 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K090141

Trade/Device Name: Prontosan™ Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 16, 2009 Received: January 21, 2009

Dear Ms. Giaquinto:

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 - Ms. Lisa Giaquinto, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 N. Melkerson

Mark N. Melk Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090141 ///

B. Braun Medical, Inc. 510(k) Premarket Notification March 12, 2009

4. INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known):	K090141
Device Name:	Prontosan™ Wound Gel

Indications For Use: Prontosan™ Wound Gel is intended for moistening and cleansing wounds by maceration of wound coatings and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds, and abrasions.

Prescription Use . X (Per 21 CFR 801 109)

AND/OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krause for MXM March 16, 2009
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K090141

Regulation Number and Section

N/A