PRONTOSAN ANTIMICROBIAL WOUND GEL by B. BRAUN MEDICAL, INC.

OTC Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns. Professional Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Device Description

Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management that is sterile by aseptic manufacturing until the product is first opened. PHMB is added to the product in the concentration of 0.1% w/w as a preservative to inhibit the growth of microorganisms within the product. Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

AI/ML Overview

The provided text describes a 510(k) submission for the Prontosan® Wound Gel. The submission focuses on establishing substantial equivalence to previously cleared predicate devices, primarily through in-vitro testing for preservative effectiveness and by referencing prior biocompatibility and functional testing. It is not a study about an AI-powered device, medical imaging, or any diagnostic/prognostic tool that would typically involve acceptance criteria for algorithms, human readers, or ground truth establishment as outlined in your request.

Therefore, most of the information requested in your prompt (e.g., acceptance criteria for a device's performance, sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this submission. This document pertains to a medical device (wound gel) and its regulatory clearance process, which relies on demonstrating safety and effectiveness, often through comparison to existing products, rather than validating an algorithm's performance against clinical endpoints or expert interpretations.

Here's a breakdown of why each point is not fully addressable from the given text:

A table of acceptance criteria and the reported device performance:
- Not Applicable. The document describes "in-vitro testing conducted to demonstrate the effectiveness of the preservative in Prontosan® Wound Gel and substantial equivalence with predicate device, Anasept® Antimicrobial Skin and Wound Gel." However, specific acceptance criteria (e.g., percentage reduction in microbial growth, specific performance metrics) and detailed results are not provided in this 510(k) summary. The summary concludes that "The non-clinical testing conducted with the proposed device demonstrates that the proposed device is as safe and effective as the predicate device," implying that any set criteria were met.
Sample sized used for the test set and the data provenance:
- Not Applicable. This information is not provided. The testing mentioned is "in-vitro testing" for preservative effectiveness, not a clinical trial or a test of an algorithm on a dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "ground truth" in the context of expert interpretation, as this is not a diagnostic device or an AI algorithm relying on human labels. The testing is laboratory-based (in-vitro).
Adjudication method for the test set:
- Not Applicable. No human interpretation or adjudication is described.
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 is not an AI device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
The type of ground truth used:
- Not Applicable. The "truth" in this context would be laboratory measurements of preservative effectiveness and material properties, compared against established standards or predicate device performance. Not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/diagnostic device validation.
The sample size for the training set:
- Not Applicable. This is not an AI device, so there is no training set.
How the ground truth for the training set was established:
- Not Applicable. There is no training set or associated ground truth.

Summary based on the provided text:

The device, Prontosan® Wound Gel, gained 510(k) clearance (K101882) based on demonstrating substantial equivalence to predicate devices (Prontosan® Wound Gel, K090141, and Anasept® Antimicrobial Skin and Wound Gel, K073547). The primary evidence cited for this submission is:

In-vitro testing conducted to prove the effectiveness of the preservative (0.1% w/w PHMB) in Prontosan® Wound Gel.
The fact that Prontosan® Wound Gel (K101882) is the same product as in the original Prontosan Wound Gel submission (K090141), with the only difference being expanded indications for use.
The biocompatibility and functional performance testing conducted on Prontosan Wound Gel in K090141 is considered applicable to K101882.

The conclusion is that this non-clinical testing demonstrates the proposed device is as safe and effective as the predicate device, thereby meeting the requirements for 510(k) clearance for its stated Indications for Use.

Summary

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B. Braun Medical Inc. Response to FDA Request for Additional Information 510(k) K101882 Prontosan® Wound Gel

5. 510(k) SUMMARY

DATE: October 15, 2010 NOV - 3 2010 SUBMITTER: B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500 Contact: Matthew J. Homa, Sr. Analyst, Regulatory Affairs Phone: (610) 596-2558 Fax: (610) 266-4962 E-mail: matthew.homa@bbraun.com DEVICE NAME: Prontosan® Wound Gel COMMON OR Wound Cleanser, Wound Dressing USUAL NAME: DEVICE CLASSIFICATION: Class II, Product Code FRO, Unclassified PREDICATE DEVICES: Prontosan® Wound Gel, B. Braun Medical, Inc., K090141 Class II, FRO, Unclassified Anasept® Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., K073547, Class II, FRO, Unclassified Prontosan® Wound Gel is a clear, colorless and virtually DESCRIPTION: odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management that is sterile by aseptic manufacturing until the product is first opened. PHMB is added to the product in the concentration of 0.1% w/w as a preservative to inhibit the growth of microorganisms within the product. Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

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K101882
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B. Braun Medical Inc. Response to FDA Request for Additional Information 510(k) K101882 Prontosan® Wound Gel

OTC Use: Prontosan Wound Gel is intended to cleanse and INTENDED USE: moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns. Professional Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings. SUBSTANTIAL Two predicate devices are utilized for substantial EQUIVALENCE: equivalence, Prontosan® Wound Gel (K090141) and Anasept® Antimicrobial Skin and Wound Gel (K073547). Prontosan Wound Gel has an intended use similar to Anacapa Technologies' Anasept® Antimicrobial Skin and Wound Gel, i.e., to remove foreign matter , and Anasept® Antimicrobial Skin and Wound Gel is also labeled for OTC use. Prontosan Wound Gel is the same product as in the original Prontosan Wound Gel submission, K090141. Both of these gels are comprised of the same ingredients and are processed and filled in the same manner. The biocompatibility and functional performance testing conducted on Prontosan Wound Gel in K090141 is applicable to this submission. The only difference between Prontosan Wound Gel, K090141, and this submission is the indications and intended use. CONCLUSION: In-vitro testing was conducted to demonstrate the effectiveness of the preservative in Prontosan® Wound Gel and substantial equivalence with predicate device, Anasept® Antimicrobial Skin and Wound Gel. The non-clinical testing conducted with the proposed device demonstrates that the proposed device is as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

B. Braun Medical Inc. % Mr. Matthew J. Homa Senior Analyst, Regulatory Affairs 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K101882

Trade/Device Name: Prontosan® Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: September 17, 2010 Received: September 20, 2010

Dear-Mr .- Homa .- - -

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

NOV = 3 2010

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Page 2 - Mr. Matthew J. Homa

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 (OS) 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.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark A. Milkerson

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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4. INDICATIONS FOR USE STATEMENT

Page l ___ of -

Labels	Values
510(k) Number (if known):	K101882
Device Name:	Prontosan® Wound Gel

NOV - 3 2010

Indications For Use:

OTC Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns.

Professional Use: Prontosan Wound Gel is intend to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dainl Krome ber MXU

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101862

Regulation Number and Section

N/A