Prontosan® Wound Irrigation Solution is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

Device Description

The subject device of this submission is Prontosan® Wound Irrigation Solution indicated for over-the-counter use. Prontosan Wound Irrigation Solution is currently cleared in a prescription use only version. Prontosan Wound Irrigation Solution is a clear, colorless and nearly odorless liquid intended for the management of wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as dirt and debris. The subject device is offered in 40 ml ampoules and 350 ml squeeze bottles with screw caps. The solution contains polyhexanide, a preservative that inhibits microbial growth within the product.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Prontosan® Wound Irrigation Solution:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Microbial Growth Inhibition (USP <51> Category 2)	Demonstrated effectiveness to inhibit the growth of microorganisms within the product. (Specific results not quantified, but stated as effective for all tested organisms.)

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

The document describes an Antimicrobial Effectiveness Testing study.

Test Set Organisms: The study used a standard panel of Gram-positive and Gram-negative bacteria, and fungi.
- Bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, methicillin-resistant Staphylococcus aureus, Vancomycin-resistant enterococcus, Serratia marcescens, Acinetobacter baumannii, Proteus mirabilis, Staphylococcus epidermidis, Enterococcus faecalis, Enterobacter cloacae.
- Fungi: Candida albicans, Aspergillus brasilienis (niger).
Data Provenance: Not explicitly stated, but it's an in-vitro laboratory test conducted according to USP <51> standards. This is generally considered a controlled laboratory environment rather than patient data from a specific country, and it's a prospective test designed to evaluate the product's preservative efficacy.

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

Not applicable. The study is a laboratory-based antimicrobial effectiveness test, not one requiring expert human interpretation of medical images or clinical outcomes. The "ground truth" is defined by the objective measurement of microbial growth inhibition according to USP <51> protocol.

4. Adjudication Method for the Test Set:

Not applicable. This was a laboratory test with objective measurements based on USP <51> methodology, not requiring adjudication of human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This submission is for a wound irrigation solution, not for an AI-powered diagnostic or interpretive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This concept is not applicable to a wound irrigation solution. The "performance" here refers to the chemical and preservative efficacy of the solution itself, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was objective laboratory measurements based on a validated standard (USP <51>) for antimicrobial effectiveness. This involves inoculating the product with specific microorganisms and observing their growth or inhibition over time, rather than expert consensus, pathology, or outcomes data in a clinical setting.

8. The Sample Size for the Training Set:

Not applicable. This device is a wound irrigation solution, not an AI or machine learning model that requires a training set. The "training set" concept is irrelevant here.

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

Not applicable, as there is no training set for this type of device.

Summary of the Study:

The study described is an Antimicrobial Effectiveness Testing conducted according to USP <51> category 2. This non-clinical test evaluated the ability of the Prontosan® Wound Irrigation Solution (intended for over-the-counter use) to inhibit the growth of common bacterial and fungal microorganisms within the product itself. The listed organisms represent typical pathogens found in wound beds. The study concluded that the device was effective in inhibiting microbial growth, thereby demonstrating its stability and preservative efficacy. This testing was performed to support the substantial equivalence claim, particularly regarding the solution's identity (formulation and processing) with its prescription-use predicate and its similarity in active ingredients to Prontosan® Wound Gel.

Summary

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APR - 6 2011

B. Braun Medical Inc. 510(k) Premarket Notification Prontosan® Wound Irrigation Solution

March 9, 201 1

5. 510(k) SUMMARY

DATE:

ﺬ ﻓﻲ

March 9, 2011

SUBMITTER:

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

Contact: Nancy Skocypec, Regulatory Affairs Specialist Phone: (610) 596-2796 Fax: (610) 266-4962 E-mail: nancy.skocypec@bbraun.com

DEVICE NAME:

Prontosan® Wound Irrigation Solution

Wound Cleanser, Wound Dressing, Drug

COMMON OR

USUAL NAME:

DEVICE CLASSIFICATION: Product Code FRO, Unclassified

PREDICATE DEVICES: Prontosan® Wound Irrigation Solution, B. Braun Medical, Inc., K072876, Class II, Product Code FRO, Unclassified

Prontosan® Wound Gel, B.Braun Medical, Inc., K101882, Class II, Product Code FRO, Unclassified

DESCRIPTION:

Prontosan Wound Irrigation Solution is a clear, colorless and nearly odorless liquid intended for the management of wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as dirt and debris. The subject device is offered in 40 ml ampoules and 350 ml squeeze bottles with screw caps.

The solution contains polyhexanide, a preservative that inhibits microbial growth within the product.

INTENDED USE: Prontosan® Wound Irrigation Solution for over-the-counter use, is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

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SUBSTANTIAL EQUIVALENCE:

ﺗﮭ

Two predicate devices are utilized for substantial equivalence, Prontosan® Wound Irrigation Solution (K072876) and Prontosan® Wound Gel (K101882).

The proposed Prontosan Wound Irrigation Solution, indicated for over-the-counter use, is identical to the product indicated for prescription use in the original Prontosan Wound Irrigation Solution submission. Both of these solutions have identical K072876. formulations and they are processed and filled in the same manner.

The proposed Prontosan Wound Irrigation Solution, indicated for over-the-counter use, is similar to Prontosan Wound Gel (K101882). The active ingredients for both products are identical. Prontosan Wound Gel is cleared for both over-the-counter and prescription indications.

Antimicrobial Effectiveness Testing was conducted with the proposed device according to USP <51> category 2. Gram positive and gram negative bacteria and fungi typically found in a wound bed were used in this testing. The proposed device was tested against the following bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, methicillin-resistant Staphylococcus Vancomycin-resistant enterococcus, Serratia aureus. marcescens, Acinetobacter baumannii, Proteus mirabilis, Staphylococcus epidermidis, Enterococcus faecalis and Enterobacter cloacae and the following fungi: Candida albicans, and Aspergillus brasilienis (niger). The test results demonstrate the effectiveness of Prontosan Wound Irrigation Solution to inhibit the growth of microorganisms within the product.

The Prontosan Wound Irrigation Solution device indicated for over-the-counter use, is identical to the predicate Prontosan Wound Irrigation Solution device indicated for The proposed Prontosan Wound prescription use. Irrigation Solution indicated for over-the-counter use and Prontosan Wound Gel have similar labeling, including the indication for over-the-counter use.

B.Braun believes the Prontosan Wound Irrigation Solution indicated for over-the-counter use is substantially

NON-CLINICAL TESTING:

CONCLUSION:

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B. Braun Medical Inc. 510(k) Premarket Notification Prontosan® Wound Irrigation Solution

equivalent to to the currently cleared and marketed Prontosan® Wound Irrigation Solution for prescription use and Prontosan® Wound Gel for over-the-counter use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle design breaking the circle's border.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

B. Braun Medical, Inc. % Ms. Nancy Skocypec Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

APR - 6 201

Re: K110744

Trade/Device Name: Prontosan® Would Irrigation Solution Regulatory Class: Unclassified Product Code: FRO Dated: September 30. 2010 Received: October 1, 2010

Dear Ms. Skocypec:

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

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Page 2 - Ms. Nancy Skocypec

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Pan 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/ReportalProblem/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 yours.

Aig B. R
for

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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March 9, 2011

4. INDICATIONS FOR USE STATEMENT

Page __ 1 of 1

510(k) Number (if known): _

Device Name:

Prontosan® Wound Irrigation Solution

< 110744

Indications For Use:

Prontosan® Wound Irrigation Solution is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

Prescription Use (Per 21 CFR 801.109)

:: : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

... ..........................................................................................................................................................................

Over-The-Counter Use ___ X

4 ਨ

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

Concurrence of CDRH, ffice of Device Evaluation (ODE)

Daniel Krone fu MXM
(Division Sign-Off)

Divisior of Surgical, Orthopedic,
and Restorative Devices

5 i(i)(k) Number K110744

Regulation Number and Section

N/A