PRONTOSAN WOUND IRRIGATION SOLUTION

K110744 · B.Braun Medical, Inc. · FRO · Apr 6, 2011 · SU

Device Facts

• Record ID: K110744
• Device Name: PRONTOSAN WOUND IRRIGATION SOLUTION
• Applicant: B.Braun Medical, Inc.
• Product Code: FRO · SU
• Decision Date: Apr 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

Prontosan Wound Irrigation Solution is a clear, colorless, nearly odorless liquid containing polyhexanide as a preservative to inhibit microbial growth. The device functions via mechanical action; fluid moving across the wound surface aids in the removal of foreign material, dirt, and debris. It is intended for over-the-counter use by patients for the management of minor wounds. The solution is supplied in 40 ml ampoules or 350 ml squeeze bottles. By cleaning the wound and moistening dressings, the device supports wound management and helps maintain a clean wound environment.

Clinical Evidence

No clinical data. Bench testing only. Antimicrobial Effectiveness Testing was conducted according to USP <51> category 2 against various gram-positive and gram-negative bacteria (e.g., S. aureus, P. aeruginosa, E. coli, MRSA, VRE) and fungi (C. albicans, A. brasilienis). Results demonstrated the solution's effectiveness in inhibiting microbial growth within the product.

Technological Characteristics

Liquid solution containing polyhexanide preservative. Supplied in 40 ml ampoules or 350 ml squeeze bottles. Mechanism of action is mechanical irrigation. No electronic components, software, or energy sources.

Indications for Use

Indicated for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns in patients requiring wound care.

Predicate Devices

• Prontosan® Wound Irrigation Solution (K072876)
• Prontosan® Wound Gel (K101882)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail]

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:

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.

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.

17

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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 [phone] or [phone] 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)

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

OR

Over-The-Counter Use ___ X

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(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