PRONTOSAN ANTIMICROBIAL WOUND GEL

K090141 · B.Braun Medical, Inc. · FRO · Mar 17, 2009 · SU

Device Facts

• Record ID: K090141
• Device Name: PRONTOSAN ANTIMICROBIAL WOUND GEL
• Applicant: B.Braun Medical, Inc.
• Product Code: FRO · SU
• Decision Date: Mar 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Prontosan™ Wound Gel is a clear, colorless liquid-gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose, and purified water. It is used for managing wounds by sustaining moisture between dressing changes and aiding in the manual removal of wound exudates and encrustations. The gel is aseptically filled into 30 mL low-density polyethylene squeeze bottles. It is applied to wounds to macerate coatings and lubricate absorbent dressings. The device is intended for clinical use to support wound healing and maintenance.

Clinical Evidence

No clinical data. Safety and effectiveness supported by biocompatibility testing, USP <51> antimicrobial effectiveness testing, USP <85> bacterial endotoxin testing, and shelf-life testing.

Technological Characteristics

Liquid-gel formulation containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose, and purified water. Packaged in 30 mL low-density polyethylene squeeze bottles with screw caps. Aseptically filled via blow-fill-seal process.

Indications for Use

Indicated for moistening and cleansing wounds, including ulcers, burns, post-surgical wounds, and abrasions, to aid in the removal of wound coatings and exudates.

Predicate Devices

• Prontosan™ Wound Irrigation Solution (K072876)

Submission Summary (Full Text)

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

DEVICE NAME:

Prontosan™ Wound Gel

COMMON OR USUAL NAME:

Wound Cleanser, Wound Dressing

| DEVICE<br>CLASSIFICATION: | 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/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