PRONTOSAN WOUND GEL X

K130857 · B.Braun Medical, Inc. · FRO · Oct 8, 2013 · SU

Device Facts

• Record ID: K130857
• Device Name: PRONTOSAN WOUND GEL X
• Applicant: B.Braun Medical, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions. OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.

Device Story

Prontosan Wound Gel X is a ready-to-use, clear, odorless, amorphous hydrogel wound dressing. It functions as a physical barrier to resist microbial colonization within the dressing and reduce microbial penetration. The gel matrix contains polyhexanide (preservative), a viscosity-modifying agent, and a betaine surfactant. Supplied sterile in 250g polyfoil tubes with PP screw caps. Used in clinical or home settings for wound management to maintain a clean, moist environment. Healthcare providers or patients apply the gel topically to the wound site. The device benefits patients by protecting the wound from external microbial contamination and supporting the healing environment.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Performance testing included USP <51> (antimicrobial effectiveness) and a Strike Through Barrier Test. All results met acceptance criteria.

Technological Characteristics

Amorphous hydrogel dressing containing polyhexanide, viscosity-modifying agent, and betaine surfactant. Supplied in 250g polyfoil tubes with PP screw caps. Sterile. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for management of ulcers (diabetic foot, leg, pressure), 1st/2nd degree burns, partial/full thickness wounds, large surface area wounds, surgical incisions (Rx); and minor cuts, lacerations, minor burns, and abrasions (OTC).

Predicate Devices

• Silver Shield™ Antimicrobial Skin and Wound Gel (K062212)
• PolyFIT™+ Absorbing Antimicrobial Dressings, PolyFIT™+ High Absorbing Antimicrobial Dressings (K121522)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

October 8, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Commi Center - WO66-G608 Silver Spring, MD 20993-0002

B. Braun Medical, Incorporated Ms. Nancy Skocypec Senior Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K130857

Trade/Device Name: Prontosan" Wound Gel X Regulatory Class: Unclassified Product Code: FRO Dated: August 14, 2013 Received: August 19, 2013

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 10 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 complics 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); medical device reporting (reporting of medical device-rclated adverse cvents) (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.

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Page 2 - Ms. Nancy Skocypec

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4. INDICATIONS FOR USE STATEMENT

Page __________ of ______ l

510(k) Number (if known): K130857

Device Name:

Prontosan® Wound Gel X

Indications For Use:

Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.

Prescription Use X (Per 21 CFR 801.109)

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)

# Jiyoung Dang -S

3

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# 4. INDICATIONS FOR USE STATEMENT

Page _________________________________________________________________________________________________________________________________________________________________________

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510(k) Number (if known):

Device Name: Prontosan® Wound Gel X

Indications For Use:

OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.

Prescription Use (Per 21 CFR 801.109) OR

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)

# Jiyoung Dang -S

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### 5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| DATE: | August 14, 2013 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 |
| | Contact: Nancy Skocypec, Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| TRADE NAME: | Prontosan® Wound Gel X |
| COMMON NAME: | Wound dressing |
| Device Classification: | Unclassified, Product Code FRO |
| PREDICATE DEVICE: | Silver Shield™ Antimicrobial Skin and Wound Gel (K062212) |
| | PolyFIT™+ Absorbing Antimicrobial Dressings, PolyFIT™+ High<br>Absorbing Antimicrobial Dressings (K121522) |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.

#### INDICATIONS FOR USE

Rx - Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 15 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.

#### SUBSTANTIAL EQUIVALENCE

B. Braun Medical Inc's. Prontosan Wound Gel X is substantially equivalent to the predicate devices having similar indications for use, technological properties and performance.

#### TECHNICAL CHARACTERISTICS

Prontosan Wound Gel X has similar physical and technical characteristics to the predicate devices.

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## PERFORMANCE DATA

Biocompatibility and performance testing was performed with Prontosan Wound Gel X to support substantial equivalence to the predicate devices. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing completed included USP<51> and a Strike Through Barrier Test. Test results met the acceptance criteria.

## CONCLUSION

Based on the results of biocompatibility and performance testing, the proposed Wound Gel X is considered substantially equivalent to the predicate devices and effective for its' intended use.

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K130857

### 5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DATE:

l i

August 14, 2013

SUBMITTER:

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

Prontosan® Wound Gel X

**OCT 08 2013**

Contact: Nancy Skocypec, Regulatory Affairs Manager Phone: [phone] Fax: [phone] E-mail: [e-mail]

| TRADE NAME: |
|-------------|
|-------------|

COMMON NAME: Wound dressing

. Device Classification: Unclassified, Product Code FRO

PREDICATE DEVICE:

Silver Shield " Antimicrobial Skin and Wound Gel (K062212)

PolyFIT + Absorbing Antimicrobial Dressings, PolyFIT" + High Absorbing Antimicrobial Dressings (K121522)

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.

#### INDICATIONS FOR USE

OTC - Prontosan Wound Gel X is indicated for the management minor cuts. minor lacerations, minor burns (13) degree burns), and abrasions.

#### SUBSTANTIAL EQUIVALENCE

B. Braun Medical Inc's. Prontosan Wound Gel X is substantially equivalent to the predicate devices having similar indications for use, technological properties and performance.

#### TECHNICAL CHARACTERISTICS T

Prontosan Wound Gel X has similar physical and technical characteristics to the predicate devices.

#### PERFORMANCE DATA

Biocompatibility and performance testing was performed with Prontosan Wound Gel X to support substantial equivalence to the predicate devices. Biocompatibility testing was performed in

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accordance with ISO 10993-1. Performance testing completed included USP<51> and a Strike Through Barrier Test. Test results met the acceptance criteria. .

#### CONCLUSION

ﺰ

に

Based on the results of biocompatibility and performance testing, the proposed Wound Gel X is considered substantially equivalent to the predicate devices and effective for its' intended use.

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