Prontosan Wound Gel

K163430 · B.Braun Medical, Inc. · FRO · May 23, 2017 · SU

Device Facts

• Record ID: K163430
• Device Name: Prontosan Wound Gel
• Applicant: B.Braun Medical, Inc.
• Product Code: FRO · SU
• Decision Date: May 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

OTC Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasions, lacerations, 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 Story

Prontosan Wound Gel is a clear, colorless, nonpyrogenic gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose, and purified water. It is used to cleanse and moisten wound beds and soften encrusted dressings. The gel is applied to the wound surface, including difficult-to-access areas. It is available in both OTC and professional (Rx) versions. The device is supplied in a 30 mL low-density polyethylene squeeze bottle. It functions as a topical wound management agent to facilitate cleaning and moisture maintenance.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical formulation and design to the predicate device.

Technological Characteristics

Gel formulation containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose, and purified water. Packaged in 30 mL low-density polyethylene squeeze bottle. Nonpyrogenic. Aseptically filled.

Indications for Use

Indicated for OTC use in patients with minor cuts, abrasions, lacerations, and minor burns. Indicated for professional use in patients with ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions.

Predicate Devices

• Prontosan® Wound Gel (K101882)

Reference Devices

• Wound Gel X (K130857)

Submission Summary (Full Text)

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

May 23, 2017

B. Braun Medical, Inc. Nancy Skocypec Associate Director, Regulatory Affairs 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K163430

Trade/Device Name: Prontosan Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: April 25, 2017 Received: April 27, 2017

Dear Nancy 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K163430

Device Name Prontosan® Wound Gel

#### Indications for Use (Describe)

OTC Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasions, lacerations, 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 5. 510(k) SUMMARY

| Date: | May 22, 2017 |
|---------------------------------------|---------------------------------------------------------------------------------------------|
| Submitter: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone] |
| Contact:<br>Phone:<br>FAX:<br>E-mail: | Nancy Skocypec<br>[phone]<br>[phone]<br>[e-mail] |
| Trade Name: | Prontosan® Wound Gel |
| Common Name: | Wound Cleanser, Wound Dressing |
| Product Code:<br>Classification: | FRO, Dressing, Wound, Drug<br>Unclassified |
| Predicate Device: | Prontosan® Wound Gel, B. Braun Medical Inc., K101882 |
| Reference Device: | Wound Gel X, B. Braun Medical Inc., K130857 |

## INDICATIONS FOR USE

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

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

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filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.

# SUBSTANTIAL EQUIVALENCE

The subject device and the predicate device are the same. No changes have been made to the device design, packaging, manufacturing process, indications for use or the intended use. The changes subject to this 510(k) are for labeling content only.

## CONCLUSION

Prontosan™ Wound Gel for prescription and over the counter use is identical to the predicate device in formulation, manufacturing, packaging and intended use. B. Braun believes the predicate and subject devices to be substantially equivalent.