(167 days)
No
The 510(k) summary describes a wound gel with a chemical composition and intended use for cleansing and moistening wounds. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The device description focuses solely on the physical and chemical properties of the gel.
Yes
The device is intended to cleanse and moisten wounds, and manage various types of wounds, indicating a therapeutic purpose in aiding the healing process.
No
Justification: The device's intended use is to cleanse and moisten wounds, and it is described as a wound gel. This indicates a therapeutic or cleansing function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition, which is not stated as a function of Prontosan® Wound Gel.
No
The device description clearly states it is a gel containing chemical components and is packaged in a squeeze bottle, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Prontosan® Wound Gel is for cleansing and moistening the wound bed and managing various types of wounds (cuts, abrasions, burns, ulcers, surgical incisions). This is a topical application for wound care.
- Device Description: The description details the composition of the gel and its packaging. It describes a product applied directly to the wound surface.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
The information provided consistently points to a device used for external wound management, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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 filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Prontosan® Wound Gel, B. Braun Medical Inc., K101882
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Wound Gel X, B. Braun Medical Inc., K130857
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) SUMMARY
| Date: | May 22, 2017 |
|---|---|
| Submitter: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| (610) 266-0500 | |
| Contact: | |
| Phone: | |
| FAX: | |
| E-mail: | Nancy Skocypec |
| (610) 596-2796 | |
| (610) 266-4962 | |
| nancy.skocypec@bbraun.com | |
| Trade Name: | Prontosan® Wound Gel |
| Common Name: | Wound Cleanser, Wound Dressing |
| Product Code: | |
| Classification: | FRO, Dressing, Wound, Drug |
| 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
4
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.