(120 days)
Not Found
No
The device description and performance studies focus on the chemical composition and preservative effectiveness of a wound gel, with no mention of AI or ML technologies.
Yes
The device is a wound gel intended to cleanse, moisten, and manage various types of wounds, indicating a therapeutic purpose.
No
Prontosan Wound Gel is intended for cleansing, moistening, and managing wounds. It does not diagnose any condition or disease.
No
The device description clearly states it is a gel containing various 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. This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the composition of the gel and its function in wound management. It does not mention any components or processes related to in vitro testing of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic information about a disease or condition
- Using reagents or assays for testing
The device is a wound care product applied directly to the wound.
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, abrasion, laceration, 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
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 that is sterile by aseptic manufacturing until the product is first opened. PHMB is added to the product in the concentration of 0.1% w/w as a preservative to inhibit the growth of microorganisms within the product. 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
OTC Use and Professional Use
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
In-vitro testing was conducted to demonstrate the effectiveness of the preservative in Prontosan® Wound Gel and substantial equivalence with predicate device, Anasept® Antimicrobial Skin and Wound Gel. The non-clinical testing conducted with the proposed device demonstrates that the proposed device is as safe and effective as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
page 1 of 2
B. Braun Medical Inc. Response to FDA Request for Additional Information 510(k) K101882 Prontosan® Wound Gel
5. 510(k) SUMMARY
DATE: October 15, 2010 NOV - 3 2010 SUBMITTER: B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500 Contact: Matthew J. Homa, Sr. Analyst, Regulatory Affairs Phone: (610) 596-2558 Fax: (610) 266-4962 E-mail: matthew.homa@bbraun.com DEVICE NAME: Prontosan® Wound Gel COMMON OR Wound Cleanser, Wound Dressing USUAL NAME: DEVICE CLASSIFICATION: Class II, Product Code FRO, Unclassified PREDICATE DEVICES: Prontosan® Wound Gel, B. Braun Medical, Inc., K090141 Class II, FRO, Unclassified Anasept® Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., K073547, Class II, FRO, Unclassified Prontosan® Wound Gel is a clear, colorless and virtually DESCRIPTION: odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management that is sterile by aseptic manufacturing until the product is first opened. PHMB is added to the product in the concentration of 0.1% w/w as a preservative to inhibit the growth of microorganisms within the product. 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.
1
K101882
Page 2 of 2
B. Braun Medical Inc. Response to FDA Request for Additional Information 510(k) K101882 Prontosan® Wound Gel
OTC Use: Prontosan Wound Gel is intended to cleanse and INTENDED USE: moisten the wound bed and for the management of minor cuts, abrasion, laceration, 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. SUBSTANTIAL Two predicate devices are utilized for substantial EQUIVALENCE: equivalence, Prontosan® Wound Gel (K090141) and Anasept® Antimicrobial Skin and Wound Gel (K073547). Prontosan Wound Gel has an intended use similar to Anacapa Technologies' Anasept® Antimicrobial Skin and Wound Gel, i.e., to remove foreign matter , and Anasept® Antimicrobial Skin and Wound Gel is also labeled for OTC use. Prontosan Wound Gel is the same product as in the original Prontosan Wound Gel submission, K090141. Both of these gels are comprised of the same ingredients and are processed and filled in the same manner. The biocompatibility and functional performance testing conducted on Prontosan Wound Gel in K090141 is applicable to this submission. The only difference between Prontosan Wound Gel, K090141, and this submission is the indications and intended use. CONCLUSION: In-vitro testing was conducted to demonstrate the effectiveness of the preservative in Prontosan® Wound Gel and substantial equivalence with predicate device, Anasept® Antimicrobial Skin and Wound Gel. The non-clinical testing conducted with the proposed device demonstrates that the proposed device is as safe and effective as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
B. Braun Medical Inc. % Mr. Matthew J. Homa Senior Analyst, Regulatory Affairs 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K101882
Trade/Device Name: Prontosan® Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: September 17, 2010 Received: September 20, 2010
- Dear-Mr .- Homa .- - -
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
NOV = 3 2010
3
Page 2 - Mr. Matthew J. Homa
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 (OS) 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 Part 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark A. Milkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. INDICATIONS FOR USE STATEMENT
Page l ___ of -
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K101882 |
| Device Name: | Prontosan® Wound Gel |
NOV - 3 2010
Indications For Use:
OTC Use: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns.
Professional Use: Prontosan Wound Gel is intend 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.
Prescription Use X (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)
Dainl Krome ber MXU
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101862