(20 days)
Not Found
No
The device is a wound irrigation solution, and the description focuses on its chemical composition and mechanical action. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a wound irrigation solution intended for cleaning wounds and moistening dressings through mechanical action, which is generally considered a wound care product rather than a therapeutic device that actively treats disease or conditions. Its function is primarily cleansing and maintaining product integrity through a preservative, not therapeutic treatment of the wound itself beyond basic hygiene.
No
The device is an irrigation solution intended for cleaning wounds, not for diagnosing conditions.
No
The device description clearly states it is a liquid solution offered in ampoules and bottles, indicating 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 is for "cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns." This describes 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 focuses on the physical properties of the solution and its mechanical action in cleaning wounds. It mentions a preservative to inhibit microbial growth within the product, not to detect or measure substances in a patient sample.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition.
- Performance Studies: The performance study described is "Antimicrobial Effectiveness Testing" according to USP , which assesses the ability of the product to inhibit microbial growth within the product itself, not its ability to detect or measure microbes in a patient sample.
IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device's function is purely for external wound cleaning and management.
N/A
Intended Use / Indications for Use
Prontosan® Wound Irrigation Solution for over-the-counter use, is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.
Product codes
FRO
Device Description
The subject device of this submission is Prontosan® Wound Irrigation Solution indicated for over-the-counter use. Prontosan Wound Irrigation Solution is currently cleared in a prescription use only version.
Prontosan Wound Irrigation Solution is a clear, colorless and nearly odorless liquid intended for the management of wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as dirt and debris. The subject device is offered in 40 ml ampoules and 350 ml squeeze bottles with screw caps.
The solution contains polyhexanide, a preservative that inhibits microbial growth within the product.
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)
Antimicrobial Effectiveness Testing was conducted with the proposed device according to USP category 2. Gram positive and gram negative bacteria and fungi typically found in a wound bed were used in this testing. The proposed device was tested against the following bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, methicillin-resistant Staphylococcus aureus. Vancomycin-resistant enterococcus, Serratia marcescens, Acinetobacter baumannii, Proteus mirabilis, Staphylococcus epidermidis, Enterococcus faecalis and Enterobacter cloacae and the following fungi: Candida albicans, and Aspergillus brasilienis (niger). The test results demonstrate the effectiveness of Prontosan Wound Irrigation Solution to inhibit the growth of microorganisms within the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR - 6 2011
B. Braun Medical Inc. 510(k) Premarket Notification Prontosan® Wound Irrigation Solution
March 9, 201 1
5. 510(k) SUMMARY
DATE:
ﺬ ﻓﻲ
March 9, 2011
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Contact: Nancy Skocypec, Regulatory Affairs Specialist Phone: (610) 596-2796 Fax: (610) 266-4962 E-mail: nancy.skocypec@bbraun.com
DEVICE NAME:
Prontosan® Wound Irrigation Solution
Wound Cleanser, Wound Dressing, Drug
COMMON OR
USUAL NAME:
DEVICE CLASSIFICATION: Product Code FRO, Unclassified
PREDICATE DEVICES: Prontosan® Wound Irrigation Solution, B. Braun Medical, Inc., K072876, Class II, Product Code FRO, Unclassified
Prontosan® Wound Gel, B.Braun Medical, Inc., K101882, Class II, Product Code FRO, Unclassified
DESCRIPTION:
The subject device of this submission is Prontosan® Wound Irrigation Solution indicated for over-the-counter use. Prontosan Wound Irrigation Solution is currently cleared in a prescription use only version.
Prontosan Wound Irrigation Solution is a clear, colorless and nearly odorless liquid intended for the management of wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as dirt and debris. The subject device is offered in 40 ml ampoules and 350 ml squeeze bottles with screw caps.
The solution contains polyhexanide, a preservative that inhibits microbial growth within the product.
INTENDED USE: Prontosan® Wound Irrigation Solution for over-the-counter use, is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.
17
1
SUBSTANTIAL EQUIVALENCE:
ﺗﮭ
Two predicate devices are utilized for substantial equivalence, Prontosan® Wound Irrigation Solution (K072876) and Prontosan® Wound Gel (K101882).
The proposed Prontosan Wound Irrigation Solution, indicated for over-the-counter use, is identical to the product indicated for prescription use in the original Prontosan Wound Irrigation Solution submission. Both of these solutions have identical K072876. formulations and they are processed and filled in the same manner.
The proposed Prontosan Wound Irrigation Solution, indicated for over-the-counter use, is similar to Prontosan Wound Gel (K101882). The active ingredients for both products are identical. Prontosan Wound Gel is cleared for both over-the-counter and prescription indications.
Antimicrobial Effectiveness Testing was conducted with the proposed device according to USP category 2. Gram positive and gram negative bacteria and fungi typically found in a wound bed were used in this testing. The proposed device was tested against the following bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, methicillin-resistant Staphylococcus Vancomycin-resistant enterococcus, Serratia aureus. marcescens, Acinetobacter baumannii, Proteus mirabilis, Staphylococcus epidermidis, Enterococcus faecalis and Enterobacter cloacae and the following fungi: Candida albicans, and Aspergillus brasilienis (niger). The test results demonstrate the effectiveness of Prontosan Wound Irrigation Solution to inhibit the growth of microorganisms within the product.
The Prontosan Wound Irrigation Solution device indicated for over-the-counter use, is identical to the predicate Prontosan Wound Irrigation Solution device indicated for The proposed Prontosan Wound prescription use. Irrigation Solution indicated for over-the-counter use and Prontosan Wound Gel have similar labeling, including the indication for over-the-counter use.
B.Braun believes the Prontosan Wound Irrigation Solution indicated for over-the-counter use is substantially
NON-CLINICAL TESTING:
CONCLUSION:
2
B. Braun Medical Inc. 510(k) Premarket Notification Prontosan® Wound Irrigation Solution
equivalent to to the currently cleared and marketed Prontosan® Wound Irrigation Solution for prescription use and Prontosan® Wound Gel for over-the-counter use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle design breaking the circle's border.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
B. Braun Medical, Inc. % Ms. Nancy Skocypec Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
APR - 6 201
Re: K110744
Trade/Device Name: Prontosan® Would Irrigation Solution Regulatory Class: Unclassified Product Code: FRO Dated: September 30. 2010 Received: October 1, 2010
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 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
4
Page 2 - Ms. Nancy Skocypec
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Pan 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/ReportalProblem/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 yours.
Aig B. R
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
March 9, 2011
4. INDICATIONS FOR USE STATEMENT
Page __ 1 of 1
510(k) Number (if known): _
Device Name:
Prontosan® Wound Irrigation Solution