(150 days)
Not Found
No
The device description and intended use clearly define a wound irrigation solution and an adaptor, with no mention of any computational or analytical capabilities that would involve AI or ML.
Yes
The device is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings, which are therapeutic actions to aid in the healing process.
No
The device is a wound irrigation solution used for cleaning and moistening wounds, not for diagnosing medical conditions.
No
The device description clearly states it is a liquid solution and includes physical components like ampoules, bottles, and an adaptor.
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/lubricating wound dressings. This is a direct application to the body surface for therapeutic or supportive purposes, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a solution and an adaptor for applying it to wounds. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays for in vitro testing
- Performance metrics like sensitivity, specificity, etc., which are common for diagnostic tests.
The device is clearly intended for external application to wounds for cleaning and support, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Wound Irrigation Solution is a clear. clear. colorless liquid containing Prontosan undecylenamidopropyl betaine, polyaminopropyl biguanide, sodium hydroxide and purified water. The solution is aseptically filled using a blow fill seal process into low density polyethylene 40 mL ampoules; 350 mL squeeze bottles and 1000 mL bottles with screw caps. Prontosan Wound Irrigation Solution is used for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt and debris. The Prontosan Wound Irrigation Solution Adaptor is a component that may be screwed on to the current Prontosan Wound Irrigation Solution containers (350 ml and 1000 ml bottles) and provides alternate spout geometry for which to access the solution inside the bottle. It is provided in sterile form, labeled for single patient use only.
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)
No new non-clinical testing has been performed for this submission. The changes to the labeling are test results from testing previously performed on this product and submitted to the FDA in a prior submission.
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.
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.
Not Found
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 consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
B. Braun Medical Inc. Nancy Skocypec Regulatory Affairs Manager 901 Marcon Blvd Allentown, Pennsylvania 18109
Re: K161623
Trade/Device Name: Prontosan Wound Irrigation Solution, 40 M1, Prontosan Wound Irrigation Solution, 350 M1, Prontosan Wound Irrigation Solution, 1000 Ml Regulatory Class: Unclassified Product Code: FRO Dated: June 6, 2016 Received: June 13, 2016
Dear Ms. 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 (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.
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
51D(k) Number (if known)
Device Name Prontosan Wound Irrigation Solution
Indications for Use (Describe)
Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
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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3
B. Braun Medical Inc. 510(k) Premarket Notification Prontosan® Wound Irrigation Solution
510(k) Summarv
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
610-266-0500 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Nancy Skocypec
Regulatory Affairs Manager |
| DEVICE NAME: | Prontosan® Wound Irrigation Solution |
| COMMON OR
USUAL NAME: | Wound Cleanser, Wound Dressing |
| DEVICE
CLASSIFICATION: | Product Code FRO, Unclassified |
| PREDICATE
DEVICE: | Prontosan® Wound Irrigation Solution, K072876
B. Braun Medical Inc., General and Plastic Surgery, Unclassified |
INTENDED USE
Prontosan Wound Irrigation Solution is for cleaning wounds, and for moistening and lubricating absorbent wound dressings.
INDICATIONS FOR USE:
Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
DEVICE DESCRIPTION:
Wound Irrigation Solution is a clear. clear. colorless liquid containing Prontosan undecylenamidopropyl betaine, polyaminopropyl biguanide, sodium hydroxide and purified water. The solution is aseptically filled using a blow fill seal process into low density polyethylene 40 mL ampoules; 350 mL squeeze bottles and 1000 mL bottles with screw caps. Prontosan Wound Irrigation Solution is used for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt and debris. The Prontosan Wound Irrigation Solution Adaptor is a component that may be screwed on to the current Prontosan Wound Irrigation Solution containers (350 ml and 1000 ml bottles) and provides alternate spout geometry for which to access the solution inside the bottle. It is provided in sterile form, labeled for single patient use only.
4
SUBSTANTIAL EQUIVALENCE:
The subject device and the predicate device are exactly the same. No changes have been made to the device, manufacturing process, the packaging process or the intended use. The modification subject to this 510(k) is for labeling content only.
NON-CLINICAL TESTING:
No new non-clinical testing has been performed for this submission. The changes to the labeling are test results from testing previously performed on this product and submitted to the FDA in a prior submission.
CONCLUSION:
Prontosan® Wound Irrigation Solution for prescription 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.