(254 days)
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.
Prontosan Wound Irrigation Solution is a clear, colorless containing liauid 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 and 350 mL squeeze 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 provided text is a 510(k) summary for a medical device (Prontosan™ Wound Irrigation Solution). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or expert agreement that would typically be found in an AI/software as a medical device (SaMD) submission.
This document focuses on demonstrating substantial equivalence to an existing predicate device based on:
- Similar Indications for Use: The new device and the predicate device (Dermacyn® Wound Care solution) are both intended for cleaning and irrigating wounds and moistening wound dressings.
- Biocompatibility Testing: To ensure the materials used are safe for bodily contact.
- Functional Performance Testing: To verify the solution performs its intended physical functions.
- Shelf Life Testing: To ensure stability over time.
- Comparison Testing: Directly comparing the proposed device with the predicate device to show similarities and confirm no new safety/effectiveness issues.
Therefore, for the type of information requested (acceptance criteria and study details related to device performance metrics, human-in-the-loop, ground truth, etc., typically found in SaMD studies), the provided text does not contain this information.
Here's a breakdown of why each requested point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This document doesn't provide specific performance metrics or acceptance criteria in the way an AI/software device would (e.g., sensitivity, specificity thresholds). It only states that comparison testing "demonstrated that Prontosan Wound Irrigation Solution, the proposed device is similar to Dermacyn Wound Care solution, the predicate device."
- Sample sized used for the test set and the data provenance: Not applicable or provided. The "testing" mentioned is likely laboratory or chemical analysis, not clinical trials with sample sizes in the context of disease detection or diagnosis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound irrigation solution would relate to its chemical composition, sterility, physical properties, and safety, not expert interpretation of images or clinical data.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study demonstrates improved human performance with AI assistance, which is irrelevant for a wound irrigation solution.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable. This device is a solution, not an algorithm.
- Type of ground truth used: For this type of device, the "ground truth" would be established by rigorous chemical analysis, sterility testing, and biocompatibility standards, not expert consensus or pathology in a diagnostic sense.
- Sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical wound irrigation solution, not an AI/software medical device. As such, it relies on different types of evidence (biocompatibility, functional testing, comparison to predicate) to establish substantial equivalence, rather than the performance metrics and study designs typically associated with AI/SaMD devices.
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510(k) SUMMARY
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Contact: Rebecca Stolarick Director, Regulatory Affairs Phone: (610) 596-2536 Fax: (610) 266-4962 E-mail: Rebecca.stoalrick@bbraun.com
DEVICE NAME: Prontosan™ Wound Irrigation Solution
COMMON OR USUAL NAME:
Wound Cleanser, Wound Dressing
DEVICE CLASSIFICATION: Class II, Product Code FRO, Unclassified
PREDICATE DEVICES: Dermacyn® Wound Care solution Oculus Innovative Sciences, Inc. Regulatory Class: Unclassified, Product Code: FRO 510(k) K060113 March 19, 2007
DESCRIPTION: Prontosan Wound Irrigation Solution is a clear, colorless containing liauid 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 and 350 mL squeeze 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.
INTENDED USE: Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, postsurgical wounds and abrasions.
JUN 1 9 2008
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K 072876
Page 2 of 2
SUBSTANTIAL EQUIVALENCE:
The proposed device and the predicate device have similar indications for use. The safety and effectiveness of Prontosan™ Irrigation Solution is supported by biocompatibility testing, functional performance testing and shelf life testing conducted with the proposed device. Comparison testing conducted with Prontosan Wound Irrigation Solution and Dermacyn® Wound Care solution demonstrated that Prontosan Wound Irrigation Solution, the proposed device is similar to Dermacyn Wound Care solution, the predicate device. This testing also demonstrates that there are no new issues of safety and effectiveness for the proposed device. Prontosan Wound Irrigation Solution and Dermacyn Wound Care solution are both intended for cleaning and irrigating wounds and moistening wound dressings.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 Zuud
B. Braun Medical, Inc. % Ms. Rebecca Stolarick Director, Regulatory Affairs 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K072876
Trade/Device Name: Prontosan™ Wound Irrigation Solution Regulation Number: Unclassified Product Code: FRO Dated: June 9, 2008 Received: June 11, 2008
Dear Ms. Stolarick:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Rebecca Stolarick
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name: Prontosan™ Wound Irrigation Solution
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.
Prescription Use
AND/OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offic
for mxm
(Division Sign Off)
Division of General, Restorative. and Neurological Devices
510(k) Number K072876
N/A