(254 days)
Not Found
No
The device is a wound irrigation solution and the description focuses on its chemical composition and mechanical action, with no mention of AI or ML.
No
This device is a wound irrigation solution used for cleaning and moistening wounds, which is a supportive rather than a direct therapeutic action as it does not actively treat or heal the wound itself.
No
Explanation: The device is described as a wound irrigation solution for cleaning, moistening, and lubricating wounds, and its performance studies relate to biocompatibility, functional performance, and shelf life, not to diagnosing conditions or diseases.
No
The device description clearly states it is a liquid solution packaged in ampoules and squeeze bottles, 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 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 analyzing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description details a solution applied externally to wounds. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic markers, assays, or laboratory procedures.
- Mechanism of Action: The mechanism of action described is mechanical cleaning and aiding in the removal of foreign material, which is a physical action on the wound surface.
- Performance Studies: The performance studies focus on biocompatibility, functional performance, and shelf life, which are typical for devices applied externally. They do not involve studies related to diagnostic accuracy or performance in analyzing biological samples.
In summary, the function and intended use of Prontosan Wound Irrigation Solution are consistent with a topical wound care product, not 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
FRO
Device 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.
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
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.
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
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
1
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.
2
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.
3
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
4
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