(147 days)
This device is for the application of Tisseel® Fibrin Sealant.
Not Found
This is a 510(k) clearance letter for the Baxter DuploSpray MIS Applicator, a Piston Syringe. The letter indicates that the device is substantially equivalent to legally marketed predicate devices. This type of regulatory document typically does not contain the kind of detailed study data, acceptance criteria, or ground truth information you're asking for regarding AI-driven device performance.
Therefore,Based on the provided document, the requested information regarding acceptance criteria and study details for device performance cannot be extracted. The document is a 510(k) clearance letter for a medical device (Baxter DuploSpray MIS Applicator), not a study report or a detailed technical specification with performance metrics.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, data provenance, or details about retrospective/prospective studies.
- Number and qualifications of experts used to establish ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with/without AI assistance.
- Results of a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for a training set.
- How the ground truth for a training set was established.
This document serves as regulatory clearance based on substantial equivalence to existing devices, implying that its safety and effectiveness are comparable, but it doesn't detail specific performance studies with quantitative metrics or AI components.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
SEP 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Lopac Manager of Quality Assurance and Regulatory Affairs Micromedics, Incorporated 1270 Eagan Industrial Road, Suite #120 St. Paul, Minnesota 55121-1385
Re: K061092
Trade/Device Name: Baxter DuploSpray MIS Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 9, 2006 Received: August 10, 2006
Dear Mr. Lopac:
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 (1 will) it has 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.
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Page 2 - Mr. Lopac
Please be advised that FDA's issuance of a substantial equivalence determination does not I loase oe act rised that 122 retermination that your device complies with other requirements modi that I Dr I has made statutes and regulations administered by other Federal agencies. or the Act of any 1 ederal base as a requirements, including, but not limited to: registration r ou listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 ce read of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bettronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins feter wifification. The FDA finding of substantial equivalence of your device to a premarket notified bevice 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), r you dontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
K061092 510(k) Number (if known):
Device Name: Baxter DuploSpray MIS Applicator
Indications for Use:
This device is for the application of Tisseel® Fibrin Sealant.
X OR Prescription Use: (Per 21 CFT 801.109)
Over-The-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auten D. W.
11 3:50-Off) on of Anesthesiology, General Hospital, :on Control, Dental Devices
Number: K96/42
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).