(44 days)
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood accermination on ong cardiac interventional procedures as measured by a change in platelet count due to activation of functional It may be used at the point-of-care on the Ichor platelets. hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Collagen for Plateletworks™" device. It outlines the FDA's determination of substantial equivalence and regulatory class for the device. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related questions you've asked.
The document is a regulatory approval letter, not a scientific study report or clinical trial summary. It refers to an "enclosure" for indications for use, but the enclosure itself (which starts on page 2 of the provided text) only describes the intended use of the device, not its performance metrics or how those metrics were validated.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present (the device is an "Automated Platelet Aggregation System," implying an automated measurement, but no performance study details are given).
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document mainly states that the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered comparable based on the information submitted in the 510(k) application. The specifics of the studies proving this equivalence are not included in this letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them, resembling a bird in flight.
SEP 2 8 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Patricia Franks Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752
Re: K012723
Trade/Device Name: Collagen for Plateletworks™M Regulation Number: 21 CFR § 864.5700 Regulation Name: System, Automated Platelet Aggregation Regulatory Class: II Product Code: JOZ Dated: August 13, 2001 Received: August 15, 2001
Dear Ms. Franks:
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
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Page 2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Korz 723 510(k) Number (if known):
Plateletworks™ Device Name:
Indications for Use:
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood accermination on ong cardiac interventional procedures as measured by a change in platelet count due to activation of functional It may be used at the point-of-care on the Ichor platelets. hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.
Josephine Santidei
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).