(280 days)
The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.
Not Found
Based on the provided text, the document is a 510(k) clearance letter for the "Jostra Venous Hardshell Cardiotomy Reservoir VHK 4200." This document primarily addresses regulatory clearance and substantial equivalence to a predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria for an AI/ML powered medical device.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially in the context of AI/ML devices) is not available in the provided text.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or test sets.
- Details on experts used for ground truth, adjudication methods, or ground truth types.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Details on training set sample size or how ground truth for training was established.
The document asserts that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than presenting a de novo performance study against new acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 1999
Ms. Kathy Johnson Product Manager Jostra U.S.A. 8403 Cross Park Drive Suite 3-G Austin, TX 78754
K982136 Re : Jostra Venous Hardshell Cardiotomic Reservoir VHK 4200 Regulatory Class: II (Two) Product Code: 74 DTN December 10, 1998 Dated: Received: December 29, 1998
Dear Ms. Johnson
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Kathy Johnson
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):K982136
Device Name:Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200
Indications For Use:
The Jostra Venous Hardshell Cardiotomy Resevoir VHK 4200 is intended for use in adult cardiopulmonary bypass procedures of short duration of 6 hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K182136
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
: : :
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.