(246 days)
None
Not Found
No
The summary describes a physical filter for use in cardiopulmonary bypass and contains no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in medical devices.
No.
The device is a filter used for non-cellular fluid in an extracorporeal circuit, which means it processes blood outside the body, but it is used prior to cardiopulmonary bypass and discarded once the circuit is primed; it does not directly treat a disease or medical condition.
No
The filter is intended for pre-bypass use to filter non-cellular fluid in the extracorporeal circuit, not to diagnose a condition.
No
The device description explicitly states "DPB30 Disposable Pre-bypass Filter," which is a physical hardware component used in an extracorporeal circuit. The intended use also describes a physical filter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the filter is for use with non-cellular fluid in the extracorporeal circuit prior to the initiation of cardiopulmonary bypass. This is a mechanical filtration process performed outside the body, not a diagnostic test performed in vitro (in a test tube or other artificial environment) on samples taken from the body.
- Device Description: The description is simply "DPB30 Disposable Pre-bypass Filter," which aligns with a mechanical filtration device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This filter's function is purely mechanical filtration of fluids used in a medical procedure.
N/A
Intended Use / Indications for Use
- The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass.
- The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed
- The device is intended for adult population only. .
Product codes
74 JOW
Device Description
DPB30 Disposable Pre-bypass Filter
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
adult population only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4280 Cardiopulmonary prebypass filter.
(a)
Identification. A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three heads, representing the department's mission to protect the health of all Americans. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying a sense of authority and trustworthiness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1999
Ms. Rochelle M. Mickschl Medical Device Respresentative Porous Media Corporation 1350 Hammond Road St. Paul, MN 55110
Re : K990276 DPB30 Disposable Pre-bypass Filter Requlatory Class: II (Two) Product Code: 74 JOW Dated: August 26, 1999 Received: August 27, 1999
Dear Ms. Mickschl:
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 leqally 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 general controls provisions of the Act include the Act. requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Regulation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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.
1
Page 2 - Ms. Rochelle M. Mickschl
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) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR Other general information on your responsibilities under 807.97) . . 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 Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K990276/S2
Device Name: DPB30 Disposable Pre-bypass Filter
Indications For Use:
- The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass.
- The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed
- The device is intended for adult population only. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sue Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K990276 510(k) Number_