(207 days)
Not Found
Not Found
No
The summary describes a physical filter for an extracorporeal circuit and contains no mention of software, algorithms, or AI/ML terms.
No
The device is a pre-bypass filter intended for use with non-cellular fluid in an extracorporeal circuit, indicating it is a component of a medical procedure rather than directly treating a disease or condition itself.
No
Explanation: The device is described as a "Disposable Pre-Bypass Filter" intended for use in an extracorporeal circuit to filter non-cellular fluid. Its function is to filter, not to diagnose a condition or disease.
No
The intended use and device description clearly indicate a physical filter for use in an extracorporeal circuit, which is a hardware component.
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 an extracorporeal circuit prior to cardiopulmonary bypass. This is a mechanical filtration process happening outside the body, not a diagnostic test performed on a biological sample in vitro (in glass/in a lab).
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other typical characteristics of an IVD.
Therefore, this device is a medical device used in a surgical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
- THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.
Product codes
KRJ
Device Description
Not Found
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
Not Found
Key Metrics
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
Public Health Service
Image /page/0/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, stacked on top of each other.
FEB 1 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rochelle M. Mickschl Medical Device Representative Porous Media Corporation 1350 Hammond Road St. Paul, MN 55110
K982385 Re: Porous Media DPB20™ Disposable Cardiopulmonary Pre-Bypass Filter Requlatory Class: II (Two) KRJ Product Code: November 4, 1998 Dated: Received: November 5, 1998
Dear Ms. Michkschl:
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 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 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 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 In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. 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.
1
Page 2 - Ms. Rochelle M. Mickschl
This letter will allow you to begin marketing your device as Info ibed in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed or bubbeantial oqueens 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 reguration (ir cri), please contact the Office of Compliance at Graghobere as roossy promally, for questions on the promotion and advertising of your device, please contact the Office of advertibing or Jour 2017-1639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (arch Joilities under the Act may be obtained from the Division responsiblications 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. Callahan
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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Page _ 1 _ of __ 1
K982385 510(k) Number (if known): _
DPB20™ Disposable Pre-bypass Filter Device Name:
Indications For Use:
- . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
- THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
- . Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use > (Per 21 CFR 801.1091)
Over-The-Counter Use (Optional Format 1-2-96)
Sette & Snyper G
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K982385