POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER

K982385 · Porous Media Corp. · KRJ · Feb 1, 1999 · Cardiovascular

Device Facts

• Record ID: K982385
• Device Name: POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
• Applicant: Porous Media Corp.
• Product Code: KRJ · Cardiovascular
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4280
• Device Class: Class 2

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.

Device Story

DPB20™ Disposable Pre-bypass Filter is a single-use device used in extracorporeal circuits. It filters non-cellular priming fluids before cardiopulmonary bypass initiation. Operated by perfusionists or clinical staff in surgical settings. Device is discarded immediately after circuit priming. Benefits include removal of particulates from priming fluids, reducing potential patient exposure to contaminants during bypass.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable filter for extracorporeal circuits; single-use design; mechanical filtration principle; non-cellular fluid compatibility.

Indications for Use

Indicated for use with non-cellular fluid in the extracorporeal circuit prior to the initiation of cardiopulmonary bypass. Designed for single use; discard after circuit priming.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Public Health Service

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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.

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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 [phone] or [phone] 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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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.

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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