POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER

• K Number: K982385
• Device Name: POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
• Manufacturer: POROUS MEDIA CORP.
• Date Cleared: 1999-02-01 ( 207 days)
• Product Code: KRJ , NOV
• Regulation Number: 870.4280
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended 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 Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a disposable cardiopulmonary pre-bypass filter, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory pathway for this type of medical device. There is no mention of an AI/ML component or study involving such.

Regulation Number and Section

§ 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.