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K Number
K990276
Device Name
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1999-10-01

(246 days)

Product Code
KRJ
Regulation Number
870.4280
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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. .
Device Description

DPB30 Disposable Pre-bypass Filter

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called "DPB30 Disposable Pre-bypass Filter." This document does not contain information about acceptance criteria, clinical study results, or detailed performance data.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that for a 510(k) submission, the manufacturer focused on demonstrating that their device is as safe and effective as existing, legally marketed devices, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given document. The document only covers:

  • Device Name: DPB30 Disposable Pre-bypass Filter
  • Intended Use: For use only with non-cellular fluid in the extra-corporeal circuit prior to the initiation of cardiopulmonary bypass. Designed for single use and intended for the adult population only.
  • Regulatory Class: II (Two)
  • Product Code: 74 JOW

To answer your questions about acceptance criteria and a study proving the device meets them, I would need a different type of document, such as a clinical study report or a detailed summary of safety and effectiveness (SSE) for a PMA (Premarket Approval) device, or a more comprehensive 510(k) summary that includes performance data.

§ 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.