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K Number
K954828
Device Name
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
Manufacturer
GIBECK, INC.
Date Cleared
1996-05-02

(195 days)

Product Code
CAH
Regulation Number
868.5260
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

combination products, i.e. bacterial/viral filters and heat and moisture exchangers

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for a medical device (Gibeck Iso-Gard® HEPA Filter-HME). It provides information about the device's performance characteristics and its substantial equivalence to a predicate device.

However, the provided text does not contain the information requested for an AI/ML device study. It describes a physical medical device (a filter/heat and moisture exchanger) and its testing against physical performance criteria, not an AI algorithm.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: While there are performance metrics (bacterial/viral filtration efficiency, moisture output), these are for a physical filter, not an AI algorithm.
  2. Sample size used for the test set and the data provenance: Not applicable to a physical filter.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  6. Standalone (algorithm only) performance: Not applicable.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

This document pertains to the regulatory submission for a physical medical device and its physical performance testing, not to an AI/ML diagnostic or prognostic device study.

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).