(195 days)
Not Found
combination products, i.e. bacterial/viral filters and heat and moisture exchangers
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:
- 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.
- Sample size used for the test set and the data provenance: Not applicable to a physical filter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- 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.
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Image /page/0/Picture/0 description: The image shows the word "Gibeck" in a bold, sans-serif font. To the left of the word is a stylized logo that appears to be a globe with a horizontal line through the center. The logo and the word "Gibeck" are both in black, contrasting with the white background.
MAY - 2 1996
K954828
510(k) Summary of Safety and Effectiveness Subject:
Gibeck Iso-Gard® HEPA Filter-HME and Product: Iso-Gard® HEPA Filter-HME with Port
Summary:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Iso-Gard HEPA Filter-HME and Iso-Gard HEPA Filter-HME with Port are combination products, i.e. bacterial/viral filters and heat and moisture exchangers, and are substantially equivalent to the Humid-Vent Filter. The bacterial filtration efficiency has been demonstrated to be >99.99 for a mean particle size of 3.0 microns. The viral filtration efficiency has been demonstrated to be >99.99 for a mean particle size of 3.1 microns. The moisture output has been demonstrated to be 26.6 mg H2O/l air at 300 ml tidal volume and 22.2 mg H2O/l air at 600 ml tidal volume.
The principal differences between the Iso-Gard HEPA Filter-HME, the Iso-Gard HEPA Filter-HME with Port and the Humid-Vent Filter are the design of the housing and the filtration/HME media utilized. These differences are not considered to be critical to the intended therapeutic. diagnostic, prosthetic or surgical use of the device nor should these differences significantly affect the safety or effectiveness of the device when used as labeled.
Submitter/Contact Person
2/9/96
Date
Gibeck, Inc. 10640 East 59th Street · P.O. Box 36430 · Indianapolis, IN 46236 Telephone: (317) 823-6866 · Telefax: (317) 823-1662 A Member of the Giberk Group
§ 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).