(195 days)
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No
The device description and performance studies focus on the physical filtration and moisture exchange properties of the device, with no mention of AI or ML.
Yes.
The device's description as "bacterial/viral filters and heat and moisture exchangers" implies a therapeutic function by filtering pathogens and managing moisture, which are clinical interventions for patient care.
No
The device is described as a combination of bacterial/viral filters and heat/moisture exchangers, primarily focused on filtration efficiency and moisture output. There is no mention of it being used to diagnose diseases or conditions.
No
The device description and performance studies clearly indicate a physical product (filters and heat/moisture exchangers) with measurable physical properties (filtration efficiency, moisture output), not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states the device is a "combination product, i.e. bacterial/viral filters and heat and moisture exchangers." This indicates a function related to filtering air and managing moisture in a respiratory circuit, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces the intended use as filters and heat/moisture exchangers.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on filtration efficiency and moisture output, which are relevant to respiratory support devices, not diagnostic tests.
Therefore, the device described is a respiratory accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Humid-Vent Filter
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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