(89 days)
For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
The Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is a disposable, single patient use breathing filter consisting of a gas-permeable filter medium captured between two clear plastic housings. When the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter medium within the filter. The medium traps bacteria and viruses carried within the airstream.
This document describes a medical device, the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter, and its comparison to a predicate device, the Gibeck product no. 1910 Iso-Gard Depth Filter. The provided text is a non-confidential 510(k) Summary of Safety and Effectiveness submission and does not detail an AI/ML device or a study involving human readers or AI assistance. Therefore, it is impossible to extract information related to AI-specific criteria, such as multi-reader multi-case (MRMC) studies, effect size of AI improvement, standalone algorithm performance, or ground truth establishment for training sets.
However, based on the provided text, I can infer the acceptance criteria (performance of the predicate device) and the reported device performance for the physical filter.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device: Gibeck Iso-Gard Depth Filter) | Reported Device Performance (Hudson RCI Cat. No. 1605 Bacteria / Viral Filter) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | > 99.9% | 99.999% |
| Viral Filtration Efficiency (VFE) | > 99.9% | 99.99% |
| Dead Space | 35 mL | 42 mL |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "The Hudson RCI Bacteria/Viral Filter and the Gibeck filter have been tested by an independent laboratory for bacterial and viral filtration performance." This implies a test set was used for each filter, but the number of samples is not provided.
- Data Provenance: The testing was conducted by an "independent laboratory." No country of origin is specified. The study appears to be retrospective in the sense that the performance data for both devices was collected and then compared.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a physical filter, not an AI/ML diagnostic tool. The "ground truth" for filter performance is based on laboratory testing against established bacterial and viral challenges.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for a physical filter performance study. The reported efficiency values are likely direct measurements from laboratory tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device is a physical filter. This document does not describe an AI/ML device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical filter. This document does not describe an AI/ML device.
7. The type of ground truth used:
The ground truth for the performance metrics (BFE, VFE, Dead Space) was established through laboratory testing using standardized methods for bacterial and viral challenge, and dead space measurement.
8. The sample size for the training set:
This is not applicable as the device is a physical filter and not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
This is not applicable as the device is a physical filter and not an AI/ML model that requires training data.
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AUG 14 1996
Image /page/0/Picture/1 description: The image shows a logo for Hudson RCI. The logo features a stylized "H" and "RCI" in bold, black letters. The "H" is formed by thick, horizontal lines, and the "RCI" is placed to the right of the "H". The logo has a slightly angled, three-dimensional appearance.
May 14, 1996
Non-confidential 510(k) Summary of Safety and Effectiveness
| Submitter: | Hudson Respiratory Care, Inc. |
|---|---|
| 27711 Diaz Road | |
| P.O. Box 9020 | |
| Temecula, CA 92589-9020 | |
| Tel: 909-676-5611 |
Contact: Arden Morley Director of Regulatory Affairs/Product Evaluation Tel: 909-676-5611, extension 1247
Device name
Trade or proprietary name: Cat. No. 1605 Bacteria / Viral Filter Classification name: Breathing Circuit Bacterial Filter Common or usual name: breathing filter
Predicate device
Gibeck product no. 1910 Iso-Gard Depth Filter, also known as the Dryden II Filter K# 792097
Device description
The Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is a disposable, single patient use breathing filter consisting of a gas-permeable filter medium captured between two clear plastic housings. When the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter medium within the filter. The medium traps bacteria and viruses carried within the airstream.
Intended use
For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
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Image /page/0/Picture/16 description: The image is a logo for the Zenith Award 1992. The logo features the letters "AAC" in a stylized font, with a mountain range graphic above the letters. The word "ZENITH" is placed above the word "AWARD" and the year "1992" is placed below the word "AWARD".
HUDSON RESPIRATORY CARF INC 27711 Diaz Road · P.O. Box 9020 Temecula, CA 92589-9020 Tel. 909-676-5611 · Fax 909-676-1578
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May 14, 1996
Image /page/1/Picture/1 description: The image shows a logo for Hudson RCI. The logo consists of the letters "HCI" in a stylized font, with a horizontal striped pattern behind the letters. Below the letters, the words "HUDSON RCI" are written in a bold font. The logo is black and white.
Non-confidential 510(k) Summary of Safety and Effectiveness
Technological Comparison
Both the Hudson RCI Bacteria /Viral Filter and the Gibeck filter have similar intended uses and clinical applications. Both devices are intended for use in all patient populations requiring ventilatory support or supplemental oxygen where infection from airborne bacteria or viruses is of concern. Both devices are intended for use in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits and the like). Neither device is intended for direct contact with the patient, nor does either of the devices use or impart energy. Both devices utilize a similar method of operation in that gas passes through a filter medium which traps bacteria and viruses carried within the airstream.
Both the Hudson RCI Bacteria/Viral Filter and the Gibeck filter utilize similar gas permeable hydrophobic media for the filters. The Hudson RCI filter features a circular/spherical housing, while the Gibeck filter utilizes a squared housing. Both devices feature a design which possess ISO 22mm ID and ISO 22mm OD/15mm ID connectors. The Hudson RCI Bacteria/Viral filter may be offered with an optional gas sampling port. The Gibeck filter does not offer this feature. The addition of a gas sampling port would allow the practitioner to monitor exhaled gases while protecting the gas monitoring equipment from bacterial or viral contamination.
The Hudson RCI Bacteria/Viral Filter and the Gibeck filter have been tested by an independent laboratory for bacterial and viral filtration performance. Both filters displayed a bacterial filtration efficiency (BFE) and viral filtration efficiency (VFE) of greater than 99.9%, with the Hudson RCI filter displaying a BFE of 99.999% and a VFE of 99.99%. A dead space test was performed on both the Hudson RCI and Gibeck filters. The Hudson RCI filter possesses a dead space of 42mL, while the Gibeck filter possesses a dead space of 35mL. Although the dead space for the Hudson RCI filter is slightly greater than that of the Gibeck filter, the clinician compensates for dead space during ventilatory set-up.
Conclusion
Based upon comparison to the identified predicate device and the results of the testing performed, Hudson RCI concludes that the Hudson RCI Bacteria/Viral filter is safe and effective and performs as well or better than the Gibeck Iso-Gard Filter.
Image /page/1/Picture/13 description: The image shows a logo for the Zenith Award 1992. The logo features the letters "ARC" in a stylized font, with a mountain range graphic above the letters. The word "ZENITH" is written below the letters, and the year "1992" is written below the word "AWARD".
Image /page/1/Picture/10 description: The image shows a logo with the letters "AAC" stacked on top of each other. Above the letters is a mountain range symbol. Below the letters, the words "ZENITH AWARD 1989" are written. The logo is in black and white.
HUDSON RESPIRATORY CARE INC 27711 Diaz Road · P.O. Box 9020 Temecula, CA 92589 9020 Tel. 909-676-5611 · Fax 909-676-1578 183
§ 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).