(89 days)
792097
K# 792097
No
The device description and performance studies focus on the physical filtration properties of the device and do not mention any computational or algorithmic components.
No
The device is a filter designed to prevent infection, not to treat a pre-existing medical condition or illness.
No
The device is a filter designed to remove bacteria and viruses from respiratory gases, not to diagnose medical conditions.
No
The device description clearly states it is a physical filter consisting of a filter medium and plastic housings, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is a filter designed to remove bacteria and viruses from respiratory gases before they are inhaled or exhaled by a patient. It acts on the air/gas itself, not on a biological specimen taken from the patient.
- Intended Use: The intended use clearly states it's for filtering respiratory gases in conjunction with other respiratory devices. It's a component of a breathing circuit, not a diagnostic tool.
The device is a breathing circuit filter, which is a different category of medical device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all patient populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
bacterial filtration efficiency (BFE) of 99.999%, viral filtration efficiency (VFE) of 99.99%, dead space of 42mL
Predicate Device(s)
Gibeck product no. 1910 Iso-Gard Depth Filter, also known as the Dryden II Filter K# 792097
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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.
182
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
1
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