BACTERIA/VIRAL FILTER

K961914 · Hudson Respiratory Care, Inc. · CAH · Aug 14, 1996 · Anesthesiology

Device Facts

• Record ID: K961914
• Device Name: BACTERIA/VIRAL FILTER
• Applicant: Hudson Respiratory Care, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Aug 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Disposable, single-patient-use breathing filter; consists of gas-permeable, electrostatically-charged hydrophobic filter medium housed between two clear plastic shells. Device inserted into breathing circuits via standard 15mm/22mm fittings. Respiratory gases pass through medium; filter traps bacteria and viruses. Optional gas sampling port allows monitoring of exhaled gases while protecting monitoring equipment from contamination. Used in clinical settings where patients receive ventilatory support or supplemental oxygen. Clinicians manage device integration into circuits; compensate for device dead space during ventilatory setup. Benefits patient by reducing risk of airborne infection transmission within respiratory circuits.

Clinical Evidence

Bench testing only. Independent laboratory testing compared bacterial filtration efficiency (BFE) and viral filtration efficiency (VFE) against predicate. Hudson RCI filter achieved BFE of 99.999% and VFE of 99.99%. Dead space testing performed (42mL vs 35mL).

Technological Characteristics

Disposable breathing circuit filter. Materials: clear plastic housing, electrostatically-charged hydrophobic filter medium. Connectors: ISO 22mm ID and ISO 22mm OD/15mm ID. Form factor: circular/spherical housing. Optional gas sampling port. No energy source. No direct patient contact.

Indications for Use

Indicated for all patient populations requiring ventilatory support or supplemental oxygen where filtration of respiratory gases is required to prevent airborne bacterial and viral contamination.

Regulatory Classification

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.

Predicate Devices

• Gibeck Iso-Gard Depth Filter (Dryden II Filter) (K792097)

Submission Summary (Full Text)

{0}

AUG 14 1996
HUDSON RCI
K961914

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: [phone]

Contact: Arden Morley
Director of Regulatory Affairs/Product Evaluation
Tel: [phone], 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

AAC
ZENITH AMARO 1992
AAC
ZENITH AMARO 1989
HUDSON RESPIRATORY CARE INC.
27711 Diaz Road • P.O. Box 9020
Temecula, CA 92589-9020
Tel. [phone] • Fax [phone]

{1}

May 14, 1996
HUDSON RCI
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.

183

HUDSON RESPIRATORY CARE INC.
27711 Diaz Road • P.O. Box 9020
Temecula, CA 92589-9020
Tel. [phone] • Fax [phone]