ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT

K954828 · Gibeck, Inc. · CAH · May 2, 1996 · Anesthesiology

Device Facts

• Record ID: K954828
• Device Name: ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
• Applicant: Gibeck, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: May 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Combination bacterial/viral filter and heat and moisture exchanger (HME); placed in respiratory circuits; filters inhaled/exhaled gases; retains moisture and heat from exhaled air to humidify inhaled air; used in clinical settings (OR, ICU) by respiratory therapists or anesthesiologists; protects patient and equipment from cross-contamination; provides passive humidification to prevent airway drying.

Clinical Evidence

Bench testing only. Bacterial filtration efficiency >99.99% (mean particle size 3.0 microns); viral filtration efficiency >99.99% (mean particle size 3.1 microns); moisture output 26.6 mg H2O/l at 300 ml tidal volume and 22.2 mg H2O/l at 600 ml tidal volume.

Technological Characteristics

Combination bacterial/viral filter and HME. Housing and filtration/HME media construction. Passive heat and moisture exchange principle. Mechanical filtration.

Indications for Use

Indicated for use as a bacterial/viral filter and heat and moisture exchanger (HME) in respiratory circuits for patients requiring mechanical ventilation or anesthesia.

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

• Humid-Vent Filter

Submission Summary (Full Text)

{0}

Gibeck
MAY - 2 1996
K954828

Subject: 510(k) Summary of Safety and Effectiveness

Product: Gibeck Iso-Gard® HEPA Filter-HME and 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.


2/9/96 Date

Gibeck, Inc.
10640 East 59th Street • P.O. Box 36430 • Indianapolis, IN 46236
Telephone: [phone] • Telefax: [phone]
A Member of the Gibe:k Group