HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)

K964382 · Gibeck, Inc. · CAH · Apr 15, 1997 · Anesthesiology

Device Facts

• Record ID: K964382
• Device Name: HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
• Applicant: Gibeck, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Apr 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375.

Device Story

Heat and moisture exchanger (HME) device; functions as passive humidifier for respiratory circuits; captures heat and moisture from exhaled breath to condition inhaled air; used in clinical settings during mechanical ventilation or anesthesia; operated by clinicians; reduces dead space and weight compared to predicate; supports tidal volumes 150-1000 ml; aids in maintaining airway humidity and preventing patient dehydration.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Heat and moisture exchanger; passive humidification; reduced size/dead space design; supports 150-1000 ml tidal volume range.

Indications for Use

Indicated for patients requiring heat and moisture exchange during mechanical ventilation or anesthesia, supporting tidal volumes of 150-1000 ml.

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 Humid-Vent Filter

Submission Summary (Full Text)

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K964382
April 15, 1997

Subject: 510(k) Summary of Safety and Effectiveness

Product: Gibeck Humid-Vent® Filter Compact Angled/Humid-Vent® Filter Compact Straight

## 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 Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375. These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.

The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.

The principal difference between the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight and the Humid-Vent Filter is the size of the device. This change is not considered to be critical to the intended therapeutic, diagnostic, prosthetic or surgical use of the device nor should this change significantly affect the safety or effectiveness of the device when used as labeled.



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