DISPOSABLE GAS SAMPLING INTERFACE KITS

K960972 · Marquest Medical Products, Inc. · CCK · Oct 18, 1996 · Anesthesiology

Device Facts

• Record ID: K960972
• Device Name: DISPOSABLE GAS SAMPLING INTERFACE KITS
• Applicant: Marquest Medical Products, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

Indicated use - When a sample of a patient's expired gas is to be analyzed. Targeted population - Any patient requiring monitoring of expired gases. Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy

Device Story

Small-bore tubing with luer fittings; facilitates transport of patient expired gas samples to external gas analyzers. Used in hospital environments (anesthesia, ICU, PACU, respiratory therapy) by clinicians. Device features various lengths, diameters, and optional in-line filters. Single-use disposable design.

Clinical Evidence

Bench testing only; performance testing of luer fittings confirms equivalence to predicate.

Technological Characteristics

Small-bore tubing with luer fittings; materials include PVC, PC, ABS, Acrylic, and PE. Optional in-line filter. Single-use, disposable.

Indications for Use

Indicated for patients requiring expired gas monitoring in hospital settings including anesthesia, ICU, PACU, and respiratory therapy.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Gibeck, Inc. disposable gas sampling lines (K841722)

Submission Summary (Full Text)

{0}

The New Marq of Excellence
K900972
OCT 18 1996

Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, Colorado 80112 U.S.A.
303 790 4835 phone
303 799 0210 fax

Non-Confidential Summary of Safety and Effectiveness
March 1, 1996

page 1 of 2

Marquest Medical Products, Inc.
11039 East Lansing Circle
Englewood, CO 80112
Tel - [phone]
Fax - [phone]

Official contact: Tom Dielmann, Director, Regulatory Affairs / Quality Assurance

Proprietary or Trade Name: Gas Sampling Interface Kits

Common/Usual Name: Disposable Gas Sampling Lines

Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase

Intended device: Gas Sampling Interface Kits

Predicate devices: Gibeck, Inc. - disposable gas sampling lines - K841722

Device description: The intended product is a small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer. The device may be of various lengths, tubing diameters and have an in-line filter.

Intended use:

Indicated use - When a sample of a patient's expired gas is to be analyzed.

Targeted population - Any patient requiring monitoring of expired gases.

Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy

Comparison to predicate devices:

| Attribute | Marquest | Dryden (Gibeck) |
| --- | --- | --- |
| Use | | |
| Indicated for use with expired gas sampling monitors | Yes | Yes |

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{1}

Non-Confidential Summary of Safety and Effectiveness (continued)

March 1, 1996

page 2 of 2

Comparison to predicate devices: (continued)

| Attribute | Marquest | Dryden (Gibeck) |
| --- | --- | --- |
| Use (continued) | | |
| Intended for use in anesthesia | Yes | Yes |
| Intended for use in respiratory therapy | Yes | Yes |
| Indicated for single use | Yes | Yes |
| Design | | |
| Luer fittings | Yes | Yes |
| Clear | Yes | Yes |
| Various diameters of tubing | Yes | Yes |
| Various lengths of tubing | Yes | Yes |
| Maybe supplied with filter | Yes | Yes |
| Materials | | |
| Luers made of PVC, PC, ABS, Acrylic | Yes | Yes |
| Tubing - PVC, PE, PVC/PE | Yes | Yes |
| Performance Testing | | |
| Luer fittings | Yes | Yes |

## B. Differences

Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.

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