(221 days)
Not Found
No
The device description is for a simple tube with fittings and an optional filter, with no mention of any computational or analytical capabilities beyond delivering a gas sample. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as a tube for delivering a sample of expired gas to an analyzer, which indicates it's used for diagnostic or monitoring purposes, not for treating a condition directly.
No
The device is described as a "small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer." It is a gas sampling line, which is used to transport samples to a diagnostic device (the analyzer), but it does not perform analysis or diagnosis itself.
No
The device description clearly states it is a "small bore tube with luer fittings," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a tube used to transport a sample of expired gas from a patient to an analyzer. While the analyzer itself might be an IVD (if it analyzes the gas for diagnostic purposes), the tube itself is simply a conduit for the sample.
- Lack of Diagnostic Function: The tube does not perform any diagnostic test or analysis on the sample. Its sole purpose is to facilitate the delivery of the sample to another device that performs the analysis.
- Predicate Device: The predicate device listed (K841722 - Gibeck, Inc. - disposable gas sampling lines) is also described as a gas sampling line, which aligns with the function of a sample transport device, not an IVD.
Therefore, this device falls under the category of a medical device used for sample collection and transport, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for 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
Product codes
Not Found
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
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
Not Found
Intended User / Care Setting
Hospital, anesthesia, ICU, PACU, respiratory therapy
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)
Performance Testing: Luer fittings
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with the text "The New Marq of Excellence". The logo is a stylized letter Q, with three horizontal lines inside the Q. The text is in a serif font and is located to the right of the logo. The logo and text are black and white.
OCT 1 8 1996
Ka60972
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 Fast Lansing Circle
gas sampling monitors
Tel - (303) 790-4835
| 11039 East Lansing Circle
| Englewood, CO 80112 | Fax - (303) 799-0210 | |
|---|---|---|
| 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 | X | X |
Yes
Yes
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.