(96 days)
No
The summary describes a simple tubing device for gas sampling and makes no mention of AI or ML.
No
The device is described as "gas sampling lines" intended to connect to an expired gas monitor. Its function is to sample gas, not to provide therapy or treatment to a patient.
No
Explanation: The device is described as "gas sampling lines" that connect to a breathing circuit and an expired gas monitor. Its purpose is to facilitate the sampling of gas, not to interpret or diagnose based on the gas analysis. The monitor itself would perform the diagnostic function.
No
The device description clearly states it is "Small bore tubing of various internal diameters and lengths," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a breathing circuit to an expired gas monitor. This is a device used to facilitate the measurement of gases from the patient's breath, not to perform a diagnostic test on a biological sample in vitro (outside the body).
- Device Description: The description details tubing and connectors for gas transport, not reagents, calibrators, or other components typically associated with IVD tests.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is a component used in a system that measures expired gases, which can be used for monitoring or diagnostic purposes, but the gas sampling line itself is a conduit, not a diagnostic test.
N/A
Intended Use / Indications for Use
The gas sampling lines are intended to connect from a port in the breathing circit to the expired gas monitor. Disposable, single use.
The gas sampling lines are intended to connect to a port in the breathing circuit to the expired gas monitor. Disposable, single use.
Product codes
CCK
Device Description
Small bore tubing of various internal diameters and lengths, commonly referred to as gas-sampling lines. These connect to a port in the breathing circuit. May incorporate standard luer connector fittings and / or in-line filter at monitor end.
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 applicable
Intended User / Care Setting
Hospital, Sub-acute Institutions
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
K0235-79
JAN 2 8 2003
Gas Sampling Lines
Premarket Notification 510(k)
2.1 510(k) Summary of Safety and Effectiveness
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 October 23, 2002
ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055-9501 Tel (317) 335-3780 Fax (317) 335-9270
| Official Contact: | Paul Dryden - President |
|---|---|
| Proprietary or Trade Name: | Gas Sampling Lines |
| Common/Usual Name: | Gas sampling accessories |
| Classification Name: | Analyzer, Gas, Carbon dioxide, gaseous phase - accessory |
| Predicate Devices: | Catheter Research, Inc. - K946044 |
| Disposable gas sampling lines |
Device Description:
Environment of Use:
Small bore tubing of various internal diameters and lengths, commonly referred to as gas-sampling lines. These connect to a port in the breathing circuit. May incorporate standard luer connector fittings and / or in-line filter at monitor end.
Intended Use: The gas sampling lines are intended to connect from a port in the breathing circit to the expired gas monitor. Disposable, single use.
Hospital, Sub-acute Institutions
Page 11
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 October 23, 2002
General Technical Characteristics
| Attribute | ProMedic - Proposed device |
|---|---|
| Indications for use | The gas sampling lines are intended to connect |
| from a port in the breathing circuit to the expired | |
| gas monitor | |
| Intended for single use | Yes |
| Prescription | Yes |
| Intended population | Not applicable |
| Intended Environment of Use | Hospital, Sub-acute Institutions |
| Design | |
| Connects to a luer port in the breathing circuit and | |
| then sampling the gas, which is then transferred | |
| via the small bore tubing to the monitor | Yes |
| Of various lengths and diameters | Yes |
| May incorporate an in-line filter intended to | |
| prevent water from entering the monitor | Yes |
| Materials | |
| Tubing - PVC or PVC / PE | Yes |
| Luer connectors - PVC, PC | Yes |
| Sampling line - not in gas path | Yes |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 594-2 - Conical fittings for luer tapers | Yes |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 2003
Mr. Paul Dryden President ProMedic, Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K023579
Trade/Device Name: Gas Sampling Lines Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 14, 2002 Received: November 19, 2002
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runres
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.3 Indications for Use
Page 1 of 1
| 510(k) Number: | 14023579 (To be assigned) |
|---|---|
| Device Name: | Gas Sampling Lines |
| Intended Use: | The gas sampling lines are intended to connect to a port in |
| the breathing circuit to the expired gas monitor. |
Disposable, single use. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801.109)
✓
or
Over-the-counter use ________________________________________________________________________________________________________________________________________________________
HWesterlin
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023374