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.

AI/ML Overview

The provided text, K0235-79, describes a 510(k) premarket notification for "Gas Sampling Lines." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and study methodologies for an AI/CADe device's clinical performance assessment is not applicable to this submission.

Here's why and what the document does discuss:

Device Type: This submission is for medical tubing (Gas Sampling Lines), which are considered accessories for carbon dioxide gas analyzers. These are standard medical devices, not AI or CADe systems.
Regulatory Pathway: The 510(k) pathway for these types of devices relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This typically involves engineering and bench testing, materials biocompatibility, and sometimes limited performance testing against established standards, but not clinical trials with performance metrics like sensitivity, specificity, or reader studies.
Key Information Provided:
- Intended Use: "The gas sampling lines are intended to connect from a port in the breathing circuit to the expired gas monitor. Disposable, single use."
- Device Description: Small bore tubing of various internal diameters and lengths, connecting to a port in the breathing circuit, possibly with standard luer connectors and/or an in-line filter.
- Predicate Devices: Catheter Research, Inc. - K946044 (Disposable gas sampling lines).
- Performance Standards (Applicable): ISO 594-2 - Conical fittings for luer tapers. This is an engineering standard for luer connections, not a clinical performance standard.
- Differences from Predicate: The submission states, "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." This implies that the tests performed (likely engineering and materials compatibility) showed no significant differences that would raise new questions of safety or effectiveness.

In summary, for K0235-79, the following information is not available or not applicable because it's a 510(k) for a non-AI/CADe device focused on substantial equivalence:

A table of acceptance criteria and the reported device performance: Not provided in the context of clinical performance metrics. Instead, the "performance standard" mentioned is ISO 594-2.
Sample sized used for the test set and the data provenance: Not relevant for a device like this; studies would be bench/engineering tests, not clinical test sets with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
The type of ground truth used: Not applicable in the context of clinical outcomes.
The sample size for the training set: Not applicable (no AI/ML model involved).
How the ground truth for the training set was established: Not applicable.

Summary

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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. - K946044Disposable gas sampling lines

Device Description:

Environment of Use:

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

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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 connectfrom a port in the breathing circuit to the expiredgas 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 andthen sampling the gas, which is then transferredvia the small bore tubing to the monitor	Yes
Of various lengths and diameters	Yes
May incorporate an in-line filter intended toprevent 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.

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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.

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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

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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 inthe breathing circuit to the expired gas monitor.Disposable, single use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per CFR 801.109)
✓

Over-the-counter use ________________________________________________________________________________________________________________________________________________________

HWesterlin

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023374

Regulation Number and Section

§ 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).