The intended use of the MAC-Line Oz/CO2 Nasal Cannula sample line is to conduct a sample of the adult/pediatric subject's breathing from the subject, via a nasal cannula, to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation.

The MAC-Line O2/CO2 Nasal Cannula sample line device is used whenever the physician needs to measure the CO2 in an adult or pediatric non intubated subject's breathing via a nasal cannula while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Device Description

The common product name for this device is Nasal Cannula Gas sampling line for capnograph with integrated Oxygen Administration means for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The complete device is a combined device consisting of two devices, as described below, integrated to simultaneously perform the function of both devices.

The CO2 gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a nasal cannula at one end of the device for connecting to the patient's nose, a Microstream sample tube with a Male or Female Luer lock on the other end for connecting to the capnograph. The CO2 Cannula is identical to the Oridion CO2 Nasal Cannula K980325.

Attached and integrated with the CO2 nasal cannula is another device for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The O₂ cannula has a tube with a standard O₂ connector bushing on the end for connecting to a normal O2 supply. The O2 device is classified as class I according to 21CFR868.5340.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (MAC-Line O2/CO2 Nasal Cannula sample line) and outlines its intended use, device description, predicate devices, and biocompatibility testing. It does not contain information regarding an AI model, acceptance criteria for an AI model, or a study proving an AI device meets acceptance criteria.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

A table of acceptance criteria and the reported device performance (for an AI model)
Sample size used for the test set and the data provenance (for an AI model)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for an AI model)
Adjudication method (for an AI model test set)
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (for an AI model)
The sample size for the training set (for an AI model)
How the ground truth for the training set was established (for an AI model)

The document focuses on the regulatory clearance of a physical medical device (a nasal cannula with integrated oxygen and CO2 sampling) based on substantial equivalence to predicate devices and biocompatibility testing. There is no mention of an AI component or any studies related to AI model performance.

Summary

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AUG 1 5 2001

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3.0 510(k) Summary

Product name

Proprietary: MAC-Line O₂/CO₂ Nasal Cannula sample line Common: Nasal Cannula Gas sampling line for capnograph with integrated Oxygen Administration means for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation.

Establishment registration number Establishment registration number: 8044004

Establishment Address:

ORIDION MEDICAL 1987 LTD. HAR HOTZVIM SCIENCE BASED INDUSTRIAL PARK POB 45025 91450 JERUSALEM, ISRAEL

Device Listing Fda Form 2892: A 733250

Product classification

The MAC-Line Q2/CO2 Nasal Cannula sample line is classified as Class II according to 21CFR868.1400 (73CCK)

INTENDED USE:

DEVICE DESCRIPTION

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873

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PREDICATE DEVICE

There are three predicate devices:

The Oridion O2/CO2 predicate device is the Microstream O2/CO2 . Nasal Cannula Filterline.
The Adult predicate device is the Hospitak disposable CO2 Gas . sampling/Oxygen delivery Cannula K915228.
The Pediatric predicate device is the Salter Laboratories Model . 4701 CO2 Gas sampling/Oxygen delivery Cannula.

SUBSTANTIAL EQUIVALENCE:

The MAC-Line O2/CO2 Nasal Cannula sample line is a combination device that combines a CO2 sampling nasal cannula with a O2 supply nasal cannula.

. The MAC-Line O2/CO2 Nasal Cannula sample line is essentially equivalent to the Hospitak disposable CO2 Gas sampling/Oxygen delivery Cannula K915228.
The Oridion Pediatric MAC-Line O2/CO2 Nasal Cannula sample . line is essentially equivalent to the Salter Laboratories Model 4701 CO2 Gas sampling/Oxygen delivery Cannula

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בש"ד BIOCOMPATIBILITY

Requirements

The parts of this product which comes into contact with the patient's nose have been tested for biocompatibility. The methods used for testing were:

1. Physicochemical tests, plastics, complete (Aqueous exfract)
1. Cytotoxicity study using the ISO elution method (Extract)
1. ISO Sensitization test in 15 Guinea Pigs, per extract (Maximization method) Saline Extract, Cottonseed Extract
1. ISO Acute Intracutaneous Reactive study in three rabbits, Saline Extract, Cottonseed Extract.
1. Detailed reports are found in Appendix A

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2001

Mr. Sanford Brown Regulatory Affairs Manager Oridion Medical 1987 Ltd. P.O. Box 45025 Jerusalem 91450 Israel

K012395 Re:

Mac-Line O, /CO, Nasal Cannula Sample Line Regulation Number: 868.1400 Regulatory Class: II (two) Product Code: 73 CCK Dated: July 23, 2001 Received: July 27, 2001

Dear Mr. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Sanford Brown

This letter will allow you to begin marketing your device as described in your 510(k) premarket I ntil letter . The FDA finding of substantial equivalence of your device to a legally marketed notheated wice 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,

Darth Tilla
James F. Dillard III

mes E. I Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 INDICATIONS FOR USE FORM

510(k) Number (if known): _ K Olz 3 9 5

Device Name: MAC-Line O2/CO2 Nasal Cannula sample line

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number

Dale Tell
K02345

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873

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).