The Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.

Device Description

The Oridion Polaris Capnograph (the device being modified-K950388) is a device that measures end tidal CO2 (EtCO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR). The capnograph module of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status.

AI/ML Overview

This 510(k) summary does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as it primarily focuses on demonstrating substantial equivalence to a predicate device. However, it does reference compliance with a standard.

Here's an attempt to extract and infer information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with EN864 for Capnographs	"The Polaris 2004 Capnograph...meets the standard EN864 for capnographs that has been accepted by the FDA." (This implies the device performance met the technical specifications and accuracy requirements outlined in EN864 for parameters like EtCO2 measurement accuracy, breath rate accuracy, response time, etc., although specific numerical values are not provided in this document.)
Basic design, intended use, and indication remain the same as predicate device	"The basic design, intended use and indication of the Polaris 2004 remain the same..."
Design modifications do not alter fundamental technology, materials, or manufacturing processes.	"...the design modifications have not altered the technology, materials or manufacturing processes of the Polaris."
No new issues of safety or efficacy	"The changes pose no new issues of safety or efficacy."
Equivalent flow and gas sampling system to predicate	"The Polaris and the modified device (Polaris 2004) use the identical flow and gas sampling system and pneumatic system."
Equivalent CO2 module function to predicate (MiniMediCO2 vs. generic CO2 module)	"The modified device, the Polaris 2004 Capnograph, incorporates all the functions of the Polaris monitor. It is equivalent, in terms of indications for use and technological characteristics to the Polaris Capnograph K950388."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document primarily discusses device modifications and equivalence to a predicate, not performance testing on a specific "test set" of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. As no specific "test set" or clinical study with patient data results are detailed, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. 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

There is no mention of an MRMC study. This device is a capnograph, a medical instrument that measures physiological parameters. It does not appear to involve image interpretation or AI for diagnostic assistance to human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not explicitly stated as a "standalone" study in the context of an algorithm. However, the device itself, the Polaris 2004 Capnograph, operates independently to measure and display CO2 and respiration rate. The document implies that its performance (e.g., accuracy of CO2 measurement) was validated against the EN864 standard. This standard would dictate the methods for testing the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The primary "ground truth" referenced for performance is the EN864 standard for capnographs. This standard likely specifies objective criteria and methods for evaluating the accuracy and performance of carbon dioxide analyzers, which would involve calibrated gas mixtures or other validated reference methods.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a hardware medical instrument for physiological measurement, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

Summary of what the document implies about validation:

The primary "study" proving the device meets acceptance criteria is the demonstration that the modified Polaris 2004 Capnograph conforms to the EN864 standard for capnographs. The 510(k) process for this device relies heavily on the concept of substantial equivalence to a previously cleared predicate device (Polaris Capnograph K950388). The document emphasizes that the modifications introduced (e.g., MiniMediCO2 module, aluminum manifold, removal of water trap with Filterline K980324) do not alter the fundamental safety, efficacy, or intended use, and leverage components or concepts already cleared by the FDA in other devices (e.g., MiniMediCO2 module in Microcap K981114, Filterline in K980324). Therefore, the "proof" is largely based on demonstrating that these changes maintain the performance characteristics of the predicate device and meet an internationally recognized standard.

Summary

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K040011

MAY 1 3 2004

510(k) Summary of Safety and Effectiveness Information

PRODUCT NAME

Proprietary: Polaris 2004 Carbon Dioxide Gas Analyzer Common:

ESTABLISHMENT REGISTRATION NUMBER

Establishment Registration Number: 8044004 ESTABLISHMENT ADDRESS: Oridion Medical 1987 Ltd.

POB 45025 91450 Jerusalem Israel

CONTACT PERSON:

Sanford Brown, Regulatory Affairs Director Oridion Medical 1987 Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem, Israel Telephone: +972-2-589-9115 FAX: +972-2-586-6680 Email: sandy.brown@oridion.com

DEVICE LISTING FDA FORM 2892:

B051971

DEVICE DESCRIPTION

Substantial Equivalence Information

The modified device, the Polaris 2004 Capnograph, incorporates all the functions of the Polaris monitor. It is equivalent, in terms of indications for use and technological characteristics to the Polaris Capnograph K950388.

CLASSIFICATION Class II 73CCK

The Polaris 2004 Capnograph has been classified as follows:

21 CFR, Section 868.1400, carbon dioxide analyzer. The Capnograph device measures the concentration of carbon dioxide in a gas mixture by the use of infrared radiation as described in 868.1400. Its classification is Class II (performance standards). Since no

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performance standards have been issued, it will be regulated by the Special Controls penormanoo bandards neets the standard EN864 for capnographs that has been accepted by the FDA.

Differences Between The Polaris Capnograph and the modified Polaris 2004.

The cleared Polaris Capnograph device uses the Oridion generic CO2 module and the modified Polaris 2004 device uses the Oridion MiniMediCO2 module The Oridion MiniMediCO2 CO2 module is essentially equivalent to the CO2 module used in the Oridion Microcap (K981114). The MiniMediCO2 module takes advantage of the current availability of smaller mechanical, electrical and electronic components with lower availables ower requirements. The basic design, intended use and indication of the Polaris 2004 remain the same and the design modifications have not altered the f oldno 2001 Fornalif the chnology, materials or manufacturing processes of the Polaris. The gas sampling line Fitterline K980324, specified for use with this modified device, eliminates the need for a water trap. The changes pose no new issues of safety or efficacy.

Flow And Gas Sampling System

The Polaris and the modified device (Polaris 2004) use the identical flow and gas sampling system and pneumatic system. The Polaris uses plastic tubing and plastic connectors to construct the pneumatic system. The modified device uses an aluminum oonnifold to replace all the plastic tubing and connectors thereby reducing the size and cost and improving the reliability. The pump and solenoid used in the current device have been replaced by smaller more efficient and reliable components. The water trap used on the current device has been removed since the Oridion gas sample Filterline (K980324) accessory eliminates the need for a water trap. The removal of the water trap on Oridion capnographs has been universal (K964239, K981114, K980324, K023400) since the introduction of the Filterline CO2 gas sampling lines (K980324, K980327, K011536, K011050).

Indications for Use:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of an eagle with three overlapping wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2004

Oridion Medical 1987 Limited C/O Mr. Sandy Brown Regulatory Affairs Director Oridion Capnography, Incorporated P.O. Box 45025 91450 Jerusalem, Israel

Re: K040011

Trade/Device Name: Polaris 2004 Capnograph Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: March 11, 2004 Received: March 16, 2004

Dear Mr Brown:

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 adultcration.

If your device is classified (see above) into cither class II (Spccial 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. Brown

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 modified in 21 may Federal statutes and regulations administered by other Federal agencies. of the Act of all ] Pouchal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice une noting (2) eart forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form 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) Prins letter notification. The FDA finding of substantial equivalence of your device to a premaired 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), 11 you deate speed to the Office of Compliance at (301) 594-4613. 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 maj South 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 yours,

Susan Suarez

A Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number (if known): K040011

Device Name: Polaris 2004 Capnograph

Indications for Use:

The Polaris 2004 Capnograph is intended for the continuous, non-invasive The Folans 2004 Oaphograph is internation rate and carbon dioxide concentration of measurement and montoning of roopnation railance and adult patients wherever these the oxplied and required by attending medical personnel.

Prescription Use __________ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ceeen Sulum

Infection i 510(k) Numbe

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).