(129 days)
No
The summary describes a standard capnograph device that measures CO2 and breath rate, with no mention of AI or ML technologies.
No.
The device is for continuous, non-invasive measurement and monitoring of respiration rate and carbon dioxide concentration, which are diagnostic and monitoring functions, not therapeutic.
Yes
Explanation: The device is described as measuring "end tidal CO2 (EtCO2)" and displaying "breath rate (BR)" to "aid in determining the patient's ventilatory status." These measurements and their use in assessing patient status qualify it as a diagnostic device.
No
The device description explicitly states it is a "capnograph module" and a "carbon dioxide gas analyzer," which are hardware components used to measure CO2 concentration.
Based on the provided information, the Polaris 2004 Capnograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- Polaris 2004 Function: The Polaris 2004 Capnograph measures and monitors the concentration of CO2 in the expired and inspired breath of a patient. This is a direct measurement of a physiological process (respiration) happening within the body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states "continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath." This aligns with a device used for physiological monitoring, not laboratory testing of specimens.
Therefore, the Polaris 2004 Capnograph falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
CCK
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.
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
neonatal, pediatric and adult
Intended User / Care Setting
attending medical personnel
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)
K981114, K980324, K964239, K023400, K980327, K011536, K011050
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
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
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.
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
1
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:
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.
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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.
3
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
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