(19 days)
No
The device description and intended use focus on the physical components and function of a nasal cannula for gas sampling and oxygen delivery. There is no mention of AI, ML, or any computational analysis of the collected data within the device itself.
No.
The device is used to measure CO2 and administer oxygen, but its primary function as described is for monitoring (sampling CO2) and delivering oxygen, not for directly treating a disease or condition in a therapeutic manner beyond oxygen supplementation, which is typically supportive.
No
The device is a nasal cannula and sample line used to transport a patient's breathing sample to a "gas measurement device (capnograph)". The capnograph is the diagnostic device that measures CO2, while this device merely facilitates the delivery of the sample to the diagnostic device.
No
The device description clearly outlines physical components (nasal cannula, sample tube, Luer lock, O2 tube, O2 connector bushing) and their integration, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The MAC-Line Oz/CO2 Nasal Cannula sample line is designed to sample breathing gases (CO2) from a patient and administer oxygen. This is a direct interaction with the patient's respiratory system, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "measuring the CO2 in an adult or pediatric non intubated subject's breathing" and "simultaneously administering supplemental oxygen." This describes a physiological monitoring and therapeutic delivery function, not an in vitro diagnostic test.
- Device Description: The description details a nasal cannula for connecting to the patient and a sample tube for connecting to a gas measurement device (capnograph). It also describes an integrated oxygen delivery system. None of these components or functions align with the definition of an IVD.
- Classification: The oxygen administration component is classified as Class I according to 21CFR868.5340, which is for medical gas administration devices, not IVDs. The CO2 gas sampling component is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400), which is also a physiological monitoring device, not an IVD.
In summary, the device is a medical device used for physiological monitoring (CO2 sampling) and therapeutic delivery (oxygen administration), not for performing tests on samples taken from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
73 CCK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nose and mouth
Indicated Patient Age Range
adult/pediatric
Intended User / Care Setting
Not Found
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)
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:
-
- Physicochemical tests, plastics, complete (Aqueous exfract)
-
- Cytotoxicity study using the ISO elution method (Extract)
-
- ISO Sensitization test in 15 Guinea Pigs, per extract (Maximization method) Saline Extract, Cottonseed Extract
-
- ISO Acute Intracutaneous Reactive study in three rabbits, Saline Extract, Cottonseed Extract.
-
- Detailed reports are found in Appendix A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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AUG 1 5 2001
Image /page/0/Picture/1 description: The image shows the logo for Oridion. The logo consists of a stylized globe made up of horizontal lines, positioned above the word "Oridion" in a serif font. The globe is black and white, and the text is black.
2/2395
בס"ד
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:
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.
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
Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice:+972 2 589-9115 • Fax:+972 2 582-8873
1
Image /page/1/Picture/0 description: The image shows the logo for Oridion. The logo consists of a stylized globe-like shape above the word "Oridion" in a serif font. The globe is made up of curved lines, giving it a textured appearance. The overall design is simple and professional.
בס"ד
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.
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:
-
- Physicochemical tests, plastics, complete (Aqueous exfract)
-
- Cytotoxicity study using the ISO elution method (Extract)
-
- ISO Sensitization test in 15 Guinea Pigs, per extract (Maximization method) Saline Extract, Cottonseed Extract
-
- ISO Acute Intracutaneous Reactive study in three rabbits, Saline Extract, Cottonseed Extract.
-
- Detailed reports are found in Appendix A
3
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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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בס"ד
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:
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.
(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