(9 days)
Not Found
No
The description focuses on the physical components and function of a gas sampling cannula for use with a capnograph, with no mention of AI or ML.
No.
The device is used to collect a sample of a patient's breathing for CO2 measurement and to administer supplemental oxygen, which are diagnostic and supportive functions, not therapeutic.
No
The device is an oral nasal cannula which is a sampling line used to collect a patient's breathing sample for a capnograph (carbon dioxide analyzer). The capnograph, not the cannula itself, performs the diagnostic measurement. The cannula facilitates the collection of the sample, but does not diagnose.
No
The device description clearly describes a physical medical device (cannula, tubing, connectors) used for gas sampling and oxygen delivery, not a software-only product.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a cannula and sampling line used to collect a sample of the patient's breathing (exhaled air) for analysis by a separate device (a capnograph). It also delivers oxygen.
- Sample Type: The sample being collected is exhaled breath, which is a gas, not a biological sample taken from the body in the traditional sense of an IVD (like blood, urine, or tissue).
- Analysis Location: The analysis of the CO2 level happens within the capnograph, not within the cannula or sampling line itself. The cannula is a conduit for the sample.
The device is a medical device used in conjunction with an IVD (the capnograph, which analyzes the CO2 in the breath sample), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The MAC-Line O₂/CO₂ Oral Nasal Cannula sample line is used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation. It can be used for adult, intermediate or pediatric nonintubated patients.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK
Device Description
The common product name for this device is Oral Nasal Cannula Gas sampling line The common product hame for the contrastration means for simultaneously for caphograph with integrated Oxygen projected near the nose and mouth for inhalation.
The gas sampling cannula is used with a capnograph (carbon dioxide analyzer The gas sampling cannula is assuming Cannula at one end of the device for 2 TCFN 000. 1400). There is a camping of the mate Luer Lock on the other end for connecting to the capnograph.
A plastic tube joins the two connectors. One end of the tube is connected to the A plastic lube joins the wo connoctore. One on the other end of the tube is source of the pation. The capnograph has a pump that creates a vacuum connected to a odphograph. The satient's breathing (exhalation) through the sampling tube into the capnograph.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Near the nose and mouth
Indicated Patient Age Range
adult, intermediate or pediatric
Intended User / Care Setting
Physician / 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Microstream O₂/CO₂ Oral Nasal Cannula FilterLine K011536, Salter Labs PN 4003 Adult dual oral nasal CO₂ sample cannula with oxygen delivery. (K864902), Salter Labs PN 4103 Pediatric dual oral nasal CO₂ sample cannula with oxygen delivery. (K864902)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 2 9 2001
Image /page/0/Picture/2 description: The image shows the word "Oridion" in a serif font, with a stylized logo above it. The logo is a circular shape with horizontal lines that give it a textured appearance. The logo is positioned directly above the word "Oridion", creating a visual association between the two elements.
בס"ד
3.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Product name
Proprietary: MAC-Line O2/CO2 Oral Nasal Cannula sample line
Common:
Oral Nasal Cannula Gas sampling line for use with a 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 O2/CO2 Oral Nasal Cannula sample line is classified Class II, Product Code 73 CCK.
Intended use:
The MAC-Line O2/CO2 Oral Nasal Cannula sample line is used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation. It can be used for adult, intermediate or pediatric non intubated patients.
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בס"ד Device description
The common product name for this device is Oral Nasal Cannula Gas sampling line The common product hame for the contrastration means for simultaneously for caphograph with integrated Oxygen projected near the nose and mouth for inhalation.
The gas sampling cannula is used with a capnograph (carbon dioxide analyzer The gas sampling cannula is assuming Cannula at one end of the device for 2 TCFN 000. 1400). There is a camping of the mate Luer Lock on the other end for connecting to the capnograph.
A plastic tube joins the two connectors. One end of the tube is connected to the A plastic lube joins the wo connoctore. One on the other end of the tube is source of the pation. The capnograph has a pump that creates a vacuum connected to a odphograph. The satient's breathing (exhalation) through the sampling tube into the capnograph.
Substantial equivalence:
The MAC-Line O₂/CO₂ Oral Nasal Cannula sample line is Substantial Equivalent to:
- a. Microstream O₂/CO₂ Oral Nasal Cannula FilterLine K011536.
- b. Salter Labs PN 4003 Adult dual oral nasal CO₂ sample cannula with oxygen delivery. (K864902).
- c. Salter Labs PN 4103 Pediatric dual oral nasal CO₂ sample cannula with oxygen delivery. (K864902).
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2001
Mr. Sanford Brown Oridion Medical 1987 Ltd. P.O. Box 45025 Har Hotzvim Industrial Park 91450 Jerusalem, Israel
Re: K013845
MAC-Line O2/CO2 Oral Nasal Cannula Sample Line Regulation Number: 868.1400 Regulation Name: Carbon-Dioxide Gas Analyzer Regulatory Class: II (two) Product Code: 73 CCK Dated: October 10, 2001 Received: November 20, 2001
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 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.
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
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Page 2 - Mr. Sanford Brown
or any Federal statutes and regulations administered by other Federal agencies. You must of ally rederal statutes and regulations ancluding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Part 607), labeling (21 CFR Part 800), government 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your becinon 5 10(k) I ms letter will anow you to ogin mainening of substantial equivalence of your device to a legally premaince notineation: "The PDF intelling of evice 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 IT you desire specific advice to: 750 vitro diagnostic devices), please contact the Office of additionally 21 CHT Fat 007.10 for his raally, for questions on the promotion and advertising of Compliance at (301) 597 1010. First of Compliance at (301) 594-4639. Also, please note the your device, prease connecting by reference to premarket notification" (21CFR Part 807.97). I guilation chiltied, "Misoranang of responsibilities under the Act may be obtained from the Other general miorination on your seemational 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,
Darly Tillh
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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בס"ד
בס"ד October 10, 2001
5.0 Indications For Use
KO13845 510(k) Number (if known): _
Device Name:
Indications For Use: Device Name: MAC-Line O₂/CO₂ Oral Nasal Cannula sample line
Indications For Use:
The MAC-Line O₂/CO₂ Oral Nasal Cannula sample line is used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation. It can be used for adult, intermediate or pediatric nonintubated patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013745
Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: +972 2 589-9115 • Fax:+972 2 582-8873