(19 days)
Not Found
No
The device description is for a simple gas sampling nasal cannula used with a capnograph. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the presence of AI or ML. The function is purely mechanical (sampling gas) and relies on the connected capnograph for analysis.
No.
The device is used to sample a patient's breathing for CO2 analysis, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is a sample line that collects breath from a patient and delivers it to a separate gas measurement device (capnograph) for analysis. While it facilitates the collection of data for diagnosis, it does not perform the diagnostic function itself; the capnograph does.
No
The device description clearly outlines physical components like a nasal sampling cannula, Luer Lock connectors, and a plastic tube, indicating it is a hardware device used for gas sampling.
Based on the provided information, the MAC-Line CO2 Nasal Cannula sample line 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.
- Device Function: The MAC-Line CO2 Nasal Cannula sample line is a device used to collect a sample of the patient's exhaled breath and transport it to a separate gas measurement device (capnograph). It does not perform any diagnostic testing on the sample itself.
- Intended Use: The intended use is to "monitor the breathing in a non intubated patient" and "conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation." This describes a sample collection and transport function, not an in vitro diagnostic test.
- Device Description: The description clearly states it's a "gas sampling nasal cannula" used "with a capnograph." The capnograph is the device that performs the analysis of the CO2 content.
The device is a component used in conjunction with a diagnostic device (the capnograph), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The intended use of the MAC-Line CO2 Nasal Cannula sample line is to conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.
The MAC-Line CO2 Nasal Cannula sample line is used whenever the physician THE MAO-Line OO2 Nature and our has breathing in a non intubated patient.
The intended use of the MAC-Line CO₂ Nasal Cannula sample line is to conduct a The intended use of the will to the gatient to the gas measurement device for sample of the patient's battern of CO2 in the patient's exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK
Device Description
The common product name for this device is a gas sampling nasal cannula. The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a Nasal Sampling Cannula at one end of the device for connecting to the patient's nose and a Female or Male Luer Lock on the other end for connecting to the Capnograph. The design and construction of the Microstream Nasal Cannula is identical to the Microstream Nasal Cannula Filterline (K980325) except for the modification of removing the in line hydrophobic filter
The two connectors are joined by a plastic tube.
One end of the tube is connected to the source of the patient's exhalation (nose) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.
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
Adult model 4000, Pediatric model 4100 and Infant model 4200
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)
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.
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
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בס"ד
3.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Product name
Proprietary: MAC-Line CO2 Nasal Cannula sample line Gas sampling line for capnograph Common:
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 CO2 Nasal Cannula sample line is classified Class II, Product Code 73 CCK.
Intended use:
The intended use of the MAC-Line CO2 Nasal Cannula sample line is to conduct a sample of the patient's breathing from the patient to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.
Device description
The common product name for this device is a gas sampling nasal cannula. The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a Nasal Sampling Cannula at one end of the device for connecting to the patient's nose and a Female or Male Luer Lock on the other end for connecting to the Capnograph. The design and construction of the Microstream Nasal Cannula is identical to the Microstream Nasal Cannula Filterline (K980325) except for the modification of removing the in line hydrophobic filter
The two connectors are joined by a plastic tube.
1
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בס"ד
One end of the tube is connected to the source of the patient's exhalation (nose) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.
Substantial equivalence
The MAC-Line CO2 Nasal Cannula sample line is Substantial Equivalent to the Salter Laboratories Nasal Cannula (Adult model 4000, Pediatric model 4100 and Infant model 4200) K863703 and the Oridion Microstream Nasal Cannula Filterline (K980325 ) modified by removing the hydrophobic in line filter
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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
K012391 Re:
Mac-Line CO2 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 we have teviewed your becally of the substantially equivalent (for the indications for use above and we nave determined ans arketed predicate devices marketed in interstate commerce stated in the enerosale) is regarly manates of the Medical Device Amendments, or to devices that provision in the may 20, 1970, are chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (100). "The general controls provisions of the Act include requirements for annual provisions of the Free. "The generod 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 (1 remance ripped any ready 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 mspotionist the FOC and 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.
3
Page 2 - Mr. Sanford Brown
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 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,
Dak Tille
James F. Dillard III
ames 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
5.0 Indications For Use
510(k) Number (if known): _ KOLZ 391
Device Name:
July 23, 2001
Indications For Use:
The MAC-Line CO2 Nasal Cannula sample line is used whenever the physician THE MAO-Line OO2 Nature and our has breathing in a non intubated patient.
The intended use of the MAC-Line CO₂ Nasal Cannula sample line is to conduct a The intended use of the will to the gatient to the gas measurement device for sample of the patient's battern of CO2 in the patient's exhalation. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.
(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) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K012391 |
|---|---|
| --------------- | --------- |
Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: +972 2 589-9115 • Fax: +972 2 582-8873
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