(19 days)
The MAC-Line CO2 Nasal Cannula sample line is used whenever the physician wants to monitor the breathing in a non intubated patient. 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 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.
This submission (K012391) for the MAC-Line CO2 Nasal Cannula sample line does not describe a study involving acceptance criteria or device performance as would typically be found for novel technologies or those requiring extensive clinical validation. Instead, this 510(k) summary is for a relatively simple medical device that is found to be "Substantially Equivalent" to already legally marketed predicate devices.
The core of this submission revolves around establishing substantial equivalence by demonstrating that the modified device (MAC-Line CO2 Nasal Cannula sample line) is identical in design and construction to a previously cleared device (Oridion Microstream Nasal Cannula Filterline K980325), with the only modification being the removal of an in-line hydrophobic filter.
Therefore, many of the requested elements for a detailed study description are not applicable in this context.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document explicitly states: "The intended use of the modified device, as described in its labeling, has not changed as a result of the modification." And "...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."
- Since the device is virtually identical to a cleared predicate (except for a filter removal) and its intended use remains unchanged, no new performance criteria or testing for device performance are reported. The assumption is that the performance characteristics, already established for the predicate device, remain valid.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No new test set or data provenance is mentioned as this is a substantial equivalence claim based on design similarity, not new performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth establishment is not relevant for this type of submission which relies on design comparison rather than clinical performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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
- Not Applicable. This is a simple medical device, not an AI-powered diagnostic tool. Thus, MRMC studies or AI involvement are completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No "ground truth" as typically understood in performance studies is used for this substantial equivalence submission. The "ground truth" for the clearance is essentially the established safety and efficacy of the predicate device.
8. The sample size for the training set
- Not Applicable. There is no training set for this type of device submission.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or ground truth establishment for a training set described.
In summary:
This 510(k) submission for the MAC-Line CO2 Nasal Cannula sample line is a prime example of demonstrating substantial equivalence for a relatively low-risk device (Class II) where the primary argument is that the device is so similar to an already cleared predicate that new performance studies are not required. The "study" here is essentially a detailed comparison of the new device's specifications to those of its predicate, showing that the only difference (removal of an in-line filter) does not alter the fundamental safety or effectiveness for its intended use.
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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.
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Image /page/1/Picture/0 description: The image shows the word "Oridion" in a serif font, with a stylized globe-like symbol above it. The symbol is composed of many small, curved lines that create a textured, three-dimensional effect. The overall impression is of a logo or brand mark, possibly for a company or organization named Oridion.
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.
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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 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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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
Page No. 10
§ 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).