MAC-LINE CO2 NASAL CANNULA SAMPLE LINE

K012391 · Oridion Medical 1987 , Ltd. · CCK · Aug 15, 2001 · Anesthesiology

Device Facts

• Record ID: K012391
• Device Name: MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
• Applicant: Oridion Medical 1987 , Ltd.
• Product Code: CCK · Anesthesiology
• Decision Date: Aug 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

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 Story

Gas sampling nasal cannula; connects patient's nose to capnograph via plastic tubing. Capnograph pump creates vacuum to draw exhalation sample through tube for CO2 analysis. Used in clinical settings for non-intubated patients. Provides real-time CO2 measurement to healthcare providers to assist in respiratory monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plastic tubing with nasal cannula at one end and Luer Lock connector at the other. Passive gas sampling device; no energy source. Designed for use with capnograph (21 CFR 868.1400).

Indications for Use

Indicated for non-intubated patients requiring CO2 monitoring of exhalation.

Regulatory Classification

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.

Predicate Devices

• Salter Laboratories Nasal Cannula (Adult model 4000, Pediatric model 4100 and Infant model 4200) (K863703)
• Oridion Microstream Nasal Cannula Filterline (K980325)

Submission Summary (Full Text)

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K012391

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# 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
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(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K012391 |
|---------------|---------|
|---------------|---------|

Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: [phone] • Fax: [phone]

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