MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE

K013845 · Oridion Medical 1987 , Ltd. · CCK · Nov 29, 2001 · Anesthesiology

Device Facts

• Record ID: K013845
• Device Name: MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
• Applicant: Oridion Medical 1987 , Ltd.
• Product Code: CCK · Anesthesiology
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Device is an oral-nasal cannula for simultaneous gas sampling and oxygen delivery. Input: patient exhaled breath; Output: gas sample delivered to capnograph via sampling tube. Device consists of a cannula interface at one end and a Luer Lock connector at the other, joined by a plastic tube. Operates by connecting to a capnograph pump, which creates a vacuum to draw exhaled breath through the sampling tube for CO2 analysis. Used in clinical settings for non-intubated patients; operated by healthcare professionals. Facilitates continuous CO2 monitoring while providing supplemental oxygen, aiding in respiratory status assessment and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plastic tubing with oral-nasal cannula interface and Luer Lock connector. Passive gas sampling and oxygen delivery system. No electronic components or software.

Indications for Use

Indicated for adult, intermediate, and pediatric non-intubated patients requiring simultaneous CO2 sampling for capnography and supplemental oxygen administration.

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

• 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)

Submission Summary (Full Text)

{0}------------------------------------------------

K013845

# 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.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "Oridion" in a serif font, with a stylized, spherical logo above it. The logo appears to be a textured or hatched sphere, giving it a three-dimensional look. The overall impression is that of a corporate logo, possibly for a company named Oridion.

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).

{2}------------------------------------------------

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

{3}------------------------------------------------

#### 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 [phone]. First of Compliance at [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

K013845

Image /page/4/Picture/1 description: The image shows the word "Oridion" in a serif font, with a stylized logo above it. The logo is a circular shape with many horizontal lines that give it a textured appearance. The word "Oridion" is in all lowercase letters and is centered below the logo.

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: [phone] • Fax:[phone]