ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the text "K012394" at the top. Below the text is a circular image that appears to be a logo. The text "Oridion" is at the bottom of the image. #### בט"ד # 3.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION Product name Proprietary: Oridion MAC-Line Oral Nasal Cannula sample line Oral Nasal 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 Oridion MAC-Line Oral Nasal Cannula sample line is classified Class II, Product Code 73 CCK. ### Intended use: The intended use of the Oridion MAC-Line Oral 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 an oral nasal cannula gas sampling line. The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a sampling cannula at one end of the device for connecting to the patient's nose and mouth and a Male or Female Luer on the other end for connecting to the capnograph. The design and construction of the Oridion MAC-Line Oral Nasal Cannula sample line is identical to the Microstream Nasal Cannula Filterline (K011050) except for the modification which consists of removing the hydrophobic in line filter. The two connectors are joined by a plastic tube. Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: +972 2 589-9115 • Fax: +972 2 582-8873 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Oridion. The logo consists of a stylized globe-like shape made up of horizontal lines, positioned above the word "Oridion" in a serif typeface. The globe is black and white, and the text is black. בס"ד One end of the tube is connected to the source of the patient's exhalation (nose and mouth 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 Oridion MAC-Line Oral Nasal Cannula sample line is substantial equivalent to the Microstream Oral Nasal Cannula Filterline (K011050) and the Salter Labs Model 4001 Adult, Salter Labs Model 4101 Pediatric (FDA K864199), Oral Nasal Cannula, these devices legally marketed in the USA {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. #### Public Health Service AUG 1 5 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Sanford Brown Regulatory Affairs Manager Oridion Medical 1987 Ltd. P.O. Box 45025 Jerusalem 91450 Israel K012394 Re: Oridion Mac-Line Oral 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 reviewed your betermined 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 priva to may = 3, = 1, = 1, = 1, = 1, = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costisions of the Act. The general controls provisions of the Act include requirements for annual provision, 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 (Premarket Approval), 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 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 comply with the GMP regulation 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 I his lower will and wyour your 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 II you desire specific a 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, (1) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 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 morification on your respeat 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, V. Oak Tell James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Oridion" in a serif font, with a stylized logo above it. The logo appears to be a sphere or globe made up of many small, horizontal lines or segments. The overall impression is that of a corporate logo, possibly for a technology or global business. בס"ד July 23, 2001 # 5.0 Indications For Use 510(k) Number (if known): k012394 Device Name: July 23, 2001 Indications For Use: The Oridion MAC-Line Oral Nasal Cannula sample line device is used whenever the The Ondion MAO-Eine Official Sunners Sunners breathing in a non intubated patient. The intended use of the Oridion MAC-Line Oral Nasal Cannula sample line is to THE Interiation a sample of the patient's breathing from the patient 'to the gas Conduct a "Sample of the pations 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<br>(Per 21 CFR 801.109)<br>(Optional Format 1-2-96) | X | |----------------------------------------------------------------------|---| |----------------------------------------------------------------------|---| OR | Over-The-Counter Use | <div></div> | |----------------------|-------------| |----------------------|-------------| Division of Cardiovascular & Respiratory Devices | 510(k) Number | K0123914 | |---------------|----------| |---------------|----------| Oridion Medical 1987 Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: +972 2 589-9115 • Fax:+972 2 582-8873 Page No. 9