The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a Male Luer Lock at one end of the device for connecting to the Airway Adapter in the ventilator or Anesthesia Machine Airway and a Female Luer Lock on the other end for connecting to the Capnograph. The two connectors are joined by a plastic tube an in line hydrophobic filter and an in line Nafion (K881264A) moisture membrane tube.

One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar 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.

AI/ML Overview

The information provided is a 510(k) premarket notification for a medical device called "Microstream Filterline ICU." This document focuses on establishing substantial equivalence to a predicate device and does not contain acceptance criteria, a detailed study description with performance metrics, or information typically found in a clinical validation study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

The document states:

Intended Use: To conduct a sample of the patient's breathing from a ventilator or anesthesia machine airway to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation.
Device Description: A gas sampling tube with a Male Luer Lock for connecting to an airway adapter and a Female Luer Lock for connecting to a Capnograph. It includes an in-line hydrophobic filter and an in-line Nafion moisture membrane tube.
Substantial Equivalence: The Microstream ICU Filterline is "identical to the same device described as an accessory to the NPB-75/Microcap Capnograph/Pulse Oximeter in approved submittal K964239."

Conclusion:

This submission is a premarket notification asserting substantial equivalence, leveraging the prior approval of an identical device (K964239). It does not present new performance data from a specific study to meet acceptance criteria. The FDA's review confirms this substantial equivalence based on the provided information, not on a new, independent performance study with defined acceptance criteria and results.

Summary

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K980327

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APR 1 6 1998

בסייד

Summary of safety and effectiveness information in this submission ട്.
1. 1. Product name

ﮐﺴﯿﺴﯿﻨﮯ

Proprietary: Microstream Filterline ICU Common: Gas sampling line for capnograph
1. 1. Establishment registration number Establishment registration number: 8044004
1. 1. Establishment address:

Oridion Medical Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem. Israel

Device listing FDA form 2892: 5. 4.
A 733250
1. 1. Product Classification
    The Microstream Filterline ICU sample line has not been classified. It was included as an accessory in FDA submission K964239. We believe that it falls under 21CFR868 anesthesiology devices.
5.6. Intended use:
The intended use of the Microstream Filterline ICU sample line is to conduct a sample of the patient's breathing from a ventilator or anesthesia machine airway to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation.

Device description 5.7.

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The most common way (for intubated patients) to connect the sampling tube to a point where it can get a sample of the patients breathing is to connect one end of the sample tube to a point on the ventilator or anesthesia machine airway circuit.

The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The Microstream Filterline ICU has integrated an in line hydrophobic filter between the patient and the capnograph to reduce the amount of patient generated moisture that can enter the capnograph.

The Nafion membrane is used because, in some cases, the air or gas being supplied to the patient by the respirator or anesthesia machine is humidified. This causes the patients exhalation and the breath sample entering the sample tube to be highly humidified. In this case we have added a short Nafion gas membrane tube to the sampling line. The tube made from Nafion membrane material mallows moisture to pass through the wall of the tube (to ambient) while the gas sample continues on to the capnograph. Nafion tubing membrane is used in all commercially available capnographs for the same purpose.

5. 8. Substantial equivalence

The Microstream ICU Filterline is identical to the same device described as an accessory to the NPB-75/Microcap Capnograph/Pulse Oximeter in approved submittal K964239.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

Mr. Sanford Brown Oridion Medical Ltd. P.O. Box 45025 Jerusalem 91450 Israel

Re: K980327 Microstream Filterline ICU Regulatory Class: II (two) Product Code: 73 CCK Dated: January 26, 1998 Received: January 28, 1998

Dear Mr. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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.

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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) 594-4648. 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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בסייד January 26, 1998

Indications For Use

K980327 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Microstream Filterline ICU____________________________________________________________________________________________________________________________________________________

Indications For Use:

The Microstream Filterline ICU device is used whenever the physician needs to measure the CO2 in an intubated patient's breathing.

(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)

..............................................................................................................................................................................

. P. ~

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_ka60327

Oridion Medical Ltd. • POB 45025 • Jerusalem 91450 Israel • Voice: •972 2 589-9111 • Fax: •972 2 582-8868

PAGE 7 of 16

Regulation Number and Section

§ 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).