(78 days)
K881264A
No
The device description details a passive gas sampling tube with filters and membranes, and there is no mention of any computational analysis, algorithms, or learning processes. The analysis of the gas is performed by a separate capnograph.
No
The device is described as a gas sampling tube used to measure CO2, not to treat a medical condition or restore health. It is an accessory to a capnograph, which is an analytical device.
No
The device description clearly states "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)." This indicates it's an accessory that assists a diagnostic device (the capnograph) but does not itself directly perform a diagnostic function. It is a conduit for a sample.
No
The device description clearly outlines physical components like a gas sampling tube, Luer Locks, plastic tube, hydrophobic filter, and moisture membrane tube, indicating it is a hardware device.
Based on the provided information, the Microstream Filterline ICU device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Microstream Filterline ICU device is a gas sampling tube used to transport a sample of the patient's exhaled breath to a capnograph for analysis of CO2 content.
- Specimen Type: Exhaled breath is a gas, not a biological specimen taken from the body in the traditional sense of blood, urine, tissue, etc., which are the typical specimens for IVD testing.
- Purpose: The purpose is to measure CO2 in the breathing, which is a physiological measurement related to respiration, not a diagnostic test performed on a biological sample to identify a disease or condition.
The device is an accessory to a capnograph, which is a medical device used for monitoring physiological parameters (CO2 levels in this case). While the information gathered by the capnograph can be used by a physician for diagnosis and treatment decisions, the sampling tube itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
The Microstream Filterline ICU device is used whenever the physician needs to measure the CO2 in an intubated patient's breathing.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's breathing from a ventilator or anesthesia machine airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K881264A
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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APR 1 6 1998
בסייד
- Summary of safety and effectiveness information in this submission ട്.
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- Product name
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ﮐﺴﯿﺴﯿﻨﮯ
- Proprietary: Microstream Filterline ICU Common: Gas sampling line for capnograph
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- Establishment registration number Establishment registration number: 8044004
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- Establishment address:
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Oridion Medical Ltd. Har Hotzvim Science Based Industrial Park POB 45025 91450 Jerusalem. Israel
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Device listing FDA form 2892: 5. 4.
A 733250 -
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- 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.
- Product Classification
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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.
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.
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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
1
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.
2
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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
4
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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
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