(157 days)
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No
The device is a simple tubing and filter system for gas sampling, with no mention of computational analysis or algorithms.
No
The device is a CO2 monitoring line used for sampling gases, not for treatment or therapy. It functions as an accessory to gas monitoring equipment.
No
The device is a CO2 monitoring line used to connect a CO2 sampling port to an expired gas monitor; it facilitates gas sampling but does not perform the diagnostic analysis itself.
No
The device description clearly outlines physical components (tubing, connectors, filter) and performance studies related to physical properties (resistance to flow, leakage, dimensions), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a CO2 sampling port to an expired gas monitor. This is a physical connection for gas transport, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description details tubing for gas sampling from a patient's breath. It facilitates the collection and transport of a gas sample, but it doesn't analyze the sample itself or provide a diagnostic result.
- Lack of Diagnostic Function: The device's function is purely mechanical – to transport gas. It doesn't contain reagents, perform chemical reactions, or analyze biological samples to provide diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics like resistance to flow, leakage, and connector integrity, which are relevant to a gas transport device, not an IVD.
- Predicate Device: The predicate device is a "Disposable Gas Sampling Lines," which aligns with the function of transporting gas samples, not performing an in vitro diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device handles expired breath, which is a gas, and its role is to facilitate the measurement of CO2 by a separate monitoring device.
N/A
Intended Use / Indications for Use
The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.
Product codes
CCK
Device Description
The monitoring line tubing is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. When used with a face mask the line connects between the female luer lock connector on the mask and a capnograph or similar gas monitoring device. The gas monitoring device will have a pump which pulls air from inside mask, along the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Any patient from which gas monitoring is required
Intended User / Care Setting
Hospitals
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
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Summary of Performance Studies
Nonclinical tests submitted to demonstrate substantial equivalence for the Monitoring Lines and Monitoring Lines with Filter include resistance to flow, leakage, connectors, outer diameter, inner diameter and static water load. All materials used in the C02 Monitoring Lines and Monitoring Lines with Filter have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The monitoring line and hydrophobic filter conform to clauses 4.2 to 4.7 of ISO 594-2:1998, which are considered the 'functional' aspects of the luer lock design, ranging from separation and assembly forces to durability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 5 510(k) Summary of Safety and Effectiveness
DEC 2 0 2012
Name: INTERSURGICAL INCORPORATED Address: 417 Electronics Parkway Liverpool, NY 13088 Date: December 19, 2012 Contact Person: Michael Zalewski - Assistant VP - RA/CS Phone Number: 315-451-2900 Fax Number: 315-451-3696
Trade Name: C02 Monitoring Line and C02 Monitoring Line with Filter
Common Name: C02 Monitoring Line and C02 Monitoring Line with Filter
Classification: 21 CFR 868.1400, Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase - Accessory - Classification Product Code: CCK
Predicate Device:
Catheter Research Inc., Disposable Gas Sampling Lines, K946044. The CRI monitoring lines are designed for connection between a gas monitoring device and a patient interface device in which gas monitoring is required. CRI gas sampling lines are available with or without a hydrophobic filter for the prevention of water transfer along the sampling line and into the gas sampling equipment.
Description:
C02 Monitoring Line and Monitoring Line with Filter
The monitoring line tubing is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. When used with a face mask the line connects between the female luer lock connector on the mask and a capnograph or similar gas monitoring device. The gas monitoring device will have a pump which pulls air from inside mask, along the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment.
Indications for Use:
The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor
1
Section 5 510(k) Summary of Safety and Effectiveness (cont.)
Technological Characteristics Summary:
The intended use of the Intersurgical C02 Monitoring Line and Monitoring Line with Filter is comparable to the referenced predicate devices. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for resistance to flow, leakage, connectors, outer diameter, inner diameter and static water load.
| CO2 Monitoring Line | Gas Sampling Line | |
|---|---|---|
| K946044 | ||
| Intended Use: | ||
| Target population | Any patient from which gas | |
| monitoring is required | Any patient from which gas | |
| monitoring is required | ||
| Indications for use | The C02 monitoring lines are | |
| intended to connect from a C02 | ||
| sampling port to the expired gas | ||
| monitor. | The gas sampling lines are | |
| intended to connect from a port | ||
| in the face mask breathing | ||
| circuit to the expired gas | ||
| monitor. | ||
| Where used | Hospitals | Hospitals |
| Product Labelling | CO2 Monitoring Line | Gas Sampling Line |
| Single Use or Reusable? | Single Use | Single Use |
| Design and Performance: | ||
| Resistance to Flow | 8.1mbar at 100ml/min flow | |
| 20.7ml/min at 300ml/min flow | 12.5mbar at 100ml/min flow | |
| 35.9ml/min at 300ml/min flow | ||
| Leakage |