(166 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a simple tubing device for gas sampling, with no mention of AI or ML capabilities.
No
The device is a CO2 monitoring line, which is a component used for sampling gas from a patient's exhaled breath to be analyzed by gas sampling equipment. It does not directly provide therapy or treatment to the patient.
No
This device is a CO2 monitoring line, which is a component used with gas sampling equipment and an analyzer. It collects gas but does not independently diagnose.
No
The device description clearly describes physical tubing, connectors, and optional filters, indicating it is a hardware device for gas sampling.
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 patient interface to an expired gas monitor for sampling exhaled breath. This is a sampling accessory for a diagnostic device (the gas monitor), not a diagnostic device itself.
- Device Description: The description focuses on the physical characteristics of the tubing and filter, designed to facilitate the transport of gas. It does not describe any components that perform a diagnostic test on a sample in vitro.
- Lack of Diagnostic Function: The device itself does not analyze or provide any diagnostic information about the patient's CO2 levels. It merely transports the sample to a separate device that performs the analysis.
- No Mention of Reagents or Assays: IVD devices typically involve reagents or assays used to test a biological sample. This device does not mention any such components.
The device is a medical device, specifically a sampling line used in conjunction with a gas monitoring system. The gas monitoring system itself would be the diagnostic device.
N/A
Intended Use / Indications for Use
CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
Flexicare's CO2 monitoring line is single patient use, small diameter tubing intended to be connected to a luer lock connector on a patient interface to allow for gas sampling from a patients exhaled breath by gas sampling equipment. The Gas monitoring/analysing device will feature a pump, which draws expired breath from the patient through the monitoring line and into the gas analyser.
Flexicare's CO2 monitoring line is available with or without a 0.45um hydrophobic filter, which prevents the transfer of water vapour down the monitoring line and into the gas sampling equipment.
Flexicare's CO2 monitoring lines feature clear construction to aid visual inspection of the device.
The CO2 monitoring line is a single patient use device, designed for use with one patient over a single course of treatment. The CO2 monitoring line is supplied in a sealed poly bag in a non sterile state and is not to be sterilized.
The Flexicare CO2 monitoring lines feature 2M & 3M length tubes.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Tests Performed:
Visual inspection, Resistance to flow, Dimensional inspection. Length, ID, OD, Leakage, Performance - CO2 monitoring, Tensile testing, Luer connectors - Dimensional, leakage, connection, stress cracking, Accelerated age testing, Cytotoxicity, Irritation, sensitization, Genotoxicity.
Key Results:
All samples passed the predetermined acceptance criteria for all tests. The Flexicare device performed as well as or better than the Predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to flow: 8.8 mbar at 100ml/min flow, 30.2 mbar at 300ml/min flow (without filter); 30.0 mbar at 100ml/min flow, 95.7 mbar at 300ml/min flow (with filter).
Leakage:
§ 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
Image /page/0/Picture/0 description: The image shows the logo for "Flexicare". The logo is in black and white and features a stylized "F" with two curved lines above it. The word "Flexicare" is written in a bold, sans-serif font to the right of the "F". Below the word "Flexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
510(k) Summary
Trade name
C.F.R Section: Device tvpe: Product Code:
Manufacturer:
Regulatory Affairs Contact:
Christopher Watkins Quality Requlatory & Technical Director Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom
CO2 monitoring line & CO2 monitoring line with filter
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Telephone:
Date Summary Prepared:
Common Name:
Classification:
Predicate Device
Description:
00 44 1443 471 593
22nd April 2014
CO2 monitoring line
Class 2
сск
21 CFR 868.1400.
Flexicare Medical Limited
Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom
Intersurgical - CO2 Monitoring line and CO2 monitoring line with filter, which was cleared for marketing by 510(k) No K122075
Flexicare's CO2 monitoring line is single patient use, small diameter tubing intended to be connected to a luer lock connector on a patient interface to allow for gas sampling from a patients exhaled breath by gas sampling equipment. The Gas monitoring/analysing device will feature a pump, which draws expired breath from the patient through the monitoring line and into the gas analyser.
Flexicare's CO2 monitoring line is available with or without a 0.45um hydrophobic filter, which prevents the transfer of water vapour down the monitoring line and into the gas sampling equipment.
Flexicare's CO2 monitoring lines feature clear construction to aid visual inspection of the device.
The CO2 monitoring line is a single patient use device, designed for use with one patient over a single course of treatment. The CO2 monitoring line is supplied in a sealed poly bag in a non sterile state and is not to be sterilized.
The Flexicare CO2 monitoring lines feature 2M & 3M length tubes.
APR 3 0 2014
1
1
Image /page/1/Picture/0 description: The image shows the logo for Flexicare. The logo is black and white and features a stylized "F" followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Part Numbers:
| Part Number | Product description |
|---|---|
| 010-700U | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 2M |
| 010-705U | CO2 MONITORING LINE WITH FEMALE/FEMALE CONNECTORS - 2M |
| 010-710U | CO2 MONITORING LINE WITH MALE/FEMALE CONNECTORS - 2M |
| 010-700XU | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 3M |
| 010-700AU | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 2M - WITH FILTER |
| 010-705AU | CO2 MONITORING LINE WITH FEMALE/FEMALE CONNECTORS - 2M - WITH FILTER |
| 010-710AU | CO2 MONITORING LINE WITH MALE/FEMALE CONNECTORS - 2M - WITH FILTER |
| 010-700XAU | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 3M - WITH FILTER |
Sizing
| Part Number | Length (mm) | Tube OD (mm) | Tube ID (mm) |
|---|---|---|---|
| 010-700U | 2000 | 2.7 | 1.2 |
| 010-705U | 2000 | 2.7 | 1.2 |
| 010-710U | 2000 | 2.7 | 1.2 |
| 010-700XU | 3000 | 2.7 | 1.2 |
| 010-700AU | 2000 | 2.7 | 1.2 |
| 010-705AU | 2000 | 2.7 | 1.2 |
| 010-710AU | 2000 | 2.7 | 1.2 |
| 010-700XAU | 3000 | 2.7 | 1.2 |
Intended Use:
CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
Substantial Equivalence
Flexicare's CO2 monitoring line & CO2 monitoring line with filter have the same intended use as predicate device:
Intersurgical - CO2 Monitoring line and CO2 monitoring line with filter, which was cleared for marketing by 510(k) No K122075
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are single patient use devices.
Neither Flexicare's CO2 monitoring lines or Intersurgical CO2 monitoring lines are life supporting or life sustaining.
Neither Flexicare's CO2 monitoring lines or Intersurgical CO2 monitoring lines use software, and are not electronically driven.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are supplied non- sterile in individual poly bags.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are designed for the same intended use in the same intended conditions.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines consist of 3-4 components made from injection molded & extruded plastics.
2
Image /page/2/Picture/0 description: The image shows the logo for "Flexicare". The logo is black and white and features a stylized "F" with two curved lines. The word "Flexicare" is written in a bold, sans-serif font to the right of the "F". Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are supplied either with or without 0.45µm hydrophobic filters. Flexicare's hydrophobic filter appeared to be identical to the Intersurgical filters in appearance and product marking. It is likely they are sourced from the same supplier.
From the performance testing it was discovered both Flexicare's and the predicate device tubes are manufactured from flexible PVC, and that both devices feature male and female luers with the option of a hydrophobic filter.
The technological characteristics of Flexicare's CO2 monitoring line and Intersurgical's CO2 monitoring line are very similar. These similarities are evident in the comparison table below.
| | Flexicare - CO2 monitoring line
K133516 | Intersurgical - CO2 Monitoring Line
K122075 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Intended use | | |
| Target
Population | Any patient from which gas monitoring is
required | Any patient from which gas monitoring is required |
| Indications for,
use | CO2 Monitoring lines are intended to
connect from a patient interface CO2
sampling port to the expired gas monitor. | The CO2 monitoring lines are intended to connect
from a CO2 sampling port to the expired gas
monitor |
| Place of use | Hospitals | Hospitals |
| Product labeling | CO2 monitoring line | CO2 monitoring line |
| Single use or re-
usable? | Single use | Single use |
| Design and
performance | | |
| Resistance to
flow | 8.8 mbar at 100ml/min flow
30.2 mbar at 300ml/min flow | 15.2 mbar at 100ml/min flow
51.2 mbar at 300ml/min flow |
| Leakage |