(166 days)
CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
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.
Here's a breakdown of the acceptance criteria and study information for the Flexicare CO2 monitoring line, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard / Pre-determined Acceptance Criteria | Reported Flexicare Device Performance |
|---|---|---|
| Visual inspection | Pre-determined Acceptance Criteria | All samples pass |
| Resistance to flow | Pre-determined Acceptance Criteria | All samples pass |
| Dimensional inspection. Length, ID, OD | Pre-determined Acceptance Criteria | All samples pass |
| Leakage | Pre-determined Acceptance Criteria | All samples pass |
| Performance - CO2 monitoring | Pre-determined Acceptance Criteria | All samples pass |
| Tensile testing | Pre-determined Acceptance Criteria | All samples pass |
| Luer connectors - Dimensional, leakage, connection, stress cracking | ISO 594-1 / BS EN 20594-1:1994, ISO 594-2 (BS EN 1707:1997) | All samples pass |
| Accelerated age testing | ASTM F1980 | All samples pass |
| Cytotoxicity, Irritation, sensitization | BS EN ISO 10993-10:2010, BS EN ISO 10993-5:2009 | All samples pass |
| Genotoxicity | BS EN ISO 10993-3:2009 | All samples pass |
Specific Resistance to Flow Performance Details:
- CO2 monitoring line (without filter):
- Flexicare: 8.8 mbar at 100ml/min flow, 30.2 mbar at 300ml/min flow
- Predicate: 15.2 mbar at 100ml/min flow, 51.2 mbar at 300ml/min flow
- CO2 monitoring line (with filter):
- Flexicare: 30.0 mbar at 100ml/min flow, 95.7 mbar at 300ml/min flow
- Predicate: 33.4 mbar at 100ml/min flow, 114.5 mbar at 300ml/min flow
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of samples used for each test (the sample size). However, it consistently states "All samples pass" for each test.
The data provenance is from Flexicare Medical Limited, United Kingdom, as indicated by the manufacturer's details and the report being dated in the UK. The tests described are part of a premarket notification (510(k)) submission, meaning they were conducted specifically for this regulatory purpose. The nature of these tests (performance, dimensional, biocompatibility etc.) implies they are prospective in the sense that they were designed and executed to evaluate the new device against established criteria and a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests performed are primarily engineering and laboratory-based assessments of physical and functional characteristics against defined standards and criteria, rather than expert-driven clinical evaluations requiring ground truth establishment by medical experts.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The tests are objective measurements against standards or functional comparisons, not subjective clinical assessments requiring adjudication. The results are reported as "All samples pass," indicating direct conformance to acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a CO2 monitoring line, which is a passive tubing device. The comparison studies focused on physical and functional equivalence to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device does not involve any software or electronic components, therefore no algorithm is present to be evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Pre-determined Acceptance Criteria: These are internal specifications or performance targets set by Flexicare.
- International Standards: e.g., ISO 594-1, ISO 594-2, ASTM F1980, BS EN ISO 10993-3, -5, -10.
- Comparison to a Predicate Device: The performance of the Flexicare device (e.g., resistance to flow, CO2 detection capability, leakage, tensile strength) was directly compared to the Intersurgical predicate device (K122075) to demonstrate similar or better performance.
For the CO2 monitoring performance, the ground truth was whether the device could consistently detect CO2 from beneath the nostrils, similar to the predicate device. The document states: "Both manufacturers' devices detected CO2 consistently, proving substantial equivalence."
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a simple mechanical tubing product and does not involve machine learning or AI, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided, as there is no training set.
§ 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).