(73 days)
The ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen, up to 4 L/min, to a patient while providing a means to sample expired gas. The target population is adult and pediatric patients.
The proposed devices consist of a bifurcated nasal prong with two separate gas conduits. One side of the divided cannula is connected to a gas source for delivering low flow oxygen through flexible tubing to the patient. The other side of the divided cannula directs exhaled gas through flexible tubing to a carbon dioxide monitoring device
The acceptance criteria and the study proving the device meets them are described below for the CareFusion ETCO2 Nasal Cannula.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing | The device meets the requirements of ISO 10993-1:2009, indicating it is biologically compatible. |
| Performance - Luer Taper Fit (General) | ISO 594-1 Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment: Part 1 - General Requirements | The device meets the requirements of ISO 594-1, indicating proper conical fitting. |
| Performance - Luer Taper Fit (Locking) | ISO 594-2 Conical fitting with 6% (Luer) taper for syringes, needles and certain other medical equipment: Part 2 - Lock Fittings | The device meets the requirements of ISO 594-2, indicating proper locking luer fittings. |
| Performance - Tubing and Connectors | BS EN 13544-2:2002 + A1:2009 Respiratory Therapy Equipment - Part 2: Tubing and Connectors | The device meets the requirements of BS EN 13544-2:2002 + A1:2009, indicating conformance for respiratory tubing and connectors. |
| Performance - Conical Connectors | ANSI/ISO 5356-1:2004 (MOD) Anesthetic and respiratory equipment - conical connectors - Part 1: Cones and Sockets | The device meets the requirements of ANSI/ISO 5356-1:2004 (MOD), indicating conformance for anesthetic and respiratory conical connectors. |
| Risk Management | ISO 14971:2009 Medical devices — Application of Risk Management to Medical Devices | The device meets the requirements of ISO 14971:2009, indicating appropriate application of risk management. |
| Gas Flow Bench Testing (O2 Delivery Line) | Maximum Flow Resistance: 138 mmH2O per foot @ 4 lpm, Pediatric (Acceptance Criteria: Maximum 138 mmH2O/foot) Maximum Flow Resistance: 119 mmH2O per foot @ 4 lpm, Adult (Acceptance Criteria: Maximum 119 mmH2O/foot) | The device's O2 delivery line demonstrates flow resistance within the specified limits for both pediatric (≤138 mmH2O/foot) and adult (≤119 mmH2O/foot) applications at 4 lpm, meeting the performance criteria. The exact reported values are not explicitly stated as "X mmH2O/foot" but rather as "Maximum Flow Resistance" followed by the acceptance criteria, implying that the device's performance does not exceed these maximums. |
| Gas Flow Bench Testing (CO2 Cannula Sampling Line) | Maximum Flow Resistance: 51 mmH2O per foot @ 0.5 lpm, Pediatric (Acceptance Criteria: Maximum 51 mmH2O/foot) Maximum Flow Resistance: 65 mmH2O per foot @ 0.5 lpm, Adult (Acceptance Criteria: Maximum 65 mmH2O/foot) | The device's CO2 cannula sampling line demonstrates flow resistance within the specified limits for both pediatric (≤51 mmH2O/foot) and adult (≤65 mmH2O/foot) applications at 0.5 lpm, meeting the performance criteria. Similar to the O2 line, the reporting structure suggests adherence to these maximums. |
| Gas Flow Bench Testing (CO2 Sampling Line) | Maximum Flow Resistance: 64 mmH2O per foot @ 0.5 lpm (Acceptance Criteria: Maximum 64 mmH2O/foot) | The device's CO2 sampling line demonstrates flow resistance within the specified limit (≤64 mmH2O/foot) at 0.5 lpm, meeting the performance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "non-clinical tests" and "bench testing" without providing specific sample sizes for each test.
- Data Provenance: The tests are non-clinical, implying they were conducted in a laboratory or engineering setting ("bench testing"). There is no mention of country of origin for the data, but the manufacturer, CareFusion, is based in McGaw Park, IL, USA. The study design is not a clinical study, so the retrospective/prospective distinction is not directly applicable in the typical sense; these are device verification and validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable (N/A) as the study performed was non-clinical bench testing for a medical device (ETCO2 Nasal Cannula), not a study involving human data interpretation or diagnostic accuracy. Therefore, there was no "ground truth" to be established by human experts in the context of diagnostic performance. The "ground truth" for these tests would be the established engineering and safety standards themselves.
4. Adjudication method for the test set:
This information is not applicable (N/A) for the same reason as point 3. Adjudication methods are typically used in studies where there is subjective interpretation or disagreement among experts, which is not the case for non-clinical bench testing against objective standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This is a non-clinical submission for a physical medical device (nasal cannula) and does not involve AI or human readers for diagnostic assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable (N/A). The device is a physical medical device (nasal cannula) and does not involve an algorithm, AI, or software for standalone performance.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests was the established technical and safety standards (e.g., ISO, BS EN, ANSI/ISO standards, and specific maximum flow resistance values determined by engineering specifications). The device was tested against these predefined performance requirements.
8. The sample size for the training set:
Not applicable (N/A). There was no training set, as this project involved non-clinical testing of a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable (N/A). As there was no training set, there was no ground truth for a training set to be established.
§ 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).