(650 days)
Endure ETCO2/O2 Nasal Cannula has two functions
-
- It is intended to deliver supplemental Oxygen to patients and
- to obtain CO2 sampling of exhaled air
Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.
Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.
Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.
The provided text describes the 510(k) premarket notification for the Endure ETCO2/O2 Nasal Cannula (K213767). It indicates that the device is substantially equivalent to a legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The document focuses on demonstrating this equivalence, rather than setting and proving acceptance criteria in the traditional sense of a clinical trial for a new therapeutic or diagnostic device.
However, based on the information provided, we can infer the "acceptance criteria" through the comparative performance testing and the "study" that proves the device meets (or is equivalent to) those criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the Endure ETCO2/O2 Nasal Cannula performs similarly or identically to the predicate device (Oridion K010024) in key functional areas.
| Feature/Test | Acceptance Criteria (Implied: Similar/Identical to Predicate K010024) | Reported Device Performance (Endure ETCO2/O2 Nasal Cannula K213767) |
|---|---|---|
| Indication for Use | To sample exhaled gas via nasal cannula and simultaneously provide supplemental Oxygen near the nose and mouth for inhalation | 1) To deliver supplemental Oxygen to patients and 2) to obtain CO2 sampling of exhaled air |
| Environment of Use | Hospitals, sub-acute, pre-hospital settings | Hospitals, sub-acute, pre-hospital settings |
| Intended Population | Adults and Pediatrics - Patient requiring supplemental oxygen and/or sampling of expired gases | Adults and Pediatrics - Patient requiring supplemental oxygen and/or sampling of expired gases |
| Duration of Use | Single patient use - Disposable, Less than 24 hours | Single patient use - Disposable, Less than 24 hours |
| Single Patient Use | Yes | Yes |
| Dispensing | Only on prescription or as ordered by a medical provider. | Only as per the order of a physician or medical provider. |
| Basic Components | Nasal cannula, Oxygen tubing, Gas sampling line | Nasal Cannula, Oxygen tubing, Gas sampling line |
| Patient Interface | Nasal cannula | Nasal Cannula |
| Design | Split / channeled nasal cannula, sampling in one and Oxygen delivery in the other | Split / channeled nasal cannula with sampling in one and Oxygen delivery in the other |
| Material | Flexible PVC | Flexible PVC |
| Sampling Tube Specifications | ID-0.06" / OD-0.1" / Length -2" (for predicate) | ID-0.08" / OD-0.1" / Length -2" |
| Biocompatibility | ISO 10993-1 compliant (Cytotoxicity, Sensitization, Intracutaneous Irritation) | ISO 10993-1 compliant (Cytotoxicity, Sensitization, Intracutaneous Irritation) |
| Gas Pathway Test | Compliance with ISO 18562 | Compliance with ISO 18562 |
| CO2 Sampling/ETCO2 levels | Similar performance to predicate device | Found to be similar between the predicate device and the proposed device. |
| O2 Flow Rates | Similar performance to predicate device (at 2, 4, and 6 LPM) | Found to be similar between the predicate device and the proposed device. |
| Physical Measurements | Similar to predicate device | Found to be similar between the predicate device and the proposed one. |
| Luer Fitting | Similar and leak-free to predicate device | Found to be similar and leak-free. |
| Shelf Life | 5 years | 3 years (with supporting aging studies) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The performance testing appears to be primarily laboratory-based comparisons between the proposed device and the predicate.
- Test Set Sample Size: Not explicitly stated for performance tests. The comparison of physical measurements, CO2 sampling, and O2 flow rates implies a limited number of devices were tested against each other.
- Data Provenance: Not applicable in the context of patient data for the performance comparison. The tests were likely conducted in a controlled lab environment. The document states "Age testing done with cannulas manufactured in 2019" which suggests a retrospective analysis of previously manufactured devices for aging studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert clinical assessment for ground truth. The performance testing involves objective measurements (e.g., CO2 levels, O2 flow, physical dimensions) and adherence to standards (e.g., ISO 10993, ISO 18562).
4. Adjudication Method for the Test Set
Not applicable. There is no clinical imaging or diagnostic interpretation involved that would require an adjudication method like 2+1 or 3+1.
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
Not applicable. This device is a medical accessory for delivering oxygen and sampling CO2, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: Compliance with international standard ISO 10993-1 and ISO 18562. This represents established biological safety standards.
- For Performance Testing (CO2, O2, Physical): Comparison against the performance of the legally marketed predicate device (K010024 Oridion Nasal CO2/O2 Cannula). The predicate device's performance established the "ground truth" or benchmark for equivalence.
- For Age Testing/Shelf Life: Laboratory-based aging studies where the performance of aged devices is compared to new devices (and found equivalent to "cannulas manufactured in 2022").
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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).