(258 days)
The Hudson RCI SOFTECH® Plus ETCO2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
The SOFTECH Plus ETCO2 Cannula is a non-sterile disposable, single patient use device that acts as an adjunct to oxygen therapy with its primary function providing a means to deliver low flow oxygen, while sampling part of the patients exhaled gas. The SOFTECH Plus ETCO2 Cannula has a split nare blank with oxygen delivery through one nasal prongs while allowing sampling of the patient's exhaled gas from the corresponding nasal prongs.
Here's an analysis of the SOFTECH Plus ETCO2 Cannula's acceptance criteria and the supporting study information, based on the provided text:
Acceptance Criteria and Device Performance for SOFTECH Plus ETCO2 Cannula
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device in comparison to a predicate device, focusing on substantial equivalence. The "acceptance criteria" are implied by the nature of the performance testing conducted to demonstrate this equivalence. The stated performance testing for the SOFTECH Plus ETCO2 Cannula primarily validates its functionality in:
- ETCO2 Performance: Ability to sample expired gas accurately at various oxygen flow rates.
- Biocompatibility: Safety for patient contact.
- Material Composition: Specifically, the absence or presence of DEHP.
Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are generally aligned with demonstrating that the SOFTECH Plus ETCO2 Cannula performs as safely and effectively as the predicate device (Double Lumen Oxygen Delivery Gas Sampling Nasal Cannula, Hudson RCI Bi-Flo -K961150) for its intended use. Exact quantitative performance metrics (e.g., specific ETCO2 measurement accuracy ranges) are not explicitly provided in this summary but are implied by the successful completion of the tests.
| Acceptance Criteria (Implied) | Reported (or Demonstrated) Device Performance (Summary) |
|---|---|
| ETCO2 Performance with Simultaneous Oxygen Delivery | Demonstrated effective ETCO2 sampling in simulated conditions at various oxygen flow rates. The test results demonstrate substantial equivalence to the predicate device. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation) | Passed biocompatibility testing as per ISO 10993-1. |
| DEHP Content | Passed DEHP testing (implying it meets the predicate's DEHP characteristics or has demonstrated acceptable differences). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the individual performance tests (ETCO2, biocompatibility, DEHP). It merely states that "The proposed device was tested."
- Sample Size: Not specified.
- Data Provenance: The studies were conducted by Teleflex Medical, Inc. (the manufacturer). The text does not specify the country of origin of the data itself (e.g., patient data, if any were used), but mentions tests were performed in "simulated conditions." Given the 510(k) submission to the FDA, it can be inferred the testing was conducted in a manner compliant with US regulatory requirements, likely in the US or an equivalent regulatory jurisdiction. The studies appear to be prospective insofar as they were conducted to test the newly proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This document does not refer to experts establishing ground truth in the context of clinical data or image interpretation. The testing performed (ETCO2 performance in simulated conditions, biocompatibility, DEHP testing) relies on standardized testing methodologies and laboratory analysis, not expert clinical consensus for "ground truth." Therefore, this information is not applicable to the details provided in this summary.
4. Adjudication Method for the Test Set:
Not applicable, as the tests are objective measurements (e.g., ETCO2 readings, biological responses, chemical composition) rather than interpretations requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human reader performance (with and without AI assistance) is being evaluated. The SOFTECH Plus ETCO2 Cannula is a gas sampling and oxygen delivery device, not a diagnostic imaging device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Yes, the performance testing described is inherently "standalone" in the sense that the device's functional characteristics (ETCO2 sampling, biocompatibility) were evaluated directly, independent of human interaction beyond the setup and operation of the test environment. There is no "algorithm" in the sense of AI or image interpretation here; it is a physical medical device being tested for its specified functions.
7. The Type of Ground Truth Used:
The ground truth for the performance testing would be established by:
- Defined Standards and Measurable Outputs: For ETCO2 performance, the "ground truth" would be the actual concentration of CO2 in the simulated exhaled gas, independently measured by a calibrated reference instrument. The cannula's reading would then be compared against this reference.
- ISO Standards for Biocompatibility: The "ground truth" for biocompatibility is whether the device materials elicit adverse biological responses as defined by ISO 10993-1.
- Chemical Analysis for Material Composition: For DEHP testing, the "ground truth" is the quantitative chemical analysis confirming the presence or absence (or concentration) of DEHP.
8. The Sample Size for the Training Set:
Not applicable. This device is a passive gas sampling and oxygen delivery cannula. It does not employ an algorithm or machine learning component that requires a "training set." The performance tests are for the physical device itself.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).