(249 days)
Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.
Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph.
The device's main components are PVC tubing, airway adapter and a luer connector.
Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.
Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.
An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite.
The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Microstream Luer Adult-Pediatric Intubated Sampling Line and Microstream Advance Adult-Pediatric Intubated Filter Line.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text outlines performance tests conducted, but it merges the acceptance criteria with the performance results. For clarity, I will present the acceptance criteria based on the "Same as predicate" statements and the performance reported when new criteria were established for the modified devices.
| Feature | Acceptance Criteria (Based on Predicate or New) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 and FDA guidance (Cytotoxicity, Sensitization, Irritation, Risk Assessment for prolonged use >24 hours-30 days) | Conducted according to ISO 10993 and FDA guidance. Results demonstrated safe use. |
| Pressure Drop | Microstream Luer: ≤70 mBar @ 180 ml/min, sea level | ≤70 mBar @ 180 ml/min, sea level |
| Microstream Advance: ≤75 mBar @ max 4m length; 50 ml/min, sea level | ≤75 mBar @ max 4m length; 50 ml/min, sea level | |
| Accessory (MRI): ≤75 mBar @ 50 ml/min, sea level | ≤75 mBar @ 50 ml/min, sea level | |
| Leak Tightness | 2 mBar/sec leak rate @ 100 mBar under pressure (Same as K980324/K980327) | Met (Identical to K980324/K980327, implying 2 mBar/sec leak rate @ 100 mBar under pressure) |
| Tensile Strength | Pull test of at least 2 kg (Same as K980324/K980327) | Met (Identical to K980324/K980327, implying pull test of at least 2 kg) |
| Mode of Operation | Luer: For use with any Capnograph with luer connection | Met |
| Advance: For use with Microstream Capnography technology | Met | |
| Single Patient Use | Yes (Same as predicates) | Met |
| Tubing Material | Made without phthalates (New requirement for modified device) | Met (Modified to entirely without phthalates) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench testing was conducted to ensure the devices' performance." This implies physical testing of the devices. However, the specific sample size (number of units tested) for the bench tests is not explicitly mentioned in the provided text.
The data provenance is laboratory-based bench testing of the physical devices. There is no indication of country of origin for the data or whether it was retrospective or prospective in the context of patient data, as this was a bench study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as the study described is a bench performance study and not a clinical study with a test set requiring expert ground truth establishment. The "ground truth" for these tests would be the established engineering and ISO standards for device performance (e.g., specific tensile strength, pressure drop limits).
4. Adjudication Method for the Test Set:
This information is not applicable as the study is a bench performance study and does not involve adjudication by experts for clinical outcomes or image interpretation.
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:
This information is not applicable as the device is a physical medical device (sampling line) and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical medical device and does not have an algorithm for standalone performance.
7. The Type of Ground Truth Used:
For this bench study, the "ground truth" refers to established engineering standards, regulatory requirements (e.g., ISO 10993 for biocompatibility), and performance specifications derived from the predicate devices. For example, for tensile strength, the ground truth is "at least 2kg," and for leak tightness, "2 mBar/sec leak rate @ 100 mBar."
8. The Sample Size for the Training Set:
This information is not applicable as the study is a bench performance study of a physical device and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as in point 8.
§ 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).