(118 days)
The ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for display of real time and derived monitoring data of the following breathing gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.
ISA is a sidestream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to a Host/Backboard Device for display of respiratory parameters. ISA is connected to the patient breathing circuit via the Nomoline sampling line that includes a water separation section and a bacteria filter.
The following ISA models are available:
a) ISA CO2 (model/catalogue number 800101), measurement of CO2.
b) ISA AX+ (model/catalogue number 800601), measurement of CO2, N2O and 5 Anesthetic agents with automatic agent identification
c) ISA OR+ (model/catalogue number 800401), measurement of CO2, O2, N2O and 5 Anesthetic agents with automatic agent identification (includes paramagnetic oxygen sensor).
The ISA product family also includes the disposable Nomoline sampling line. A clamp adapter and modura holder are offered as optional accessories.
- Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on a comparative evaluation against a predicate device. The performance is reported as being "equivalent or superior" to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance (ISA models: 800101, 800601, 800401) |
|---|---|
| Gas measurement capabilities (CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane, Desflurane, O2) | Same as predicate device |
| Performance throughout the operating range | Equivalent or superior to predicate device |
| Safety | Equivalent or superior to predicate device |
| Effectiveness | Equivalent or superior to predicate device |
| Electric power consumption | Equivalent to predicate device |
| Utilization of disposable single-patient-use connections | Equivalent to predicate device |
| Labeling and materials used | Equivalent to predicate device |
- Sample Size Used for the Test Set and Data Provenance:
The document mentions "Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices."
- Sample Size: Not explicitly stated. The phrase "throughout the operating range" suggests a comprehensive set of conditions were tested, but the specific number of samples or data points is not provided.
- Data Provenance: The testing was conducted by Phasein AB (Sweden).
- Country of Origin: Sweden.
- Retrospective or Prospective: The testing appears to be prospective, specifically designed to evaluate the performance of the new device against the predicate.
- Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The study relies primarily on a comparison against a "legally marketed anesthesia and ventilation devices" and "calibrated gas samples." This implies that the "ground truth" was established by the known concentrations of the calibrated gas samples and the established performance of the predicate device.
- Number of Experts: Not applicable in the traditional sense of human experts interpreting data. The ground truth seems to be objectively defined by the calibrated gas samples and the predicate's known performance.
- Qualifications of Experts: Not applicable.
- Adjudication Method for the Test Set:
Not applicable. The ground truth was established by calibrated gas samples and the predicate device's performance, not by expert consensus requiring adjudication.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a gas analyzer, not an imaging or diagnostic device that typically involves human readers. The comparison was device-to-device.
- Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, this was a standalone performance study. The ISA device's performance in analyzing gases was directly compared to a predicate device and calibrated gas samples. There is no mention of a human-in-the-loop component for the measurement of the gases, although the output data is intended for display to medical professionals who would then interpret it.
- Type of Ground Truth Used:
The ground truth used was a combination of:
- Calibrated Gas Samples: Standardized gas mixtures with known concentrations, providing an objective ground truth for gas measurement accuracy.
- Performance of a Predicate Device: The Datex-Ohmeda S/5 (K051092) was used as a benchmark, implying its established and legally marketed performance served as a form of ground truth for comparison.
- Sample Size for the Training Set:
The document does not describe a "training set." The testing performed was for efficacy and safety against a predicate, not for training an algorithm. This device is an infrared gas analyzer, which operates on physical principles of gas absorption rather than machine learning algorithms that typically require training data.
- How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no mention of a training set or machine learning algorithm.
§ 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).