(117 days)
The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered.
The Module 91518 is intended to be used with, and is controlled by, any Spacelabs Medical monitor, except the SLP100.
The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel.
Although the Module 91518 alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.
The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is an easy-to-use modular unit in the Spacelabs Medical product family. The Module 91518 is a multigas sidestream analyzer intended to provide a measurement of the following parameters;
- CO2 produced by the patient;
- . O2 and N2O administered to the patient;
- Anesthetic agents administered to the patient which includes: .
- Desflurane;
- O Enflurane:
- Halothane; O
- lsoflurane; and O
- Sevorflur-ane.
- . Respiratory rate of the patient; and
- Calculated MAC and age-dependent MAC values. .
The Module 91518 automatically identifies which anesthetic agent or mixture of anesthetic agents is present, and measures the concentration of the identified agent(s). An alarm is issued if a mixture of more than two anesthetic agents is dctected.
The Module 91518 interfaces with all Spacelabs Medical monitors, except the SLP100. The monitor provides a numeric display for the gas concentrations and respiratory rate, and a waveform display for O2 and CO2. The Module 91518 is intended to be used for monitoring all hospitalized patients under the direction of qualified medical personnel.
Here's an analysis of the provided text regarding the Spacelabs Medical Multigas Analyzer Module 91518 and its acceptance criteria and supporting study information:
Based on the provided text, the documentation does not contain the detailed information typically found in a clinical study report or a robust performance validation study with specific acceptance criteria and reported device performance metrics in a quantitative manner. Instead, this is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested sections (1-9) cannot be fully answered with the provided information. I will provide the information that is available and highlight what is missing.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided K053599 510(k) Premarket Notification for the Spacelabs Medical Multigas Analyzer Module 91518 primarily establishes substantial equivalence to predicate devices rather than presenting a standalone validation study with explicit acceptance criteria and corresponding reported performance in a tabular format.
Key Finding: The submission relies on demonstrating that the Module 91518 is "substantially equivalent in design concepts, technologies and materials" to the predicate devices (Spacelabs Medical Module 90518 (K954962) and Date-Ohmeda Compact Airway Module E-CAIOVX (K051092)). The validation is described as "rigorous testing that, in part, support the compliance of the Module 91518 to the Standards mentioned in Section 6.1 of this submission." However, the details of these rigorous tests, the specific acceptance criteria (e.g., accuracy ranges for gas measurements, response times), and the numerical results are not included in this summary document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this summary. Likely based on performance requirements of predicate devices and relevant standards (e.g., ISO for medical gas analyzers). | Not explicitly stated in this summary. The submission indicates "rigorous testing" supported compliance with standards, implying the device met the performance outlined in those standards and/or matched the performance of the predicate devices. |
Explanation: The document states that "rigorous testing" validated the device and supported compliance with "Standards mentioned in Section 6.1." Without access to Section 6.1 or the full submission, the specific acceptance criteria (e.g., accuracy, precision, response time for each gas) and the detailed results are not available in this summary. The primary "acceptance" from the FDA's perspective in a 510(k) is the determination of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in this summary document.
- Data Provenance: Not specified in this summary document. Given this is a device for measuring gas concentrations, the "test set" would likely refer to specific gas mixtures or simulated breath patterns used for calibration and validation testing in a laboratory or engineering environment, rather than human patient data in the context of a clinical trial. The testing is described as occurring during the "validation" phase, implying a prospective testing approach against known standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable or not specified.
- Qualifications of Experts: Not applicable or not specified.
Explanation: For a multigas analyzer, the "ground truth" for gas concentrations would be established by validated scientific methods and calibrated reference instruments (e.g., mass spectrometers, certified gas mixtures). This is not typically an expert-driven "ground truth" like in imaging or diagnostic pathology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or not specified.
Explanation: Adjudication methods are typically used when subjective interpretations are involved (e.g., by human readers in a clinical trial). For a performance test of a gas analyzer, results are compared against a known, objectively measured "ground truth" from reference equipment.
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
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: This device is a measurement instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting results in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the device itself provides standalone measurements and alarms.
Explanation: The Module 91518 is a diagnostic/monitoring device that continuously measures gas concentrations and respiratory rate and identifies anesthetic agents. Its performance validation would inherently be a "standalone" assessment of its accuracy, precision, and response time in these measurements. It operates without direct human-in-the-loop interpretation of its core measurement functions, though clinical personnel use and interpret the displayed values and alarms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Calibrated reference gas mixtures and/or reference instruments.
Explanation: For a device measuring gas concentrations, ground truth is established using highly accurate and calibrated reference techniques and known, certified gas concentrations.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable or not specified.
Explanation: This device is not described as using machine learning or AI in a way that would require a "training set" in the conventional sense (e.g., image data for AI model training). Its function is based on established physical and chemical principles of gas analysis. The "software" referred to in the summary would be traditional embedded software, not a machine learning model.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
Explanation: As mentioned above, a "training set" as understood in machine learning is not implied by the provided summary. If any internal calibration or characterization data (sometimes loosely referred to as "training" in a broad engineering sense) was used, its ground truth would have been established through highly precise laboratory measurements using reference standards.
§ 868.1700 Nitrous oxide gas analyzer.
(a)
Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.(b)
Classification. Class II (performance standards).