(140 days)
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.
The CARESCAPE™ Respiratory Modules, E-sCO, E-sCOV, E-sCAiO and E-sCAiOV and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate) and ventilatory parameters (airway pressure, flow and breathing volumes) of hospital patients. Parameters measured by the CARESCAPE™ Respiratory Modules and accessories are CO2, N2O, O2, Anesthetic agents, Agent ID and Spirometry depending on the model used. The CARESCAPE™ Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPETM Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE™ Respiratory Modules acquire the detected signals from the sensors of the modules, calculate the parameter values and communicate them to the host device. The CARESCAPE™ Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system. The CARESCAPE™ Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host monitors based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.
This 510(k) summary describes a device submission for the CARESCAPE™ Respiratory Modules, which are intended for monitoring respiratory and ventilatory parameters in adult, pediatric, and neonatal patients.
Based on the provided text, the device did not undergo clinical studies to support substantial equivalence. The submission relies on non-clinical testing and comparison to a predicate device. Therefore, a direct response to some of the requested points regarding acceptance criteria and a study demonstrating performance against those criteria cannot be fully provided from this document alone, as the document states that clinical studies were not required.
However, I can extract information related to the device's technical specifications, non-clinical evaluations, and safety considerations, which serve as the basis for its substantial equivalence determination.
Acceptance Criteria and Device Performance (Based on Non-Clinical Tests and Standards Compliance)
Since no clinical study demonstrating device performance against specific acceptance criteria is provided, the "acceptance criteria" here refer to compliance with voluntary standards and the predicate device's performance, as asserted by the manufacturer in the context of a 510(k) submission. The device's "performance" is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device and successful completion of non-clinical tests.
Table 1: Acceptance Criteria (Standards Compliance) and Reported Device Performance
| Acceptance Criteria (Standards and Design Aspects) | Reported Device Performance (Summary) |
|---|---|
| Safety Standards: | |
| IEC 60601-1:1988, A1:1991, A2:1995, Corr1:1995 (General Safety) | Designed and tested for compliance with this standard. |
| IEC 60601-1-2:2001, A1:2004 (Electromagnetic Compatibility) | Designed and tested for compliance with this standard. |
| IEC 60601-1-4:2000 Consol. Ed. 1.1 (Programmable Medical Systems) | Designed and tested for compliance with this standard. |
| IEC 60601-1-6:2006 (Usability) | Designed and tested for compliance with this standard. |
| EN1041:2008 (Information Supplied by Manufacturer) | Designed and tested for compliance with this standard. |
| ISO 21647:2009 (Respiratory Gas Monitors Specific Requirements) | Designed and tested for compliance, with noted non-compliances (see below) |
| IEC 62366:2007 (Usability Engineering) | Designed and tested for compliance with this standard. |
| Non-Clinical Test Outcomes: | |
| Risk Analysis | Completed |
| Requirements Reviews | Completed |
| Design Reviews | Completed |
| Unit Level Testing (Module verification) | Completed |
| Integration Testing (System verification) | Completed |
| Final Acceptance Testing (Validation) | Completed |
| Performance Testing (Verification) | Completed |
| Safety Testing (Verification) | Completed |
| Equivalence to Predicate Device (K051092): | |
| Fundamental Technology | Same as predicate devices. |
| Safety and Effectiveness | As safe and effective as predicate devices. |
Note on ISO 21647:2009 Non-Compliances:
The document explicitly states non-compliance with several clauses of ISO 21647:2009 for certain older monitoring systems when used with the new modules. These pertain to:
- Clause 49.101: RGM providing a medium priority alarm signal when power falls below minimum.
- Clause 57.3 aa): Detachable power supply cord protection against accidental disconnection.
- Clause 102: Compliance with all requirements of IEC 60601-1-8:2003 (alarm systems).
- Clause 201.1.2: RGM providing a means to detect gas reading alarm conditions and alarm priority for unidentified anesthetic agents.
- Clause 201.1.2: Alarm signals for mixtures of halogenated agents based on MAC levels.
- Clause 201.8.3: Manufacturer-configured alarm preset for audio-paused or alarm-paused interval.
These non-compliances are acknowledged and apply to specific older monitor models (S/5 Anesthesia monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia Monitor, S/5 Compact Critical Care Monitor, CARESCAPE B650, CARESCAPE B850). The FDA's substantial equivalence determination implies these non-compliances were deemed acceptable in the context of the overall safety and effectiveness of the device as cleared.
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- No specific sample size for a clinical test set is mentioned. The device did not require clinical studies. Non-clinical tests were performed, but details on sample sizes for these internal verification and validation activities (e.g., how many units tested, how many scenarios) are not provided in this summary.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by the manufacturer, GE Healthcare Finland Oy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with expert-established ground truth was used for this 510(k) submission. The ground truth for non-clinical performance and safety testing would be based on engineering specifications, reference measurement standards, and accepted validation methodologies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test data requiring adjudication was involved in this submission.
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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:
- No. This device is a respiratory gas monitor, not an AI software intended to assist human readers (e.g., in medical image interpretation). Therefore, an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for a "standalone" algorithmic performance study in the context of AI. The device itself performs measurements and calculates parameters. Its "standalone" performance is implicitly covered by the performance testing and compliance with standards. It is a measurement device, not an interpretative AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established by calibrated reference equipment, known physical quantities, and compliance with the specified requirements and standards.
-
The sample size for the training set:
- Not applicable. This device is a hardware and software system for physiological monitoring, not a machine learning or AI model trained on a specific dataset.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).