(134 days)
The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments.
The Capnostream20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
The Capnostream20 bedside monitor is a two parameter monitor consisting of a CO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed. The device is classified as CCK Class II according to 21 CFR § 868.1400 - Carbon Dioxide Analyzer with DQA 21 CFR § 870.2700 Pulse Oximeter listed as an additional or alternate classification.
This device has two modules that are classified as follows:
- 21 CFR 868.1400, Carbon Dioxide Analyzer (Classification CCK) .
- 21 CFR 870.2700 Pulse Oximeter (Classification DQA) .
Each module is controlled by dedicated software that is an integral part of the respective module.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a SPECIAL 510(k) submission, indicating that the device (Capnostream20 with microMediCO2 CO2 module) is being submitted for substantial equivalence to a previously cleared predicate device (Capnostream20 with miniMediCO2 CO2 module). In such submissions, the primary "study" is often a demonstration of equivalence to the predicate device, rather than a de novo clinical trial with novel acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device's established performance and meeting relevant regulatory standards. The device performance is generally stated as being equivalent to or meeting the same standards as the predicate.
| Attribute | Acceptance Criteria (based on Predicate/Standards) | Reported Device Performance (Capnostream20 with microMediCO2 CO2 module) |
|---|---|---|
| Indications for Use | Identical to the predicate device (continuous, non-invasive measurement and monitoring of CO2 concentration, respiration rate, SpO2, and pulse rate for neonatal, pediatric, and adult patients in various medical environments; integrated pulmonary index (IPI) as an adjunct). | Identical to the indications for use in the predicate device. |
| Target Population | Neonatal, pediatric, and adult patients. | Neonatal, pediatric, and adult patients. |
| Design | Equivalent to the Capnostream20 described in K082268, with the microMediCO2 CO2 module having enhanced processing and memory and being smaller. Functional features and intended use must be substantially equivalent. | Identical to the Capnostream20 described in K082268 with the exception of the introduction of the micromediCO2 CO2 module. Functional features and intended use are substantially equivalent. |
| Where Used | Identical to the predicate device (by trained healthcare providers in critical care settings like anesthesiology, intensive care, NICU, etc.). | Identical to the predicate device (by physicians, nurses and other trained health care providers in critical care patient settings, such as anesthesiology, intensive care medicine, neonatal intensive care and other health care areas). |
| Performance Standards | Compliance with ISO 21647 (Respiratory gas monitors) and ISO 9919 (Pulse oximeter equipment - Particular requirements for basic safety and essential performance). The new module provides the same inputs (FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI, continuous CO2 numeric and waveform). | ISO 21647, ISO 9919. The module provides the following inputs to the host monitor: FiCO2, EtCO2 numeric, EtCO2 waveform, Respiratory Rate, IPI (Integrated Pulmonary Index), and continuous CO2 numeric and waveform. (Implies compliance). |
| Safety Standards | Compliance with IEC/EN 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance), IEC/EN 60601-1-2 (Electromagnetic compatibility), IEC 60601-1-8 (Alarm systems - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems), UL 60601-1, and ISO 14971 (Medical devices - Application of risk management to medical devices). Hazard analysis concluded residual risks were acceptable. | IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-8, UL 60601-1, ISO 14971. Hazard analysis confirmed acceptable residual risks. Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed. |
| Biocompatibility | No biocompatibility issues and no testing required, similar to the predicate. | No issues of biocompatibility, no testing done. |
| Sterility | Not requiring sterilization and marked non-sterile, similar to the predicate. | Does not require sterilization and is shipped marked non-sterile. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not provide a specific sample size for a "test set" in the context of clinical data for the new microMediCO2 CO2 module. The submission focuses on design and performance verification/validation against existing predicate standards, rather than new clinical trials with patient data. The "test set" here refers to engineering and bench testing to demonstrate compliance with standards and equivalence.
- Data Provenance: Not applicable in the context of clinical patient data. The provenance of the validation data would be from Oridion's internal testing and compliance activities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified or applicable in the context of expert-adjudicated ground truth for a clinical dataset. The "ground truth" for this engineering-focused submission is derived from established international standards (ISO, IEC, UL) and a comparison to the predicate device's performance. Performance testing would likely involve engineers and technicians.
- Qualifications of Experts: Not specified, as it's not a clinical study requiring expert adjudication of patient cases.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This submission doesn't describe a clinical study requiring adjudication of expert interpretations. The verification and validation activities would follow standard engineering and quality assurance protocols, where measurements are compared against specifications and standards, not through expert consensus on medical findings.
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, an MRMC comparative effectiveness study was not done, and it is not relevant to this submission. The device is a monitor providing physiological parameters, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not explicitly termed "standalone algorithm performance" as it would be for AI. However, the document states: "Verification and validation of the new module as a standalone and when integrated in the monitor were successfully completed." This indicates that the microMediCO2 CO2 module's performance was evaluated independently before integration into the Capnostream20 monitor. This is essentially demonstrating the technical performance of the module itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device, in terms of its performance, is based on:
- Reference measurements/standards: For CO2 and SpO2 accuracy, this would involve comparing the device's readings against highly accurate reference instruments or calibrated gas mixtures as dictated by ISO standards (ISO 21647, ISO 9919).
- Predicate device's performance: The fundamental "ground truth" for this 510(k) is that the new module performs equivalently to the previously cleared predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physiological monitor, not a machine learning model that requires a "training set" in the AI sense. Its calibration and operational parameters are determined through engineering design and testing, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" in this context.
§ 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).