(226 days)
The Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines.
The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.
IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters.
The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.
The Microstream™ CO2 NanoPod is a finished medical device that when connected to a host monitor is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, including End-tidal CO2 (EtCO2), Fractional Concentration of Inspired CO2 (FiCO2), and CO2 based respiration rate, for adult, pediatric, and neonatal patients utilizing Microstream™CO2 or Microstream™ Advance CO2 sampling lines.
The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. The IPI measurement is intended for use in pediatric and adult patients only, and A/hr and ODI measurements are intended for age 22 and up. Both IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod to calculate these parameters.
The Microstream™ CO2 NanoPod encloses a NanoMediCO2 capnography module, which measures inspired/expired carbon dioxide and respiration rate. The NanoPod is powered by the host monitor on a DC supply.
The Microstream™ CO2 NanoPod system includes the following sub-systems:
- . NanoPod is the medical device enclosure that encloses the NanoMediCO2 module. The NanoPod has a connected active cable that has a LEMO connector end, which connects to a host monitoring system.
- . NanoMediCO2 capnography module is enclosed in the NanoPod. The NanoMediCO2 module measures inspired and expired carbon dioxide and respiration rate. The active cable is what provides bidirectional communication between the Host monitor and the NanoMediCO2 module enclosed inside the NanoPod.
- . Interface Board is enclosed inside NanoPod which consists of an LED exposed on the outside of the NanoPod to provide the functional status of the subject device to the user.
- l Cradle is a plastic holder used to connect the NanoPod with a GCX clamp or other mounting solution, which can then be used to mount the NanoPod on a pole or bedrail. There are no sharp edges on the Microstream™ CO2 NanoPod, which enables the medical device to be held in the hand at times when it is removed from its mounting cradle.
The Microstream™ and or Microstream™ Advance CO2 sampling lines can attach to the NanoPod CO2 port on the NanoPod enclosure. Microstream™ Capnography parameters are displayed the Microstream™ and or Microstream™ Advance CO2 sampling line is connected to the NanoPod CO2 Port and the Microstream™ CO2 NanoPod is connected via LEMO connector to a host monitoring system. Please note that the Microstream™ and Microstream™ Advance sampling lines have been cleared in their own respective 510K submissions.
Due to the nature of the provided document (a 510(k) summary for a medical device), the information typically presented as "acceptance criteria" and "study proving it meets criteria" from the perspective of an AI/software device is not directly applicable. This document describes a hardware medical device (CO2 monitor) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against a clinical ground truth via a study.
Therefore, many of the requested fields (sample size, expert qualifications, adjudication, MRMC, standalone performance, etc.) are not available in this document because they pertain to clinical studies or AI/software validation, which were explicitly stated as not required for this device's clearance.
However, I can extract the information relevant to this medical device's clearance process as best as possible, interpreting "acceptance criteria" as the performance and safety requirements it needed to meet for its 510(k) clearance, and "study" as the testing performed.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Performance/Safety) | Reported Device Performance (Summary of Testing) |
|---|---|
| Compliance with Performance Standards (ISO 80601-2-55 for CO2 monitors) | The Microstream™ CO2 NanoPod has "successfully undergone performance, safety, electromagnetic and environmental testing to ensure compliance with expected performance standards," including ISO 80601-2-55. |
| Compliance with Main Safety Standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 80601-2-49 via section 202.8.102, Figure 202 104) | The device underwent testing to ensure compliance with these electrical safety, EMC, and usability standards. |
| Software Validation (to ensure performance and substantial equivalence) | "Software testing was performed to validate the performance of the Microstream™ CO2 NanoPod and its substantial equivalence to the predicate device." |
| Hazard Analysis (ISO 14971:2019) demonstrating acceptable residual risks | "A hazard analysis was carried out on the Microstream™ CO2 NanoPod in compliance with ISO 14971:2019. This hazard analysis concluded that any residual risks were judged as acceptable when weighed against the intended benefits of use of the device." |
| Substantial Equivalence to Predicate Device (Capnostream™35 Portable Respiratory Monitor, K150272) in intended use, technological characteristics, and performance | The document repeatedly states that the device is "substantially equivalent" to the predicate, with differences detailed (external module vs. standalone monitor, no SpO2 in subject device). "Based on the results of the verification and validation studies, Covidien has established that the subject device, the Microstream™ CO2 NanoPod, is substantially equivalent to the predicate device." "The subject device, Microstream™ CO2 NanoPod is equivalent in intended use, technological characteristics, and performance to the existing legally marketed device. Testing did not raise any issue of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This was a hardware device undergoing bench and software testing, not a clinical study with patient data.
- Data Provenance: Not applicable. The testing was laboratory-based, focused on device performance according to engineering and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the clinical sense (e.g., diagnosis by experts) was not established. The "ground truth" for the device's performance would be the reference measurements from calibrated equipment against which the device was tested.
4. Adjudication method for the test set:
- Not applicable. There was no clinical test set requiring adjudication of 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:
- Not applicable. This device is a measurement tool (CO2 monitor), not an AI-assisted diagnostic device, and no MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; the concept of a "standalone algorithm" is not relevant here. The device itself performs the measurements.
7. The type of ground truth used:
- The "ground truth" for the device's performance would be the established reference standards and calibrated instrumentation used in the bench performance testing to verify the accuracy of CO2 measurements, respiration rate, etc. This is typical for the validation of medical measurement devices.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the machine learning sense. Its operation is based on established physical principles (Non-dispersive infrared spectroscopy) and predefined algorithms.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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).