(145 days)
The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric 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, EsCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX 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), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.
Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE 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 signals detected by the module sensors, 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 devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.
This Special 510(k) introduces two new spirometry accessories: 2104297-001 D-lite++ Patient Spirometry Set. 2m/7ft and 2104297-002 D-lite++ Patient Spirometry Set, 3m/10ft. The design of the D-lite++ Patient Spirometry Sets is based on the design of previously cleared accessories 8004381 D-lite+ Spirometry Kit, adult, 2m/7ft and 8004382 D-lite+ Spirometry Kit, adult, 3m/10ft (510(k) K171028) used for spirometry, gas exchange and gas measurement and owned by GE Healthcare Finland Oy. The main modifications are in the design of the spirometry sensor part of the product; the gas sampling line connector shape and location have been modified and spirometry connector internal volumes have been expanded. The only new material introduced is cyanoacrylate glue CB 2011 used for attaching the spirometry connector to the sensor body. The only new manufacturing method introduced is ultrasonic welding used for attaching the gas sampling line connector to the sensor body. The CARESCAPE Respiratory Module measurement specifications are unaffected except for a minor decrease in gas exchange VO2 and VCO2 accuracy specifications with respiration rates above 30 breaths/min when the measurement is performed using the D-lite++ Patient Spirometry Sets. The specification change does not raise different questions of safety or effectiveness of the CARESCAPE Respiratory Modules.
There are no changes to indications for use, hardware, software, mechanics or electrical safety of the CARESCAPE Respiratory Modules due to the D-lite++ Patient Spirometry Sets. The introduction of the D-lite++ Patient Spirometry Sets does not add or change the functionality or fundamental scientific technology of the CARESCAPE Respiratory Modules. The D-lite++ Patient Spirometry Sets employ the same fundamental scientific technology as the existing accessories 8004381 D-lite+ Spirometry Kit, adult, 2m/7ft and 8004382 D-lite+ Spirometry Kit, adult, 3m/10ft used for spirometry, gas exchange and gas measurement with the CARESCAPE Respiratory Modules.
The provided text describes a Special 510(k) submission for the CARESCAPE Respiratory Modules, focusing on the introduction of new spirometry accessories (D-lite++ Patient Spirometry Sets). The crucial aspect for this request is that no clinical studies were conducted, as noted in "Summary of Clinical Tests: The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
Instead, the submission relies on bench testing to demonstrate that the modified device performs as intended and within specifications, particularly concerning spirometry, gas exchange, and gas accuracy measurements when the new accessories are used. The report explicitly states, "Bench testing supports the substantial equivalence determination of the modified CARESCAPE Respiratory Modules when compared to the predicate device."
Therefore, many of the requested elements, such as the number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for a clinical test set, are not applicable to this submission because no clinical study was performed.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "The CARESCAPE Respirator Module measurement specifications are unaffected except for a minor decrease in gas exchange VO2 and VCO2 accuracy specifications with respiration rates above 30 breaths/min when the measurement is performed using the new accessories." It also states that the device "perform[s] as intended and within specification." However, specific quantitative acceptance criteria and their corresponding reported performance values for spirometry, gas exchange, and gas accuracy are not detailed in the provided text. The text implies that the device meets its own specifications with the minor adjustment mentioned.
| Performance Metric | Acceptance Criteria (Not explicitly stated with values) | Reported Device Performance (Implied) |
|---|---|---|
| Spirometry Accuracy | Within established specifications for CARESCAPE Respiratory Modules (Implicit) | Performs as intended and within specification when D-lite++ Patient Spirometry Sets are used. (Implicitly meets specifications) |
| Gas Exchange VO2 Accuracy | Within established specifications for CARESCAPE Respiratory Modules, with a minor decrease allowed for respiration rates > 30 breaths/min (Implicit) | Performs as intended and within specification; minor decrease in accuracy for respiration rates > 30 breaths/min with new accessories. |
| Gas Exchange VCO2 Accuracy | Within established specifications for CARESCAPE Respiratory Modules, with a minor decrease allowed for respiration rates > 30 breaths/min (Implicit) | Performs as intended and within specification; minor decrease in accuracy for respiration rates > 30 breaths/min with new accessories. |
| Gas Accuracy Measurement | Within established specifications for CARESCAPE Respiratory Modules (Implicit) | Performs as intended and within specification when D-lite++ Patient Spirometry Sets are used. (Implicitly meets specifications) |
| Tightness of ultrasonic welding | Sufficient to ensure proper function and safety (Implicit) | Testing performed to ensure tightness. (Implied successful) |
| Biological Safety (D-lite++ Spirometry Sets) | No biological safety risks for the patient (Implicit) | Biological assessment performed to verify no biological safety risks. (Implied successful) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified, as "bench testing" was performed rather than a human-patient-based clinical test set. The testing involved verification of spirometry, gas exchange, and gas accuracy measurements, and tightness of ultrasonic welding.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or manufacturing environment, likely in Finland where GE Healthcare Finland Oy is located. It is retrospective in the sense that it evaluates the modified device's performance against existing specifications.
3. 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 requiring expert ground truth was performed.
4. Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication was performed.
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. No MRMC comparative effectiveness study was done. This device is a respiratory module and accessories, 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:
- Not applicable in the typical sense of an algorithm's standalone performance. The testing performed was related to the device's measurement accuracy and physical integrity. The device itself (CARESCAPE Respiratory Modules) operates in conjunction with a host device and is intended for use by qualified medical personnel, but its primary function is measurement, not algorithmic interpretation requiring human-in-the-loop comparison.
7. The type of ground truth used:
- For the bench testing, the "ground truth" would be the known, precise values generated by calibration equipment or reference standards against which the device's measurements (spirometry, gas exchange, gas concentrations) were compared. This is a scientific, instrument-based ground truth.
8. The sample size for the training set:
- Not applicable. This submission describes modifications to an existing device and its accessories, not a new AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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).