(356 days)
The Envoy is intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.
The Spirometry module is used to provide an objective measurement of lung function. The Spirometry module is intended for use in the hospital clinical environment only (e.g. in the RICU). The module is used for the continuous monitoring of mechanically ventilated adult and pediatric patients, or adult and pediatric patients able to breathe spontaneously. In both cases, the patient is connected to the module via an endotracheal tube or mask. The module is to be used only for patients with tidal volumes greater than 100 ml.
The Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules to monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. Data presented from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
The Envoy vital signs modules acquire vital signs data from the patient, and display their indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.
The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such, it is not a life supporting, nor is it implantable and therefore sterility is not a consideration.
The Envoy is not a kit and does not contain any drug or biological products. The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY).
The provided document is a 510(k) premarket notification for a new Spirometry module added to the Envoy Patient Monitor. The document indicates that the device has been subject to "extensive safety and performance testing" but does not contain the detailed study results needed to fully answer your request.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides some specifications for the OEM Airway Adapter/Flow sensor which can be considered performance criteria and reported performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Range | 2 - 180 lpm (33 - 3000 ml/s) |
| Accuracy | ± 5 % reading, or 0.5 lpm |
| Dead Space | 6.9 ml |
| Degree of protection against electrical shock | Type BF applied part |
| Sampling | 100 sps |
Missing Information for Table: The document states that the system included "various performance tests designed to ENSURE that the device complies to applicable requirements and performance specifications" but does not explicitly list the acceptance criteria or the full detailed results for all monitored parameters (Vt_e, PIP, PEEP, MAP, Plat, PF_i, PF_e, RR, Ve, I:E, COMP, RES, RSBI).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "extensive safety and performance testing" but does not provide details on the number of samples or cases used.
- Data Provenance: Not specified. It is not clear whether the testing involved retrospective or prospective data, or the geographical origin of any patient data, if used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe a process for establishing ground truth using experts. The testing seems to be based on engineering performance specifications rather than clinical reads.
4. Adjudication method for the test set
- Not applicable/Not specified. Since expert ground truth establishment is not described, adjudication methods are also not mentioned.
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
- No. This is not an AI/CAD device. It is a physiological patient monitor with a spirometry module. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The performance testing described refers to the device itself and its components. The document explicitly states, "The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY)." However, the performance specifications are for the module's technical capabilities (e.g., flow range, accuracy), which would be tested in a standalone capacity within the system.
7. The type of ground truth used
- Engineering Specifications/Reference Standards. The reported accuracy and flow range suggest comparison against known, calibrated inputs or reference standards rather than clinical consensus or pathology. Examples: "Accuracy: ± 5 % reading, or 0.5 lpm."
8. The sample size for the training set
- Not applicable/Not specified. This device is a hardware-based physiological monitor, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned or implied for this type of device.
Study Proving Device Meets Acceptance Criteria:
The document states: "The Envoy Spirometry module has been subject to extensive safety and performance testing. The survey of the system included various performance tests designed to ensure that the device complies to applicable requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards."
This is a general statement that indicates testing was done, but the document does not detail the specific study, methodology, or results of this "extensive safety and performance testing" beyond the specifications provided in the table above. It does not provide a formal "study" report within this 510(k) summary.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.