(261 days)
The Vivo 60 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.)
The Vivo 60 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.
The Vivo 60 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.
The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 60 is not intended to be used as a transport or critical care ventilator.
The Vivo 60 Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.
Flow and pressure are read through flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.
Operator actions are performed via the front panel where the buttons and an LCD screen are located. There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.
The Vivo 60 can be operated by external AC or DC power supply and contains an integrated battery as well as an additional click on battery.
The Vivo 60 can be used with three types of patient circuits: single limb patient circuits including an active exhalation valve, single limb patient circuits including a passive leakage port, and dual limb patient circuits.
This document describes the regulatory submission for the Vivo 60 ventilator and its substantial equivalence to predicate devices (Vivo 50 and Astral 110/150). It outlines various performance tests conducted to demonstrate compliance with specifications and recognized standards.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a single, consolidated table of acceptance criteria (i.e., specific numerical or qualitative thresholds that the device had to meet) alongside the reported device performance in the format you requested. Instead, it lists numerous recognized standards to which the device was tested and then broadly states that the device "conforms with all requirements specifications and applicable standards" and "meets its accuracy specifications."
Here's a partial summary of the performance testing mentioned, but without explicit acceptance criteria or detailed quantitative results:
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1: 2005+CORR. 1:2006+CORR.2:2007+AM1:2012 | "Verified conformance with all requirements specifications and applicable standards." |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2: 2014 (Ed. 4) | "Verified conformance with all requirements specifications and applicable standards." |
| Alarms Systems | Conformance to IEC 60601-1-8: 2006 | "Confirmed proper operation of physiologic and technical alarms." |
| Respiratory Gas Monitors | Conformance to ISO 80601-2-55: 2011 (1st Ed) | "Verified conformance with all requirements specifications and applicable standards." |
| Pulse Oximeter Equipment | Conformance to ISO 80601-2-61:2011 (1st Ed) | "Verified conformance with all requirements specifications and applicable standards." |
| Home Healthcare Ventilators | Conformance to ISO 80601-2-72:2015 (1st Ed) | "Verified conformance with all requirements specifications and applicable standards." |
| Rough Handling Shocks | Conformance to IEC 60068-2-31:2008 | "Verified conformance with all requirements specifications and applicable standards." |
| Battery Testing | Conformance to IEC 62133: 2012 (2nd Ed) | "Confirmed proper operation of the Vivo 60 power management system including transitioning between the different internal and external power sources, power source alarms, and battery operating time." |
| Biocompatibility | Conformance to ISO 10993-1:2009 | "Biocompatibility testing performed: • Cytotoxicity • Sensitization • Irritation/intracutaneous reactivity • Acute systemic toxicity • Pyrogenicity • Subacute/subchronic toxicity Genotoxicity Implantation Hemocompatibility." (All presumably passed, as the conclusion states conformance.) |
| VOC Testing | Conformance to Compendium Method TO-15 and ASTM D5466-01 | "Verified conformance with all requirements specifications and applicable standards." |
| Particulates Testing | Conformance to EPA PM2.5 standard | "Verified conformance with all requirements specifications and applicable standards." |
| Waveform Performance | Waveforms comparable to predicate devices (Vivo 50 and Astral) | "The comparison of the recorded waveforms supports the claim that Vivo 60 is substantially equivalent to the predicate devices." |
| Triggering | Detecting each patient effort within permissible trigger delay without false-triggers | "Showed that the Vivo 60 performed as intended, detecting each patient effort within the permissible trigger delay without false-triggers." |
| Accuracy of Controls/Monitored | Meets accuracy specifications | "Confirmed that the Vivo 60 meets its accuracy specifications." |
| Treatment/Alarm Settings Range | Conforms to specifications | "Confirmed the range and operation of settings for all treatment and alarm parameters conform to specifications." |
| Cybersecurity | Conformance to cybersecurity specifications | "Conformance with all cybersecurity specifications." |
| Software Verification/Validation | Predetermined pass/fail criteria for unit, integration, and system level tests | "All tests passed." |
| Summative Usability | Critical tasks associated with changes from Vivo 50 to Vivo 60 performed adequately (implied from "summative usability... was performed") | "Summative usability / human factors testing was performed including critical tasks associated with the changes from the Vivo 50 to the Vivo 60." (Implied successful completion as part of overall conformance.) |
| RFID Immunity | Immunity to emissions from RFID sources at specified frequencies | "Testing for immunity to emissions from RFID sources was conducted at 125kHz, 134.2kHz, 13.56MHz, 902MHz and using an Electronic Article Surveillance system." (Implied successful completion as part of overall conformance.) |
| Cleaning Validation | No physical or performance degradation after cleaning | "Cleaning validation was performed to ensure no physical or performance degradation occurred." (Implied successful completion as part of overall conformance.) |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size for any specific test set for the performance testing. For most tests, it mentions "the Vivo 60" or "comparative testing with the Vivo 50 and Astral predicate devices" without specifying the number of devices or number of tests performed.
Data provenance is not mentioned (e.g., country of origin, retrospective or prospective). The testing appears to be primarily lab-based engineering verification and validation testing rather than clinical study data from patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The testing described is largely engineering and technical conformance, which would typically rely on calibrated instruments and defined standards rather than expert medical interpretation for "ground truth" as it would be for an AI diagnostic device.
4. Adjudication Method
This information is not provided. Given the nature of the tests outlined (e.g., electrical safety, waveform comparison, accuracy of controls), expert adjudication as seen in clinical studies for diagnostic accuracy would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This device is a ventilator, not an AI-powered diagnostic system where human readers would be assessing cases with and without AI assistance. The performance testing focuses on the device's technical and safety specifications.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study in the context of an AI algorithm was not explicitly described for diagnostic performance. However, the numerous performance tests listed (e.g., waveform performance, triggering, accuracy of controls, software V&V) can be considered "standalone" in the sense that they evaluate the device's inherent function against its specifications and standards, independent of direct human operational impact during the test. The ventilator's control algorithms were tested, but not as a "standalone AI" for diagnostic purposes.
7. Type of Ground Truth Used
The ground truth for the performance testing appears to be based on:
- Recognized Standards: e.g., IEC 60601-1, ISO 80601-2-72, EPA PM2.5.
- Manufacturer's Specifications: The device was tested to confirm it "meets its accuracy specifications" and "conform to specifications."
- Predicate Device Performance: Waveform comparisons were made to predicate devices (Vivo 50 and Astral).
- Expected Functionality: For triggering, the "ground truth" was detecting patient efforts without false triggers, as "intended."
8. Sample Size for the Training Set
This information is not applicable/provided. The Vivo 60 is a conventional mechanical ventilator, not an AI/machine learning device that requires a training set in the typical sense of AI algorithm development for diagnostic or predictive tasks. Its "algorithms" refer to control logic, not learned models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as #8. The control algorithms of the ventilator are based on engineering design and physiological principles, not on "ground truth" established from data used to train a machine learning model.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).