(90 days)
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 lbs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation.
The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The modified NEWPORT HT50 Ventilator is an electrically powered, microprocessor controlled, variable flow generating ventilator which provides Assist Control, SIMV and SPONT/CPAP modes of ventilation in combination with servo-solenoidcontrolled, built-in PEEP.
The modified NEWPORT HT50 may be powered by external power (100-240 VAC or 12-30 VDC) or internal battery system power. Any time external power is connected to the ventilator, the internal battery system is charging.
Here's an analysis of the acceptance criteria and study information for the NEWPORT HT50® Ventilator based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes acceptance criteria and reported device performance primarily in terms of battery life and functional integrity following the addition of a new battery system.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dual PAC™ Internal Battery System Functionality: | |
| Correct switching to backup battery at target voltage. | Verified (tested) |
| Proper charging circuit function. | Verified (tested) |
| Ventilator operation on main and backup battery. | Verified (tested) |
| Proper warnings regarding battery status. | Verified (tested) |
| Proper switching to backup battery if main battery is defective. | Verified (tested) |
| Proper warning to user if backup battery is defective. | Verified (tested) |
| Low Battery alarm activation (message, LED, audible). | Confirmed, indicates minimum 30 minutes remaining. |
| Minimum 30 minutes of combined battery power after low battery alarm before shutdown. | Confirmed, provides minimum 30 minutes. |
| Battery Empty alarm activation (message, LED, audible). | Confirmed, indicates minimum 15 minutes remaining. |
| Minimum 15 minutes of combined battery power after battery empty alarm before shutdown. | Confirmed, provides minimum 15 minutes. |
| Re-Verification of All Functions and Alarms: | |
| Proper functionality and alarming for all ventilator operations (to ensure no inadvertent impact from software revisions). | Confirmed (complete re-verification performed). |
| EMC and Safety Testing: | |
| Meets electrical safety requirements with new battery pack. | Verified (tested). |
| Meets environmental requirements with new battery pack. | Verified (tested). |
| Meets EMC requirements with new battery pack. | Verified (tested). |
| Transport Use Standards: | |
| Compliance with MIL-STD-810E Environmental Test Methods. | Verified (testing based on this standard). |
| Compliance with IEC 68-2 Environmental Testing. | Verified (testing based on this standard). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of patient data or clinical trials. Instead, the testing described appears to be primarily engineering verification and validation of the device itself and its new battery system.
- Sample Size: Not applicable in the traditional sense of patient data. The "sample" would be the device itself (presumably one or more units).
- Data Provenance: The testing was integral to the device development and modification, suggesting it was conducted prospectively by the manufacturer (Newport Medical Instruments, Inc.). There is no mention of country of origin for external data as no such data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described testing did not involve establishing ground truth from patient data with expert review. The "ground truth" here would be the defined engineering specifications and regulatory standards that the device performance was measured against. The experts involved would be the engineers and quality assurance personnel at Newport Medical Instruments responsible for designing, testing, and verifying the device's compliance. Their qualifications are not explicitly stated in the submission but would include expertise in ventilator design, electrical engineering, software engineering, and regulatory compliance.
4. Adjudication Method for the Test Set
This is not applicable as there was no expert review or consensus-based ground truth establishment using patient data. The "adjudication" in this context would be the internal review and approval processes by the manufacturer's engineering and quality teams to confirm that the test results met the predefined specifications and standards.
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, an MRMC comparative effectiveness study was not done. This submission is for a continuous ventilator, not an AI-assisted diagnostic or interpretative device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a mechanical ventilator, not an algorithm, and its operation inherently involves a human operator (qualified, trained personnel under the direction of a physician). The performance testing was for the device's physical and functional capabilities, not an algorithm's standalone accuracy.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Engineering Specifications: Designed performance parameters for the ventilator and its DUAL PAC™ Internal Battery system (e.g., specific voltage switching points, charging circuit functionality, alarm thresholds, and minimum battery run times).
- Regulatory Standards: Compliance with relevant national and international standards for medical devices, electrical safety, environmental testing, and EMC (e.g., MIL-STD-810E, IEC 68-2).
- Predicate Device Performance: The modified device's performance was also assessed against the established safety and effectiveness of its predicate devices.
8. The Sample Size for the Training Set
This is not applicable. The device is a mechanical ventilator, not a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set mentioned or implied for a mechanical ventilator.
§ 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).