(408 days)
The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, greater than 10 kg or 22 lbs., who require the following general types of ventilatory support, as prescribed by an attending physician: positive pressure ventilation and assist/control. SIMV, CPAP modes of ventilation. The ventilator is suitable for use in post-acute, emergency room, home care environments (P/N HT50-H) and for transport applications (P/N HT50-T). Transport application is only applicable to the HT50-T.
The Newport HT50 Ventilator is a self-contained, electrically powered, microprocessor controlled ventilator. With performance characteristics and clinical features that can support pediatric (≥10 kg) through adult patients, the HT50 is the device of choice for use in sub-acute, emergency room and home care environments (P/N HT50-H) and for transport applications (P/N HT50-T).
Front panel controls allow trained operators to select between a number of operational modes, pressure support and volume or pressure control. A comprehensive alarm system is built-in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides up to 10 hours of power. With its patented, self-contained gas supply source, the HT50 requires no external air compressor.
The provided document describes a 510(k) submission for the Newport HT50 Ventilator, focusing on establishing substantial equivalence to legally marketed predicate devices. It does not contain a comprehensive study with detailed acceptance criteria and performance data as would be found in a clinical trial report.
Here's a breakdown of the information available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format or detailed reported device performance. Instead, it states that the device "meets all applicable device specification requirements for performance testing as identified in the FDA Reviewer guidance for ventilators and heated humidifiers."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in quantitative terms in the provided document. | "Meets all applicable device specification requirements for performance testing as identified in the FDA Reviewer guidance for ventilators and heated humidifiers." |
| Substantial equivalence to predicate devices (TBird Legacy Ventilator and Pulmonetics LTV1000 ventilator) for: |
- Continuous or intermittent ventilatory support
- Pediatric (≥ 10 kg) through adult applications
- Common modalities (volume control, pressure control, pressure support)
- Clinical range of function
- Safety features (alarms, backup ventilation, fail-safe mechanisms)
- Transport functions (internal battery, ease of use, simple circuit design) | The Newport HT50 Ventilator has been "clinically and functionally proven to be safe and efficacious" and "shares substantial equivalency with the TBird Legacy ventilator and the Pulmonetics LTV1000 ventilator" across the specified criteria. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a "test set" in the context of human data or a clinical study. The evaluation appears to be based on non-clinical performance testing and comparison to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is typically relevant for studies involving qualitative assessments or diagnostic accuracy, which are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. As there is no described clinical test set requiring ground truth establishment by experts, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence through performance characteristics and functional comparison to predicate devices, rather than a study involving human readers and AI assistance.
6. Standalone (Algorithm Only) Performance
No. The document describes a medical device (ventilator) and its performance, not an algorithm in the context of AI without human intervention. The performance reported refers to the device's operational capabilities.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not applicable here. The "truth" or benchmark for this submission is the performance and characteristics of the legally marketed predicate devices (TBird Legacy Ventilator and Pulmonetics LTV1000 ventilator) and compliance with FDA reviewer guidance for ventilators. The claim is one of "substantial equivalence" based on functional and clinical similarity, as well as meeting performance specifications.
8. Sample Size for the Training Set
Not applicable. The document does not describe a "training set" in the context of machine learning or AI development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no described training set.
§ 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).