Search Results

The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).

The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

The Newport HT70 Ventilator provides ventilatory support for neonate, infant, pediatric and adult patients. It can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician. The HT70 ventilator design provides maximum mobility and safety for short or long distance transport of critically ill patients and also for patients who are going about their normal activities of daily life.

The HT70 may be operated from AC or DC external power sources or from the integrated battery system. Any time the ventilator is connected to external power, the integrated battery system is charged, including while the ventilator is in use. The HT70 ventilator has A/CMV, SIMV and SPONT ventilatory modes (Pressure or Volume).

The controls of the HT70 ventilator are easily found on the front touch screen and panel. The touch screen can be set up in Hospital, Transport or Basic functional Domains to provide the user with full or limited access. The HT70 has a Trends screen for displaying data graphically. User Help screens present information for all controls and features.

This document describes a 510(k) submission for the Newport HT70™ Ventilator, seeking authorization for enhancements including an on-airway flow sensor for exhaled volume monitoring and flow trigger, and SpO2 monitoring. This is a traditional 510(k) submission to authorize a modification to an already existing device and therefore does not include a comparative effectiveness study. No standalone studies were included with the submission packet. Hence, based on the provided document, I am unable to provide a response for the following sections:

1. A table of acceptance criteria and the reported device performance: This document does not describe the specific performance characteristics being evaluated, nor does it list any acceptance criteria. It states that the device has undergone "extensive verification, validation and design safety testing," which confirm it meets "design, performance, and safety requirements," but no specific metrics are provided.
2. Adjudication method
3. 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
4. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
5. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
6. The sample size for the training set
7. How the ground truth for the training set was established

Here's what can be extracted from the provided text:

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified. The document states "extensive verification, validation and design safety testing" were performed, but no specific sample size for a test set is mentioned for the enhancements.
• Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as the document does not mention any ground truth establishment by experts for the device's performance related to the enhancements. The submission focuses on device modifications and testing to ensure it meets design and safety requirements, rather than a diagnostic performance evaluation against an expert-established ground truth.

Ask a specific question about this device