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

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 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 is a state of the art ventilator that combines ruggedness, exceptional mobility, and ease of use with clinical proficiency to provide ventilatory support for infant, pediatric and adult patients. It has a durable exterior and robust overall design that stands up to the harsh environments found in emergency response, transport and homecare environments. The HT70's unique 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 is user friendly with all controls easily found on the front touchscreen and panel; there are no complicated menus or difficult sequences to follow in order to make necessary adjustments for common operations. It may be operated from AC or DC external power sources or from the "hot-swappable" 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 Newport HT70™ Family of Ventilators is a device intended to provide continuous or intermittent positive pressure mechanical ventilatory support.

Here's an analysis based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific tests. The document refers to "a series of tests" but does not quantify the number of units or test iterations.
• Data Provenance: The tests are non-clinical and would have been conducted by the manufacturer, Newport Medical Instruments, Inc., likely at their facilities in Costa Mesa, CA, USA. The data is retrospective in that it's prior to the 510(k) submission, but it's new data generated for this specific device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable to this 510(k) submission. The Newport HT70 Ventilator is a medical device designed to perform a physical function (mechanical ventilation) and its performance is evaluated against engineering, electrical, and software specifications, rather than against an expert-derived ground truth based on interpretation (e.g., image analysis for disease detection).

4. Adjudication Method for the Test Set

• Not applicable. As the performance assessment is based on objective measurements against predefined specifications, an adjudication method for reconciling expert opinions is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance

• No. An MRMC study is not applicable here. This device is a ventilator, not an AI-assisted diagnostic or decision-support tool where human readers interact with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of AI algorithms. While the ventilator's software and hardware perform functions independently of continuous human-in-the-loop operation, this is not an "algorithm-only" performance as understood in AI/ML contexts. The device's performance is tested as a complete system of hardware and software.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests were the engineering design specifications, performance requirements, and safety standards (e.g., electromagnetic compatibility standards, electrical safety standards, internal performance metrics for ventilation parameters). For substantial equivalence, the "ground truth" was the performance and operating principles of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a conventional medical device (ventilator) and does not involve AI/Machine Learning, therefore there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Ask a specific question about this device