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510(k) Data Aggregation
(133 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
The AURA Family of Ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support through invasive or non-invasive interfaces to individuals that require such medical care. Specifically, the AURA Family of Ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.).
The AURA ventilator is a restricted medical device intended for use by qualified, trained, personnel under the direction of a physician.
The AURA ventilator is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The AURA Ventilator provides ventilatory support for infant, pediatric and adult patients. The AURA ventilator is a prescription device that can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician.
The AURA ventilator 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 AURA ventilator has A/CMV, SIMV, SPONT and VTPC ventilatory modes (Pressure or Volume).
The controls of the AURA 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 AURA has a Trends screen for displaying data graphically. User Help screens present information for all controls and features. The AURA family of ventilators has models that can be differentiated based on whether or not the device has SpO2 monitoring capability.
Here's a breakdown of the acceptance criteria and study information for the AURA Ventilator (K121891) based on the provided text:
Important Note: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and describes the general types of testing performed. It does not detail specific acceptance criteria values (e.g., a specific pressure accuracy tolerance) or the direct results showing compliance with those values for each test. Instead, it broadly states that "all of which confirms that the device meets its design, performance, and electrical safety requirements" and "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties."
Therefore, the table below reflects the categories of performance that were tested, as outlined in the "Nonclinical Data" section, rather than precise numerical acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Category Tested) | Reported Device Performance and Compliance Statement |
|---|---|
| Volume Control | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Pressure Support | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Pressure Control | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Trigger Function | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| PEEP/Bias Flow | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Flow Patterns | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Air/Oxygen Entrainment/Monitoring | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Screens | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Waveforms | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Power Performance | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Intake Valve/Exhalation Resistance | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Respiration Rate, Inspiration time & I/E Ratio | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Functional Safety | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Alarms | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Endurance | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| O2 Cylinder Time Monitoring | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| SpO2 Monitoring (if applicable to model variant) | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Battery Time Monitoring | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Volume Target Pressure Control (VTPC) | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| SIMV | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Export Data | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Maintenance Due | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Usability Test on Less Trained Users | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Emergency/Transport and Environmental Safety | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Shipping Container | "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify discrete "test sets" or their sample sizes in terms of patient data or case numbers. The testing described is
primarily nonclinical verification and validation testing on the device itself (e.g., performance of various ventilatory functions, electrical safety, usability). - Data Provenance: Not applicable as the testing described is primarily laboratory/engineering testing of the device, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" for this type of nonclinical device testing is established by engineering specifications, regulatory standards, and generally accepted principles of ventilator function, rather than expert consensus on medical images or patient outcomes. The "Usability Test on Less Trained Users" implies involvement of human testers, but details on the number or their "qualifications" beyond being "less trained users" are not provided.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human readers are interpreting data (like medical images) and their discrepancies need to be resolved. This document describes device performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly described or conducted. The submission focuses on device performance and substantial equivalence to existing predicate devices, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, implicitly. The "Nonclinical Data" section describes extensive verification and validation testing of the AURA ventilator's various functions (e.g., volume control, pressure support, alarms, battery life). This testing inherently evaluates the device's performance in a standalone capacity, ensuring it meets its specifications without human intervention during its functional operation. (Note: This is different from a standalone AI algorithm's performance in interpreting data.)
7. Type of Ground Truth Used
- The ground truth used for the described nonclinical testing is based on engineering specifications, design requirements, and applicable regulatory/performance standards for ventilators.
8. Sample Size for the Training Set
- Not applicable. This document describes the development and testing of a medical device (ventilator hardware/software), not an AI algorithm that requires a "training set" of data in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as point 8.
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(223 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
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:
- 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.
- Adjudication method
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- 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.
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(72 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
The e360 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility,
The Newport e360. Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical féatures support infant/pediatric (≥20 mL) through adult patients. Front panel controls allow trained operators to select ventilation controls for volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes. A comprehensive alarm system is built-in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides approximately 45 minutes of power. The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
The provided text is a 510(k) summary for the Newport e360™ Ventilator and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.
The document describes a conventional medical device (a ventilator) and its submission for 510(k) clearance by the FDA. The "study" mentioned is a series of nonclinical tests to verify changes to the ventilator, not a study evaluating an AI algorithm's performance against acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
Here's why each point cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory clearance for a ventilator, not performance metrics of an AI.
- Sample size used for the test set and the data provenance: Not present. The "tests" refer to nonclinical verification of engineering changes to the ventilator, not a test set for an AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment for an AI is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No AI test set, no adjudication.
- 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: Not present. This document is not about an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. No algorithm is being evaluated.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No ground truth for an AI.
- The sample size for the training set: Not present. No AI training set.
- How the ground truth for the training set was established: Not present. No AI training set.
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(232 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design, Performance, and Safety Specifications (General) | "All test results confirm the device to meet its design, performance, and safety specifications." |
| Electromagnetic Compatibility | Confirmed to meet specifications. |
| Electrical Safety | Confirmed to meet specifications. |
| Software and Hardware Verification and Validation | Confirmed to meet specifications. |
| Mechanical Properties | "All testing demonstrates that the Newport HT70 performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Substantial Equivalence to Predicate Devices | "The device's intended use is comparable to the referenced predicate devices, and its operating principles, ventilation modes and performance parameters are comparable to the predicate devices." |
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.
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(90 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
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.
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(100 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.
The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital transport includes patient transport within the hospital or hospital-type facility.
The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.
Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.
Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.
A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.
The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
Here's a breakdown of the acceptance criteria and study information for the Newport e500 Wave Ventilator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Ventilation Control Modes | Selectable under volume control, pressure control, and volume target pressure control breath types in A/CMV, SIMV, and SPONT modes. |
| Patient Population Supported | Infant/pediatric (>20 mL) through adult patients. |
| Alarms - Standards Compliance | Meet or exceed standards of critical care ventilators and developed in compliance with ISO9703-1, ISO9703-2, and EN475. |
| Alarms - Type | Span both technical (ventilator related) and non-technical (patient related) alarms. |
| Tidal Volume Support | ≥ 20 mL |
| Intended Environments | Hospital-type, and intra-hospital transport environments. Hospital use (general care, OR, special procedures, ICU/critical care). Hospital-type use (surgicenters, sub-acute, special nursing facilities). Intra-hospital transport. |
| Overall Performance | All test results met pre-defined acceptance criteria for hardware, software, electrical safety, functional safety, EMC, packaging, and environmental testing. |
Missing Information:
The document states that "All test results met pre-defined acceptance criteria," but it does not explicitly list the specific values or thresholds for these criteria (e.g., what constitutes "meeting" a standard, or the exact ranges for performance metrics). It provides a high-level statement of compliance.
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). It describes "Comprehensive verification and validation testing," which implies laboratory or simulated testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The testing described is verification and validation, likely against engineering specifications and industry standards, not against "ground truth" established by clinical experts in the sense of diagnostic accuracy.
4. Adjudication Method for the Test Set
- This information is not provided. Given the nature of the testing described (hardware, software, electrical safety, etc.), an adjudication method by human experts for a "test set" in the context of diagnostic performance is not applicable. The device's performance was evaluated against technical specifications and safety standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done or mentioned. This type of study is relevant for AI/diagnostic devices where human readers interpret medical images or data. The Newport e500 Wave Ventilator is a continuous ventilator, not a diagnostic imaging device.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
- The document describes "Comprehensive verification and validation testing" including hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. This implies standalone testing of the device's components and overall system performance without human intervention in the loop, to ensure it meets its pre-defined specifications and safety standards. However, it's not "algorithm only" in the sense of a standalone AI model's performance being evaluated. It's the performance of the integrated device system.
7. Type of Ground Truth Used
- The "ground truth" for the testing appears to be pre-defined acceptance criteria based on:
- Engineering specifications and design requirements.
- Compliance with international standards (ISO9703-1, ISO9703-2, EN475 for alarms).
- Functional safety requirements.
- Electrical safety requirements.
- EMC (Electromagnetic Compatibility) standards.
8. Sample Size for the Training Set
- This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models that learn from data. While the ventilator is microprocessor-controlled, the document does not suggest it uses a machine learning algorithm that would require a distinct "training set" for its core functionality as described.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not indicated for this device's type of functionality in the provided text, this information is not applicable or provided.
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(25 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
The e360 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility
The Newport e360 Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (≥20 mL) through adult patients. Front panel controls allow trained operators to select ventilation controls for volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes. A comprehensive alarm system is built- in to alert the user to violations of preset safety limits. When fully charged, the internal battery provides approximately 45 minutes of power. The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
This document is a 510(k) summary for the Newport e360 Ventilator. The information provided focuses on the device's description, intended use, and general testing, rather than a detailed study proving performance against specific acceptance criteria in a clinical context. Therefore, many of the requested categories about clinical study design and outcomes cannot be fully addressed from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Hardware Performance | Met pre-defined acceptance criteria (implicit) |
| Software Performance | Met pre-defined acceptance criteria (implicit) |
| Electrical Safety | Met pre-defined acceptance criteria (implicit) |
| Functional Safety | Met pre-defined acceptance criteria (implicit) |
| EMC (Electromagnetic Compatibility) | Met pre-defined acceptance criteria (implicit) |
| Packaging | Met pre-defined acceptance criteria (implicit) |
| Environmental | Met pre-defined acceptance criteria (implicit) |
| Alarm System Performance | "The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995)." |
Explanation: The document states, "Comprehensive verification and validation testing was performed with the Newport e360 Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria." However, it does not provide specific numerical or qualitative acceptance criteria for these categories, nor does it detail the specific performance results for each. It only states that the criteria were met. The alarm system's performance is specifically mentioned as meeting or exceeding critical care ventilator standards and FDA guidance.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in this document. The testing described is verification and validation, which often involves engineering and regulatory tests, not necessarily a "test set" in the context of clinical data for AI/ML performance.
- Data Provenance: Not applicable. This document describes testing for a ventilator device, not an AI/ML algorithm that relies on patient data for its performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert-established ground truth from clinical data. The "ground truth" for a ventilator's performance is typically defined by engineering specifications, regulatory standards, and physical measurements.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes.
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
- Not applicable. This document describes a medical device (ventilator) and its engineering-based verification and validation, not an AI-assisted diagnostic or interpretive system that would be subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not a study of an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance would be based on:
- Engineering Specifications: Designed performance parameters.
- Regulatory Standards: Compliance with FDA Draft Reviewer Guidance for Ventilators (1995) and other relevant industry standards for medical devices (e.g., electrical safety, EMC).
- Physical Measurements and Testing: Verification of output pressures, volumes, modes, alarm thresholds, etc., using specialized equipment.
8. The sample size for the training set
- Not applicable. This is not an AI/ML system requiring a training set from data.
9. How the ground truth for the training set was established
- Not applicable.
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(203 days)
NEWPORT MEDICAL INSTRUMENTS
The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.
The Newport C250 Air Compressor is electric and produces air from the normal environment to supply compressed air for Newport ventilators.
This document appears to be a 510(k) summary for a medical device, the Newport C250 Air Compressor. It details the device's intended use, its substantial equivalence to predicate devices, and the testing performed. However, it does not contain a study that proves the device meets specific acceptance criteria in the format requested.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that comprehensive testing was conducted "in accordance with various industry recognized standards" and that "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table.
The standards mentioned are:
- IEC 60601-1-2:1993
- CSA 22.2 No 601-1-M90
- UL 2601-1
- EN 55011:1998 &A1:1999
These are general safety and electromagnetic compatibility (EMC) standards for medical electrical equipment. They would have specific test limits and pass/fail criteria, but these are not enumerated in the 510(k) summary. The summary only states that the device meets its specifications and is safe/effective, implying it passed the tests against these standards.
2. Sample size used for the test set and the data provenance:
This type of information is not applicable to this 510(k) submission. The Newport C250 Air Compressor is an electromechanical device, not an AI/software device that processes data in the way typically associated with "test sets" or data provenance (e.g., country of origin for clinical images). Testing would involve a fixed number of physical units of the compressor, often a single unit or a small batch, subjected to rigorous environmental, electrical, and performance tests. The data provenance would be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to the Newport C250 Air Compressor. "Ground truth" established by experts is relevant for diagnostic or image analysis AI/software, not for a physical air compressor whose performance is measured by objective physical parameters (e.g., pressure, flow, purity, noise, electrical safety).
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in labeling or assessing data, which is not relevant for the testing of this physical device.
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:
Not applicable. This is a physical medical device (an air compressor), not an AI-assisted diagnostic or image analysis system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to its premarket submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for a device like an air compressor would be its physical specifications and objective measurements of its performance (e.g., pressure output, air purity, noise levels, power consumption) against established engineering and safety standards.
8. The sample size for the training set:
Not applicable. Training sets are used for machine learning models, not for physical electromechanical devices like an air compressor.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
Summary of what the document does provide regarding acceptance and testing:
- Acceptance Criteria (Implied): The device's specifications (e.g., "supply a source of clean, oil-free pressurized air at 42 psig") and compliance with the listed industry standards (IEC 60601-1-2, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011). While not numerically stated here, these standards contain specific, measurable acceptance criteria.
- Study/Testing Information: "Comprehensive testing has been conducted... in accordance with various industry recognized standards." The results of this testing "provides assurance that the device meets its specifications and is safe and effective for its intended use." The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate, often through a combination of design, performance testing, and comparison of technical characteristics to the predicate. The FDA's clearance implies they were satisfied with the demonstration of compliance with the standards and the device's specifications.
This 510(k) summary is typical for a Class II electromechanical device that does not involve AI or complex data analysis, hence the absence of the detailed information about test sets, experts, or training data that you requested.
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(134 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
The NebSonic N550 Nebulizer delivers nebulized medication for patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic is indicated for adult, pediatric, and neonatal patients.
The NebSonic N550 Nebulizer is an ultrasonic nebulizer designed to deliver nebulized medication to patients being mechanically ventilated without affecting ventilator performance or patient data. It is powered by external AC (100-240 volts), allowing its use with patients on mechanical ventilation or for patient use independent of a ventilator. The NebSonic N550 Nebulizer contains piezoelectric crystal that generates ultrasonic vibrations that travel through distilled water in a vial to liquid medication in a medication cup. The vibrations convert the medication into an aerosol mist. The nebulized medication is carried to the patient by the gas traveling through the ventilator breathing circuit.
The provided text describes a 510(k) submission for the Newport NebSonic N550 Ultrasonic Nebulizer, a traditional 510(k) submission (K041082). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's efficacy through a clinical study with acceptance criteria in the typical sense.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define specific "acceptance criteria" in terms of clinical or performance benchmarks (e.g., a specific percentage improvement in a clinical outcome, or a defined accuracy threshold for a diagnostic device). Instead, it states that:
"Testing was conducted to characterize particle size and drug mass generated by the NebSonic N550 Nebulizer in comparison to a predicate device. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use."
This implies that the "acceptance criteria" were met if the device's particle size and drug mass characteristics were comparable or within an acceptable range relative to the predicate device. However, the specific numerical criteria for "comparable" are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Particle size generation comparable to predicate device. | "Characterized... in comparison to a predicate device." (Specific values not provided) |
| Drug mass generation comparable to predicate device. | "Characterized... in comparison to a predicate device." (Specific values not provided) |
| Meets specifications. | "Provides assurance that the device meets its specifications." (Specific specifications not provided) |
| Safe and effective for intended use. | "Provides assurance that the device... is safe and effective for its intended use." (Conclusion based on testing) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "thoroughly evaluated at the unit and system level" and "comprehensive testing," but it does not specify the sample size for any test set. The data provenance is also not explicitly stated as retrospective or prospective, or country of origin. Given the nature of a medical device submission for a nebulizer, it's highly likely that this testing involved in vitro laboratory experiments on a sample of manufactured devices, rather than human subjects or a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for a nebulizer's performance typically comes from direct measurements using specialized equipment (e.g., laser diffraction for particle size, gravimetric analysis for drug mass), not expert consensus in the way a diagnostic imaging study would require.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication is relevant for subjective assessments, typically in clinical trials or diagnostic studies. For objective performance metrics like particle size and drug mass, direct measurement is performed.
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
This information is not applicable. The NebSonic N550 is an ultrasonic nebulizer, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an ultrasonic nebulizer, a physical medical device for drug delivery, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance (particle size and drug mass) would have been established through direct experimental measurements in a laboratory setting, using standardized methodologies for nebulizer characterization. This is an objective measurement, not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical product directly performing its function, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth for such a set.
Summary of the Study:
The study described for the NebSonic N550 Nebulizer was a device performance characterization study primarily focused on demonstrating substantial equivalence to existing predicate devices. It involved:
- In vitro testing of the nebulizer's performance.
- Measured parameters: particle size and drug mass generation.
- Comparison to predicate devices (Siemens Servo Ultra Nebulizer, Models 145 and 345; Puritan-Bennett EasyNeb Nebulizer).
- Compliance with various industry recognized standards (IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999) for electrical safety and electromagnetic compatibility.
The 510(k) clearance (K041082) indicates that the FDA found this testing and comparison sufficient to determine that the NebSonic N550 Nebulizer is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use. The documentation provided focuses on the regulatory submission process for a traditional medical device, not a diagnostic or AI-powered system, which would necessitate different evaluation methodologies.
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(318 days)
NEWPORT MEDICAL INSTRUMENTS, INC.
The e500 Ventilator is intended to provide continuous (ET tube) or noncontinuous (mask) ventilatory support and monitoring for infant, peditric and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.
The intended environments include hospital, hospitaltype and intra- hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities suc h as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
The Newport e500 Wave Ventilator is a self-contained, electrically powered microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (=20mL) through adult patients.
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 an average of 1.5 hours of power.
The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
The provided text describes a 510(k) submission for the Newport e500 Wave Ventilator, asserting its substantial equivalence to predicate devices. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in a format that lends itself to direct extraction for the requested table and analytical points.
Instead, the document focuses on regulatory compliance, outlining the device's characteristics, intended use, and comparison to predicate devices, along with the results of non-clinical tests demonstrating adherence to various standards. It concludes that the device has "functionally proven to be safe" and "meets its stated performance specifications."
Therefore, I cannot directly populate the requested table or provide detailed responses to points 1-9 as a specific "study" with set acceptance criteria, sample sizes, and ground truth establishment is not presented in the provided text.
The closest information available is:
- Acceptance Criteria (implied): Conformance to various domestic and international standards (IEC601-1, CISPR 11, EN60601-1-2, EN 794-1, ISO9703-1&2, ASTM F 1100-90, MIL-STD461D, MIL-STD810E) and the "FDA Reviewer Guidance for Ventilators" and "Reviewer Guidance for Premarket Computer Controlled Medical Devices Undergoing 510(k) Review." The device must also be "safe" and "effective" as the predicate devices.
- Reported Device Performance: "The Newport e500 Wave Ventilator meets all applicable device specification requirements for performance testing" and "functionally proven to be safe. The device meets its stated performance specifications."
Without a dedicated study section detailing performance against specific, quantifiable acceptance criteria, the other points (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document. The document primarily focuses on regulatory approval through substantial equivalence and compliance with established standards, rather than presenting a performance study against novel acceptance criteria.
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