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510(k) Data Aggregation
(379 days)
The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
a. Suction
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.
b. Supplementary Oxygen
The MOVES® SLC™ is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.
c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.
The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), a portable multifunction patient support and monitoring system with the following capabilities:
- Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
- Delivery of oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
- Patient monitoring functions including the following patient parameters: Pulse Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
- Suction/aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure.
The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.
The provided text is a 510(k) summary for the MOVES® SLC™ medical device, which is an emergency ventilator with additional functions. This document describes the device, its indications for use, and its comparison to predicate devices to demonstrate substantial equivalence. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
Specifically, the document:
- Does not provide a clear table of acceptance criteria and reported device performance. It offers a comparison table of features and characteristics between the MOVES® SLC™ and predicate devices, including some performance specifications like frequency range, tidal volume, and SPO2 accuracy, but these are comparative, not acceptance criteria.
- Does not mention anything about sample sizes used for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This is because the device is a piece of hardware (ventilator, monitoring, suction, oxygen concentrator) and not an AI/software device that would typically involve such studies for regulatory clearance.
- Does not discuss a training set or how ground truth for a training set was established. This is irrelevant for a hardware medical device of this type.
- States that "Testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements" and a "Summary of Performance Testing" section mentions that "The results of performance testing demonstrate that the characteristics the MOVES® SLC™ are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction." However, it does not explicitly detail the specific performance test results against a defined set of acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on features, characteristics, and compliance with general medical device standards, rather than proving performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.
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(172 days)
The INOmax® DS delivery system delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.
The INOmax® DS provides continuous integrated monitoring of inspired O₂, NO₂, and NO, and a comprehensive alarm system.
The INOmax® DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax® DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
The INOmax DSIR® uses a "dual-channel" design to ensure the safe delivery of INOMAX®. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO₂, and O₂ cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX® delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX® delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.
The provided document describes the INOmax DSIR® (Delivery System), a device for delivering nitric oxide to patients. The submission is a 510(k) for a software update (version 3.0) and compatibility with two additional respiratory care devices (Hamilton C1 and T1 Ventilators).
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance |
|---|---|
| 02 dilution | Tested and confirmed compatibility with the new respiratory care devices. (Implied that 02 dilution was within acceptable limits, as the "Testing Conclusion" states the device performed within published specifications.) |
| Effect on delivered pressures | Tested and confirmed compatibility with the new respiratory care devices. (Implied that delivered pressures were within acceptable limits, as the "Testing Conclusion" states the device performed within published specifications.) |
| INOmax DSIR® delivery accuracy | Tested and confirmed compatibility with the new respiratory care devices. (Implied that delivery accuracy was maintained, as the "Testing Conclusion" states the device performed within published specifications.) |
| NO2 generation | Tested and confirmed compatibility with the new respiratory care devices. (Implied that NO2 generation was within acceptable limits, as the "Testing Conclusion" states the device performed within published specifications.) |
| Software Functionality (new/modified user convenience features and alarms) | Software verification confirmed the INOmax DSIR® is compliant with its system level requirements and that the new/modified user convenience features and alarms function as specified. |
| Electrical Safety (IEC 60601-1:2005) | Support for substantial equivalence was provided as a result of risk management and testing which included electrical safety tests. (Implied compliance with the standard). |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | Support for substantial equivalence was provided as a result of risk management and testing which included performance tests. (Implied compliance with the standard). |
| Alarm Systems (IEC 60601-1-8:2006) | Support for substantial equivalence was provided as a result of risk management and testing which included safety tests. (Implied compliance with the standard, and new alarm functionality was verified for the "Low Calibration Failed" alarm). |
| Usability (Human Factors Engineering) (ANSI/AAMI HE75) | A formative usability study was conducted to aid in the development of requirements. (While a formative study is mentioned, the text doesn't explicitly state the acceptance criteria derived from this or the outcome in terms of meeting specific usability performance metrics, only that it aided requirement development.) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes testing for the new software version and compatibility with two new ventilators. The "test set" consisted of:
- Two additional respiratory care devices: Hamilton C1 Ventilator (K120574) and Hamilton T1 Ventilator (K120670).
- INOmax DSIR® settings: Five settings were used: 0 (baseline), 1, 5, 20, 40, and 80 ppm, for each setting and mode of ventilation, as well as the Backup mode.
The data provenance is non-clinical testing, performed in a controlled laboratory setting (likely within the company or a certified testing facility). There is no indication of country of origin of the data, but the company is based in Madison, Wisconsin, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
There is no mention of "experts" being used to establish ground truth in the context of the device's technical performance. The "ground truth" for this engineering validation would be the physical measurements taken by calibrated instruments, and the functionality verification against predetermined specifications. The text does not refer to human experts evaluating the "ground truth" of the device's performance characteristics.
4. Adjudication Method for the Test Set
Not applicable. This was a technical performance verification study, not a study involving human interpretation where adjudication would typically be used to resolve discrepancies in expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, INOmax DSix®, with updated software and interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was effectively a standalone performance evaluation of the device. The testing described assesses the device's ability to accurately deliver nitric oxide, monitor gases, and function with specific ventilators, without human intervention being part of the performance measurement itself (though human users operate the system). The tests focused on the device's intrinsic mechanical and software performance.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was instrumental measurements of various parameters (e.g., O2 dilution, delivered pressures, NO delivery accuracy, NO2 generation) and functional verification against predetermined specifications for software features and alarms.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware/software system, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "software update" refers to deterministic code changes and feature enhancements, not a learned model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/ML. The "ground truth" for the device's design and functionality would be established through engineering specifications, previous predicate device performance, and compliance with recognized standards.
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