(158 days)
The MOVES™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.
The MOVES™ is intended to deliver high inspired oxygen concentrations via the MOVES™ O2 mask to spontaneously breathing patients who require elevated inspired oxygen.
MOVESTM is intended to be used in a transport or emergency setting on adult patients who weigh between 40 and 120kg.
MOVES™ provides the following supplemental functions for patients that it is ventilating or to whom it is delivering elevated inspired oxygen:
a. Suction
The MOVES™ 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 MOVESTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.
C. Patient Monitoring
The MOVESTM 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 alams will be available to the care provider from the monitor.
The MOVES™ is 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 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 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 510(k) summary for the MOVES™ device does not contain specific acceptance criteria in quantitative terms (e.g., minimum sensitivity, specificity, or error rates) or detailed results of a study designed to prove the device meets such criteria. Instead, it relies on a comparison to predicate devices and adherence to recognized standards.
Here's an analysis based on the information provided, outlining what is or isn't present regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it claims substantial equivalence to predicate devices and compliance with various IEC, ISO, ASTM, and ANSI/AAMI standards. The "reported device performance" is described qualitatively as meeting "all of its performance requirements" and being "substantially equivalent" to predicate devices.
| Acceptance Criterion (Implicit/General) | Reported Device Performance (Qualitative) |
|---|---|
| Ventilator characteristics equivalent to predicates | Characteristics are substantially equivalent to predicates. |
| Patient monitoring performance equivalent to predicates | Performance is substantially equivalent to predicates. |
| Ability to deliver supplemental oxygen equivalent to predicates | Ability is substantially equivalent to predicates. |
| Airway suction performance equivalent to predicates | Performance is substantially equivalent to predicates. |
| No unmitigated risks compared to predicate devices | Introduces no unmitigated risks. |
| Compliance with relevant recognized consensus safety and performance standards | Complies with IEC 60601-1, -1-2, -2-27, -2-30, -2-34, -2-49; ISO 21647, 9919; EN-794-3; ASTM E1112-00; ANSI/AAMI EC-13, SP10. |
| EMC, environmental, shock & vibration testing | Performed in accordance with IEC 60601-1-2, EN794-3, MIL-STD-810F. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The summary refers to "performance testing" but does not detail the methodology, sample sizes (e.g., number of test subjects, test scenarios, or data points), or provenance of any data used in such testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The validation approach is based on demonstrating equivalence to existing devices and compliance with technical standards.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a study requiring a test set with adjudicated ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The device is not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the context presented. The MOVES™ is a medical device for patient support and monitoring, not an algorithm being evaluated for standalone diagnostic or assistive performance. The "performance testing" mentioned refers to the device's functional operation.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/imaging studies (e.g., pathology, expert consensus) is not directly applicable here. For this type of device, the "ground truth" would be the engineering specifications and performance capabilities of the device as measured against recognized standards and the performance of predicate devices. For example, a ventilation parameter's accuracy would be verified against a reference standard or precision instrument, not an expert opinion.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. The MOVES™ device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense. Its "computer-controlled" nature implies programmatic logic rather than learned models.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a "training set" or a machine learning component requiring one.
In summary: The 510(k) process for the MOVES™ device focused on demonstrating substantial equivalence to already cleared predicate devices and compliance with relevant industry standards. The summary does not provide specific quantitative acceptance criteria or detailed results from a clinical or performance study with defined sample sizes, expert involvement, or ground truth establishment in the way one would expect for an AI/diagnostic software submission. The "performance testing" mentioned is general and aimed at confirming functional operation and safety against established standards and predicate device performance.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).