(391 days)
The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.
The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring.
The VORTRAN® APM-Plus is an airway pressure monitor. The provided text outlines the device's technical specifications and comparison to predicate devices, but it explicitly states "Clinical Studies None" under the "Performance Data" section (Page 11).
Therefore, based on the provided text, a study proving the device meets acceptance criteria through clinical performance data, a multi-reader multi-case (MRMC) study, or a standalone algorithm-only study was not conducted or provided as part of this 510(k) submission.
The performance data provided for the VORTRAN® APM-Plus focuses on:
- Biocompatibility Testing: Comparing patient-contacting materials to a cleared reference device (K103639).
- Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8.
- Software Verification and Validation Testing: Development in accordance with FDA guidelines and IEC 62304.
- Risk Management: Compliance with ISO 14971.
- Shelf Life: An accelerated shelf life test showing a simulated age of 1 year.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance based on clinical study data, human reader performance, or standalone algorithm performance from the given document.
The tables of "Performance Specifications" (starting on page 8) list the device's stated ranges and accuracies, essentially defining its intended performance characteristics or "acceptance criteria" from a technical specification standpoint rather than from a clinical study outcome.
However, if we interpret "acceptance criteria and reported device performance" as the technical specifications and their stated values, we can construct the following table based on the "Performance Specifications" section (pages 8-9):
Technical Acceptance Criteria and Reported Device Performance (Based on Stated Specifications)
| Acceptance Criteria (Target Specification) | Reported Device Performance (Stated Value) |
|---|---|
| Pressure Display Range | 0 to 55 cm-H2O |
| Pressure Display Accuracy | ± 1 cm-H2O |
| Pressure Display Resolution (Resuscitator Mode) | 1 cm-H2O |
| Pressure Display Resolution (PAP Mode) | 0.1 cm-H2O |
| Respiratory Rate Display Range | 0 to 99 BPM |
| Respiratory Display Rate Accuracy | ± 10% |
| Respiratory Rate Display Resolution | 1 Breath per Minute |
| I-Time & E-Time Display Range | 0 to 9.9 seconds |
| I-Time & E-Time Display Accuracy | ± 10% |
| I-Time & E-Time Display Resolution | 0.1 second |
| I:E Ratio Display Range | 1:0.0 to 1:9.9 |
| I:E Ratio Display Accuracy | ± 10% |
| I:E Ratio Display Resolution | 0.1 |
| Alarm Delay (Non-Cycling Alarm Only) | 1-20 seconds |
| High Pressure Alarm Range | 1 to 50 cm-H2O |
| High Pressure Alarm Resolution | 1 cm-H2O |
| Low Pressure Alarm Range | 1 to 15 cm-H2O |
| Low Pressure Alarm Resolution | 1 cm-H2O |
| High Rate Alarm Range | 12 to 99 BPM |
| High Rate Alarm Resolution | 1 BPM |
| Non-Cycling Alarm Range | 1 to 20 seconds |
| Non-Cycling Alarm Resolution | 1 second |
| Low Battery Alarm | YES |
| Battery Life (Worst-Case) | 164 Hours |
| Calibration | None (Stated) |
Since "Clinical Studies None" is stated, the following information cannot be extracted from the provided document:
- Sample sizes used for the test set and data provenance: Not applicable as no clinical test set was described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for clinical performance. The software verification and validation would have tested the algorithm's functionality against its specified requirements, but not in a clinical "standalone" performance study.
- The type of ground truth used: Not applicable for clinical performance. Ground truth for technical specifications would be derived from laboratory calibration and testing.
- The sample size for the training set: Not applicable as a clinical training set is not described. This device is an airway pressure monitor, not typically an AI/ML device that requires a "training set" in the conventional sense for clinical performance. Its software capabilities are described as "microprocessor controlled" and for "calculating related characteristics" and triggering alarms (Page 4).
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) clearance for the VORTRAN® APM-Plus was based on substantial equivalence to predicate devices and adherence to relevant electrical safety, software, and quality system standards, without the need for clinical performance studies.
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).