(185 days)
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
The VAR-Monitor is a battery (9 VDC) operated device that is mounted onto the VAR to monitor cycling conditions during operation.
The provided text describes a 510(k) summary for the "VAR with VAR-Monitor™" device, which is a powered emergency ventilator.
Here's an analysis based on the given information:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the VAR with VAR-Monitor is its compliance with ASTM F 920-93 (Reapproved 1999), "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mechanical Performance: Meets or exceeds ASTM Designation: F 920-93 | Passed: "The VAR with VAR-Monitor meets and exceeds 'Standard |
| (Reapproved 1999) "Standard Specification for Minimum Performance and Safety | Specification for Minimum Performance and Safety Requirements for Resuscitators |
| Requirements for Resuscitators Intended for Use with Humans." | Intended for Use with Humans,' ASTM Designation: F 920-93 (Reapproved 1999)." |
| Alarm Functionality: Detection of non-cycling condition and activation of | Functionality Confirmed: "VAR-Monitor detects a non-cycling condition of |
| visual and audible alarms within a preset time of eight (8) seconds. | the VAR modulator Indicating that no pressure changes have occurred. When the |
| VAR-Monitor is powered on and ready, the device will check for the 'pressure | |
| signal.' If the pressure stays unchanged for more than the preset time of eight | |
| (8) seconds, both visual and audible alarms will be activated." | |
| Clinical Efficacy (Indirect through equivalence): Substantially equivalent | Substantially Equivalent: "In conclusion, the modified VAR with VAR-Monitor |
| to legally marketed predicate devices in terms of intended use, | is substantially equivalent (SE) to legally marketed predicate devices." |
| operational characteristics, and safety. | |
| Absence of Adverse S&E Information: No new safety or effectiveness concerns. | None: "Adverse S & E Information: None" |
| Overall Conclusion: Passed all required tests and met all predetermined | Conclusion: "The VAR with VAR-Monitor passed all required tests and |
| acceptance criteria for applicable standards. | demonstrated that it meets all predetermined acceptance criteria for applicable |
| standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical Tests: None" and does not refer to a "test set" in the context of clinical data. The evaluation appears to be based on engineering tests against the ASTM standard and comparison to predicate devices, rather than a clinical study with patients or a specific dataset. Therefore, there is no mention of sample size or data provenance in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As "Clinical Tests: None" is stated, there is no indication of a test set requiring ground truth established by experts. The evaluation primarily relies on compliance with the ASTM standard and comparison to predicate devices.
4. Adjudication Method for the Test Set
Given that no clinical test set is described, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "Clinical Tests: None." This type of study would fall under clinical testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical device (ventilator) with a monitor, not an algorithm in the typical AI sense. The performance evaluation focuses on the mechanical and alarm functions of the device itself, which are inherently "standalone" in their operation rather than involving a human-in-the-loop for interpreting algorithm outputs.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is primarily derived from:
- Engineering Standards: Compliance with ASTM F 920-93 (Reapproved 1999) for performance and safety.
- Operational Characteristics: Whether the device successfully detects a non-cycling condition and triggers alarms within the specified time.
- Predicate Device Comparison: The established safety and effectiveness of the existing predicate devices (RespirTech PRO, RespirTech PRO O₂C, VAR-Plus Model PCM).
There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for a specific clinical dataset.
8. The Sample Size for the Training Set
The document does not describe the development of an AI algorithm or a "training set." The device is a ventilator with an alarm monitor, evaluated against engineering standards and substantial equivalence to predicate devices, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or AI algorithm.
§ 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).