(77 days)
The Pneupac VR1 range are hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. They are designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions:
Pneupac VR1 Standard - Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/insufficiency or no respiratory function.
Pneupac VR1 Responder Basic ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with no respiratory function.
Pneupac VR1 Standard and VR1 Responder is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and interhospital transport.
The Pneupac VR1 range comprises two variants - Pneupac VR1 (standard model) and Pneupac VR1 Responder (standard model without spontaneous breathing system).
The Pneupac VR1 Standard and VR1 Responder allow two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control.
The Pneupac VR1 Standard and VR1 Responder use the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation.
The Pneupac VR1 Standard and VR1 Responder incorporate a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH20 optional) which operates in an identical manner to the predicate devices.
The Pneupac VR1 Standard and VR1 Responder consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items;
- User replaceable patient valve
- Oxygen input gas hose assemblies
- Breathing filter
- Biological breathing filter kit (optional for contaminated atmospheres)
- Masks, airways and airway adjuncts
- Manual suction
- Oxygen therapy kits
- Oxygen cylinders and regulators
- Carrying bag
- Breathing circuits
- PEEP accessories
The specification for the recommended, optional biological breathing filter are as follows; - Filter efficiency at least 99.99% efficient against a 0.3micron mass median aerodynamic diameter aerosol challenge at 32 1/min.
- Airflow resistance at 32 1/min. is 10-17 mm H2O
- Connector size 40mm DIN NATO compatible threads
The mass of Pneupac VRI Standard and VRI Responder resuscitators is; Pneupac VR1 0.880lb. 0.400kg Pneupac VR1 Responder 0.825lb, 0.375kg
The Pneupac VR1 Standard and VR1 Responder standard control module has the following features: - Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to 1050ml/10bpm using a single tidal volume/frequency control
- Demand breathing system (not featured on the VRI Responder model)
- Spontaneous breathing under power failure
- Audible pressure relief alarm
- Integrated, user replaceable patient valve
- Automatic or Manual mode selector
- Manual mode push button and omni-directional lever
The provided document describes the Pneupac VR1 Standard and VR1 Responder, which are ventilatory resuscitators. The information primarily focuses on safety and performance testing to ensure compliance with relevant standards, rather than a study with specific acceptance criteria in terms of algorithm performance or human-in-the-loop improvements. This is a premarket notification (510(k)) and largely demonstrates substantial equivalence to a predicate device through engineering and performance testing.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as compliance with recognized standards and the device performing within its specifications, as well as being comparable to the predicate device. Specific quantitative thresholds for performance are cited from these standards.
| Acceptance Criterion (Standard or Requirement) | Reported Device Performance |
|---|---|
| Safety Testing: | |
| ASTM F 920-93 'Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans' | "The resuscitator passed all of these tests and met all requirements of the standards." |
| RTCA DO160D section 4.6.2 10,000ft to 20,000ft | "The resuscitator passed all of these tests and met all requirements of the standards." |
| RTCA DO160D section 8 profile C | "The resuscitator passed all of these tests and met all requirements of the standards." |
| RTCA DO160D section 12 | "The resuscitator passed all of these tests and met all requirements of the standards." |
| Environmental Testing: | |
| Operating and extended temperature/humidity, ETR784 to ASTM F920-93 section 8.2 and Smiths input requirements | "The results demonstrated that the Pneupac VR1 Standard and VR1 Responder complied with the guidelines and standards and that they performed within their specifications and functional requirements." |
| Storage temperature/humidity, ETR745 to ASTM F920-93 section 8.1 | "The results demonstrated that the Pneupac VR1 Standard and VR1 Responder complied with the guidelines and standards and that they performed within their specifications and functional requirements." |
| Vibration, ETR754 to MIL-STD 810F section 514.4 and RTCA DO160D section 8 profile C | "The results demonstrated that the Pneupac VR1 Standard and VR1 Responder complied with the guidelines and standards and that they performed within their specifications and functional requirements." |
| Altitude, ETR755 to MIL-STD 810F section 500.4, RTCA DO160D section 4.6.2 10,000ft to 20,000ft and Smiths input requirements | "The results demonstrated that the Pneupac VR1 Standard and VR1 Responder complied with the guidelines and standards and that they performed within their specifications and functional requirements." |
| MRI, ETR752 to 3 Tesla | "The results demonstrated that the Pneupac VR1 Standard and VR1 Responder complied with the guidelines and standards and that they performed within their specifications and functional requirements." (Intended use states "will operate safely in an MRI environment up to 3 Tesla.") |
| IP rating, ETR750 to IEC 529 rating IP5x, IPx5, Ipx6 and Ipx7 | "The results demonstrated that the Pneupac VR1 Standard and VR1 Responder complied with the guidelines and standards and that they performed within their specifications and functional requirements." |
| Filtration Efficiency (Optional filter) | At least 99.99% efficient against a 0.3micron mass median aerodynamic diameter aerosol challenge at 32 1/min. |
| Airflow resistance (Optional filter) | 10-17 mm H2O at 32 1/min. |
| Comparison to Predicate Device | "Based on these results, it is our determination that the device model(s) are safe, effective and perform as well as the legally marketed predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
This document describes hardware testing of a medical device (ventilatory resuscitator), not an AI algorithm. Therefore, concepts like "test set," "sample size," "data provenance," and "country of origin" as they relate to data for AI models are not directly applicable.
The testing involved physical devices and their adherence to engineering standards. The provenance of the device design and manufacturing is Smiths Medical International Limited, based in the UK. The testing itself would have been conducted in a laboratory setting, likely in the UK or a certified testing facility elsewhere. The study is prospective in the sense that the new device was subjected to defined tests to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Again, this is not an AI study. "Ground truth" in this context refers to the defined specifications and the requirements of the standards (e.g., ASTM F 920-93). These standards are developed by expert consensus within relevant fields (e.g., medical device engineering, clinical practice), but the document does not detail the number or specific qualifications of individuals involved in establishing these particular test outcomes as ground truth. The "ground truth" is that the device either met or did not meet the specified performance under test conditions.
4. Adjudication Method for the Test Set
Not applicable as an adjudication method for an AI algorithm test set. The compliance with standards and specifications is determined by direct measurement and observation of the device's performance during testing. This would be a Pass/Fail determination against the standard's criteria.
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. This is a hardware device (ventilator), not an AI/software device intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, this is a physical medical device. It does not involve an algorithm with standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering and performance specifications derived from recognized medical device standards (e.g., ASTM F 920-93, RTCA DO160D, MIL-STD 810F, IEC 529) and the manufacturer's own input requirements. The predicate device's performance also serves as a benchmark for comparison.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm requiring a training set, the concept of establishing ground truth for it is irrelevant in this context.
§ 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).