(122 days)
The Pneupac VR1 Airmix is a hand-held, portable, time maled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: Pneupac VR1 Airmix 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 and including a control for providing oxygen concentrations of either 100% or 50% nominal.
Pneupac VR1 Airmix 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 inter- hospital transport. The Pneupac VR1 Airmix allows 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 Airmix includes a control for providing oxygen concentrations of either 100% or 50% nominal. The Pneupac VR1 Airmix uses the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation. The Pneupac VR1 Airmix incorporates a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH2O optional) which operates in an identical manner to the predicate devices. The Pneupac VR1 Airmix 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 mass of Pneupac VR1 Airmix is 1.001lb, 0.455kg. The Pneupac VR 1 Airmix 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, 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, Airmix control for providing oxygen concentrations of either 100% or 50% nominal.
Here's an analysis of the provided 510(k) summary regarding the Pneupac VR1 Airmix device, adhering to your requested format.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial or standalone performance study. Therefore, some of your requested information (e.g., sample sizes for test sets, number of experts for ground truth, MRMC study details) is typically not found in this type of submission.
1. Table of acceptance criteria and the reported device performance
The submission demonstrates the device's performance against established safety and performance standards for ventilators and resuscitators. The acceptance criteria essentially align with meeting the requirements of these standards.
| Acceptance Criteria (aligned with standards) | Reported Device Performance |
|---|---|
| Safety Testing (ASTM F 920-93) | Passed all tests and met all requirements. |
| Environmental & Performance Testing: | |
| - Operating environment compliance (ETR848 to ASTM F920-93 section 8.2) | Complied |
| - Storage temperature/humidity (ETR848 to ASTM F920-93 section 8.1) | Complied |
| - Vibration (ETR835 to MIL-STD 810F section 514.4 & RTCA DO160D section 8 profile C) | Complied |
| - Altitude (ETR853 to MIL-STD 810F section 500.4, RTCA DO160D section 4.6.2 & Smiths requirements) | Complied |
| - MRI (ETR 917 to 3 Tesla) | Complied |
| - IP rating (ETR849 to IEC 529 rating IP5x, IPx5 and Ipx6) | Complied |
| - Driving sand & dust (ETR849 to RTCA DO160D section 12) | Complied |
| - Oxygen consumption | Complied |
| - Mechanical shock (drop) (ETR863 to ASTM F920-93 section A1.5.4 and EN794-3:1998 section 21.102) | Complied |
| - Rigidity (ETR 921 to EN60601-1:1990) | Complied |
| - Impact (ETR 919 to EN60601-1:1990) | Complied |
| - Cleaning & sterilisation (ETR 743 AND ETR 926) | Complied |
| Overall Performance | Performed within its specifications and functional requirements. |
| Comparison to Predicate Devices | Demonstrated similarity in performance to Pneupac VR1 (standard) and Oxylog 1000. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided 510(k) summary. Performance data appears to be based on engineering verification and validation testing of the device itself rather than clinical patient data.
- Data Provenance: The testing was conducted internally by Smiths Medical International Limited (or certified laboratories on their behalf) to comply with recognized international standards (e.g., ASTM, MIL-STD, RTCA, IEC, EN). The country of origin for the data generation would likely be the UK, given the submitter's address. The data is based on the performance of the device itself under various simulated conditions, not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. The "ground truth" for this type of device (a ventilator) is its ability to meet engineering specifications and performance standards. This is typically assessed through objective measurements against predefined criteria, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., reading medical images). Here, the device's performance is objectively measured against technical standards.
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 device is a medical device (ventilator), not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study and discussions of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense. The "standalone" performance here refers to the device and its components meeting the specified technical and safety standards independently. The performance data presented (e.g., passing ASTM tests, complying with environmental standards) represents the device's inherent capability to function as intended without direct human intervention once configured.
7. The type of ground truth used
The "ground truth" here is defined by the objective, measurable requirements specified in the referenced international standards (e.g., ASTM F 920-93 for minimum performance and safety, MIL-STD, RTCA, IEC, EN for environmental and mechanical tests). The device's performance was compared against these established benchmarks.
8. The sample size for the training set
Not applicable. This device is a mechanical/electrical ventilator, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).