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510(k) Data Aggregation
(208 days)
BigEasy Non-Rebreathing Valve
The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BigEasy™ Non-Rebreathing Valve.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meeting ISO 10993-1 requirements for Cytotoxicity, Irritation, and Sensitization. | The BigEasy™ Non-Rebreathing Valve passed all required biocompatibility tests (Cytotoxicity, Irritation, Sensitization) based on ISO10993-1:2009/2010 and the 2013 FDA Guidance Document. |
| Packaging and Assembly / Shipping | Meeting packaging and assembly / shipping requirements. | The BigEasy™ Non-Rebreathing Valve met the packaging and assembly / shipping testing acceptance criteria. |
| Environmental | Meeting environmental requirements for storage and operation. (Specific ranges provided: Operating Temperature: -18°C to 50°C, Storage Temperature: -40°C to 60°C, Storage Relative Humidity: 10% to 95%) | The BigEasy™ Non-Rebreathing Valve met the environmental requirements acceptance criteria. (Specific values: Operating Temperature: -18°C to 50°C, Storage Temperature: -40°C to 60°C, Storage Relative Humidity: 10% to 95% were also listed as specifications). |
| Volatile Organic Compounds (VOCs), Ozone, CO, CO2 and Fine Particle Discharge | Meeting TO-15 standards for VOCs and requirements for the discharge of other gases and particles below the standards' thresholds. | The BigEasy™ Non-Rebreathing Valve met the requirements for VOCs, Ozone, CO, CO2, and Fine Particles. |
| Materials Specifications | Meeting materials specifications requirements. | The BigEasy™ Non-Rebreathing Valve met the materials specifications acceptance criteria. |
| Labeling Verification | Meeting labeling verification requirements. | The BigEasy™ Non-Rebreathing Valve met the labeling verification acceptance criteria. |
| Inlet and Outlet Fittings | Meeting inlet and outlet fitting requirements (Standard 22mm ID for inlet, Standard 22mm OD/15mm ID for outlet). | The BigEasy™ Non-Rebreathing Valve met the fittings acceptance criteria. |
| Resistance to Inhalation and Exhalation | Meeting resistance requirements after and during environmental exposure, vomitus contamination, water submersion, and mechanical displacement. | The BigEasy™ Non-Rebreathing Valve met the resistance criteria. (Specific values: Inspiratory Resistance: 1.9 cm H2O at 50 LPM, Expiratory Resistance: 0.25 cm H2O at 50 LPM were also listed as specifications). |
| Drop Test | Withstanding a drop on a concrete floor from 1 meter. | The BigEasy™ Non-Rebreathing Valve met the drop test requirements. |
| Mean Concentration of Oxygen at 15 LPM and Circuit Backpressure at 30 LPM | Determining the mean oxygen concentration and backpressure during oxygen delivery. | The BigEasy™ Non-Rebreathing Valve met the requirements for oxygen delivery. |
| Assembly and Application | Validation that the device can be assembled and applied according to the Instructions For Use (IFU). | Participants were able to perform the intended actions while following the IFU. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test or the data provenance (country of origin, retrospective/prospective). The studies are described as "Non-clinical test results" and "Bench Tests," which typically implies laboratory testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Given that the tests are primarily "Bench Tests" and "Biocompatibility Testing," they typically involve objective measurements against established standards, rather than expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The tests appear to be objective measurements against predefined standards, thus not requiring an adjudication method by human experts.
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 MRMC comparative effectiveness study was done. This device is a non-rebreathing valve, which is a physical medical device, not an AI-powered diagnostic tool. The "performance testing" focuses on physical and material properties, not diagnostic accuracy with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done, but it was for the physical device itself, not an algorithm. The device was tested independently against various physical, material, and operational standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests was based on established industry standards and regulations, such as:
- AS 4259-1995 (Ancillary devices for expired air resuscitation)
- ISO 13544-2:2002 (Respiratory Therapy Equipment – Part 2: Tubing and Connectors)
- ISO 5356-1:2004 (Anaesthetic and Respiratory Equipment – Conical Connectors - Part 1: Cones and Sockets)
- BS EN ISO 10651-4:2009 (Lung Ventilators – Part 4: Particular requirements for operator-powered non-rebreathing valves)
- ISTA-2A:2011 (Packaged-Products weighing 150 lbs (68 kg) or Less)
- ISO 10993-1:2009 COR 1 2010 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process)
- FDA Guidance Document (Draft) (Reviewer Guidance on Face Masks and Shield for CPR)
- BS EN ISO 15223-1:2012 (Medical Devices – Symbols to be used with Medical Devices Labels, Labelling and Information to be supplied– Part 1: General Requirements)
- EPA-453/R-98-008B (Method TO-15, Determination Of Volatile Organic Compounds (VOCs) In Air)
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm requiring a 'training set.'
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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