(215 days)
The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP).
The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure.
All are intended for neonates and infants (≤ 10kg or 22 lbs) in a delivery room and a NICU.
There are four (4) models of the Resusci Flow resuscitator.
- Resusci Flow ●
- Resusci Flow with blender ●
- Resusci Flow 104PV .
- Resusci Flow 104EV .
They all have the same basic design. Table 1 outlines the basic features and differences of each model.
The Atom Medical Corporation's Resusci Flow series resuscitator (models: Resusci Flow, Resusci Flow with blender, Resusci Flow 104 PV, and Resusci Flow 104 EV) underwent performance testing to demonstrate substantial equivalence to predicate devices and adherence to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several performance tests conducted, referencing ISO standards and internal criteria. The reported device performance for all listed criteria was that the Resusci Flow series "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates."
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| ISO 10651-5 clause 5.1.10 Display accuracy of the airway pressure gauge | Met pass/fail criteria and standards requirements |
| Gas discharge flow rate from the patient circuit | Met pass/fail criteria and standards requirements |
| ISO 10651-5 Clause 7.7.1 Delivered concentration accuracy of oxygen | Met pass/fail criteria and standards requirements |
| ISO 10651-5 clause 7.1.2.2 Inspiratory resistance | Met pass/fail criteria and standards requirements |
| ISO 10651-5 clause 7.2.4 pressure limitation | Met pass/fail criteria and standards requirements |
| ISO 10651-5 clause 7.2.4 and 5.1.10 Pressure characteristics of peak inspiratory pressure (PIP inspiratory resistance) | Met pass/fail criteria and standards requirements |
| Confirm the maximum open pressure (Pmax) | Met pass/fail criteria and standards requirements |
| ISO 10651-5 clause 7.2.4 and 5.1.10 positive end-expiratory pressure (PEEP) | Met pass/fail criteria and standards requirements |
| Environment Performance | Met pass/fail criteria and standards requirements |
| Vibration Testing | Met pass/fail criteria and standards requirements |
| Drop Testing | Met pass/fail criteria and standards requirements |
| Test pressure loss alarm | Met pass/fail criteria and standards requirements |
| ISO 11195 Gas mixers alarm for loss of pressure | Met pass/fail criteria and standards requirements |
| ISO 10079-3 for suction equipment | Met pass/fail criteria and standards requirements |
| Safety requirements | Met pass/fail criteria and standards requirements |
| Vomitus Resistance | Met pass/fail criteria and standards requirements |
| Expiratory Resistance | Met pass/fail criteria and standards requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "bench tests" were performed. However, it does not specify the sample size (number of devices, number of tests run for each criterion) used for these tests. The data provenance is internal to Atom Medical Corporation ("We have performed bench tests"), implying the tests were conducted by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location (Tokyo, Japan). The tests are described as performance testing, implying a prospective evaluation of the device's capabilities against established standards and predicates, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The provided text details bench testing against international standards and comparison to predicate devices, rather than a clinical study requiring expert assessment of ground truth in a clinical context. Therefore, this information is not applicable. The "ground truth" for the bench tests would be the specifications and requirements outlined in the cited ISO standards.
4. Adjudication Method for the Test Set:
Not applicable, as this describes bench testing against established standards and specifications, not a clinical study requiring expert adjudication of clinical outcomes or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence through bench testing and comparison to predicate device specifications. There is no mention of human readers or AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study in the form of "bench tests" was done. The performance of the Resusci Flow series was evaluated against a list of ISO standards and internal criteria. The conclusion was that the devices "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates." This constitutes an evaluation of the algorithm (or device in this case) alone without human-in-the-loop performance.
7. Type of Ground Truth Used:
The ground truth used for the performance testing was based on:
- International Standards: Specifically, ISO 10651-5 for powered resuscitators, ISO 10079-3 for suction equipment, and ISO 11195 for gas mixers. These standards define the acceptable performance parameters and test methods.
- Predicate Device Specifications: The applicant claims the device has "equivalent specifications of performance as the predicate" devices (Fisher & Paykel NeoPuff and GE Giraffe/Panda T-piece resuscitator). This implies that the performance parameters of the predicate devices served as a benchmark for equivalence.
- Internal Pass/Fail Criteria: The document mentions "all pass/fail criteria," which would typically be internal, pre-defined thresholds for acceptable performance for each test.
8. Sample Size for the Training Set:
Not applicable. This is a medical device submission based on substantial equivalence through bench testing, not an artificial intelligence/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm in this submission.
§ 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).