Search Results
Found 1 results
510(k) Data Aggregation
(161 days)
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Environment of use - Hospitals, delivery suites, NICU
There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.
- Resuscitation Unit 105PV .
- . Resuscitation Unit 105EV
They have the same basic design. Table 1 outlines the basic features and differences of each model.
The Atom Medical Corporation Resuscitation Unit 105EV and 105PV are medical devices intended to remove secretions from neonatal/infant airways and to provide blended air and oxygen at a desired concentration (21-100%) to respiratory assist devices. The devices underwent performance testing to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate devices) | Reported Device Performance (Resuscitation Unit 105EV/PV) |
|---|---|
| Air/O₂ blender:- Range: 21-100%- Accuracy: ±3%O₂ | Achieved 21-100% oxygen concentration with ±3%O₂ accuracy (implied by substantial equivalence to predicates like Bio-Med Devices BMD air/oxygen blender K925982 and Precision Medical Precision Blender K053232). |
| Airway pressure manometer:- Range: -20 to 80cmH₂O- Accuracy: ±1% of full scale | Achieved -20 to 80cmH₂O range with ±1% of full scale accuracy (implied by substantial equivalence to Atom V-505 Infant Warmer K060461, which features an airway pressure manometer). |
| Relieving valve:- Set to 5.9 kPa (60 cmH₂O) for preventing excessive airway pressure | The device has a relieving valve with a default setting of 5.9kPa (60cmH₂O), which is a feature not present in some predicates, indicating it meets or exceeds this safety aspect. |
| Gas sources input pressure:- Air/O₂: 206-517kPa | Achieved 300-500kPa (which falls within the predicate's range of 206-517kPa and implies compliance). |
| Gas flow rate range (blender):- ≥ 30 lpm (for certain predicates) | < 15 lpm for the blender module (Note: This is a point of difference with some predicates, but the filing argues that the overall performance and equivalence are maintained) |
| Suction bottle capacity:- Not specified (for some predicates) | Up to 1200 ml |
| Vacuum source:- Model 105PV: wall suction vacuum- Model 105EV: venturi method | Model 105PV - wall suction vacuumModel 105EV - venturi method |
| Vacuum range:- 0-200 mmHg (for Atom V-505 Infant Warmer)- 0-150 mmHg (for GE Giraffe and Panda) | 0-200 mmHg (for Model 105EV) |
| Vacuum Flow range:- 15 lpm (for GE Giraffe and Panda) | ~20 lpm |
| Compliance with standards:- ISO 10651-5 Gas powered resuscitators- ISO 10079-3 Suction equipment- ISO 11195 Alarm | Declared compliance with applicable sections of ISO 10651-5 and ISO 10079-3. Performed ISO 11195 Alarm testing. |
| Performance in specific tests:- Flow accuracy- Pressure gauge accuracy- ISO 10651-5 O2 concentration- ISO 10079-3: Suction, Overfill, Suction seal, Aspiration, Pressure, External gas source, suction equipment, Noise | Performed tests for Flow accuracy, Pressure gauge accuracy, ISO 10651-5 O2 concentration, and various sections of ISO 10079-3. All tests "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates." |
2. Sample Size for Test Set and Data Provenance:
The document describes "bench tests" and general "performance testing" of the device. It does not specify a "test set" in terms of patient data or specific clinical cases, but rather refers to in-vitro or laboratory testing. Therefore, sample size and data provenance are not applicable in the traditional sense of a clinical study. The testing appears to be based on engineering and performance verification against specifications and standards.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable as the study described is a bench test and performance verification, not a clinical study requiring expert-established ground truth for diagnostic accuracy or similar endpoints. The ground truth would be the established engineering specifications and international standards.
4. Adjudication Method:
This information is not applicable as the study described is a bench test and performance verification, not a clinical study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The submission focuses on device performance against engineering specifications and equivalence to predicate devices, not on direct human reader performance with or without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided or applicable.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The device is an air/oxygen blender with suction capabilities, a mechanical medical device, not an AI or algorithm-based system where "standalone performance" of an algorithm would be assessed.
7. Type of Ground Truth Used:
The ground truth used for this performance testing was device specifications, international standards (ISO 10651-5, ISO 10079-3, ISO 11195), and the performance characteristics of legally marketed predicate devices. The testing aimed to confirm that the Resuscitation Unit 105EV and 105PV met these predefined engineering and regulatory requirements.
8. Sample Size for Training Set:
This information is not applicable. The device is a mechanical medical device, not a machine learning model, so there is no "training set" in the context of AI/ML development.
9. How Ground Truth for Training Set was Established:
This information is not applicable for the same reasons as above (not an AI/ML device).
Ask a specific question about this device
Page 1 of 1