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510(k) Data Aggregation
(105 days)
MERCURY MEDICAL, INC.
The Neo-Tee™ T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb).
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) underwent performance testing to demonstrate its substantial equivalence to predicate devices and adherence to industry standards, specifically ISO 10651:2006.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Test requirements) | Reported Device Performance |
|---|---|---|
| Vomitus Resistance | Must subsequently pass Oxygen Concentration, Inspiratory Resistance, Expiratory Resistance, PEEP, Delivered Volume and Pressure Limitation tests | Met the requirements |
| Water Immersion | Resuscitator must continue to function within the tolerances for normal use | Continued to function within normal use tolerances |
| Oxygen Concentration | Volumetric concentration of oxygen must be > 85% | Met the requirements (> 85% oxygen concentration) |
| Inspiratory Resistance | Pressure at patient connection port must be > -6 cm H2O with inspiratory airflow of 6 L/min | Met the requirements (> -6 cm H2O) |
| Expiratory Resistance | Pressure at patient connection port must be 3.75 mL @ C10, R20 | Met the requirements ( 3.75 mL) |
| Pressure Limitation | Pressure must not exceed 60 cm H2O @ 60 L/min | Met the requirements (not exceeding 60 cm H2O) |
| Storage/Operating Conditions | Must subsequently pass Delivered Volume and Pressure Limitation tests | Subsequently passed Delivered Volume and Pressure Limitation tests |
| Drop | Resuscitator must continue to function within the tolerances for normal use | Continued to function within normal use tolerances |
2. Sample size used for the test set and the data provenance:
The summary does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described refers to bench tests performed on the device itself. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not applicable or provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these performance tests is defined by the technical specifications outlined in the industry standard ISO 10651:2006 and the pre-established performance characteristics of the predicate devices. Expert clinical consensus or data annotation by medical professionals is not part of this type of engineering performance testing.
4. Adjudication method for the test set:
Not applicable, as this was a series of bench tests against defined engineering standards and predicate device performance, not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on device performance against engineering standards and comparison to predicate device specifications.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The Mercury Medical T-Piece Resuscitator is a mechanical gas-powered device, not an algorithm or AI system. Its performance evaluation is inherently "standalone" in the sense that it refers to the device's physical and functional capabilities, not an algorithm's output.
7. The type of ground truth used:
The ground truth for this device's performance evaluation is based on:
- Industry Standard: ISO 10651:2006 (for "Manually operated resuscitators").
- Predicate Device Specifications: The performance characteristics of the GE Giraffe and Panda (K070210) and Fisher & Paykel NeoPuff (K892885) devices served as benchmarks for substantial equivalence.
8. The sample size for the training set:
Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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