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510(k) Data Aggregation
(385 days)
SafeT T-Piece Resuscitator
The SafeT 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 10 kg (22 lb).
The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb). It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure. The T-Piece resuscitator can be connected to the patient via a face mask or tube. The subject device consists of several components: T-Piece patient valve with variable PEEP dial and integrated manometer, Adjustable inspiratory pressure controller, 40 cm H2O pressure relief valve, 7' Oxygen tubing with a red universal (Fits-all) connector, 20" x 10 mm circuit tubing, Face mask.
The provided text is a 510(k) summary for the Ventlab, LLC SafeT T-Piece Resuscitator, a medical device for emergency respiratory support. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA clearance.
Crucially, this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. It focuses on the substantial equivalence of a physical medical device (a resuscitator) based on its technological characteristics and performance testing against established standards, not on an algorithm's performance in interpreting medical images or data.
Therefore, many of the requested points, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, are not applicable to the context of this document.
However, I can extract the closest analogous information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a specific "acceptance criteria" table in the way one might for an AI device (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the compliance with applicable performance standards and the comparative data to predicate devices. The "reported device performance" is demonstrated by stating that the subject device "met all quantitative and qualitative requirements" of these standards and by the head-to-head comparison data presented in the "Substantial Equivalence Comparison Table" and subsequent discussion.
The most direct representation of "acceptance criteria" and "reported device performance" is found within the "Substantial Equivalence Comparison Table" itself, where critical performance metrics of the SafeT T-Piece Resuscitator are compared against those of the predicate device (Mercury Medical Neo-Tee) and a reference device (Fisher & Paykel NeoPuff).
Here is a partial table, extracted and reformatted from the "Substantial Equivalence Comparison Table" that acts as the primary evidence of meeting "acceptance criteria" (i.e., being substantially equivalent to the predicate device):
| Characteristic / Performance Metric | SafeT T-Piece Resuscitator (Reported Performance) | Mercury Medical Neo-Tee (Predicate Device) | Acceptance Criteria/Comparison Outcome (from document) |
|---|---|---|---|
| Indications of Use | Emergency respiratory support for neonates/infants |
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(77 days)
T-PIECE RESUSCITATOR
The 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 patients weighing greater than 10kg (>22lb).
The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).
It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure.
The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.
The provided document describes the Mercury T-Piece Resuscitator and its substantial equivalence to predicate devices, focusing on non-clinical testing for performance. This is a 510(k) premarket notification summary, which means the device is being compared to an already legally marketed device (predicate device) and does not involve AI or complex analytical studies in the way modern AI/ML medical devices would.
Therefore, many of the requested categories in the prompt are not applicable to this document. I will focus on the information that can be extracted directly from the provided text.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are generally aligned with the performance requirements outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators. The "Reported Device Performance" column reflects the specifications of the proposed Mercury Medical T-Piece Resuscitator as presented in comparison tables with its predicate devices.
| Acceptance Criteria (Derived from Predicate & ISO 10651-5) | Reported Device Performance (Mercury Medical T-Piece Resuscitator) |
|---|---|
| Indications for Use: Provide emergency respiratory support by face mask or tube; patients > 10kg (>22lbs). | The 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 patients weighing greater than 10kg (>22lb). |
| Environment of Use: Hospital, sub-acute facilities, and pre-hospital (EMS). | Hospital, sub-acute facilities, and pre-hospital (EMS). |
| Patient Population: Patients greater than 10 Kg (>22 lbs.). | Patients greater than 10 Kg (>22 lbs.) |
| Ventilation Frequency: Manually delivered by the user up to 60 BPM. | Manually delivered by the user up to 60 BPM. |
| Maximum Pressure Relief: Factory set at 40 cm H2O (predicate range 5-80 cm H2O). | 60 cm H2O (Factory set at 40 cm H2O). |
| Delivered Pressure: Up to 60 cm H2O (predicate range 5-80 cm H2O). | Up to 60 cm H2O. |
| Delivered Volume: (Predicate range 190 - 675 ml with flow rates between 4 - 36 lpm). | 60 - 700 ml with flow rates between 5 - 35 lpm. |
| Inspiratory Resistance: (Predicate: Less than - 5 cm H2O). | 2 cm H2O at minimum PEEP setting @ 60 lpm. |
| Expiratory Resistance: (Predicate: Less than + 5 cm H2O). | 2.4 cm H2O at minimum PEEP setting @ 60 lpm. |
| Oxygen Concentration with optional blender: (Predicate range: 21-100%). | 21 - 98% based upon blender setting. |
| Manometer Range: (Predicate range: -20 to 80 cm H2O). | Up to 60 cmH2O (Cleared under K954486). |
| Manometer Accuracy: (Predicate: +/- 2 cm H2O). | +/- 3 cm H2O up to 15 cm H2O; +/- 5 cm H2O > 15 cm H2O. |
| Peak Inspiratory Pressure (PIP): (Predicate range: 5-80 cm H2O). | 0-60 cm H2O. |
| Positive End-Expiratory Pressure (PEEP): (Predicate uses CPAP instead; reference NeoTee has PEEP). | 0 to 60 cm H2O. |
| Operational Gas Flow Rate: (Predicate range: 0-60 lpm). | 0 - 35 lpm. |
| Operational time with 400 L cylinder: (Predicate @ 36 lpm - 10 minutes). | @ 35 lpm - 11 minutes. |
| Dead space of circuit: (Predicate: |
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(105 days)
MERCURY MEDICAL T-PIECE RESUSCITATOR
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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