(81 days)
The TBird Homecare ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:
- Positive pressure ventilation .
- . Assist/Control, SIMV, CPAP modes of ventilation
The ventilator is suitable for use in institutional and home settings.
The TBird Homecare ventilator employs a revolutionary turbine gas delivery system along with sophisticated microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird Homecare has an extensive patient range.
Here's an analysis of the provided text regarding the TBird Homecare Volume Ventilator, focusing on acceptance criteria and supporting studies:
It is important to note that the provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive, detailed clinical study results in the same way a PMA (Premarket Approval) submission would. As such, direct "acceptance criteria" and detailed "study" information as one might expect for a new, novel device might not be explicitly present in this format. The "study" here largely refers to the verification testing against standards.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory requirements and predicate comparison) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Safety: | |
| - Meets ASTM F1246 (Electrically Powered Home Care Ventilators) requirements. | "The TBird Homecare Volume Ventilator has been verified to meet the requirements of ASTM F1246 (1991)." (Page 9) |
| - Meets Draft Reviewer Guidance for Ventilators (July 1995) 10V/m susceptibility. | "Additional shielding has been added to meet the 10V/m susceptibility requirement of the 'Draft Reviewer Guidance for Ventilators (July 1995)'." (Page 7) |
| - Patient safety mechanisms (e.g., pressure relief) | "The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction." (Page 3) "The … pressure relief valve...limits by the setting of the relief valve." (Page 3) "Over pressure relief valve system and recommend its use as a patient system mechanism." (Page 9) |
| - Fail-safe mechanisms (e.g., in case of power failure) | "In the event the ventilator fails to deliver a breath, the patient may inspire spontaneously by drawing room air through the sub ambient relief valve." (Page 3) "The Watchdog Timer and Hardware Fault Monitors will shut down the ventilator in the event a malfunction is detected." (Page 5-6) "If any [power supply] is out of the safe operating range, the ventilator will shut down." (Page 6) |
| - Suitable for intended use environment (home, institutional) | "The ventilator is suitable for use in institutional, home, and transport settings." (Page 1) |
| Performance: | |
| - Provides continuous or intermittent mechanical ventilatory support. | "The TBird Homecare ventilator is intended to provide continuous or intermittent mechanical ventilatory support..." (Page 1) |
| - Applicable for adult and pediatric patients weighing at least 10 kg. | "Applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.)." (Page 1) |
| - Supports Positive Pressure Ventilation, Assist/Control, SIMV, CPAP modes. | "Positive pressure ventilation," "Assist/Control, SIMV, CPAP modes of ventilation." (Page 1) |
| - Delivers accurate flow, pressure, and oxygen. | "Working under the controller, this system delivers flow to satisfy the criteria for all requested breath types..." (Page 2) "The speed and differential pressure transducers signals are used as control inputs to ensure that the proper flow rate is delivered as backpressure varies." (Page 2) "The controller uses this signal for flow triggering and the exhaled tidal volume monitor." (Page 3) "The exhalation valve... regulated... to achieve the set PEEP." (Page 3) "The controller opens and closes the valves as required to supply the correct amount of oxygen to satisfy the current O2 setting and flow demand." (Page 3) |
| - Reliability of alarm and control settings. | "The necessary algorithms, formulae, and control functions which define the ventilator behavior are contained in the software program which is executed by the CPU." (Page 5) "Each Alarm Setpoint Display is a 3-or 4 digit group of red 7-segment LED digits which, under software control, shows the present numeric setting of a ventilator alarm." "Each Control Setpoint Display is a 3-or 4 digit group of green 7-segment LED digits which, under software control, shows the present numeric setting of a ventilator control." (Page 4) |
| - Broader range for high pressure alarm (5-120 cmH2O). | "The TBird Homecare unit offers a broader range for the high pressure alarm, 5-120 cmH2O." (Page 9) |
| - Broader range of control settings and monitors. | "The TBird Homecare unit offers a broader range of control settings and monitors as compared to the Aequitron LP10 and Bear 33." (Page 9) |
| Functional Equivalence/Improvements to Predicates: | |
| - Inclusion of Pressure Support mode. | "Pressure Support mode is available from numerous manufacturers of ventilators." (Page 7) "Allowing the patient to control their ventilation and minimizes the potential for barotrauma." (Page 7) |
| - Use of flow triggering (over pressure triggering). | "Flow triggering eliminates many of these pitfalls. Flow triggering systems reduce the patient's work of breathing." (Page 8) |
| - Simplified user interface. | "The TBird Homecare ventilator employs a straight-forward single control knob user interface." (Page 8) "The new value will also to put into effect if the ventilator remains untouched for five seconds after changing the parameter." "Allows the clinician to change any parameters before the new mode and changes are implemented. All of the front panel controls except, monitor select, alarm silence, and manual breath can be temporarily locked out in order to prevent accidental changes." (Page 8-9) |
| - Meets peak flow rate demands. | "Sudden large flow demands by the patient are more likely to be met by these units reducing sporadic and temporary patient anxiety." (Page 9) |
| - Precisely delivers oxygen (with optional blending system). | "An optional oxygen blending system... will be incorporated to provide more precise oxygen delivery." (Page 7) |
Study Details
Given that this is a 510(k) for a modification (intended use for home care) and claims substantial equivalence, the "study" described is primarily verification testing against recognized standards and comparison to predicate devices, rather than a clinical trial.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical samples. Instead, it refers to performance testing of the device itself.
- Sample Size: Not applicable in the context of patient data for this type of submission. Performance testing would involve multiple runs and measurements on the device, but specific numbers are not provided.
- Data Provenance: The device "has been verified to meet the requirements of ASTM F1246 (1991)." This implies engineering and bench testing data, rather than clinical data from a specific country. This type of data is internal to the manufacturer's testing and development process. It is "prospective" in the sense that the device was designed and tested to meet these standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for verifying a device against a standard like ASTM F1246 is the standard itself and the objective measurements performed by engineers and technicians during verification testing. There were no "experts" establishing ground truth in the sense of clinical consensus on patient cases.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication.
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
Not applicable. This device is a ventilator, not an imaging or diagnostic device that would typically involve "human readers" or "AI assistance" in the way implied by an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, a ventilator, which inherently has human interaction (healthcare provider setting parameters, patient use). The "standalone" performance here refers to the device's ability to meet its technical specifications independently, which is covered by the performance testing against standards.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is derived from:
- Technical Specifications and Design Requirements: The device was designed to achieve certain measurable performance characteristics (e.g., flow rates, pressure control, alarm ranges, battery life).
- Recognized Standards: ASTM F1246 (1991) served as a primary ground truth for homecare ventilator requirements.
- Predicate Device Performance: The functional capabilities and safety profiles of the already marketed TBird VS, Aequitron LP10, and Bear 33 Volume Ventilators served as benchmarks for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm trained on data in the modern sense. The "training" for the device's control system would be the engineering design and software development, refined through iterative testing and calibration.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the context of AI/ML. The "ground truth" for the ventilator's functional design and control algorithms would have been established through:
- Physiological Principles: Understanding of respiratory mechanics, gas exchange, and patient ventilation needs.
- Engineering Principles: Control theory, fluid dynamics, electrical engineering, materials science, and software development best practices.
- Clinical Requirements and Standards of Care: How ventilators are used clinically and the parameters necessary for effective and safe patient support. This informs the algorithms and control logic.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).