(230 days)
The LTV® 1100 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a 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 5kg (11 lbs.), who require the following types of ventilatory support:
Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) or non-invasively (via mask or nasal prongs).
Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
The ventilator is suitable for use in institutional, home, or transport settings.
The LTV® 1100 ventilator is designed to provide the functionality in a small package. The LTV® 1100 ventilator provides the following features:
- ventilator is (10.5" x 13.5" x 3.25", 14.5 lbs). A
- Turbine technology allows the ventilator to operate without an external compressed gas source. A
- CPAP2, SIMV3, Control, Assist/Control and Apnea Backup ventilation modes. A
- NPPV4 mode ventilation, providing an alarm package suitable for mask ventilation of patients A that do not require life support ventilation.
- Volume Control and Pressure Support ventilation. A
- Spontaneous Breathing Trial (SBT) to assist with weaning and discontinuation of ventilatory A support.
- Variable alarm settings including High Peak Pressure, Low Peak Pressure, Low Minute Volume, A Apnea, High Breath Rate, High PEEP and Low PEEP.
- Low-Pressure Oxygen Bieed-in A
- Lockable front panel controls. A
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Eookubio from panel Control Continute Ventilation (VE), PEEP, PIP and Tidal Volume (Vte).
- Real-time patient circuit pressure display with Peak Inspiratory Pressure indicator. A
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Variable termination conditions for Pressure Support breaths, including maximum inspiratory time termination and percentage of peak flow.
- Leak Compensation to improve triggering when a circuit leak is present. a
- A Single or dual tone output capabilities.
- A Operation from a variety of power sources including AC power, internal battery and external DC power sources.
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Flow Sensor and No Flow Sensor configuration modes allow for a flow sensing patient circuit or a non-flow sensing patient circuit to be used.
This document, K101643, is a 510(k) Premarket Notification for the LTV 1100 Ventilator. The summary states that "Performance testing verified that the LTV 1100 ventilator meets its performance requirements that this device is substantially equivalent to medical devices currently legally marketed in the United States."
However, the document does not provide specific acceptance criteria or detailed results of the performance testing. It also does not include information about the study design that would typically prove a device meets acceptance criteria, such as:
- A table of acceptance criteria and reported device performance: This information is not explicitly provided. The summary states that performance testing verified the device meets performance requirements, but the requirements themselves or the specific results are not detailed.
- Sample size used for the test set and data provenance: No information on sample sizes (e.g., number of test cases, hours of operation, number of individual tests) or where the testing was performed (e.g., in-house, third-party lab, country of origin) is provided. The document just states "Performance testing" was done.
- Number of experts used to establish ground truth and their qualifications: This is not applicable as the device is a ventilator, not an AI or diagnostic imaging device that requires expert review for ground truth. The performance testing would likely involve engineering and functional tests against specifications.
- Adjudication method for the test set: Not applicable for this type of device testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for a ventilator, not an imaging or diagnostic device requiring human reader interpretation.
- If a standalone (algorithm only without human-in-the-loop performance) was done: The device is a physical ventilator, and its performance would be assessed through functional and safety testing, not a "standalone algorithm performance" in the context of an AI device.
- The type of ground truth used: For a ventilator, "ground truth" would be established by predefined performance specifications, engineering standards, and industry benchmarks, rather than clinical outcomes or expert consensus on a dataset. The document implies compliance with these standards but doesn't list them.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, based on the provided text, a detailed description of acceptance criteria and the study proving the device meets them, in the typical format requested for AI/ML devices, cannot be extracted. The document is a regulatory submission focused on substantial equivalence to predicate devices, stating that performance testing was completed and the device meets requirements, rather than providing the detailed methodology and results of that testing.
The "Summary of Testing and Validation" section only generally states: "Performance testing verified that the LTV 1100 ventilator meets it's performance requirements that this device is substantially equivalent to medical devices currently legally marketed in the United States." This is a high-level statement without the specific details requested in your prompt.
§ 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).