(58 days)
The LTV 1000 ventilator is intended to provide continuous or intermittent 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 5 kg (11 lbs.), who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .
The ventilator is suitable for use in institutional, home and transport settings.
The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:
- . Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. ●
The modifications intended to be cleared by this submission are:
- . The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
- . The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.
- The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
- The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
- A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.
The provided text describes a 510(k) summary for the LTV 1000 Ventilator, focusing on modifications to an existing device rather than a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for a device which normally would involve data from human or phantom subjects, ground truth, expert opinions, or statistical analysis of algorithmic performance.
The text details:
- Device Trade Name: LTV 1000 Ventilator
- Common Name: Ventilator
- Classification Name: Ventilator, Continuous (Respirator) 868.5895
- Intended Use: To provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation (adult and pediatric patients weighing at least 5 kg). Suitable for institutional, home, and transport settings.
- Modifications: Addition of High Breath Rate Alarm, O2 cylinder duration monitoring, 100% O2 flush feature, Automatic High O2 Switchover, and improved maximum allowable oxygen input pressure.
- Equivalence to Predicate Devices: The modified LTV 1000 Ventilator is deemed substantially equivalent to the previously cleared LTV 1000 Ventilator (K032226) and the T-Bird AVS Ventilator (K981971).
Without information on a performance study specific to the modifications and their impact on clinical outcomes or diagnostic accuracy, I cannot fill out the requested table or answer the questions related to acceptance criteria, sample size, ground truth, or expert involvement.
The information provided in this 510(k) summary is focused on demonstrating substantial equivalence to a predicate device for device modifications, which is a regulatory pathway for marketing new medical devices in the US. This regulatory process typically relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, often through engineering tests and comparison of technical specifications, rather than new clinical effectiveness studies as would be seen for novel device types or those requiring PMA.
§ 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).