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The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the 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 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, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings. The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

The LTV 1200 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, CPAP, or NPPV modes of ventilation. Breath types including Volume, Pressure Control and Pressure Support. The modification intended to be cleared by this submission is: The "Indications for Use" is being expanded to label the LTV 1200 as MR Conditional. The LTV 1200 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modification.

This is a 510(k) summary for the LTV 1200 MR Conditional Ventilator, which is an expansion of the "Indications for Use" to label the device as MR Conditional. It is not a study that uses AI/algorithm. Therefore, I cannot provide the specific information requested in the prompt, as it is not applicable to this document.

However, I can extract information related to the device and its intended use:

Device Description:
The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation. It is suitable for use in institutional, home, and transport settings. It is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.) and supports positive pressure ventilation (invasive or non-invasive) in Assist/Control, SIMV, CPAP, or NPPV modes, with breath types including Volume, Pressure Control, and Pressure Support.

Modification for Clearance:
The modification for this 510(k) is to expand the "Indications for Use" to label the LTV 1200 as MR Conditional.

Intended Use (MR Conditional Version):
The MR Conditional LTV 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners.

Equivalence to Predicate Device:
The LTV 1200 MR Conditional ventilator was found to be substantially equivalent to the predicate device:

• Predicate Device: iVent 201 MR Conditional Portable Ventilator
• 510(k) Clearance: K073694
• Manufacturer: Versamed Corporation

The document states that "Testing conducted in the MR environment has demonstrated that the LTV 1200 MR Conditional ventilator is substantially equivalent to the predicate device listed below." This implies that the acceptance criteria for being "MR Conditional" were met through testing, and the performance of the LTV 1200 in the MR environment was deemed comparable to the predicate device. However, the specific acceptance criteria, reported performance values, or details of the study (like sample size, ground truth, etc.) are not provided in this 510(k) summary.

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