(63 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. .
The ventilator is suitable for use in institutional, home, or 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 addition intended to be cleared by this submission is:
- The addition of the Automobile Lighter Power Cord to be externally attached . to the LTV Series to power the LTV Ventilator while operating in an automobile. The power cord is designed to connect to +12V automobile cigarette lighter or auxiliary power outlets capable of supplying as least 20 amperes of current.
The provided document is a 510(k) summary for the "Automobile Lighter Power Cord" for the LTV 1000 ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of AI/ML or diagnostic applications.
Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance with AI, ground truth types) are not applicable to this particular submission.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
The core "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence to an existing legally marketed device (the predicate device) and ensuring the new accessory (Automobile Lighter Power Cord) does not raise new questions of safety or effectiveness.
The "study" conducted for this submission is a comparison to a predicate device to establish substantial equivalence based on intended use and technical characteristics.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Device's intended use must be the same as the predicate device. | Same intended use as the predicate device (LP-6 Ventilator with Cigarette Lighter Cable). |
| Technological Characteristics: Device must have similar technological characteristics, or differences must not raise new questions of safety or effectiveness. | The Automobile Lighter Power Cord allows the LTV 1000 Ventilator to be powered from a 12V automotive power outlet. |
| Safety and Effectiveness: Demonstrate that the device is as safe and effective as the predicate device, or that differences do not affect safety/effectiveness. | Implied by "Same intended use" and the nature of the accessory (power cord). No specific safety/effectiveness study details related to the cord's primary function are provided in this summary. |
Additional Requested Information (Not Applicable or Not Provided in this Document)
The document is a 510(k) summary for a ventilator accessory, not a diagnostic device or an AI/ML-driven device. As such, information typically found in studies for AI/ML or diagnostic performance is not present.
- Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or an AI/ML algorithm on a test set of data. The "test" is the comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of diagnostic performance is being established for this type of device.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is primarily the regulatory standard of substantial equivalence to a predicate device.
- The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
§ 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).