(247 days)
The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream.
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
The Lucid M1 System is an adjunctive, portable, non-invasive, non-ionizing radiation, point-of-care transcranial Doppler (TCD) diagnostic ultrasound system. It is designed to non-invasively measure and display cerebral blood flow velocity over the head and neck with a reusable, non-sterile 2-MHz hand-held probe. It can also be used bilaterally to monitor the blood flow velocity of the vessels insonated via the temporal window of the head with a headset with two reusable, non-sterile 2-MHz monitoring transducers. The system can also provide an emboli count for emboli detection.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond general statements of substantial equivalence to a predicate device. The information focuses on design, safety, and functional equivalence rather than quantitative performance metrics and clinical study results.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" for performance metrics in a quantitative manner. Instead, it demonstrates "substantial equivalence" to a predicate device (Spencer Technologies TCD 100 M). The "reported device performance" is largely described in terms of functional equivalence and compliance with general safety standards.
| Feature/Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Lucid M1 System Performance |
|---|---|---|
| Indications for Use | Equivalent to Spencer TCD 100 M | "adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity...and measures the occurrence of transient emboli signals." (Equivalent) |
| Product Code, Class | IYN, ITX; Class II | IYN, ITX; Class II (Equivalent) |
| Energy Used/Delivered | Ultrasound Energy | Ultrasound Energy (Equivalent) |
| Sample Volume | Similar to predicate | 2 to 12mm in 1mm steps |
| Depth | Similar to predicate | 23 to 151mm |
| Acoustic Output (ISPTA) | Global maximum derated ISPTA |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.