(336 days)
Lilium α-200E, using ultrasound, is intended to provide the diagnostic information of the visualized urine dynamics acquired from the volume of the urinary bladder.
Lilium α-200E is a portable, battery powered, software controlled ultrasound system used to acquire and display real time A-mode images of the bladder. The Lilium device consists of a main body and an ultrasonic probe. Lilium device is used to measure urine volume inside the bladder non-invasively. In addition, it provides urine volume in the bladder at regular intervals and graphically displays the gradual increase of urine collection. It alerts when a set volume is attained. The device retains history. This information aids healthcare professionals, patients, and caregivers in providing proper continence care for those with urination difficulties. The device has wireless capabilities.
The Lilium device measures urine volume by means of a probe that has four ultrasound sensors aligned vertically. The sensor aligned side is applied to outside the abdomen wall so the probe can emit ultrasound (Mode A) toward the bladder and receive the echoed signals. The device the signal intensity to measure the height and depth of the bladder. These measurements determine the size of the bladder and quantify the filling of the bladder (urine volume is displayed on the screen. The system also includes indicator lights to indicate for urine volume and for correct positioning of the device.
The operating principle of the device is as follows:
An ultrasonic probe in which ultrasound transducers are arranged is placed on the abdominal surface, above the pubic bone, along the extending direction of the urinary bladder. When the ultrasound is transmitted from the probe, transducers put on the base part of the bladder detect echoes or ultrasonic reflections first when the urine begins to accumulate. As the bladder volume increases, transducers on the upper bladder detect echoes.
The provided text describes a 510(k) submission for the Lilium α-200E, an ultrasound system for measuring bladder volume. However, the document explicitly states:
"There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."
This means that a clinical study with acceptance criteria and associated performance data as typically sought for AI/ML-based medical devices was not performed for this specific 510(k) submission. The FDA clearance was based on substantial equivalence to a predicate device and extensive non-clinical performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria because such a study was not conducted or presented in this regulatory submission.
The document discusses non-clinical performance data which includes:
- Biocompatibility testing
- Electrical safety testing
- Electromagnetic Disturbance (EMD) testing
- Acoustic Output Measurement
- Thermal Measurement
- Software verification and validation
- Storage and Transport Testing
- Usability engineering
These tests, rather than a clinical performance study with human subjects, formed the basis for demonstrating safety and effectiveness and achieving substantial equivalence.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.