(269 days)
The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.
The Pocket III is a small hand-held device in pen-shaped design. Measurement results appear numerically on the LCD graphic display. The user can perform a basic cable transfer (USB-C) or activate Bluetooth to export data to a computer. The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.
Acceptance Criteria and Device Performance Study for Quantel Medical Pocket III
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Accuracy | +/- 5 microns |
| Resolution | 1 micron |
| Corneal thickness range | 150-1200 microns |
| Ultrasonic Transducer Frequency | 30 MHz |
| Tip Diameter | 1.2 mm |
| Focal Point | 0.5 mm from tip |
| Angle | 35 degrees |
| Thermal Index |
§ 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.