(77 days)
The intended use of the ODM-2100 & ODM-2200 includes the location and visualization of ophthalmic disorders and measurement of ocular distances.
Ultrasound Imaging of the eye.
Axial biometric parameter measurement of the eye.
Diagnostic ultrasound imaging
The ODM-2100/2200 combines a B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended used of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.
The ODM-2200 uses the same software and hardware (Switch power supply, P.C. board, user's interface, transducer etc.) as ODM-2100 does. The only difference is that:
ODM-2100 uses a portable housing and built-in 10-inch video monitor; ODM-2200 uses standard SVGA. LCD monitor.
The ODM-2100/2200 includes B-mode ultrasonic cross-section imaging and A-mode axial biometric parameter measurement. Users can switch between these two modes through keyboard.
In B-mode, the 10MHz transducer emits ultrasound under electric pulse and then receives and stores its echo reflected by interfaces of different tissues. Through the sector scanning of transducer, several echo lines create real time image of eye tissue and the image is displayed on the monitor.
In A-mode, the 10MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by anterior chamber, lens and vitreum. Each length and their sum (AL) are calculated by measuring the time spent in different parts.
The provided 510(k) summary for the MEDA. Co., Ltd. ODM-2100/2200 Ultrasonic A/B Scanner for Ophthalmology indicates that no clinical tests were required or performed for the device. Therefore, no acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria can be extracted from this document.
The summary states:
"2) Clinical test: Not required"
Instead of clinical testing, the device's equivalence in safety and efficacy to a legally marketed predicate device (Sonomed Medical E-Z Scan™ AB5500*, K040668) was established through non-clinical tests. These non-clinical tests focused on compliance with safety, electromagnetic compatibility (EMC), acoustic output, and biological safety standards.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as the submission explicitly states that such clinical testing was not required for this 510(k) clearance.
§ 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.