(45 days)
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac.
Small organs includes: thyroid, parathyroid, parotid, submaxillary gland, testes and breast.
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa.
Model CTS-485 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9-inch video monitor and a special photographic unit.
The provided document is a 510(k) Premarket Notification Summary for the SIUI CTS-485 Ultrasound Imaging System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics. As such, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a device with new performance claims.
Instead, the document details the device's technical specifications and intended uses, and asserts its substantial equivalence to a predicate device (MEDISON Co. SONOACE 600, K000030). The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and find the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the device is considered safe and effective because its characteristics are similar enough to a device already on the market, not because it has met specific, novel performance benchmarks.
Therefore, I cannot populate the requested table and sections as the information is not present in the provided text.
Here's why and what information is available:
- Acceptance Criteria and Reported Device Performance: This document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance values from a clinical study. It focuses on technical specifications (e.g., display modes, grey scale, frequency of probe, depth, gain) and intended uses.
- Study Information (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): No such study is described or referenced in this 510(k) summary. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and intended use to a predicate device. The only "test" mentioned is a future "postclearance special report" for acoustic output measurements based on production line devices, which is a safety/engineering test, not a performance study as typically understood for AI/ML or new clinical claims.
§ 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.