(30 days)
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, M mode or Combined (B+ Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric Abdominal Pediatric Small Organ Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel
The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
The Interson USB Ultrasound Imaging System (Proposed) is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The system operates in B, color Doppler, M mode and combined B + color Doppler modes. The selection of transducers offered with the system permits a wide range of clinical applications including Abdominal, Fetal, Pediatric, Musculoskeletal, Cardiac, Small organ. Neuro-muscular, Urology, OB/Gyn and Peripheral vessel.
This FDA 510(k) summary does not contain the detailed information necessary to fully describe acceptance criteria and associated study results for the Interson USB Ultrasound System. The document is primarily a notification of administrative change and a summary for a "Special 510(k)" submission.
Specifically, it states:
"The proposed modification is to add the cardiac indication to the Ultrasound system with the indicated probe... Given the cardiac indication added to the labeling and no other changes to the device, non-clinical testing and clinical testing are not required."
This statement indicates that for this specific 510(k) submission (K233734), no new performance studies (non-clinical or clinical) were conducted to establish acceptance criteria or demonstrate device performance. The device is being cleared based on its substantial equivalence to a predicate device (K163443), with a new indication being added without requiring new testing.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific submission as these details are not present in the provided text.
To obtain such information, one would typically need to refer to the original 510(k) submission for the predicate device (K163443) or a more comprehensive technical documentation package.
§ 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.