(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (includes infertility monitoring of follicle development), Abdominal, Intra-Operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial). Includes imaging for guidance of biopsy and 3D Imaging.
The SA 6000C/UM 400C System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode. M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The SA 6000C/UM 400C also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Eight different models of transducers are available and any two may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials are the same as those previously cleared in the predicate device, SA 8800/HDI 1500 and SA 6000C/UM 400C ultrasound systems and transducers (K974267 and K981510). The SA 6000C/UM 400C uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 9.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The SA 6000C/UM 400C supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a Dicom 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The provided text does not contain information about acceptance criteria for a specific device performance study, nor does it describe a study proving a device meets such criteria. Instead, it is a 510(k) Premarket Notification for the SonoAce 6000C/Ultramark 400C Diagnostic Ultrasound System and its transducers.
This submission focuses on demonstrating substantial equivalence to previously marketed predicate devices (SA 8800/HDI 1500 and SA 6000/UM 400 systems). Substantial equivalence in the context of 510(k) means that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. This is typically achieved by showing that the device has the same intended use and similar technological characteristics as the predicate device(s), or if there are differences, that those differences do not raise new questions of safety or effectiveness.
The document primarily outlines:
- Device Description: What the SonoAce 6000C/UM 400C does (general purpose, mobile, software-controlled, diagnostic ultrasound system, displaying B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D, and various measurement functions).
- Intended Use: A comprehensive list of clinical applications for which the device is intended (e.g., Fetal, Abdominal, Cardiac, Peripheral-Vascular, Small Organ, etc.).
- Technological Characteristics: Details on how it operates (piezoelectric material in transducer, sound wave transmission/reflection, conversion to electrical signals for display), biocompatibility of patient contact materials, and acoustic output limits (I SPTA 720 mW/cm2, MI 1.9), stating these are the same as predicate Track 3 devices.
- Safety Standards Compliance: A list of electromechanical safety standards the device has been designed to meet (e.g., EN 60601-1, UL 2601-1).
- Transducers: A list of eight different transducer models available with the system, along with their specific indications for use.
No information is provided regarding:
- Acceptance criteria for performance metrics.
- Specific device performance data against acceptance criteria.
- Details of a study proving performance, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The FDA's letter mentions that a post-clearance special report containing "acoustic output measurements based on production line devices" will be required, indicating that some performance verification related to acoustic output happens after the initial 510(k) clearance, but the primary submission itself does not include performance study results in the context of acceptance criteria as you've requested.
Therefore, I cannot populate the table or provide the requested study details based on the provided text. The document serves as a substantial equivalence claim, not a performance study report with specific acceptance criteria and results.
§ 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.