(28 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). Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies. Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs and bony structures. Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Prostate, prostate biopsy guidance, and rectal wall studies. Neonatal head studies. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans. Intraoperative application including soft tissue structures.
The UM 400C/SA 6000C 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, Tissue Harmonic Imaging 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 UM 400C/SA 6000C 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. Nine 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. The UM 400C/SA 6000C system uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is a diagnostic 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 (occipitofrontal 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 UM 400C/SA 6000C 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 device, nor does it describe a study proving the device meets acceptance criteria.
The document is a 510(k) summary for the UM 400C/SA 6000C Ultrasound System, which is a premarket notification to the FDA. It details:
- Submitter's information
- Device name and classification
- Predicate device identification
- Device description: General purpose, mobile, software-controlled diagnostic ultrasound system with various display modes (B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler, Power Doppler, 3D, Tissue Harmonic Imaging). It also mentions measurement capabilities and analysis packages.
- Intended Use: Lists a wide range of clinical applications (Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal).
- Technological Characteristics: Describes the device's operational principle (piezoelectric material to transmit and receive sound waves) and acoustic output limits (TIS/TIB/TIC, ISPTA, MI). It states that these limits are the same as predicate Track 3 devices.
- FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices and mentions the C3-7 Curved Linear Array 4.5 MHz/60R/60D/128 elements transducer is included in this determination. It also requests a post-clearance special report with acoustic output measurements based on production line devices.
- Indications for Use Statement: Lists clinical applications and modes of operation, differentiating between previously cleared (P) and new (N) indications for the overall system and specifically for the C3-7 transducer with Tissue Harmonic Imaging (THI).
There is no mention of a clinical study, test set, ground truth establishers, adjudication methods, MRMC studies, or standalone algorithm performance. The "acceptance criteria" discussed are limited to the device's acoustic output limits, which are stated to be "the same as predicate Track 3 devices," implying adherence to established safety standards rather than performance metrics from a comparative study.
§ 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.