(50 days)
The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.
D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.
It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.
The system consists of a main unit, transducers and other accessories.
The provided 510(k) submission for the "Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6" does not contain acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Digital Ultrasonic Diagnostic Imaging System, K091680 from Edan Instruments, Inc.) based on:
- Similar technology characteristics: The current device has similar design principles and electrical classification.
- Same intended use: The indications for use are the same as the predicate device.
- Non-clinical testing: This primarily involves compliance with various safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10) and acoustic output testing.
The document explicitly states: "Clinical test: Clinical testing is not required." This means there was no study performed to establish diagnostic performance metrics (like sensitivity, specificity, accuracy) against a ground truth for the purpose of this 510(k) submission.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be provided from this document.
Here's what can be extracted based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar technology characteristics to predicate device (K091680) | Similar design principle, electrical classification, and accuracy as the predicate device (K091680). Differences (physical specifications, display type/mode) do not affect usage, safety, or effectiveness. |
| Same intended use as predicate device (K091680) | Intended for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal head, Cardiology, Peripheral Vessel, Musculo-skeleton (Conventional and Superficial), Urology (including prostate), Transrectal, and Transvaginal, identical to the predicate. |
| Compliance with Electrical Safety Standard | Compliant with IEC 60601-1. |
| Compliance with Electromagnetic Compatibility Standard | Compliant with IEC 60601-1-2. |
| Acoustic Output Testing | Compliant with the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008. Also compliant with UD-2, IEC 60601-2-37. |
| Biocompatibility Testing | Compliant with ISO 10993-1, ISO 10993-5, and ISO 10993-10. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission explicitly states "Clinical test: Clinical testing is not required." for this submission. The evaluation was based on non-clinical engineering tests and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No clinical test set or ground truth was established for this 510(k) submission.
4. Adjudication method for the test set:
- Not applicable / Not provided. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a submission for a general diagnostic ultrasound system, not an AI-powered diagnostic tool. Clinical testing was also explicitly stated as "not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a digital ultrasound imaging system, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable / Not provided. For this 510(k) submission, the "ground truth" was the performance and safety established for the predicate device, against which the new device was deemed substantially equivalent through engineering and non-clinical testing.
8. The sample size for the training set:
- Not applicable / Not provided. This is an ultrasound imaging system, not an AI/Machine Learning device that utilizes a training set for model development in the context of diagnostic accuracy.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See explanation for #8.
§ 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.