(34 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal, Musculo-skeletal Superficial.
The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 10 MHz. The modification will provide users with an additional transducer and change the acoustic lens of some transducers along with the addition of software functions.
1. Acceptance Criteria and Reported Device Performance:
There are no explicit acceptance criteria or reported device performance metrics mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device.
2. Sample Size and Data Provenance for Test Set:
No specific test set or clinical study with a defined sample size is described. The document states, "No clinical testing was required," indicating that the device was not evaluated through clinical trials for this submission.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable, as no dedicated clinical testing or ground truth establishment for a test set is described.
4. Adjudication Method for Test Set:
Not applicable, as no dedicated clinical testing or adjudication process for a test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study or any form of comparative effectiveness study involving human readers with or without AI assistance is mentioned.
6. Standalone Algorithm Performance:
The document does not describe a standalone algorithm performance study. The submission is for a traditional diagnostic ultrasound imaging system, not an AI-based algorithm.
7. Type of Ground Truth Used:
Not applicable, as no ground truth for a specific test set is described. The device's safety and effectiveness were primarily evaluated through laboratory testing and comparison to existing standards and a predicate device.
8. Sample Size for Training Set:
Not applicable, as this is not an AI/ML-based device that would require a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable, as this is not an AI/ML-based device that would require a training set and corresponding ground truth.
Summary of Information from the Provided Text:
The provided 510(k) summary for the DP-9900 Digital Ultrasonic Diagnostic Imaging System and its added transducer (75L60HB) primarily relies on:
- Substantial Equivalence: The core argument is that the device is substantially equivalent to a legally marketed predicate device (K053346).
- Laboratory Testing: "Laboratory testing was conducted to verify that the DP-9900 digital ultrasonic diagnostic imaging system with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above."
- Compliance with Standards: The device was found to conform to applicable medical device safety standards (e.g., NEMA UD 2, IEC 60601-1, IEC 60601-1-2) regarding thermal, mechanical, electrical safety, biocompatibility, and acoustic output.
- No Clinical Testing: The document explicitly states, "No clinical testing was required."
Therefore, the specific information requested in the prompt (acceptance criteria table, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not detailed as part of this traditional medical device clearance process described. The device's acceptance was based on its demonstrated equivalence to an already approved device and compliance with established safety and performance standards through laboratory testing.
§ 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.