(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and 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. This modification will provide users with a wider selection of probe characteristics. And tissue harmonic imaging enhances over image performance.
The provided 510(k) summary for the DP-9900 Digital Ultrasonic Diagnostic Imaging System does not include acceptance criteria or a study proving that the device meets specific acceptance criteria in terms of clinical performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to safety standards. The "testing" section primarily describes engineering verification and conformation to general safety standards for medical devices and acoustic output.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (No specific clinical performance acceptance criteria are mentioned for the device's diagnostic capabilities. The submission focuses on substantial equivalence to a predicate device regarding safety and efficacy, and conformity to general medical device standards.) | N/A (No specific clinical performance metrics are reported. The document states that "the technology characteristics of the DP-9900 digital ultrasonic diagnostic imaging system with these modifications do not affect the safety or efficacy of the device" and that "the device is as safe, as effective as well as the legally marketed predicate devices.") |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (No clinical test set for performance evaluation against specific criteria was required or performed).
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable (No clinical test set with expert ground truth was required or performed).
4. Adjudication Method for the Test Set
- Not applicable (No clinical test set with adjudicated ground truth was required or performed).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size of human readers with AI vs. without AI assistance: Not applicable. This is a diagnostic ultrasound system, not an AI-powered image analysis tool for interpretation.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This is a diagnostic imaging device, not a standalone algorithm.
7. Type of Ground Truth Used
- Not applicable (No clinical performance evaluation requiring ground truth was described).
8. Sample Size for the Training Set
- Not applicable (This submission describes a hardware and software system, not a machine learning model that requires a training set of data for performance).
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of Findings from the Provided Text:
The 510(k) submission for the DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a substantial equivalence (SE) submission, not one that relies on clinical performance data against specific acceptance criteria. The core argument for clearance is that the modified device (with added transducers) shares the same fundamental technology as its predicate devices and conforms to applicable safety standards.
The document explicitly states: "No clinical testing was required." This indicates that the FDA did not deem a clinical study necessary to prove the device's safety and effectiveness for its intended use, likely because its technological characteristics and intended use were very similar to existing, legally marketed predicate devices. The focus was on engineering verification and compliance with standards such as NEMA UD 2, IEC 60601-1, and IEC 60601-1-2 for acoustic output, electrical safety, thermal safety, and biocompatibility.
§ 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.