DC-90/DC-90S/DC-90Q/DC-95/DC-95/DC-88/DC-888/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-8Q/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), superficial), superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, Smart 3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE, STQ, Ultrasound Fusion Imaging, GYN/Pelvic and Combined mode:B+M, PW +B, Color+B, Power+B, PW+Color+B, Power+PW+B.
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/ DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system.
This system is a Track 3 device that employs an array of probes that include linear array, convex array, pencil phased and phased array.
This document is a 510(k) summary for the Mindray DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to predicate devices, not to present a de novo clinical study with specific acceptance criteria related to a novel AI-driven diagnostic performance.
Therefore, many of the requested categories for describing acceptance criteria and study details are Not Applicable (NA) in the context of this 510(k) Pre-Market Notification. This document primarily focuses on demonstrating that the new device, with its added transducers, needle-guided brackets, and features, performs equivalently and safely to previously cleared devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence (General): The device must be as safe and effective as a legally marketed predicate device, and have the same intended use and technological characteristics, or if there are differences, the differences do not raise new questions of safety and effectiveness and are demonstrated to be safe and effective.
No specific quantitative acceptance criteria or reported device performance metrics in the format of "Accuracy > X%" or "Sensitivity > Y%" are presented in this 510(k) summary because it's for a general diagnostic ultrasound system, not an AI-enabled diagnostic device with specific performance claims for disease detection.
The document demonstrates equivalence through:
- Intended Use: Identical to predicate.
- Technological Characteristics: Employing the same fundamental ultrasonic imaging technology.
- Performance: The new models are stated to have "the same performance and functions with the predicated device DC-80 (K192152)".
- Electrical and Physical Safety: Compliance with recognized standards and acoustic power levels below FDA limits.
- Biocompatibility: Materials for new transducers and needle-guided brackets are either the same as predicate or tested for biocompatibility.
| Acceptance Criteria Category | Details from 510(k) Summary | Reported Device Performance |
|---|---|---|
| Intended Use | Same intended use as predicate device (DC-80 K192152). Applicable for adults, pregnant women, pediatric patients, and neonates for various exams (fetal, abdominal, small organ, cardiac, vascular, etc.). | The subject device's intended uses are "consistent with traditional clinical practices, FDA guidelines and established methods of patient examination," and are explicitly stated to be the same as the predicate device. |
| Technological Characteristics (Core) | Employs the same technology as predicate devices: "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body." | The document states the subject device "employs the same technology as the predicate devices," and has the "same intended uses and basic operating modes as the predicate devices." |
| Safety - Acoustic Power Levels | Acoustic power levels are to be "below the limits of FDA." | "The acoustic power levels of DC-90/DC-90S/... are below the limits of FDA, which is the same as the predicated device DC-80 (K192152)." |
| Safety - Electrical & Physical | Designed in compliance with FDA recognized electrical and physical safety standards. | "DC-90/DC-90S/... is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-80 (K192152)." Compliance with specific standards (ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, NEMA UD 2-2004, ISO 10993-1, IEC 62366-1, IEC 60601-1-6) is stated. |
| Biocompatibility | Materials of new transducers and needle-guided brackets | |
| are to be "the same as in the predicate device" or tested for biocompatibility. | "The materials of probes and Needle-guided brackets of DC-90/DC-90S/... are the same to the predicate device DC-80 (K192152)." Additionally, "the L13-3WE transducer was testing for biocompatibility." | |
| Cleaning and Disinfection Effectiveness | Disinfection/sterilization methods for new transducers/brackets are to be provided to end-user. | "All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual." |
| Overall Safety and Effectiveness Profile | To be similar to the predicate device. | "Based on the performance data as documented in the study, the DC-90 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device." |
| Quality System Compliance | Design, development, and quality process to conform with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. | "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." |
2. Sample size used for the test set and the data provenance
NA. This 510(k) submission does not describe a clinical performance study with a "test set" in the context of an AI/ML algorithm for diagnostic performance. The non-clinical tests relate to engineering safety and performance standards (e.g., acoustic output, biocompatibility, electrical safety), not diagnostic accuracy derived from a patient dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
NA. This is not a study assessing the diagnostic performance of an AI algorithm against expert-established ground truth.
4. Adjudication method for the test set
NA. See point 3.
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
NA. This 510(k) is for a general diagnostic ultrasound system, not an AI-assisted diagnostic tool requiring an MRMC study for human reader improvement. While the device does have "Smart" features (e.g., Smart 3D, Smart Pelvic, Smart Planes FH), the submission does not present a comparative effectiveness study demonstrating the incremental benefit of these features for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
NA. This 510(k) is for a general diagnostic ultrasound system, not a standalone AI algorithm. It's an imaging device that produces images for human interpretation, potentially with some "smart" features that assist, but without a claim of standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
NA. In a 510(k) for a general ultrasound system, "ground truth" as it pertains to diagnostic accuracy of an AI algorithm is not typically established or required. The "ground truth" implied in this context would be the known physical and electrical properties of the device components and their adherence to engineering standards.
8. The sample size for the training set
NA. This submission does not describe an AI/ML algorithm with a "training set" for diagnostic performance.
9. How the ground truth for the training set was established
NA. See point 8.
§ 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.