The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.
DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.
Here's an analysis of the provided information regarding the acceptance criteria and supporting studies for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System.
Important Note: This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness as a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to safety, performance aspects comparable to the predicate, and adherence to relevant standards. Clinical effectiveness studies are explicitly stated as "Not applicable."
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the acceptance criteria are not typically expressed as specific performance metrics (like sensitivity/specificity) for a diagnostic task, but rather as compliance with safety standards and equivalence to predicate devices in terms of intended use and technological characteristics.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use Equivalence | The subject device has the same intended uses as the predicate devices (Mindray DC-70 (K163690) and DC-80 (K173471)). |
| Technological Characteristics Equivalence | The subject device has the same technological characteristics as the predicate devices, including B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging, and combined modes. It also uses similar probes. All systems transmit ultrasonic energy, perform post-processing, and allow for specialized measurements and calculations. |
| Acoustic Output Safety | Acoustic power levels are below the FDA limits, same as the predicate device DC-70 (K163690). |
| Electrical and Physical Safety | Designed in compliance with FDA recognized electrical and physical safety standards, same as the predicate device DC-70 (K163690). |
| Biocompatibility | Evaluated for biocompatibility. |
| Cleaning and Disinfection Effectiveness | Evaluated for cleaning and disinfection effectiveness. |
| Thermal Safety | Evaluated for thermal safety. |
| Mechanical Safety | Evaluated for mechanical safety. |
| Software Life Cycle Processes | Designed in compliance with IEC 62304 (Medical device software Software life cycle processes). |
| Usability Engineering | Designed in compliance with IEC:62366 (Medical devices - application of usability engineering to medical devices) and IEC 60601-1-6 (Usability). |
| Risk Management | ISO14971 (Medical devices - Application of risk management to medical devices) followed. |
| Quality Systems | Design, development, and quality process conform with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "8. Clinical Studies Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, there is no mention of a traditional test set of patient data, sample size, or data provenance (country of origin, retrospective/prospective) for proving device performance in a diagnostic context. The assessment relies on engineering and performance testing against standards and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As clinical studies were "Not applicable," there is no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for diagnostic performance evaluation.
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
Not applicable. The submission explicitly states no clinical studies were required or performed. There is no mention of AI features (other than "Smart3D", "Smart face", "Smart plane CNS", which are likely imaging enhancement features rather than AI for diagnostic interpretation) that would necessitate a comparative effectiveness study with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no clinical studies were conducted for diagnostic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For a 510(k) for an ultrasound system, the "ground truth" for demonstrating substantial equivalence primarily relates to:
- Compliance with recognized standards: The physical and electrical safety, acoustic output, and electromagnetic compatibility are tested against established engineering and medical device standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, UD 2, UD 3, ISO 10993-1).
- Performance specifications: The ultrasound system's various modes (B-Mode, M-Mode, etc.) and transducer capabilities are assessed against their defined technical specifications and compared to those of predicate devices.
- Physical and material properties: Biocompatibility, cleaning/disinfection effectiveness are evaluated according to relevant standards.
8. The Sample Size for the Training Set
Not applicable. No AI/ML model requiring a training set is described as the primary subject of the 510(k) for demonstrating substantial equivalence as a diagnostic device. The "Smart" features mentioned are likely integrated software functionalities rather than standalone AI for diagnostic interpretation requiring significant training data submitted for review.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML model for diagnostic interpretation is discussed.
§ 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.