The DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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, peripheral vessel and urology exams.
DC-70/DC-70T /DC-70 PRO/DC-70 EXP is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI 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 and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System. It details the device's substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria (e.g., minimum accuracy rates for detecting certain conditions) or detailed device performance metrics in a typical table format like one would expect for a diagnostic AI algorithm. Instead, it relies on demonstrating substantial equivalence to predicate devices by asserting that the subject device has the same technological characteristics, comparable safety and effectiveness features, and the same intended uses and basic operating modes.
The performance is implicitly "met" by showing compliance with various medical device safety and performance standards. The key reported "performance" is the sameness of features and capabilities with the predicate device.
Here's an attempt to structure it based on the available information:
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate. | The DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System has the same intended uses as the predicate device DC-8 (K132341). It is applicable for adults, pregnant women, pediatric patients and neonates,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, peripheral vessel and urology exams. |
| Technological Characteristics Equivalence: Same basic technology and operating modes. | The device has the same technological characteristics as the predicate device. All systems transmit ultrasonic energy, perform post-processing of received echoes to generate on-screen displays of anatomic structures and fluid flow. It has the same imaging modes as the predicate DC-8: B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode, and combined modes (B/M-Mode, B/PW-mode, B/PW/Color). |
| Safety and Effectiveness Equivalence: Comparable in features affecting safety and effectiveness, and compliant with relevant standards. | - Patient Contact Material: Same as predicate DC-8 (K132341). |
- Acoustic Power Levels: Below FDA limits and same as predicate DC-8 (K132341).
- Electrical & Physical Safety: Compliant with FDA recognized standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37) and same as predicate DC-8 (K132341).
- Special Functions: Identical to predicate devices DC-8 (K132341) and DC-N2 (K132779).
- Image Annotation/Reporting: Same capacity as predicate DC-8 (K132341).
- Probes: Has similar/same probes as predicate DC-8 (K132341), specifically listing C5-2E, C7-3E, C11-3E, P4-2E, P7-3E, V11-3E, V11-3BE, V11-3WE, L12-3E, L14-6NE, L14-6WE, D6-2E, DE10-3E, CW5s.
- Measurement & Calculation Functions: Same as predicate DC-8 (K132341). |
| Quality System Compliance: Manufacturing processes adhere to recognized quality standards. | The design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |
| Biocompatibility: Demonstrated biocompatibility. | Evaluated for biocompatibility and designed to conform with applicable medical safety standards, including ISO 10993-1. |
| Cleaning and Disinfection Effectiveness: Effectiveness evaluated. | Evaluated for cleaning and disinfection effectiveness. |
| Risk Management: Application of risk management processes. | ISO14971 Medical devices - Application of risk management to medical devices was applied. |
| Software Life Cycle: Software development adheres to recognized standards. | IEC 62304 Medical device software - Software life cycle processes were followed. |
| Usability Engineering: Usability considered in design. | IEC 62366 Medical devices - Application of usability engineering to medical devices was applied. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "7. Clinical Studies Not applicable. The subject of this submission, DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, there is no test set of clinical images or patient data used for evaluating the device's performance in terms of diagnostic accuracy or clinical outcomes. The evaluation is based on non-clinical tests (acoustic output, electrical safety, biocompatibility, software standards, etc.) and comparison to predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical test set was used, there were no experts used to establish ground truth in the context of diagnostic accuracy for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
Not applicable. This device is a diagnostic ultrasound system (hardware and software for image acquisition and display), not an AI-assisted diagnostic tool that modifies human reader performance. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a complete diagnostic ultrasound system, not an AI algorithm for standalone interpretation. The system itself generates the images that a human interprets.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic performance (e.g., pathology, outcomes data). The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the various engineering, safety, and performance standards listed (e.g., maximum acoustic output levels, electrical safety limits).
8. The Sample Size for the Training Set
Not applicable. As a diagnostic ultrasound system that relies on physical principles of sound wave generation and detection, and image processing, it does not use a "training set" in the context of machine learning. The system's design and software are developed based on engineering principles and validated through adherence to standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no machine learning "training set". The performance is established through adherence to recognized medical device standards and demonstrating equivalence to a legally marketed predicate device.
§ 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.