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510(k) Data Aggregation
(45 days)
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular),pediatric, small organ(breast, thyroid, testes, etc.), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular . The system is designed to be used by a trained operator in a clinical setting.
The DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance 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 probe. The software of DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System is based on the main predicate DP-50, and it has a Moderate level of concern.
This is a 510(k) premarket notification for the Shenzhen Mindray Bio-medical Electronics Co., LTD DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System. The submission claims substantial equivalence to predicate devices, primarily the DP-50 Digital Ultrasonic Diagnostic Imaging System (K111435).
The document focuses on demonstrating substantial equivalence rather than presenting formal acceptance criteria with specific performance metrics for a new AI/algorithm. However, it implicitly defines acceptance based on the equivalence of its features and performance to predicate devices.
Here's an analysis of the provided information, focusing on aspects relevant to AI/algorithm performance if new features were indeed algorithm-driven. The new features such as "Smart 3D", "Smart Face", "Smart OB", "Smart Bladder", and "iNeedle" suggest the presence of algorithms or AI components.
Since this is a 510(k) premarket notification, formal "acceptance criteria" and detailed "study results" in the typical sense of a clinical trial for breakthrough devices demonstrating specific performance metrics are often replaced by comparisons to predicate devices and adherence to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission primarily relying on substantial equivalence, explicit quantitative acceptance criteria for each individual "smart" feature (e.g., Smart Face, Smart OB) are not provided in the document in the format of a clinical study. Instead, acceptance is implied by demonstrating that the performance and technological characteristics of the new features are the same as or comparable to those already cleared in predicate devices. The "S/D" column indicates if the feature is "Same" or "Different" from the predicate. For those marked "S" (Same), the implied acceptance criterion is "performance identical to the predicate device."
Here's an interpretation based on the provided comparative tables for the "new added special functions":
| Feature Category | Feature Name | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Imaging Modes & Features | 4D | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides 4D function with real-time 3D image rendering, same as Resona 7. |
| Smart 3D | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides Smart 3D function with manual probe movement and automatic 3D rendering, same as Resona 7. | |
| Free Xros M | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Allows manipulation of M-mark line at desired angles in 2D modes (B, Color, Power), same as Resona 7. | |
| iLive | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides enhanced imaging experience with light rendering effect, global and partial scattering modes, same as Resona 7. | |
| iWorks | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides step-by-step workflow protocols to reduce operations and keystrokes, same as Resona 7. | |
| iScape View | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides panoramic imaging by piecing together B images for extended views, same as Resona 7. | |
| iNeedle | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Makes needle display clearer during biopsy/anesthesia via additional deflection transmission, same as Resona 7. | |
| iPage | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides a "Visualization" mode for displaying sectional images as parallel slices, same as Resona 7. | |
| HPRF | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Enhances the range of detecting high-velocity flow when velocities exceed processing capabilities or depth for PW Doppler scale, same as Resona 7. | |
| Smart Face | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Automatically recognizes fetal face and displays it at a recommended viewing angle, same as Resona 7. | |
| Smart OB | Technological characteristics and function are the same as predicate (Resona 7, K171233). | Provides obstetric measurement tools for calculating obstetric measurements, same as Resona 7. | |
| Smart Bladder | Technological characteristics and function are the same as predicate (DC-N3, K140030). | Measures the volume of urine in the bladder automatically, same as DC-N3. | |
| New Imaging Modes (Transducers) | PW mode (all transducers) | Technological characteristics and function are the same as predicate (DC-N2, K132779). | Provides blood flow velocity and direction in real-time spectral display, same as DC-N2. |
| Color mode (all transducers) | Technological characteristics and function are the same as predicate (DC-N2, K132779). | Detects color flow information to judge direction and speed of blood flow, same as DC-N2. | |
| Power mode (all transducers) | Technological characteristics and function are the same as predicate (DC-N2, K132779). | Provides non-directional display of blood flow intensity and DirPower for flow direction, same as DC-N2. | |
| Acoustic Output | Ispta.3 |
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(34 days)
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.
The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile {with mobile ultrasound trolley}, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.
The provided text is a 510(k) Pre-market Notification for the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System. It focuses on demonstrating substantial equivalence to already-marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information, particularly regarding detailed performance metrics, study design, and ground truth establishment, is not present in this document.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's functionality. Instead, it relies on demonstrating that the DP-20 and DP-30 systems are substantially equivalent to predicate devices (Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System (K102991), and M7 Diagnostic Ultrasound System (K103677)).
The "performance" described is in terms of general characteristics and adherence to safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Acoustic Output | Conforms with applicable medical safety standards (UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, IEC 62304) |
| Biocompatibility | Conforms with applicable medical safety standards |
| Cleaning and Disinfection Effectiveness | Conforms with applicable medical safety standards |
| Thermal Safety | Conforms with applicable medical safety standards |
| Electrical Safety | Conforms with applicable medical safety standards |
| Mechanical Safety | Conforms with applicable medical safety standards |
| Effectiveness/Functionality: | |
| Ability to acquire and display ultrasound data in B-Mode, M-Mode, or combined B+M Mode | Functions as described (acquires and displays B-Mode, M-Mode, or combined B+M Mode data) |
| Intended Uses are comparable to predicate devices | Intended uses are consistent with traditional clinical practices, FDA guidelines, and established methods of patient examination. Broad range of applications (fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vascular, urology). |
| Technological Characteristics comparable to predicate devices | Has the same technological characteristics as predicate devices. |
| Key safety and effectiveness features comparable to predicate devices | Comparable in key safety and effectiveness features to predicate devices. |
| Basic operating modes comparable to predicate devices | Has the same basic operating modes as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any specific clinical or performance test set (dataset of cases) used to establish quantitative performance metrics. The demonstration of safety and effectiveness relies on adherence to established engineering and medical device standards, and comparison to predicate devices, rather than a prospective clinical study with a defined test set of patients/images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth establishment by experts for a specific test set is mentioned, as the submission is not based on a clinical performance study with a new algorithm or diagnostic aid requiring such validation.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set and subsequent adjudication method are described in this 510(k) summary.
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. This is an ultrasound imaging system, and the submission does not involve an AI algorithm or a comparative effectiveness study of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a standalone ultrasound imaging system, not an algorithm. Its "standalone" performance is assessed at the system level through adherence to safety and operational standards and comparison to predicate devices.
7. The Type of Ground Truth Used
Not applicable in the context of a new diagnostic algorithm. The "ground truth" implicitly referred to is the established safety and performance of predicate ultrasound systems and compliance with international and national safety standards.
8. The Sample Size for the Training Set
Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons mentioned above.
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