(148 days)
The DC-8/DC-8 PRO/DC-8 CV/DC-8S/DC-8 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 cephalic, adult cephalic, transvaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (cardiac) exams.
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Color m-Mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System:
Summary of Device and Regulatory Status:
- Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
- Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- 510(k) Number: K150080
- Regulatory Class: II
- Product Codes: IYN (Ultrasonic pulsed doppler imaging system), IYO (Ultrasonic pulsed echo imaging system), ITX (Diagnostic Ultrasound Transducer)
- Predicate Device: DC-8 (K132341) - Main predicate device. Other predicate devices mentioned: Mindray M9 (K141010), GE Voluson E8 (K132913).
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K132341) rather than defining specific numerical acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) derived from clinical studies. The "acceptance criteria" can be inferred as compliance with recognized safety and performance standards and showing that modifications do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and not a detailed clinical trial report, explicit numerical acceptance criteria and performance metrics (e.g., sensitivity, specificity, AUC) for the diagnostic performance of the device itself are not provided in the document. Instead, the "acceptance criteria" are based on:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing it has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Compliance with Standards: The device meets recognized safety and performance standards.
Here's a table summarizing the implicit "acceptance criteria" from the document and the reported device performance in relation to these:
| Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|
| Similar Intended Use (vs. predicate K132341) | The subject device (DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S) has the same intended uses as the predicate device DC-8 (K132341), applicable for adults, pregnant women, pediatric patients, and neonates for various exams (fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac adult/pediatric, peripheral vessel, urology, transesophageal). |
| Similar Technological Characteristics (vs. predicate) | Employs the same technology as predicate devices (transmits ultrasonic energy, post-processing of echoes, onscreen display of anatomic structures and fluid flow, measurements and calculations). |
| Safety - Acoustic Power Levels (below FDA limits) | Acoustic power levels are below the limits of FDA, same as the predicate device DC-8 (K132341). |
| Safety - Electrical & Physical (compliance with standards) | Designed in compliance with FDA recognized electrical and physical safety standards, same as the predicate device DC-8 (K132341). |
| Biocompatibility (compliance with ISO 10993-1) | Patient contact materials are tested under ISO 10993-1. |
| Cleaning and Disinfection Effectiveness | Evaluated for cleaning and disinfection effectiveness. (Specific performance not detailed in table format, but compliance is asserted). |
| Software Functionality (for new features) | Newly added features (IVF, SCV+, iPage+, ART Flow, Elastography Imaging Function) are identical as the predicate devices. Implicitly, they perform as expected for an ultrasound system. |
| Transducer Performance (for new transducers) | Newly added transducers (SP5-1E and SC5-1E) are compared with the predicate devices. Implicitly perform comparably. |
| Compliance with Software Lifecycle Standards (IEC 62304) | Device conforms via "Software life cycle processes". |
| Compliance with Usability Standards (IEC 62366) | Device conforms via "Application of usability engineering to medical devices". |
| Compliance with Risk Management Standards (ISO 14971) | Device conforms via "Application of risk management to medical devices". |
| Compliance with Acoustic Output Measurement Standards (UD 2) | Device conforms via "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3". |
| Compliance with Real-Time Display Standards (UD 3) | Device conforms via "Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment". |
| Quality System Compliance (21 CFR 820, ISO 9001, ISO 13485) | The design, development, and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Tests: Not Applicable."
Therefore, there is no test set sample size and no data provenance as no clinical performance study was conducted to evaluate the diagnostic accuracy of the device on patient data. The evaluation relied on non-clinical tests to demonstrate substantial equivalence to an existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical performance study was conducted.
4. Adjudication Method for the Test Set
Not applicable, as no clinical performance study was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. The submission explicitly states "Clinical Tests: Not Applicable."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone diagnostic performance study was not done. The submission explicitly states "Clinical Tests: Not Applicable." The document refers to the system as a "software controlled, ultrasound diagnostic system," implying human-in-the-loop operation, but its diagnostic performance was not evaluated in a clinical setting as part of this submission. The "newly added software options" and "other software modifications" (IVF, SCV+, iPage+, ART Flow) were compared for "identity" with predicate devices, suggesting functional equivalence rather than measuring independent diagnostic performance.
7. The type of ground truth used
Not applicable, as no clinical performance study was conducted. The "ground truth" for the non-clinical tests would be the established specifications and standards the device was tested against (e.g., specific acoustic power limits, material biocompatibility standards).
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) submission for an ultrasound system, not an AI/ML algorithm that typically has a distinct training set. The "software modifications" mentioned (IVF, SCV+, iPage+, ART Flow) are integrated features of the ultrasound system and are stated to be "identical as the predicate devices," implying they leverage existing, cleared functionalities rather than being newly developed AI algorithms requiring dedicated training data for this submission.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set (in the context of AI/ML) was described or used in this submission.
§ 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.