(26 days)
The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B 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), adult cephalic, trans-rectal, trans-vaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B 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, Power/Dirpower mode, TDI mode, 3D/4D mode, Color M-mode, iScape mode, Elastography, LVQ, Ultrasound Fusion Imaging, V Flow 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 13.5MHz.
This document describes a 510(k) premarket notification for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System. This submission is for modifications and new features to a previously cleared device (K152763).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with reported device performance metrics in numerical terms (e.g., sensitivity, specificity, or image quality measures). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and verification that the added features function as intended and safely.
The key acceptance criteria appear to be:
- Identical Intended Use: The modified device has the same intended uses as the predicate device K152763.
- Safety Standards Compliance: The device meets recognized electrical, physical, and acoustic safety standards.
- Biocompatibility: Patient-contact materials of new transducers and needle-guided brackets meet ISO 10993-1.
- Acoustic Output Levels: Acoustic power levels are below FDA limits and are the same as the predicate device.
- Software Life Cycle Processes: Compliance with IEC 62304.
- Usability Engineering: Compliance with IEC 62366 and IEC 60601-1-6.
- Risk Management: Compliance with ISO 14971.
- Cleaning and Disinfection Effectiveness: Evaluated.
- Functionality of New Features: The newly added features are identical in function to those on predicate devices (implicitly meaning they perform as expected and no new safety/effectiveness concerns are introduced).
Reported Device Performance:
The document does not provide specific numerical performance data for these criteria (e.g., exact acoustic output levels, numerical results for electrical safety tests, or detailed biocompatibility reports). Instead, it states that the device has "been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety," and that it "has been designed to conform with applicable medical safety standards." For the new features, it states they are "identical as the predicated devices" in functionality.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "7. Clinical Studies - Not applicable. The subject of this submission, Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Therefore, there is no clinical test set or associated data provenance (country of origin, retrospective/prospective) mentioned in this submission. The evaluation relies on non-clinical testing and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no clinical studies were performed and no clinical test set was used, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As no clinical test set was used, no adjudication method is described.
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
No MRMC comparative effectiveness study was reported. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and the submission is for substantial equivalence based on hardware and software modifications, not AI performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or reported as this is a diagnostic ultrasound system and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no clinical studies were conducted, there is no ground truth established from clinical data (expert consensus, pathology, outcomes data). The "ground truth" for demonstrating substantial equivalence is adherence to recognized industry standards and direct comparison of specifications and functionality with previously cleared predicate devices.
8. The sample size for the training set
No training set is mentioned as this submission is not about an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for an AI/machine learning model.
In summary, this 510(k) submission demonstrates acceptance through non-clinical testing and comparison to predicate devices rather than clinical performance studies. The core argument for acceptance is that the device, with its modifications, is substantially equivalent in safety and effectiveness to existing cleared devices based on compliance with established standards and the functional identity of its features.
§ 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.