Resona I8W, Resona I8, Resona I8S, Resona I8S, Resona I8T, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa 18, Nuewa 18 Exp, Nuewa 18T, Imagyn 18, Imagyn 18T, Imagyn 18T, Imagyn 18 Exp, Nuewa 1Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD , Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Realtime 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving direct performance against specific numerical acceptance criteria for a new, breakthrough device. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing and comparison of features. The "study" refers to these non-clinical tests and comparisons.
Description of Acceptance Criteria and the Study that Proves the Device Meets Them
The Shenzhen Mindray Bio-medical Electronics Co., LTD's Resona I8W and associated systems (subject device) seek to prove substantial equivalence to predicate devices, primarily the Resona I9 (K210699). The acceptance criteria are largely focused on demonstrating that the subject device's intended use, technological characteristics, safety, and effectiveness are comparable to the legally marketed predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from 510(k) Content) | Reported Device Performance (Summary from 510(k)) |
|---|---|---|
| Intended Use Equivalence | Intended uses are consistent with predicate devices. | The subject device has the same intended uses as the predicate device Resona I9 (K210699), applicable for adults, pregnant women, pediatric patients and neonates for various exams (fetal, abdominal, intra-operative, small organ, cardiac, etc.) and modes of operation (B, M, PWD, CWD, Color, etc.). |
| Technological Characteristics Equivalence | Device operates using the same fundamental scientific technology. | Both subject and predicate systems transmit ultrasonic energy, perform post-processing to generate onscreen display of anatomic structures and fluid flow. They both allow for specialized measurements and calculations. |
| Safety - Material Biocompatibility | Patient contact materials of transducers and needle-guided brackets are the same as predicate devices. | The patient contact materials of the transducers and needle-guided brackets of the subject device are the same as the predicate devices. |
| Safety - Acoustic Output | Acoustic power levels are below FDA limits and are the same as predicate devices. | Acoustic power levels of the subject device are below FDA limits and are the same as the predicate device Resona I9 (K210699). |
| Safety - Electrical, Thermal, Mechanical | Device complies with recognized electrical and physical safety standards. | The subject device is designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). This is stated to be the same as the predicate device Resona I9 (K210699). |
| Performance - Features and Functions | Equivalent features and functions, or new features cleared in other predicate/reference devices. | The subject device has equivalent features and functions to predicate devices. Specific advanced features (USAT, HRI+, HiFR CEUS, CEUS Chrono-Parametric Mode, TCMR, 3D-Print Format, Ultra-Micro Angiography, DICOM Pediatric SR, DICOM Urology SR, Biopsy Grid) were previously cleared in Resona R9 (K222928). Smart Bladder and ClamAV were cleared in Consona N9 (K221300). IOTA was cleared in Voluson E10 (K181985). |
| Non-clinical Tests | Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety. | Non-clinical tests were performed based on recognized international and national standards (NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). The results support substantial equivalence. |
| Clinical Studies | Not required to support substantial equivalence if non-clinical data is sufficient. | No clinical studies were deemed necessary or performed to support substantial equivalence for this submission. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states "Not applicable" for clinical studies. This submission relies on non-clinical performance data and comparison to predicate devices, rather than a clinical test set with patient data. The "test set" in this context refers to the device itself being tested for compliance with safety standards and functional equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical "test set" with patient data was used to establish ground truth, this information is not relevant to this 510(k) submission. Ground truth, in the traditional sense of medical image interpretation, was not established for this device's comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring expert adjudication was conducted.
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. No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The submission does not describe any AI features that would necessitate an MRMC study to evaluate human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a diagnostic ultrasound system. While it has software controls and analysis packages, it does not represent a standalone "algorithm only" device that provides interpretations without human interaction. Its performance is demonstrated through its ability to acquire and display ultrasound images and facilitate measurements for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the clinical sense). Ground truth, in this context, is established through compliance with recognized safety standards and functional equivalence to predicate devices, not through clinical diagnostic verification against pathology or outcomes data for new clinical claims. The "ground truth" for the device's acceptable performance is its adherence to industry standards and its comparability to existing, legally marketed ultrasound systems.
8. The sample size for the training set:
- Not Applicable. This document does not describe a machine learning algorithm that underwent training with a specific dataset. It refers to a diagnostic ultrasound system.
9. How the ground truth for the training set was established:
- Not Applicable. Since there is no described machine learning training set, the establishment of its ground truth is not relevant here.
§ 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.