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510(k) Data Aggregation
(249 days)
Carnation series Diagnostic Ultrasound System
The Carnation series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams.
The Camation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.
Modes of operation include: B-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.
The proposed Carnation series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.
The Carnation series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.
Holo PW is based on the echo planar imaging, and forms the planar data by emitting and receiving multiple beams to synchronously display the blood flow at multiple sampling gates.
The Carnation series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG lead wire, Magnetic cup, Foot switch, Scanner, USB headset, Camera and Black/white video printer.
The Carnation series Diagnostic Ultrasound System utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system also includes several automated measurement function: wiCalc_Diaph, wiCalc_Vas, wiCalc_Vol.Flow, Automatic trace, wiCalc_VTI, wiCalc_IVC, wiCalc_IMT, those measurement function can assist users to carry out relevant measurement automatically. The output results of those automatic measurement function are for reference only by users, and the final results need to be confirmed and modified by users based on professional knowledge.
The Carnation series Diagnostic Ultrasound System also include the function of wiScan, wiShow, wiGuide and wiNerve. wiScan is an easy-to-use quality assurance and workflow tool that automatically guides the user through an exam to ensure required steps are performed while reducing key strokes. wiShow is a teaching video recording software, which is an independent functional module integrated in the ultrasound diagnostic system. The function enables doctors to record and edit teaching videos, and export the video to a U disk or network storage. wiGuide uses the characteristics of the magnetic field to enhance the visualization effect of the needle by detecting the magnetized needle, and can better detect the position of the needle when it is in the human body. wiNerve is an education purpose tool, which aims to automatic recognition of different anatomical structures and display the recognized anatomical structures in different colors, to help doctors to improve the skills. The results of wiNerve are not used as diagnostic evidence.
Eight models for the main units are included in this submission, that is Carnation, Carnation Fast, Carnation T, Carnation Exp, Carnation Neo, Carnation+, Carnation Pro, Carnation Ultra. There are thirteen different models of probes: C6-1B-H. C6-2-H, C8-3-H, C9-3-H, EV11-3-H, L15-4WB-H, L15-4NB-H, L15-6-H, L22-10-H, L8-3-H, SP5-1-H, P8-3-H and P12-4-H are available for the Carnation series.
The provided text is a 510(k) Summary for the Carnation series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on a specific study designed to meet pre-defined acceptance criteria for a novel device.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance studies is not present in this document. The document explicitly states that clinical studies were not required to support substantial equivalence.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for device performance (e.g., sensitivity, specificity, accuracy) are reported in this document. The substantial equivalence argument is based on similarities in intended use, technological characteristics, and compliance with recognized standards.
| Feature/Metric | Acceptance Criteria (Not explicitly defined in the document for performance) | Reported Device Performance (as implied by equivalence) |
|---|---|---|
| Intended Use | Covered by predicate device's intended use | Similar to predicate device (K180599), with all proposed indications covered by the predicate. |
| Operation Modes | Similar to predicate, with known differences covered by reference devices. | Similar to predicate (K180599), Holo PW covered by K211886, PANO by K173471. |
| Functions | Similar to predicate, with known differences covered by reference devices. | Similar to predicate, wiGuide and wiNerve similar to K211886. |
| Acoustic Power Levels | Below FDA limits. | Complies with FDA limits; same as predicate (K180599). |
| Biocompatibility | Complies with ISO 10993. | Cytotoxicity, Sensitization, Skin Irritation tests successful (in accordance with ISO 10993). |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. | Complies with IEC 60601-1, IEC 60601-2-37 (safety), and IEC 60601-1-2 (EMC). |
| Software V&V | Complies with FDA guidance for "Moderate" level of concern. | Verification and validation testing conducted; documentation provided as recommended by FDA guidance. |
| Acoustic Testing | Complies with NEMA UD 2-2004 (R2009). | Conducted in accordance with NEMA UD 2-2004 (R2009). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states, "The subject of this premarket submission, Carnation series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, there was no separate test set of data from clinical studies for performance evaluation.
- Data Provenance: Not applicable for performance data. Non-clinical testing data (biocompatibility, electrical safety, EMC, software V&V, acoustic testing) was generated by the manufacturer.
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 was required or used for performance evaluation for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set was required or used for performance evaluation for substantial equivalence.
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 done. The device is a "Diagnostic Ultrasound System" and the listed "wiCalc" and "wiNerve" functions are described as "measurement functions for reference only" or "education purpose tool" and "not used as diagnostic evidence." There is no indication of AI assistance for human readers in diagnostic interpretation being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was reported. The device is a diagnostic ultrasound system, not an AI-driven interpretation algorithm meant to function independently for diagnosis. Its automated features are for reference/education.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical performance evaluation. For non-clinical tests, "ground truth" would be the established standards and specifications (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, NEMA UD 2 for acoustics).
8. The sample size for the training set:
- Not applicable. The document does not describe the development or training of any AI model that would require a 'training set.' The automated functions ("wiCalc", "wiNerve") are not presented as AI models for diagnostic decision-making that would require extensive clinical training data.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model for diagnostic purposes is described.
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