(43 days)
The DC-7 diagnostic ultrasound system is designed for M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e. B/M Mode). The system is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult). The system includes optional biopsy needle guides that attach to the transducers.
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 2.0 MHz to 12.0 MHz.
This document refers to the Mindray DC-7 Diagnostic Ultrasound System (K092691).
Acceptance Criteria and Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific quantitative acceptance criteria for performance metrics. The core statement is that "The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices."
The "Indications for Use" section (pages 4-11 of the original document) lists the clinical applications and operating modes for the device and its various transducers. These serve as the functional requirements the device needs to meet.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety: Device conforms to applicable medical device safety standards. | Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1. Acoustic output measured and calculated per NEMA UD 2: 2004 and NEMA UD 3: 2004. |
| Effectiveness: Capable of performing specified clinical applications across various modes and transducers, similar to predicate devices. | The device is indicated for fetal, abdominal, pediatric, small organ (breast, thyroid, and testes), cephalic (neonatal and adult), transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial), and cardiac (neonatal and adult) applications. Supports M, B, pulsed doppler, continuous Doppler, color Doppler, power Doppler modes, and combined modes (i.e., B/M Mode). Includes optional biopsy needle guides. |
| Substantial Equivalence: Features and performance are comparable to predicate devices. | Declared substantially equivalent to Mindray DC-3 (K#091491), Mindray DC-6 (K#072164), GE Vivid S6 (K#071985), Siemens X300 (K#090276), GE Logiq P5 (K#060993), GE Vivid 7 (K#060542). |
Study Information
The document describes the type of information typically provided for a 510(k) submission, which focuses more on substantial equivalence to existing devices rather than a standalone clinical trial with specific performance metrics. Therefore, detailed information about a dedicated study meeting the requested criteria is largely absent.
Here's an analysis based on the provided text:
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Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The submission is based on engineering tests and comparison to predicate devices, not data from a specific patient test set in the way an AI/CADe device would typically require. The data provenance would be internal engineering verification and validation data, not patient data in the context of clinical performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not explicitly stated. For a diagnostic ultrasound system, "ground truth" typically refers to the physical and functional performance of the device against engineering specifications and industry standards, rather than expert interpretation of images for a specific disease. The "ground truth" for compliance with standards would be established by internal engineering and quality control teams.
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Adjudication method for the test set: Not applicable or not explicitly stated. This concept (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation where discrepancies need to be resolved, usually for AI/CADe devices. This is not a performance study as would be conducted for an AI device.
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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 not an AI or CADe device, but a general-purpose diagnostic ultrasound system. Hence, no MRMC study or AI-assistance effect size is mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm, and is designed for human-in-the-loop operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context refers to compliance with safety and performance standards for an ultrasound system. This includes:
- Engineering specifications and test results: Measuring acoustic output (NEMA UD 2 & 3), electrical safety (IEC 60601 series), and biocompatibility (ISO 10993-1).
- Functional performance: Verifying the device's ability to operate in the stated modes (B, M, Doppler, etc.) and for the specified clinical applications, likely through phantom testing and internal verification.
- Comparison to predicate devices: Demonstration that its performance is "as safe and effective" as established, legally marketed predicate devices, implying similar image quality and diagnostic capabilities.
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The sample size for the training set: Not applicable. This device is a traditional hardware and software diagnostic ultrasound system, not an AI/machine learning product that requires training data in the AI sense.
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How the ground truth for the training set was established: Not applicable, as it's not an AI/machine learning device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.