(71 days)
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen: Pediatric: Small Organ (breast, tests, thyroid): Heart Soft Tissue; Peripheral Vascular; Musculo-skeletal (conventional) and Urology.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
The CHISON Q3/Q5/Q6/Q8/iVis60/iVis60 EXPERT ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured either as a portable model (Q3/Q5/Q6/Q8), or as a roll-around model on wheels (iVis60 / jVis60 EXPERT). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.
The provided document is a 510(k) Premarket Notification summary for the CHISON Q8/Q6/Q5/Q3 Roll (Portable) and iVis 60 & iVis 60 EXPERT (Rollaround) Diagnostic Ultrasound Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Details on sample size used for a test set, data provenance, number of experts for ground truth, or adjudication methods for a test set.
- Any information about a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human readers with/without AI assistance.
- Data from a standalone (algorithm only) performance study.
- Information on the type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set or how ground truth for the training set was established.
Summary of Device Equivalence Instead of Performance Acceptance Criteria:
The key to this 510(k) submission is demonstrating substantial equivalence to a predicate device, the SonoScape SSI-1000 ultrasound system (K052042). This means the manufacturer is asserting their device is as safe and effective as the predicate device, not necessarily that it meets predefined quantitative performance metrics.
The study that "proves" the device meets the acceptance criteria is actually the comparison to the predicate device as outlined in Section 5 of the 510(k) Summary.
Details from the submission regarding this "proof":
- Device Comparison: "The CHISON Q Models and iVis60 Models are of comparable type and substantially equivalent to the current SSI-1000/SSI-5000 (K052042)."
- Operating Principles: "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device."
- Capabilities: "All systems allow for specialized measurements of structures and flow, and calculations. The systems have the same gray-scale and Doppler capabilities."
- Safety Standards: The CHISON ultrasound system meets safety standards: NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.
- Acoustic Output: "The systems have acoustic output levels below the applicable FDA limits."
- Intended Use Compatibility: The device shares similar indications for use across various clinical applications (Abdomen, Pediatric, Small Organ, Heart, Soft Tissue, Peripheral Vascular, Musculo-skeletal (conventional), and Urology) and operating modes (B-Mode, M-Mode, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Directional Power Doppler) with the predicate device, as detailed in the "Indications For Use" section for the system and each transducer.
In essence, for a 510(k) submission like this, the "acceptance criteria" are the demonstration of comparable intended use, technology, fundamental operating principles, and safety/effectiveness as a legally marketed predicate device. The "study" proving this is the comparative analysis presented in the 510(k) summary itself, rather than a clinical trial with specific performance endpoints.
§ 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.