(90 days)
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for the evaluation of Fetal (Obstetrics), Abdomen, Cardiac (Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.
The CHISON Q6 / Q8 / iVis60 / iVis60 / EXPERT / i7 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 (Q6/Q8), or as a roll-around model on wheels (iVis60 / iVis60 EXPERT/i7). 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 K120801 is a 510(k) premarket notification for the CHISON iVis & Q Series, i7 Diagnostic Ultrasound Systems. However, this type of submission is for establishing substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a study with ground truth.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, nor its data provenance.
- The number of experts used to establish ground truth or their qualifications.
- Adjudication methods for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size on human reader improvement with AI assistance.
- Standalone (algorithm-only) performance results.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for a training set.
- How ground truth for a training set was established.
Instead, the submission focuses on demonstrating that the CHISON ultrasound systems are "substantially equivalent in safety and effectiveness to the predicate systems" (GE Voluson E8 Diagnostic Ultrasound System, K101236) based on having:
- Comparable type and intended uses.
- The same basic operating modes (B-Mode, M-Mode, Pulsed Doppler, Continuous Doppler, Color Doppler, Power Doppler, Directional Power Doppler).
- Similar specialized measurements and calculations.
- Acoustic output levels below FDA limits.
- Compliance with applicable electrical and physical safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
The "Indications For Use" sections (pages 5-15) list the various clinical applications and operation modes for the main system and each specific transducer, indicating whether they are "N = new indication" (for the submitted device) or "P = previously cleared by FDA" (implying the predicate device covered these). This is a statement of intended use, not a performance metric from a study.
§ 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.