(110 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.
The Q6/Q8/Q9/Q10/i7/i8 /i9 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/Q9/Q10), or as a roll-around model on wheels (i7/i8/i9). 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, TDI Mode or a combination of these modes.3D/4D.
The provided 510(k) submission for the CHISON Q Series & i7, i8, i9 Diagnostic Ultrasound System primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria are met in the way requested.
The submission claims substantial equivalence by showing that the proposed device has the same intended use, basic operating modes, and similar design principles as the predicate devices (GE Voluson E6/E8/E8 Expert K101236 and CHISON iVis60EXPERT, Q6/Q8, i7 K120801). The "Modifications and Newly Added Features" (new transducers and software options) are also claimed to be substantially equivalent.
No explicit acceptance criteria or a dedicated performance study against such criteria are presented in the document. Instead, the device's conformance to safety standards and comparison to predicate device specifications are used as the basis for demonstrating safety and effectiveness.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, no explicit acceptance criteria for individual performance metrics (e.g., sensitivity, specificity, accuracy for a specific diagnostic task) are defined or reported. The "acceptance criteria" in this context are implicitly that the device performs equivalently to the predicate devices and meets relevant safety standards.
| Feature / Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate devices | "Same" as predicate (Voluson E8/E8Expert K101236 and CHISON iVis60EXPERT, Q6/Q8, i7 K120801) |
| Operating Modes | Same as predicate devices | "Same" as predicate (predicates offer B, M, PW, CFM, PD, TD, etc.; submission device adds new modes like 2D Steer, Elastography, Curved Panoramic Imaging, Supper needle, IMT) - claimed substantially equivalent despite additions. |
| Safety Compliance | Conform to specific IEC and ISO standards | Conformity to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD3, ISO 10993-1 (biocompatibility). |
| Acoustic Output | Max Derated Ispta: 720mW/cm² (Track 3); MI: 1.9 (Track 3) | Derated Ispta: 720mW/cm² maximum (Track 3); Mechanical Index: 1.9 maximum (Track 3) |
| Biocompatibility | Bio-compatible (claimed by predicate) | Bio-compatible (claimed by submission device) |
| Performance with New Transducers/Software | Substantially equivalent to predicate performance | "The results show that these modifications are substantially equivalent to the predicate devices." (No specific metrics provided). |
| Image Reverse | Range compatible with clinical needs | Predicate: Right/Left; Submission: B orientation flip: L/R, U/D (Claimed SE) |
| B persistence | Range compatible with clinical needs | Predicate (Voluson): 8 steps; Predicate (CHISON): 7 steps; Submission: 0-7 (Claimed SE) |
| Frequency Selection | Range compatible with clinical needs | Predicate (Voluson): 3 steps; Predicate (CHISON): 5 steps; Submission: 5 steps (Claimed SE) |
| Angle Correction | Range compatible with clinical needs | Predicate (Voluson): ± 0-85°, 1° step; Predicate (CHISON): ± 0-72°, 5 step; Submission: ± 0-80°, 5 step (Claimed SE) |
| Steered Linear | Range compatible with clinical needs | Predicate (Voluson): 0°-25°; Predicate (CHISON): 0-20°; Submission: -20°-20° (Claimed SE) |
| Color Maps | Sufficient for clinical visualization | Predicate (Voluson/CHISON): 8 maps; Submission: 9 maps (Claimed SE) |
| PD Color Maps | Sufficient for clinical visualization | Predicate (Voluson): 8 maps; Predicate (CHISON): 4 maps; Submission: 9 maps (Claimed SE) |
| Monitor Size | Clinically acceptable | Predicate (Voluson): 19" LCD; Predicate (CHISON): 15" LCD; Submission: 19" LCD for i7/i8/i9, 15" LCD for Q6/Q8/Q9/Q10 (Claimed SE) |
| Transducer Connectors | Sufficient for clinical functions | Predicate (Voluson): 4 ports; Predicate (CHISON i7): 4 ports; Other CHISON: 2-3 ports; Submission: i7/i8/i9: 4 ports, Q10/Q9/Q8/Q6: 2 ports (Claimed SE) |
| Power Supply | Comply with safety standards | Predicate (Voluson): AC: 100-240V; Predicate (CHISON): AC: 220-240V, 100V, 115-130V; Submission: AC: 100-240V (Complies with IEC 60601-1, 60601-1-2) |
2. Sample Size Used for the Test Set and Data Provenance
- No specific "test set" in the context of diagnostic performance (e.g., images for measuring sensitivity/specificity) is described. The conformity assessment for the device relies on laboratory testing against engineering specifications and safety standards, as well as a comparison to predicate devices.
- Data Provenance: Not applicable as no diagnostic performance test set is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. No diagnostic performance study involving expert-established ground truth is presented.
4. Adjudication Method for the Test Set
- Not applicable. No diagnostic performance test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence to pre-existing ultrasound systems based on technical specifications and safety standards, not on assessing the improvement in human reader performance with or without AI assistance. The new software options (Elastography, IMT, Curved Panoramic, Supper needle) are listed as features, but no clinical efficacy data for them is provided.
6. Standalone (Algorithm Only) Performance Study
- No standalone performance study was done. The device is a diagnostic ultrasound system, not an AI-only algorithm. The "newly added software options" are features of the ultrasound system, and their performance is subsumed under the general claim of substantial equivalence, without specific standalone performance metrics.
7. Type of Ground Truth Used
- Not applicable. For this type of 510(k) submission, "ground truth" related to diagnostic accuracy (e.g., pathology, outcomes data, expert consensus on disease presence) is not typically required or provided unless the device makes a new or significantly modified diagnostic claim that deviates from established predicate devices. The basis for safety and effectiveness is compliance with recognized standards and comparison to a legally marketed equivalent device.
8. Sample Size for the Training Set
- Not applicable. The submission does not describe an AI or machine learning component that would require a "training set" in the conventional sense for diagnostic performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set is described.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" presented is primarily a non-clinical performance evaluation and a substantial equivalence comparison to predicate devices.
-
Non-Clinical Performance Evaluation: This involved laboratory testing to verify that the system (including new transducers) met all design specifications. This testing also confirmed conformity to various medical device safety standards:
- IEC 60601-1: 2005 (General Requirements for Safety)
- IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
- IEC 60601-2-37: 2007 (Particular Requirements for Ultrasonic Equipment Safety)
- NEMA UD 2-2004 (Acoustic Output Measurement)
- NEMA UD3: 2004 (Real-time Display of Acoustic Output Indices)
- ISO 10993-1 (Biological Evaluation of Medical Devices - Biocompatibility)
-
Substantial Equivalence Comparison (to K101236 and K120801): The submission provides a detailed comparison table (Table 1) highlighting similarities in:
- Indications for Use
- Design principles (e.g., autocorrelation for color processing, FFT for Doppler)
- Operating Controls (e.g., TGC 8 slider, Depth Range, shades of gray)
- Safety Compliance (adherence to the same IEC/ISO standards)
- Patient Contact Materials (Bio-compatible)
- Scanning Modes (Electronic Sector, Convex, Linear, Mechanic Volume Sweep)
- Operation Modes (B, M, PW, CFM, PD, TD, 3D/4D, etc., including newly added features like Elastography/Curved Panoramic)
- Display characteristics and annotations
- Monitor specifications
- Measurement packages
- Transducer Types & Connectors
- Principle of Operation (high voltage burst to piezoelectric material, reflected echo detection)
- Acoustic Output (matching the predicate's stated maximums for MI and Ispta)
The conclusion drawn from this comparison is that any differences are minor and do not affect the basic design, usage, effectiveness, or safety, thereby establishing substantial equivalence. No clinical testing was required or performed for this submission.
§ 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.