(81 days)
The Vivid ig is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid in clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy, Vascular access), Thoracic/Pleural, Intraoperative (Vascular), Intracardiac and Intraluminal.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Color/CWD, B/Power/PWD.
The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alphanumeric keyboard. The system also has standard height-adjustable new ergonomic mobile cart for comfortable standing and sitting positions. The Charge Box in the Mobile Cart provides Vivid iq up to 4 hours scanning time without power supply.
There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible ICE transducers.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
The provided text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid iq. It details the device's characteristics and its comparison to predicate devices, but it explicitly states that no clinical studies were required to support substantial equivalence for this particular submission. Therefore, it is not possible to provide acceptance criteria or a study that proves the device meets those criteria, as such studies were not conducted or submitted for this 510(k).
The document is primarily focused on demonstrating substantial equivalence to a predicate device (Vivid iq K221148) through design similarities, conformance to recognized performance standards, and non-clinical performance testing.
Here's what can be extracted based on the provided text, while acknowledging the absence of clinical study data for this submission:
| Information Category | Description |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not applicable. The submission states, "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." Therefore, no specific clinical acceptance criteria or reported device performance from such a study are provided in this document. Device performance is implicitly accepted through compliance with non-clinical standards and substantial equivalence to the predicate. |
| 2. Sample size and Data Provenance (Test Set) | Not applicable. No clinical test set was used or described for this 510(k) submission. |
| 3. Number and Qualifications of Experts (Test Set) | Not applicable. No clinical test set was used or described for this 510(k) submission. |
| 4. Adjudication Method (Test Set) | Not applicable. No clinical test set was used or described for this 510(k) submission. |
| 5. MRMC Comparative Effectiveness Study | No. The document explicitly states that no clinical studies were required. Therefore, no MRMC study was conducted or reported for this submission. |
| 6. Standalone Performance Study | No. The document explicitly states that no clinical studies were required. Therefore, no standalone algorithm-only performance study was conducted or reported for this submission. |
| 7. Type of Ground Truth Used | Not applicable. No clinical studies requiring ground truth were conducted or reported for this submission. |
| 8. Sample Size for Training Set | Not applicable. The submission does not describe a machine learning algorithm that would require a training set. The device is a diagnostic ultrasound system, and its performance is evaluated through engineering and safety standards, as well as comparison to a predicate device. |
| 9. How Ground Truth for Training Set was Established | Not applicable. Please see response for point 8. |
Summary of Non-Clinical Tests (from the document):
The document does list the non-clinical tests conducted and the standards to which the device conforms:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic and mechanical safety
Voluntary Standards Complied With:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005/A2:2021
- AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020
- IEC 60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within Risk Management Process, Fifth edition, 2018
- ISO 14971, Application of risk management to medical devices. 2019
- NEMA PS 3.1 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2022d
- IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017
Quality Assurance Measures:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification & Validation)
- Safety testing (Verification)
In conclusion, for this specific 510(k) submission (K243620), "Vivid iq," the device met acceptance criteria by demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than through clinical studies with specific performance metrics.
§ 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.