(85 days)
The Versana Premier/Versana Premier Lotus/LOGIQ F is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Versana Premier/Versana Premier Lotus/LOGIQ F clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and nonvascular access).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
Versana Premier/Versana Premier Lotus/LOGIQ F is intended to be used in a hospital or medical clinic
The Versana Premier, Versana Premier Lotus and LOGIQ F is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing, and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source. The operator control panel includes function keys, trackball, and a touch panel with a digital keyboard (physical keyboard as an option) as input sources of the device. The variety of transducers include convex, linear, sector, Bi-plane probe and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal, transcranial and transesophageal. The Versana Premier, Versana Premier Lotus and LOGIQ F share a common software and hardware platform. There may be different configurations commercially offered, however they are all within the overall design of the product.
The provided text is a 510(k) Summary for a new medical device submission (K242005) for the GE Versana Premier, Versana Premier Lotus, and LOGIQ F ultrasound systems. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving that the device meets specific acceptance criteria for performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The document outlines a comparison to predicate devices, but no specific performance metrics with acceptance criteria are listed.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided, as no clinical study demonstrating performance against acceptance criteria was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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 provided. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool as described.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
Summary of what the document does state regarding meeting requirements:
The document states:
- "The subject of this premarket submission, Versana Premier/Versana Premier Lotus/LOGIO F did not require clinical studies to support substantial equivalence." (Page 8)
- It attests to the device's conformance with recognized performance standards and safety standards through non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety).
- It lists several voluntary standards the device complies with (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, NEMA PS 3.1 - 3.20, IEC 62359).
- It outlines quality assurance measures applied during development, including Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, system, performance, safety).
In essence, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and compliance with recognized safety and performance standards for ultrasound systems, rather than on a new clinical study with specific acceptance criteria met by the device's performance.
§ 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.