(56 days)
Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes. All probes on the subject device have been previously cleared on the predicate K180374 with the exception of the IC9b-RS which was previously cleared on predicate K201828. All probes available as accessories for the subject systems Voluson are used unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged The primary differences between the difference models are the Voluson S10 Expert/S10 and S8t have a touch panel in the user interface and the S8 and S6 do not. Additionally, the Voluson S10 Expert is the highest configuration offering all the features and probes available on the S Series and the other models offer a subset of them.
The provided document is a 510(k) premarket notification for the GE Healthcare Voluson S series diagnostic ultrasound system. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, or AUC for any specific diagnostic task. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, K180374 Voluson S series Diagnostic Ultrasound System, and reference device K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System.
The "reported device performance" is implicitly that the device is as safe and effective as its predicate, adhering to the same performance standards of diagnostic ultrasound systems. The summary states:
Acceptance Criteria (Implicit - Substantial Equivalence Basis):
- Acoustic power levels below applicable FDA limits.
- Similar capability in performing measurements, capturing digital images, reviewing, and reporting studies as predicate devices.
- Designed in compliance with approved electrical and physical safety standards.
- Same clinical intended use and imaging modes as predicate devices.
- Manufactured with materials found to be safe for intended use.
- Transducer materials and patient contact materials are biocompatible.
- Compliance with voluntary standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1 3.20, IEC 62359).
Reported Device Performance (Implicit - Demonstrated Equivalence):
The document asserts that the Voluson S Series meets these implicit criteria by being substantially equivalent to the predicate devices. It explicitly mentions:
- "The systems have acoustic power levels which are below the applicable FDA limits."
- "The proposed Voluson S Series and predicate Voluson S series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies."
- "The proposed Voluson S Series and predicate Voluson S series systems have been designed in compliance with approved electrical and physical safety standards."
- "Transducer materials and other patient contact materials are biocompatible."
- The system complies with a list of voluntary standards related to safety, electromagnetic compatibility, and medical diagnostic ultrasonic fields.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence."
Therefore, there is no test set in the context of clinical performance evaluation mentioned in this document, as no clinical studies were performed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no clinical studies were conducted for this submission, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, as explicitly stated that "The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not mentioned or performed, as the submission relies on substantial equivalence to predicate devices, not on proving new diagnostic performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable, as no clinical studies were conducted. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is claimed to be substantially equivalent to, based on technical and performance similarity.
8. The Sample Size for the Training Set
Not applicable. This submission is for a diagnostic ultrasound system (hardware and associated software for image acquisition and display), not an AI/Machine Learning algorithm that requires a training set in the conventional sense for a diagnostic task. The document lists "Risk Analysis," "Requirements Reviews," "Design Reviews," "Testing on unit level," "Integration testing," "Performance testing," and "Safety testing" as quality assurance measures for the development of the system. These refer to engineering and system validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/Machine Learning algorithm described in 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.