(28 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The GE Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.
The provided document K092079 is a 510(k) Premarket Notification for the GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System. This submission focuses on establishing substantial equivalence to a predicate device and introducing new transducers and extended indications for use.
Crucially, the document states "Clinical Tests: None required." (Section b) 2. of Attachment B). This indicates that a study proving the device meets specific acceptance criteria, in the traditional sense of a clinical trial with performance metrics and statistical analysis, was not performed. Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985), and other previously cleared GE ultrasound systems/transducers for the new indications.
Therefore, the following information cannot be extracted from this document: acceptance criteria with reported device performance (beyond established safety standards), sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set details.
The acceptance criteria for this submission are fundamentally satisfied by demonstrating that the modifications (new transducers and expanded indications for use) do not raise new questions of safety or effectiveness and perform as well as or better than legally marketed predicate devices.
Here's a breakdown of the available information relevant to "acceptance criteria" and how they were met in the context of a 510(k) submission focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|
| Safety: Device must conform to applicable medical device safety standards (e.g., acoustic output, biocompatibility, electrical, thermal, mechanical safety, cleaning/disinfection effectiveness). | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." (Attachment B, Section b) 1.) |
| Effectiveness: Similar intended uses and operating modes to the predicate device, or demonstrated equivalence for new indications based on prior clearance of similar technology. | "The modified GE Vivid S5/S6 is of a comparable type and substantially equivalent to the current GE Vivid S5/S6. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device and additional software that are similar to other cleared GE Ultrasound systems." (Attachment B, Section 6.) |
| Expanded Indications: New transducers and their associated clinical applications (e.g., Fetal/Obstetrics, Abdominal, Pediatric, Cardiac, Peripheral Vascular, Small Organ, Musculo-skeletal, Transesophageal, Transvaginal, Intraoperative) must be supported by previous clearances of similar technology. | For each transducer (4C-RS, 8C-RS, E8C-RS, 8L-RS, 12L-RS, 7S-RS, 10S-RS, M4S-RS, 6Tc-RS, i12L-RS, 6S-RS, 9L-RS), the Indications for Use forms clearly mark "N" for new indications, accompanied by a note stating that the transducer or application was "previously cleared" on another specified GE ultrasound system (e.g., Vivid 7 BT05 (K051449), GE LOGIQ Book Ultrasound (K032477), Vivid i/q (K082374), LOGIQ 9 (K011188), Vivid E9 (K081921), LOGIQ P5 (K060993)). "P" indicates indications previously cleared on the predicate device (K071985). |
| Compliance: Design and development process conforms to 21 CFR 820 and ISO13485 quality systems. | "The design and development process of the manufacturer conforms with 21 CFR 820, and ISO13485 quality systems." (Attachment B, Section b) 3.) |
The study that proves the device meets the acceptance criteria is the 510(k) submission itself, where GE Healthcare argues for substantial equivalence based on the points above.
Missing Information (as per the document):
- Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were required or performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. The "ground truth" here is the regulatory precedent of previously cleared devices and transducers.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the new indications is the precedent of prior FDA clearance for similar technologies and applications on other GE ultrasound systems, signifying recognized safety and effectiveness.
- The sample size for the training set: Not applicable, as no clinical tests or algorithm training were explicitly mentioned as part of this 510(k) submission for new device clearance. The device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.