(16 days)
The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.
Specific clinical applications and exam types include:
Abdominal
Dermatological
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Neonatal Cephalic
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)
The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
This document, K190476, details the 510(k) premarket notification for the FUJIFILM SonoSite Vevo MD Imaging System.
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1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance metrics from device testing. The document states that the device was evaluated for safety and effectiveness against its predicate. The "acceptance criteria" for a 510(k) typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The study presented does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) or report numerical device performance against such metrics. Instead, it relies on demonstrating equivalence through:
- Intended Use Alignment: Both the new device and the primary predicate (FUJIFILM SonoSite Vevo MD Imaging System K160674) share the same intended use.
- Technological Characteristics Comparison: The document provides a table comparing features, modes of operation, acoustic output, DICOM capabilities, and channels with the predicate devices. The new device and primary predicate are highly similar, particularly for "Track 3" devices.
- Compliance with Voluntary Standards: The device is designed to comply with several recognized standards related to biological evaluation, electrical safety, electromagnetic disturbances, ultrasonic medical diagnostic equipment, field characterization, software life cycle, and risk management. This compliance forms a key part of demonstrating safety.
Summary of "Acceptance Criteria" (Implicit) and Reported Performance:
| Category | Implicit Acceptance Criteria (for 510(k) equivalence) | Reported Device Performance (as demonstrated for equivalence) |
|---|---|---|
| Intended Use | Identical or highly similar to predicate device(s). | The Vevo MD Imaging System (this submission) has the same intended use as the predicate Vevo MD Imaging System (K160674): "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Specific clinical applications for both include Abdominal, Dermatological, Musculoskeletal (conventional/superficial), Neonatal Cephalic, Ophthalmic, Pediatric, Peripheral vessel, and Small Organ. |
| Technological Characteristics | No significant differences in features or fundamental scientific technology compared to predicate that would raise new questions of safety or effectiveness. | The Vevo MD Imaging System (this submission) is a "Track 3" device and employs the same fundamental scientific technology as its primary predicate (Vevo MD K160674). Key common features include Linear Array transducer type, 15-49MHz transducer frequency, MI/TI output display, 2D Mode, Color Doppler, M-Mode, Power Doppler, PW Doppler operation modes, DICOM 3.0 support, manual IMT measurement, 64 digital transmit and receive channels. The comparison shows substantial similarity. |
| Safety Standards | Compliance with relevant mandatory and voluntary medical device safety standards. | Evaluated for electrical, thermal, mechanical, and EMC safety. Cleaning/disinfection and biocompatibility were also evaluated. Found to conform to applicable mandatory medical device safety standards. Specifically states compliance with AAMI/ANSI/ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, IEC 62304, ISO 14971, and NEMA UD 2. All patient contact materials are biocompatible and are either used in the predicate or meet ISO 10993. |
| Clinical Performance | No new clinical concerns or requirement for clinical studies if equivalence demonstrated through non-clinical means. | Clinical studies were not required to support the determination of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means there was no clinical "test set" in the traditional sense of patient data used to evaluate performance metrics like sensitivity or specificity. The evaluation was primarily non-clinical, comparing technical specifications and adherence to standards against a predicate device. Therefore, no information on sample size or data provenance for a clinical test set is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical study was conducted for performance evaluation in this 510(k) submission, there was no "ground truth" to be established by experts for a test set of patient data.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set for performance evaluation was used.
5. 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 an imaging system, not an AI-based diagnostic aid that would involve human readers improving with AI assistance. Clinical studies were not performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an imaging system, not a standalone algorithm. Clinical studies were not performed for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study for performance evaluation was conducted where ground truth would be established. The "ground truth" for this submission revolves around the technical specifications and safety profile of the device aligning with regulated standards and the predicate device.
8. The sample size for the training set
Not applicable. As this 510(k) is for an ultrasound imaging system and not for an AI/ML-driven device or an algorithm requiring a training set, no information about a training set size is provided.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
§ 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.