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510(k) Data Aggregation
(29 days)
The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal Adult cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Needle Guidance This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic
The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal – OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel
The SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatic, Trans-esophageal (cardiac), Peripheral Vessel.
The Sonosite Diagnostic Ultrasound Systems are full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. They are intended to be used for general purpose ultrasound examination, cardiac imaging, fetal imaging and OB/GYN applications, vascular imaging and trans-rectal applications and fluid flow analysis among others. Some Sonosite Ultrasound Systems (Sonosite PX) also have needle guidance capabilities. They are intended to be used by qualified physicians and trained professionals in various patient care settings including hospitals, clinics, and point-of-care settings. Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Sonosite Ultrasound Systems and may vary among the different model configurations. The Sonosite Ultrasound Systems work on either battery or AC power. Some Sonosite Diagnostic Ultrasound Systems support Bluetooth and wireless connectivity for image transfer and over-the-air (OTA) software updates. The diagnostic ultrasound systems are manufactured with hardware components which consist of: 1) a primary console (e.g., workstation, tablet with touchscreen) with built-in software components, features, and various clinical applications, and 2) a range of compatible ultrasound transducers. A suite of compatible transducers are offered with the Sonosic Ultrasound Systems. These include linear array, curved array, phased array, intra-cavitary, static probes and trans-esophageal transducers. Linear array transducers (prefixed with the letter L) produce a rectangular field of view with uniform beam density throughout and are useful for imaging shallow structures and small parts. Curved array transducers (prefixed with the letter C) allow for a wider field of vith decreased line density at depth and reduced lateral resolution. They are the ideal probe for lung ultrasound imaging. Phased array transducers (prefixed with the letter P) are small faced transducers allowing for imaging in small spaces. They are able to change the focus of the ultrasound beam. It is the optimal transducer recommended for cardiac imaging. Trans-esophageal transducers (prefixed with the letters TE) are commonly used for evaluation of cardiac and aortic structures. Intra-cavitary transducers (prefixed with the letters IC) are used for trans-rectal ultrasounds. Some models may have additional previously-cleared accessories, or components which are manufactured by other manufacturers.
The provided document is a 510(k) Summary for multiple FUJIFILM Sonosite Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The document explicitly states: "Relevant performance data does not apply to this submission. Design control measures described within the submission support a decision of substantial equivalence."
Therefore, the document does not include a study or acceptance criteria related to a new device or algorithm performance evaluation. Instead, it relies on the predicate devices' established safety and effectiveness. The modifications mentioned are primarily "Additional user labeling ... for patients with coronavirus disease 2019 (COVID-19)" based on existing methods or society guidelines, not a new AI-powered diagnostic feature.
Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, experts, or MRMC studies, as these types of studies were explicitly stated as not applicable to this submission.
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(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.
Here's an analysis based on your requested information:
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.
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