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510(k) Data Aggregation
(73 days)
6250 ULTRASOUND SYTEMS
Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.
The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.
The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
- b. New plastic housing of the system both to include the touch screen and to give a new style
- c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
- Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed.
The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same.
The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided Special 510(k) Summary for the Esaote 6250 System describes modifications to a previously cleared ultrasound system (6150). The document does not describe a new study to establish acceptance criteria or device performance, but rather attests that the modifications do not alter the fundamental scientific technology or intended use. Therefore, the device meets the previously established acceptance criteria by demonstrating substantial equivalence to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for device modifications, explicit "acceptance criteria" for a new study are not presented. Instead, the justification relies on the modified device (6250) maintaining the same performance and safety characteristics as the predicate devices (6150 cleared via K051308, K052805, K060827, K081386 and K091009). The "performance" assessment is based on the nature of the modifications not affecting clinical functionality.
The document implicitly refers to the performance of the predicate device for all clinical applications. The "Reported Device Performance" for the 6250 system is therefore considered to be equivalent to the previously cleared 6150 system, as the modifications were primarily cosmetic (new keyboard, plastic housing, PCB layout) and software/firmware changes not affecting main software characteristics and performances.
| Feature/Characteristic | Acceptance Criteria (Implicit, based on predicate 6150) | Reported Device Performance (6250) |
|---|---|---|
| Intended Use | Identical to predicate 6150 | Maintained identical intended uses |
| Fundamental Scientific Technology | Identical to predicate 6150 | No alteration to fundamental technology |
| Clinical Modes of Operation | Identical to predicate 6150 for each transducer and application (B-Mode, XView, Multi View, Trapezoidal View, Doppler, Color Flow Mapping, Amplitude Doppler, Tissue Velocity Mapping, Tissue Enhancement Imaging, and other specified modes per application) | Maintained identical modes of operation and equivalent performance for all transducers and applications. |
| Safety Profile | Equivalent to predicate 6150 | No adverse impact on safety identified by modifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new test set or a new study with a specific sample size. The modifications are justified based on their nature, not requiring new clinical performance data to demonstrate equivalence. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective). This is typical for a Special 510(k) submission where changes are considered minor and do not impact safety or effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no new test set or clinical study is described, there is no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
As no new test set or clinical study is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or is mentioned in this Special 510(k) summary, as the modifications did not warrant a new clinical efficacy trial. The submission seeks to demonstrate substantial equivalence based on the nature of the changes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is an ultrasound imaging system with optional features (Virtual Navigator). It is not an "algorithm-only" or AI-driven diagnostic device as understood in the context of standalone performance studies for AI. The modifications described pertain to hardware and user interface elements, and minor software updates that did not change the core performance. Therefore, a standalone performance study is not applicable and not described.
7. Type of Ground Truth Used
No new ground truth was established for this Special 510(k). The regulatory approval relies on the ground truth previously established for the predicate 6150 system, which would have been based on established clinical and technical standards for ultrasound imaging.
8. Sample Size for the Training Set
Since no new algorithms or machine learning components are introduced that require a training set, the document does not mention any sample size for a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no new training set or machine learning algorithms are described in this Special 510(k) submission.
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