Search Results

Esaote's Model 6150 (MyLab70) and Model 6100 (MyLab90) are mainframe ultrasound systems used to perform diagnostic general ultrasound studies including Cardine unc Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. Additionally, the MyLab90 is indicated for Laparoscopic use.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasond session. The second modality provides additional security in assessing the morphalogy 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 congreent with the current (actual) patient position and shall therefore always been 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 MyLab70 and MyLab90 system designs remain the same as those previously cleared by FDA via K051837, K051308, and K060827, respectively, except for those features being added via this submission.

They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes and, Tissue Enhancement Imaging (CE), The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The MyLab70 and MyLab90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The MyLab70 and MyLab90 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

This is a 510(k) Pre-market Notification for the Esaote MyLab70 and MyLab90 Systems, seeking clearance for a new feature called "Virtual Navigator software" and transducers. The information provided is heavily based on claims of substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain an explicit table of acceptance criteria or quantitative performance metrics for the new Virtual Navigator software or the newly cleared transducers. Instead, it relies on demonstrating substantial equivalence to previously cleared devices. The "performance" for the new features is implicitly considered to meet the safety and effectiveness standards of the predicate devices.

For the Virtual Navigator software, the performance is described qualitatively by comparing its technological characteristics to predicate devices:

For the transducers, the performance is implied by their classification and intended use being equivalent to previously cleared transducers on the predicate devices. The document lists the following new transducers and indicates their clearance as part of this submission by stating "P" (Previously Cleared) next to a K-number, or "N" (New) if it were a new mode/application, but for transducers specific K-numbers are provided for clearance. The tables across the document for each transducer model indicate which clinical applications and modes are cleared for that specific transducer, often referencing prior K-numbers (e.g., K051837 for MyLab 90, K051308 for MyLab 70).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for any test set or the data provenance. It mentions that the MyLab70 and MyLab90 systems were "previously cleared by FDA via K051837, K051308, and K060827" and that this submission is for added features. This implies that the safety and effectiveness of the core device have been established, and this notification is for modifications. For the Virtual Navigator, the comparison matrix against predicate devices indicates the basis for clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set, as quantitative studies with new data are not presented in this summary. The submission relies on equivalence to devices cleared previously.

4. Adjudication Method for the Test Set

No information regarding adjudication methods is provided, as no new clinical test data for the device's performance is presented in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No information about an MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence for a new software feature and additional transducers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Virtual Navigator is described as providing "additional image information from a second modality like CT or MR, during a clinical ultrasond session." It also states: "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 as an additional source of information." This explicitly indicates that the Virtual Navigator is not a standalone diagnostic device. Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable, and no such study is described.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that the submission is for substantial equivalence and describes a navigation system rather than a diagnostic performance algorithm, no specific type of ground truth against expert consensus, pathology, or outcomes data is mentioned as being used in this summary. The validation would have likely focused on the accuracy of alignment and visualization against physical phantoms or established imaging modalities, rather than diagnostic accuracy against patient outcomes.

8. The Sample Size for the Training Set

No information about a training set size is provided, as this is a traditional medical device 510(k) submission for an ultrasound system with a navigation feature, not an AI/ML-driven diagnostic algorithm that typically requires explicit training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set or AI/ML algorithm requiring explicit ground truth for training is described in this summary. The Virtual Navigator is a software feature for image fusion and navigation, validated against predicate devices of similar technological characteristics.

Ask a specific question about this device