(105 days)
Esaote's Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transesophageal (cardiac), Peripheral Vessel.
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculosketal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
The Virtual Navigator software option for Esaote 6450 system is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological examinations only.
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 is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).
Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).
Model 6450 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.
Model 6450 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6450 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.
Model 6450 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.
Model 6450 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.
The marketing names for Model 6450 will be MyLabX8 and MyLabX8 eXP.
The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the 6450 Ultrasound System. It is a 510(k) summary and clearance letter for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document, as no formal clinical study with performance criteria was conducted for this submission.
Here's a breakdown of what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document explicitly states "No clinical tests were performed." The submission relies on demonstrating substantial equivalence to a predicate device (Esaote 6440 - MyLab9 eXP, K173291), not on meeting specific performance acceptance criteria through a clinical study for this 510(k). The non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety) are stated to conform to relevant standards but no specific acceptance criteria or performance metrics are detailed in the text.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used as "No clinical tests were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set was used, and therefore, no expert-established ground truth for such a set was required or reported.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. The document states "No clinical tests were performed," so an MRMC comparative effectiveness study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is an ultrasound system with a software option (Virtual Navigator). While software verification and validation were performed, this is not a standalone algorithm performance study as typically understood for AI/ML devices. The Virtual Navigator software option is intended to support a radiological clinical ultrasound examination, implying a human (radiologist) in the loop.
7. The Type of Ground Truth Used
Not applicable in the context of a clinical performance study. For the non-clinical tests performed (acoustic output, safety, etc.), the "ground truth" is adherence to established engineering and medical device safety standards (e.g., IEC 60601-1, NEMA UD-2).
8. The Sample Size for the Training Set
Not applicable. This submission does not describe an AI/ML algorithm that would undergo training with a dataset in the typical sense. The Virtual Navigator software option is a feature for image guidance using information from a second modality, implying image registration and fusion, but not a trainable algorithm with a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set is described, no ground truth establishment for a training set is mentioned.
§ 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.