(51 days)
Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Small organs, Musculoskeletal (Conventional and Superlicial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative abdominal and Other: Urologic. The 7400 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.
Model 6400 is a mainframe system equipped with wheels allowing to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes). 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 has been designed to be powered by battery.
Both 6400 and 7400 have been cleared via K111302, K132231 and K132466.
6400 and 7400 Upgrades, defined herein, combine the cleared features of both 6400 and 7400 systems with new capabilities, listed below:
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- Management of Quality Intima Media Thickness (QIMT) on both 6400 and 7400 upgrades.
- Management of Elastosonograpy qualitative analysis (ElaXto) on both 6400 and 7400 upgrades. 2.
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- Management of Laparoscopic application on 6400 upgrade.
The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided text describes a 510(k) premarket notification for Esaote S.p.A.'s 6400 and 7400 Ultrasound Systems. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with specific performance metrics defined by acceptance criteria and clinical studies.
Therefore, the document does not contain information about explicit acceptance criteria for a device's performance (e.g., sensitivity, specificity, accuracy thresholds) or a study specifically designed to prove the device meets such criteria in terms of diagnostic effectiveness for new functionalities.
Instead, the submission focuses on demonstrating that the new functionalities and upgrades to the existing ultrasound systems (6400 and 7400) employ the same fundamental technological characteristics as their predicate devices and that no clinical tests were performed to establish new performance metrics. The clearance is based on adherence to safety and performance standards for ultrasound devices and equivalence to previously cleared devices for various clinical applications and modes of operation.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This information is not applicable in the context of this 510(k) submission for substantial equivalence. The document doesn't define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for the upgraded device or report results of a study demonstrating these. The "performance" is implicitly deemed equivalent to the predicate devices and compliant with general safety standards. The document primarily focuses on listing the intended uses and modes of operation, and noting which applications are "Previously cleared by FDA" (P) or "Added under Appendix E" (E), implying that these additions are equivalent to those found in other cleared devices.
2. Sample size used for the test set and the data provenance:
No sample size for a test set is provided as no clinical tests were performed. The submission explicitly states: "No clinical tests were performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical tests requiring expert-established ground truth were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical tests requiring adjudication were performed.
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 FDA submission is for a conventional ultrasound system and its upgrades, not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for an ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Since no clinical tests were performed, there was no need to establish ground truth for a test set related to diagnostic effectiveness. The ground truth for safety and performance would relate to engineering specifications and compliance with standards.
8. The sample size for the training set:
Not applicable. The submission does not describe the development of a machine learning algorithm or AI component, thus there is no training set in the context of an AI model.
9. How the ground truth for the training set was established:
Not applicable. As there is no mention of a training set for an AI model, the method for establishing its ground truth is not relevant here.
In summary, this document is a 510(k) premarket notification for an ultrasound system upgrade, which relies on demonstrating substantial equivalence to previously cleared devices and adherence to recognized safety and performance standards, rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
§ 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.