(25 days)
MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (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 Musculoskeletal applications.
The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
The upgraded 6400 systems, (MyLabX6 and MyLabX7), are a mainframe systems equipped with wheels allowing to move the system. 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. Model 6400 manages Qualitative Elastosonography (ElaXto).
Model 6400 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6400 can drive Phased array, Linear array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Owerty alphanumeric keyboard that allows data entry.
Model 6400 is equipped with wireless capability.
Model 6400 is already cleared via K161359.
The marketing name for new devices of Model 6400 will be:
- MyLabX6
- . MyLabX7
MyLabX6 and MyLabX7, defined herein, combine the cleared features of 6400 system with new capabilities, listed below:
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- Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
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- MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
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- QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
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- 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
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- Management of probes L3-11, L4-15, mC 3-11, P 1-5, P 2-9 and P2 5-13. P 1-5, P 2-9 and mc 3-11 are available only for MyLabX7.
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- Full screen option.
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- Windows 10 Operative System.
The 6400 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.
This FDA 510(k) summary for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) does not contain detailed information about specific acceptance criteria for image quality or clinical performance and the results of a study proving those criteria are met. The document focuses on establishing substantial equivalence to previously cleared predicate devices based on technological characteristics and adherence to safety standards.
Here's a breakdown of the requested information based on the provided text, and what is explicitly stated as not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document for specific image quality or clinical performance metrics. The submission focuses on substantial equivalence based on overall indications for use and technological similarity to cleared predicate devices, rather than a new performance study with specific acceptance criteria that are numerically defined. The clinical applications listed represent the intended use and are not acceptance criteria for a performance study.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. No specific clinical test set or data provenance is mentioned as this was not a clinical performance study. The submission relies on the established performance of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No specific test set with ground truth established by experts is mentioned.
4. Adjudication method for the test set
Not applicable/Not provided. No specific test set or adjudication method is mentioned.
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/Not provided. The document does not describe any AI component or MRMC study. The device is an ultrasound system, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. The device is an ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. No specific ground truth methodology is mentioned as this was not a clinical performance study for image accuracy or diagnostic efficacy.
8. The sample size for the training set
Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.
9. How the ground truth for the training set was established
Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.
Summary of what is provided from the text:
The submission for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission generally relies on demonstrating similar technological characteristics and indications for use, and adherence to recognized performance and safety standards, rather than conducting new, elaborate clinical performance studies with specific acceptance criteria and ground truth validation for novel claims.
The document explicitly states: "No clinical tests were performed." This clarifies that the submission did not include studies with acceptance criteria related to clinical performance, a test set, expert ground truth, or MRMC studies.
The justification for substantial equivalence relies on:
- Predicate Devices: Primary predicate K161359 (6400 – MyLabSeven), and reference predicates K183191 (6420 - MyLabX5) and K173291 (6440 – MyLab9).
- Technological Characteristics: The updated devices (MyLabX6 and MyLabX7) employ the "same fundamental technological characteristics" as the predicate device (Esaote 6400 model cleared via K142008 and K161359). New capabilities (Auto NT, MicroV, QPack, 4D STIC, management of new probes, full screen option, Windows 10 OS) are stated to be "identical" to those already cleared in other Esaote models (6440 and 6420 via K173291 and K183191).
- Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, conforming to standards such as IEC 60601-1, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3, among others.
- Indications for Use: The indications for use are consistent with those of previously cleared devices.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices, primarily through engineering and safety testing, and showing that any new features are identical to those already cleared.
§ 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.