(15 days)
Esaote's 6420 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (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 be connected to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.
The upgraded 6420 system (MyLabX5) is compact mainframe system equipped with wheels allowing to move the system. The system sizes and weights allow them to be carried using the handle.
The primary modes of operation are: 2D, M-Mode, Continuous Wave Doppler (CW), Tisue Enhancement Imaging (TEI), Multi View (MView), Doppler, Pulse Wave (PW) Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.
6420 is equipped with a LCD color display where acquired images and advanced image features are shown. 6420 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). Model 6420 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.
6420 is equipped with wireless capability.
Model 6420 was previously cleared via K161168.
The upgraded 6420 system, defined herein, combines the cleared features of both the 6440 and 6420 systems with new capabilities, listed below:
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- Management of Strain 2D.
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- Addition of Auto NT option.
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- Addition Auto EF option
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- Management of probe L 4-15.
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- Addition of Full screen option.
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- Operative system Windows 10
The 6420 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.
The provided document is a 510(k) summary for the Esaote 6420 Ultrasound System. It details an upgrade to an existing device, establishing substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria in terms of quantitative performance metrics, such as sensitivity, specificity, or accuracy, for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through establishing substantial equivalence to predicate devices and conformance to recognized safety standards. The reported device performance is therefore based on its similarity to the cleared predicates and its adherence to non-clinical safety requirements.
Acceptance Criteria (Implied by Substantial Equivalence and Standards Conformance)
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Diagnostic Features | Clinical uses (indications for use) must be substantially equivalent to previously cleared predicate devices (Esaote 6420 via K161168 and Esaote 6440 via K173291), ensuring no change in intended diagnostic capabilities for various clinical applications (Fetal, Abdominal, Pediatric, Small organs, etc.). | The upgraded 6420 system combines cleared features of both the 6440 and 6420 systems. The clinical uses are stated to have not changed from the previously cleared K161168 and K173291 devices. Specific new capabilities added (Strain 2D, Auto NT, Auto EF, L 4-15 probe management, Full screen option, Windows 10 OS) are stated to be identical to those found in the Esaote 6440 (K173291). Many tables list "P" (Previously cleared by FDA) for various clinical applications and modes on the 6420 and associated probes, reinforcing that the device performance for these applications aligns with prior clearances. Examples include various imaging modes (B, M, PWD, Color Doppler, etc.) for applications like Abdominal, Pediatric, Small Organs, Peripheral Vascular, Musculo-skeletal. |
| Technological Characteristics | Fundamental technological characteristics must be the same as predicate devices. New features must be identical to those cleared in predicate devices. | The upgraded 6420 employs the "same fundamental technological characteristics" as its predicate devices. The added features (Strain 2D, Auto NT option, Auto EF option, L 4-15 probe management, Full screen option, Windows 10 OS) are explicitly stated to be "identical to those of Esaote 6440 model, cleared via K173291." |
| Safety and Performance Standards | Conformance to recognized medical device safety standards, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electromagnetic, and mechanical safety. | The upgraded 6420 system was evaluated and found to conform to: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-3, and NEMA UD-2. The device is manufactured under an ISO 9001 and ISO 13485 certified quality system. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical tests were performed." Therefore, there is no sample size for a test set and no data provenance from clinical studies. The demonstration of performance relies on substantial equivalence to existing devices and non-clinical evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since "No clinical tests were performed," there were no experts used to establish ground truth for a clinical test set.
4. Adjudication Method for the Test Set:
Not applicable, as "No clinical tests 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, as "No clinical tests were performed" and this device is an ultrasound system, not an AI-assisted diagnostic tool as described. The document does not mention any AI components or human-in-the-loop performance studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is an ultrasound imaging system, not a standalone algorithm. The performance evaluation is based on the characteristics of the hardware and software features being substantially equivalent to predicates.
7. The type of ground truth used:
Given the statement "No clinical tests were performed," there was no clinical ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for this 510(k) submission is effectively the established performance and safety profiles of the predicate devices. The submission asserts that the upgraded device's features and overall performance are analogous to these already cleared devices, and non-clinical testing confirms adherence to relevant technical standards.
8. The sample size for the training set:
Not applicable. As "No clinical tests were performed" and the device is not an AI/ML algorithm that requires a training set in the conventional sense, there is no mention of a training set or its size. The upgrades primarily involve hardware and software features already present in other cleared devices.
9. How the ground truth for the training set was established:
Not applicable for the same reasons as #8.
§ 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.