(43 days)
Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric and Other: Urologic. The 7410 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 7410 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 operations are: 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. 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. 7410 system can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On 7410 system the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7410 system is equipped with wireless capability. Model 7410 has been designed to be powered by battery.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Esaote 7410 Ultrasound System, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for an ultrasound system, which primarily demonstrates substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria or conducting a dedicated performance study against new criteria. Therefore, the "acceptance criteria" here are implicitly the performance specifications and safety standards met by the predicate devices. The "reported device performance" is the assertion that the new device (7410 System) meets these same technological characteristics and standards.
| Acceptance Criteria (Implicit from Predicate Devices & Standards) | Reported Device Performance (Esaote 7410 Ultrasound System) |
|---|---|
| Technological Characteristics |
- Equivalent fundamental technological characteristics to predicate devices (Esaote 7400, Esaote Europe 6420)
- Equivalent clinical uses to predicate devices
- Compliance with IEC60601-1
- Compliance with IEC60601-1 and IEC60601-2-37 safety requirements
- Acoustic Output Display feature per AIUM / NEMA standards (equivalent Ispta and MI maximal values)
- Similar measurements and analysis package to predicate devices
- Digital storage capabilities, including network connectivity
- Wireless capability
- Battery powering capability | - The 7410 system employs the same fundamental technological characteristics as its predicate devices (Esaote 7400 via K111032, K132331, K132466; and Esaote Europe 6420 via K141486).
- Clinical uses for the 7410 system are equivalent to those of the Esaote 7400 model and Esaote Europe 6420.
- Designed to meet IEC60601-1.
- Designed to meet IEC60601-1 and IEC60601-2-37 safety requirements.
- Provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
- Provides similar measurements and analysis package.
- Has digital storage capabilities, including network connectivity.
- Equipped with wireless capability, substantially equivalent to 7400 cleared for wireless capability.
- Designed to be powered by battery, substantially equivalent to 7400 cleared for battery powering. |
| Safety Standards / Non-Clinical Tests - Acoustic output evaluation
- Biocompatibility evaluation
- Cleaning and disinfection effectiveness evaluation
- Thermal, electromagnetic, and mechanical safety evaluation
- Conformity to IEC 60601-1
- Conformity to IEC 60601-1-2
- Conformity to IEC 60601-2-37
- Conformity to NEMA UD-3
- Conformity to NEMA UD-2 | - The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electromagnetic, and mechanical safety.
- Found to conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-3, and NEMA UD-2.
- The system is manufactured under an ISO 9001:2000 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." This is a 510(k) submission based on substantial equivalence to predicate devices and non-clinical engineering/safety testing, not a performance study involving a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as no clinical tests were performed and thus no ground truth was established by experts for a 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. This is not an AI/CADe/CADx device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an ultrasound imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical performance study was conducted requiring ground truth. The basis for clearance is substantial equivalence to legally marketed predicate devices and conformity to recognized safety standards.
8. The sample size for the training set
Not applicable, as no algorithm requiring a training set was developed or evaluated.
9. How the ground truth for the training set was established
Not applicable, as no algorithm requiring a training set was developed or evaluated.
Summary of the Document's Nature:
This document is a 510(k) Pre-market Notification for the Esaote 7410 Ultrasound System. Its primary purpose is to demonstrate substantial equivalence to already legally marketed predicate ultrasound devices (Esaote 7400 and Esaote Europe 6420). This means the new device shares the same intended use and fundamental technological characteristics, and any differences do not raise new questions of safety or effectiveness. The "studies" performed are non-clinical engineering and safety tests to ensure the device meets recognized industry standards for medical electrical equipment and diagnostic ultrasound. No new clinical performance studies were conducted to establish specific accuracy, sensitivity, or specificity metrics for diagnostic image interpretation by the device itself.
§ 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.