(39 days)
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 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.
Esaote's Model 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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.
The 7340 and 6150 system designs remain the same as those previously cleared by FDA via K081794, K051308, K052805, K060827, and K081386, respectively, except for those features being added via this submission.
The 6150 is a mainframe ultrasound system, and the 7340 is a portable ultrasound system, both are used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The systems are equipped with a LCD Color Display and are capable of operating Linear, Convex, and Phased array probes.
The 7340 and 6150 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided 510(k) summary for the Esaote 7340 & 6150 Systems is a premarket notification for new features added to previously cleared ultrasound imaging systems. It does not contain information about an in-depth study with acceptance criteria and device performance metrics in the way one might expect for a novel AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use.
Therefore, the requested information elements related to detailed study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for meeting acceptance criteria (as typically expressed for new performance claims) are not present in this type of submission. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to the identified predicate devices for the new features (Elastography and 3D/4D in specific applications).
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and noting where it is not applicable for this type of submission:
Acceptance Criteria and Device Performance
The core "acceptance criteria" for this 510(k) are demonstrating substantial equivalence. The device performance is implicitly considered equivalent to the predicate devices for the functionalities being added.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied from Predicate Equivalence) |
|---|---|
| New Features (Elastography, 3D/4D): Performance in Elastography (ElaXto) and 3D/4D modality (Transvaginal, Transrectal, Urology) should be substantially equivalent to identified predicate devices. | Elastography (ElaXto) Analysis: Substantially equivalent to Siemens eSie Elasticity Imaging module available with S2000 system (K072786). |
| 3D/4D Modality (Transvaginal, Transrectal, Urology): Substantially equivalent to 3D/4D modality in the same applications available with RIC5-9-D probe of General Electric Voluson E8 system (K061682). These systems are able to provide elastographic analysis on real-time images by applying low compression/retraction movements using the probe. They are able to provide 3D/4D modality in Transvaginal, Transrectal and Urology applications by simultaneously controlling two independent scan planes for volumetric acquisition. | |
| Safety Requirements: Meet IEC60601-1 and IEC60601-2-37 safety standards. | The 7340, 6150, Siemens S2000, and General Electric Voluson E8 systems are designed to meet IEC60601-1 and IEC60601-2-37 safety requirements. |
| Acoustic Output Display: Provide an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values. | The 7340, 6150, Siemens S2000, and General Electric Voluson E8 systems provide an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values. |
Study Information (Based on the provided Summary)
This document is a 510(k) summary, not a full study report. It focuses on demonstrating equivalence rather than presenting a performance study with acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This type of detail is not typically included in a 510(k) summary for a substantial equivalence claim based on predicate device features. It's implied that the predicate devices themselves underwent such testing. The current submission is more focused on the technical design equivalence of the new features.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. Ground truth establishment, if any for specific performance testing, would have been part of the predicate device clearances or internal testing not detailed in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. As a substantial equivalence claim, a formal adjudication process for a test set is not described.
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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 document describes features of an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm or a comparative effectiveness study with human readers. The "AI" implied might be the "Elastography (ElaXto) analysis" and "3D/4D modality", but these are presented as imaging modes, not decision-support AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is an ultrasound imaging system rather than a standalone algorithm with a distinct performance evaluation. The added features are integral to the imaging process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. For a substantial equivalence claim regarding new imaging features like elastography and 3D/4D, technical specifications, image quality assessments, and possibly phantom studies are typically used to demonstrate equivalence rather than clinical ground truth from patient outcomes or pathology, unless explicit new clinical claims are being made.
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The sample size for the training set:
- Not applicable / Not provided. These are ultrasound imaging systems with added features, not machine learning algorithms that typically require a distinct training set. The "training" in this context would likely refer to the general development and calibration process of imaging technologies, not a labeled dataset for AI.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As above, the concept of a "training set" and associated ground truth in the context of an AI/ML device is not directly relevant to this type of ultrasound system submission.
§ 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.