(64 days)
Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 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 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 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 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 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. Models 7400 and 7410 are portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are for both models: B-Mode, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Models 6400 and 7400 manages Qualitative Elastosonography (ElaXto).
All models 6400, 7400 and 7410 are equipped with a LCD color display where acquired images and advanced image features are shown. All models 6400, 7400 and 7410 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes). Model 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.
Models 7400 and 7410 the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. All models 6400, 7400 and 7410 are equipped with wireless capability. Models 7400 and 7410 have been designed to be powered by battery.
Both models 6400 and 7400 are already cleared via K142008. Model 7410 is already cleared via K142077.
Models 6400, 7400 and 7410 Upgrades, defined herein, combine the cleared features of both 6400, 7400 and 7410 systems with new capabilities, listed below:
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- Management of Intraoperative (Abdominal) application on 7410 Upgrade.
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- Management of Laparoscopic application on both 7400 and 7410 Upgrades.
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- Addition of Transrectal/Urology and Transvaginal applications in 3D/4D on 7410 Upgrade.
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- Addition of Urology application in 3D/4D on both 6400 and 7400 Upgrades.
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- Implementation of the QAS feature on 6400 and 7400 Upgrades.
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- Implementation of the Needle Visibility feature on all 6400, 7400 and 7410 Upgrades.
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- Implementation of the on-board tutorial MyLibrary feature on all 6400, 7400 and 7410 Upgrades.
The 6400, 7400 and 7410 Upgrades are manufactured under an ISO 9001 and ISO 13485 certified quality system.
The provided document is a 510(k) premarket notification for Esaote S.p.A.'s 6400, 7400, and 7410 Ultrasound Systems. It details the intended use, technological characteristics, and a summary of non-clinical tests conducted. The document does not describe a study that uses acceptance criteria and reports device performance in terms of specific metrics like sensitivity, specificity, or AUC as one might find for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and adherence to performance standards.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set ground truth) are not applicable or not available from this 510(k) summary, as it is related to an ultrasound system, not an AI/ML device that typically involves such evaluations.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and adherence to recognized performance standards. The "device performance" is therefore considered equivalent to the predicate devices and compliant with these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in intended use. | Intended use is equivalent or expanded from predicate. |
| Substantial equivalence to predicate devices in technical characteristics. | Same fundamental technological characteristics as predicates, with new capabilities. |
| Compliance with IEC 60601-1 (general safety) | Device conforms to IEC 60601-1. |
| Compliance with IEC 60601-1-2 (EMC) | Device conforms to IEC 60601-1-2. |
| Compliance with IEC 60601-2-37 (ultrasound safety) | Device conforms to IEC 60601-2-37 safety requirements. |
| Compliance with NEMA UD-3 (acoustic output display) | Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values. |
| Compliance with NEMA UD-2 (acoustic output measurement) | Device conforms to NEMA UD-2. |
| Biocompatibility | Evaluated for biocompatibility. |
| Cleaning and disinfection effectiveness | Evaluated for cleaning and disinfection effectiveness. |
| Thermal and mechanical safety | Evaluated for thermal and mechanical safety. |
| Management of new applications/features (e.g., Intraoperative (Abdominal) on 7410, Laparoscopic on 7400/7410, 3D/4D Transrectal/Urology and Transvaginal on 7410, 3D/4D Urology on 6400/7400, QAS on 6400/7400, Needle Visibility, MyLibrary) | Each new feature/application is shown to be equivalent to features in existing cleared devices. |
| Manufactured under ISO 9001 and ISO 13485 certified quality system | The 6400, 7400 and 7410 Upgrades are manufactured under an ISO 9001 and ISO 13485 certified quality system. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states "No clinical tests were performed," indicating that direct patient data or test sets for performance evaluation in the context of AI/ML or diagnostic accuracy studies were not used for this submission. The evaluation was based on non-clinical performance and substantial equivalence to existing devices.
3. 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 applicable. No clinical tests were performed, hence no ground truth was established by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. 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. No clinical tests were performed, and this is not a submission for an AI-assisted device requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device capable of standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical tests involving ground truth determination were performed.
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No "training set" or corresponding ground truth establishment is relevant to this traditional 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.