(74 days)
Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 6400 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 7400 is a compact ultrasound system ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 7400 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.
6400 is a mainframe system equipped with wheels allowing to move the system. 7400 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 operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes. 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 systems are equipped with wireless capability. The 6400 and 7400 systems are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided text is a 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than efficacy through clinical studies and acceptance criteria as would be expected for a novel device. As such, the information typically requested in your prompt (e.g., acceptance criteria, test set, experts, adjudication, MRMC studies, standalone performance, ground truth for test/training sets, and training set size) is not explicitly present in this document.
The document explicitly states: "No clinical tests were performed." This indicates that the device's performance was not evaluated against specific acceptance criteria through a clinical study in the way your prompt describes. Instead, the submission relies on demonstrating similarity to existing, legally marketed predicate devices.
However, I can extract information related to the device's characteristics and the non-clinical tests performed to support its safety and performance.
Here's the summary of what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this is a 510(k) submission based on substantial equivalence, not a novel device requiring new efficacy criteria. The "acceptance criteria" here are effectively demonstrating equivalence to the predicate devices.
- Reported Device Performance: The primary performance characteristic claimed is "substantial equivalence" to predicate devices, meaning it performs similarly in its intended uses. The document highlights functional equivalence and compliance with safety standards.
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Equivalent to predicate devices (Esaote 7350, 7340, 8100) in fundamental technology. | "The 6400 and 7400 systems employ the same fundamental technological characteristics as their predicate devices." (K050326, K052805, K060827 for 7350; K081794, K091009 for 7340; K101605 for 8100 Wi-Fi). |
| Clinical Uses/Intended Use | Equivalent to those cleared for predicate devices (Esaote 7350 and 7340). | "Clinical uses for which respectively 6400 and 7400 are designed, are equivalent to those cleared for Esaote 7350 and 7340." Both devices are intended for diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Urologic, and imaging for guidance of biopsy and needle placement. |
| Safety Requirements | Conform to IEC60601-1 and IEC60601-2-37. | "Both 6400 and 7400 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements." Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, and found to conform to these standards, as well as NEMA UD-3 and NEMA UD-2. |
| Acoustic Output Display | Provide Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values to predicate devices. | "Both 6400 and 7400 provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values." |
| Measurements and Analysis Package | Similar to predicate devices (Esaote 6400, 7400, 7350, 7340 systems). | "Esaote 6400, 7400, 7350 and 7340 systems provide a similar measurements and analysis package." |
| Digital Storage Capabilities/Connectivity | Include Network connectivity. | "Esaote 6400, 7400, 7350 and 7340 systems have digital storage capabilities, including Network connectivity." Both 6400 and 7400 are equipped with wireless capability. |
| 7400 Battery Powering | Equivalent to 7340 system cleared for battery powering. | "Esaote 7400, designed to be powered by battery, is equivalent to 7340 system, cleared for battery powering via K081794." |
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 explicitly states "No clinical tests were performed." Therefore, there is no test set in the context of clinical performance evaluation. Non-clinical tests were performed on the devices themselves to ensure compliance with standards.
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. As no clinical tests were performed, there was no test set requiring ground truth established by experts.
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 device is an ultrasound imaging system, not an AI-powered diagnostic tool that assists human readers.
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. No clinical tests were performed to evaluate an algorithm against ground truth. The "ground truth" in this submission relates to compliance with engineering and safety standards (e.g., whether acoustic output measures meet NEMA standards, or whether the device can perform the listed modes of operation as intended).
8. The sample size for the training set:
- Not applicable. This submission is for an ultrasound imaging system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This submission is for an ultrasound imaging system, not an AI/ML algorithm that requires a training set and associated ground truth.
Conclusion from the Document:
The Esaote 6400 and 7400 Ultrasound Systems received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Esaote 7350, 7340, and 8100). The submission focuses on showing that the new devices have the same technological characteristics, intended uses, and meet the same non-clinical safety and performance standards as the legally marketed predicates. No clinical studies were performed to establish performance against specific acceptance criteria for a novel functionality.
§ 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.