Search Results

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, Intraoperative abdomninal 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 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, Intraoperative abdomninal 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.

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Model 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 for both models: 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 and Doppler 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 models are equipped with wireless capability. Model 7400 has been designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrades, defined herein, combine the cleared features of both 6400 and 7400 systems with new capabilities, listed below:

• 1. Managing of Intraoperative (Abdominal) application on both 6400 and 7400 upgrades.
• 2. Management of Pulsed Wave (PW) Doppler probe on both 6400 and 7400 upgrades.

The 6400 and 7400 Upgrades are manufactured under an I50 9001:2000 and ISO 13485 certified quality system.

The provided text describes a 510(k) submission for upgrades to existing ultrasound systems (6400 and 7400). It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, it is explicitly stated that "No clinical tests were performed." This means there is no study detailed in this document that explicitly proves the device meets acceptance criteria through clinical performance metrics. The submission relies on the technological characteristics and equivalence to previously cleared devices.

Given this, I will answer the questions based on the information available, noting the absence of a specific performance study.

Acceptance Criteria and Device Performance

Since no clinical tests were performed to establish specific performance acceptance criteria for the upgrades (managing Intraoperative Abdominal application and Pulsed Wave Doppler probe), the document focuses on demonstrating that the upgraded devices maintain the safety and effectiveness of the predicate devices for their intended uses. The "acceptance criteria" are implied to be adherence to relevant safety and performance standards for ultrasound equipment and technological equivalence.

• Clinical uses for the 6400 and 7400 Upgrades are equivalent to those of Esaote 6200 (K100931) and AU6 (Technos) (K990360, K000681, K014168, K023255).
• The models continue to perform diagnostic general ultrasound studies across a wide range of applications (Cardiac, Vascular, Abdominal, Fetal, Musculoskeletal, etc.) and provide imaging for biopsy guidance and needle placement. |

Study Details (or lack thereof)

1. Sample size used for the test set and the data provenance:

   • No clinical test set was used. The submission explicitly states: "No clinical tests were performed."
   • Data provenance is therefore not applicable to a clinical test set from this submission. Non-clinical testing relied on internal validation and verification processes against established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as no clinical test set was used, and thus no ground truth established by experts for such a set in this submission.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as no clinical test set was used.

4. 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:

   • No MRMC study was done. This submission is for upgrades to an ultrasound imaging system, not an AI-assisted diagnostic device. The functionality being cleared involves managing new applications and probe types, not performance enhancement through AI.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No standalone algorithm performance study was done. This device is an ultrasound imaging system, and the "upgrades" are for hardware/software capabilities for managing specific applications and probe types, not for a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable as no clinical test set requiring ground truth was used. The "ground truth" for the non-clinical testing was conformance to engineering and medical device safety standards.

7. The sample size for the training set:

   • Not applicable, as this submission does not describe an AI/machine learning device that would typically involve a "training set." The upgrades are technological enhancements to existing ultrasound systems.

8. How the ground truth for the training set was established:

   • Not applicable, as there was no training set mentioned or implied.

Ask a specific question about this device