(38 days)
Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal, Laparoscopic and Other: Urologic. The 7348 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 7348 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, Tissue Enhancement Imaging (TEI), Multi View (MView), CW and PW Doppler, Color Flow Mapping (CFM) and Amplitude Doppler (AD). 7348 is equipped with a LCD color display where acquired images and advanced image features are shown. 7348 can drive Phased, Convex, Linear array and Doppler probes. Model 7348 has been designed to be powered by battery.
7348 has been previously cleared via K121384.
7348 Upgrade, defined herein, combine the cleared features of 7348 system with new software capabilities, listed below:
- Managing of Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode. 1.
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- Managing of M-Mode with free positioning of the acquisition line (Compass M-Mode).
- Management of Stress Echo where detection of the occurrence of stress-induced wall motion 3. abnormalities is derived through comparison of 2D loops, displaying wall motion at rest and during and after stress.
- Management of Intima Media Thickness to automatically measure the thickness between the 4. intima and the media on the image in real time.
The 7348 Upgrade is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
The provided text is a 510(k) Summary for a medical device (Esaote 7348 Ultrasound System Upgrade). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria or a study proving the device meets them in the context of clinical performance metrics.
Specifically, the document states:
- "Summary of Clinical Tests: No clinical tests were performed." This explicitly indicates that no studies were conducted to assess clinical performance using test sets against acceptance criteria.
- The entire submission relies on technological equivalence to previously cleared devices (7348 cleared via K121384 and 7340 via K081794, K091009, K110688) for its functionalities, including the new software capabilities (Tissue Velocity Mapping (TVM) and Tissue Velocity (TV) mode, Compass M-Mode, Stress Echo management, and Intima Media Thickness measurement).
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them from the given text.
Here's why and what information is missing:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document focuses on comparing the new features to existing, cleared equivalent features on predicate devices, rather than defining specific performance metrics and showing test results.
- Sample Size Used for the Test Set and Data Provenance: No test set was used for clinical performance evaluation since "No clinical tests were performed."
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable, as no clinical tests were performed requiring ground truth establishment by experts for a test set.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no clinical studies were performed.
- Standalone Performance: While the device has technological characteristics, no standalone clinical performance study was done as per the document. The capabilities (e.g., TVM, Compass M-Mode) are stated to be "equivalent to" those of the predicate device, which implies their performance is assumed to be similar based on "technological characteristics."
- Type of Ground Truth Used: Not applicable.
- Sample Size for the Training Set: Not applicable, as this is not an AI/ML device in the modern sense requiring a training set for clinical performance. The "new software capabilities" are presented as features equivalent to those already present in predicate devices.
- How the Ground Truth for the Training Set was Established: Not applicable.
§ 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.