(86 days)
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No
The document describes image processing and reconstruction but does not mention AI, ML, or related terms, nor does it describe the characteristics of an AI/ML device like training/test sets or performance metrics typically associated with such technologies.
No
The device is described as an image acquisition and processing tool, not as providing a therapeutic intervention. Its intended use is for producing 3D ultrasound images for diagnostic purposes.
No
The device is described as an image acquisition, analysis, storage, and retrieval system for 3D/4D ultrasound images for subsequent processing and reconstruction. It is a "general purpose digital 3D ultrasound image processing tool" and does not mention providing a diagnosis.
No
The device description explicitly states it incorporates a "proprietary image digitizer circuit board" and is a "high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards," indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, analyzing, storing, and retrieving digital ultrasound images for 3D and 4D image processing. It's an add-on accessory for existing ultrasound systems and is used to control transducer movement and process the acquired images.
- Device Description: The description reinforces that it's a computer system with proprietary hardware and software for processing ultrasound image data.
- Lack of Diagnostic Testing on Biological Samples: The core function of an IVD is to perform tests on biological samples (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests. It processes images generated by another medical device (an ultrasound system).
The device is a medical image processing tool, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology, The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction.
Product codes
Not Found
Device Description
The TomTec Echo-Scan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a proprietary image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The TomTec Freehand Scanning Device records ultrasound transducer spatial position in six degrees of freedom during use. 2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the word "TOMEC" in large, bold letters. Below the word "TOMEC" is the word "IMAGING" in smaller letters. The letters in both words are black and have a slightly distressed or textured appearance.
DEC 1 8 1996
September 20, 1996
510(k) Summary TomTec Echo-Scan with Freehand Scanning
Name and Address
TomTec Imaging Systems, Inc. 4775 Walnut Street, Suite C Boulder, Colorado 80301
Contact Person
Kevin Morningstar Director, Regulatory Affairs & Quality Assurance Phone (303) 473 2285 fax (303) 545 0114
Common, Classification & Proprietary Names
| Common Name: | Digital Ultrasound Image Analysis System |
|---|---|
| Classification Name: | Ultrasonic Pulsed Echo Imaging System |
| Proprietary Name: | TomTec Echo-Scan |
Predicate Device
TomTec Echo-Scan K941322, dated July 27, 1995
Device Description
The TomTec Echo-Scan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a proprietary image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The TomTec Freehand Scanning Device records ultrasound transducer spatial position in six degrees of freedom during use. 2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site.
Image /page/0/Picture/15 description: The image shows the logo for TomTec Imaging Systems, Inc. The logo consists of a series of black, angled lines arranged in a cluster above the company name. The text "TomTec Imaging Systems, Inc." is written in a simple, sans-serif font and is positioned directly below the abstract graphic element.
4775 Walnut Street · Suite C · Boulder, CO · 80301 · Phone: 303/545-9000 · Toll-free: 800/922-6543 · Fax: 303/545 Imaging Systems Inc. recognize the maring Freeland Systems Inc. and TomTer Tomorraphic Technolor-
1
Intended Use
The TomTec Echo-Scan is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The Echo-Scan acquires sets of 2D images and stores them digitally in the TomTec standard 3D image file format for subsequent 3D tomographic reconstruction and surface rendering with either the Echo-Scan or Echo-View. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology, The TomTec Freehand Scanning Device is intended for acquiring a sequence of conventional 2D ultrasound images with transducer position recorded for each image acquired. The resulting image data set is intended for storage in the TomTec standard 3D image file format for subsequent 3D tomographic image reconstruction.
Technological Characteristics Comparison
The Echo-Scan system has been modified to add freehand scanning. This change expands the selection of image acquisition accessory devices(or probe carriage devices) available to control and/or monitor ultrasound transducer movement during image acquisition. With freehand scanning, the user scans a patient with the transducer held in the hand as he customarily would. This is made possible by using a coordinate tracking system. The coordinate tracking system provides spatial coordinates which can be encoded for each 2D image acquired as the transducer is moved.
Test Discussion
Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.
Test Conclusions
Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications.