(99 days)
Not Found
No
The description focuses on 3D reconstruction from 2D images using spatial tracking and standard image processing techniques, with no mention of AI or ML algorithms.
No
The device is described as an image acquisition and processing tool for diagnostic ultrasound images, and its intended use is to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an "add-on accessory for existing ultrasound imaging systems" and records the position and movement of ultrasound transducers for systematic acquisition of 2D image slices. None of these functions suggest it provides treatment or therapy.
Yes
Explanation: The device is described as a "general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology," which are all diagnostic applications. It also states that it is an "add-on accessory for any existing diagnostic imaging ultrasound system."
No
The device description explicitly states it is a "high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards" and incorporates a "commercially available image digitizer circuit board" and an "electromagnetic sensor device" for tracking. These are hardware components, making it more than just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ECHOTECH 3D FreeScan system is described as an add-on accessory for existing ultrasound imaging systems. Its function is to acquire, process, and reconstruct 3D ultrasound images from 2D ultrasound data. This is an in vivo imaging process, meaning it is performed directly on the living patient.
- No Mention of Samples: The description does not mention the analysis of any biological samples taken from the patient.
Therefore, the device's intended use and operation fall under the category of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.
Product codes (comma separated list FDA assigned to the subject device)
90 IYO
Device Description
The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.
The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.
2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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. Additional system testing was done by a third party standards test house.
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 and by a third party conforms to the system performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
6 1998 MAY
1 11
Image /page/0/Picture/1 description: The image contains a handwritten string of characters. The string appears to be "K980308". The characters are written in a dark ink on a white background.
January 23, 1998
510(k) Summary EchoTech 3D FreeScan
Submitter (Consultant) Name and Address
Morningstar Consulting Group, Inc. P. O. Box 218 Indian Hills, CO 80454
Submitter (Consultant) Contact Person
Kevin Morningstar, Senior Consultant phone (303) 697-8198 fax: call first
Manufacturer Name and Address
EchoTech 3D Imaging Systems GmbH Zeppelinstr. 4 D-85399 Hallbergmoos Germany
Manufacturer Contact Person
Peter Wiczek, Product Line Manager Phone 49 811 5556 0 fax 49 811 5556 20
Common, Classification & Proprietary Names
Common Name: Classification Name: Proprietary Name:
Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System EchoTech 3D FreeScan
P-2
1
Predicate Device
TomTec Echo-Scan K963807 dated December 18, 1996.
Device Description
The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.
The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.
2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.
Intended Use
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.
Technological Characteristics Comparison
The EchoTech 3D FreeScan is nearly identical in performance and intended use to the TomTec EchoScan, except that the EchoScan features an assortment of computer controlled probe carriage devices and incorporates respiration gating.
2
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. Additional system testing was done by a third party standards test house.
Test Conclusions
Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the system performance specifications.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, with its wings forming three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C 1398 MAY
EchoTech 3D Imaging Systems GmbH c/o Kevin Morningstar, Senior Consultant Morningstar Consulting Group, Inc. P.O. Box 218 Indian Hills, CO 80454
Re:
K980308 EchoTech 3D FreeScan Dated: April 4, 1998 Received: April 6, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Mr. Morningstar:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 980308
510(k) Number (if known):
ECHOTECH 3D FreeScan Device Name:
Indications for Use:
The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ritle LOTOTEON of 11000an of econstruction of diagnostic ultrasound images. It is ultrasound images and 3 differial retrieve digital ultrasound images for computerized 3-Intended to acquire, analyze, other and rother accessory for existing ultrasound imaging dimensional intego prococeing to to arritorn and movement of ultrasound transducers for the systems, and is michaod to room poal image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for radiology, intendou as a general parpos angery, orthopedics, oncology, obstetrics and gynecology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jamil A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)