(28 days)
Echo-Scan™ 4.1 is intended to acquire, store, retrieve and analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Echo-Scan™ 4.1 can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose image acquisition and digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.
The TomTec acquisition software products Echo-Scan and Easy-Scan are combining 3D and 4D Acquisition Software and Echo-View™ / Easy-View Review Software for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is the appropriate Software solution for TomTec's add-on accessories for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the acquisition of 2 dimensional image slices throughout a volume of interest. The 4D Echo-Scan™ Software acquires sets of 2D images and stores them digitally in a special 3D image file format for subsequent 3D tomographic reconstruction and surface rendering.
The 4D Echo-Scan™ is a software module for the high performance computer system Compact High or Professional based on Microsoft Windows NT™ 4.0 operating system standards.
The TomTec Echo-Scan 4.x and Easy-Scan 1.x are digital ultrasound image analysis systems.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to design intent | "Test results support the conclusion that actual device performance satisfies the design intent." |
| Adherence to system performance specifications | "Actual device performance as tested internally conforms to the system performance specifications." |
| Software functionality at module level | "Software testing and validation were done at the module... level according to written test protocols established before testing was conducted." |
| Software functionality at system level | "Software testing and validation were done at the... system level according to written test protocols established before testing was conducted." |
| Improved graphic user interface | "The graphic user interface has been improved for faster and easier application." (This is a design improvement, implicitly part of successful testing for user experience) |
| Easier and more efficient handling (Easy-Scan) | "Easy-Scan is a clinical application oriented subset of the Echo-Scan Software, which makes handling easier and more efficient." (Similar to above, a design goal confirmed by testing.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any specific sample sizes for test sets (e.g., number of images, cases, or patients).
The data provenance is also not explicitly stated. Given that it's an internal test by TomTec Imaging Systems GmbH (based in Germany), it's likely the testing was conducted internally and may have involved retrospective or internally generated data. There's no mention of country of origin for any external datasets, nor whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test set. The testing described is primarily focused on software functionality and conformance to specifications, not clinical performance metrics validated against expert interpretations.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. The testing described is primarily about software validation and conformance to specifications, which typically involves internal technical review rather than expert adjudication of clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information about human readers, AI assistance, or an effect size of improvement. The device described, Echo-Scan and Easy-Scan, is a software for acquiring, storing, retrieving, and analyzing digital ultrasound images, and for 3D/4D image processing. It is not presented as an AI-assisted diagnostic tool that directly aids human interpretation in a comparative effectiveness study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not explicitly describe a standalone performance study in terms of accuracy or specific diagnostic metrics. The "Test Discussion" states that "Software testing and validation were done at the module and system level according to written test protocols." This implies testing of the algorithm's functionality and adherence to specifications (e.g., image acquisition, storage, processing, reconstruction, rendering) without necessarily evaluating its diagnostic accuracy against a ground truth dataset in a standalone manner. The focus is on the software's ability to perform its defined functions, not its ability to make diagnoses independently.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used. As noted, the testing primarily focused on confirming the software's functional performance and adherence to design specifications, rather than evaluating its diagnostic accuracy against clinical ground truth (like pathology, outcomes data, or expert consensus).
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. The described devices are acquisition and processing software, not a machine learning model that would typically have a separate training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as the device is not described as a machine learning model), there is no information on how ground truth for a training set would have been established.
Summary of Study Limitations (from the provided text):
The provided text describes a 510(k) submission for a modified ultrasound imaging software (Echo-Scan 4.x and Easy-Scan 1.x) that has been ported to a new operating system (Windows NT) with an improved graphic user interface. The testing discussed is primarily focused on software validation and verification to ensure that the modified software performs its intended functions (acquisition, storage, retrieval, 3D/4D processing, reconstruction, rendering) as designed and to the specified standards.
The document lacks details on clinical performance studies, diagnostic accuracy evaluations, expert reviews, or the methodologies typically associated with assessing the clinical effectiveness or diagnostic capabilities of AI-driven medical devices. The testing appears to confirm the software's internal operational correctness and adherence to technical specifications, rather than its performance in a clinical diagnostic context validated against external ground truth.
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Image /page/0/Picture/2 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features the word "Tomtec" in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters. The logo is simple and modern.
August 30, 1999
Special 510(k) Summary Echo-Scan 4.x
Easv-Scan 1.x
Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
Contact Person
Florian Eisenberger Director, Requlatory Affairs & Quality Assurance ++49-89-32175-830 Phone ++49-89-32175-750 fax
Common, Classification & Proprietary Names
Common Name: Classification Name: Proprietary Name:
Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System Echo Scan Easy-Scan
Predicate Device
TomTec Echo-Scan K963807
Device Description
The TomTec acquisition software products Echo-Scan and Easy-Scan are
combining 3D and 4D Acquisition Software and Echo-View™ / Easy-View Review Software for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. It is the appropriate Software solution for TomTec's addon accessories for existing ultrasound imaging systems, and is intended to control position and movement of ultrasound transducers for the acquisition of 2 dimensional image slices throughout a volume of interest. The 4D Echo-Scan™ Software acquires sets of 2D images and stores them digitally in a special 3D image file format for subsequent 3D tomographic reconstruction and surface rendering
The 4D Echo-Scan™ is a software module for the high performance computer system Compact High or Professional based on Microsoft Windows NT™ 4.0 operating system standards.
R
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Image /page/1/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
Intended Use
Echo-Scan™ is intended to acquire, store, retrieve and analyze digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Echo-Scan™ can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose image acquisition and digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.
Technological Characteristics Comparison
The new Echo-Scan NT is a modified version of the filed Echo-Scan system, which has been transferred to Windows NT operating system standards. The graphic user interface has been improved for faster and easier application. Easy-Scan is a clinical application oriented subset of the Echo-Scan Software, which makes handling easier and more efficient.
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.
August 30, 1999 Florian Eisenberger
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Florian Eisenberger Manager Regulatory Affairs TomTec Imaging Systems Edisonstrasse 6 857176 Unterschleissheim, Germany
NOV - 5 1999
Re:
K993394 Echo Scan 4.x, Easy Scan 1.x Dated: September 30, 1999 Received: October 8, 1999 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.2050/Procode: 90 LLZ
Dear Ms. Eisenberger:
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 legally marketed predicate 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). 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 (Special Controls) or class III (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 (QS) 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/cdrh/dsma/dsmamain.html".
Sincerely vours.
.
ent. Daniel G. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993394
Device Name: TOMTEC Echo Scan
Indications For Use
Echo-Scan™ 4.1 is intended to acquire, store, retrieve and analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Echo-Scan™ 4.1 can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose image acquisition and digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.
(PLEASE DO NOT WRITE BELOW LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segeem
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use
§ 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.