(78 days)
Sono-Scan/Cardio-Scan™ is intended to acquire, store, retrieve and analyze digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4dimensional (dynamic 3D) image processing.
Sono-Scan/Cardio-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.
The TomTec acquisition software products Sono Scan and Cardio Scan are combining 3D and 4D Acquisition 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 transdacers for the addition of 2 = "M" 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 Sono Scan™ is a software module for the high performance computer system Compact High or Professional based on Microsoft Windows 2000/XP™ operating system standards.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets them. It primarily focuses on the 510(k) summary for TomTec Sono-Scan, Sono-Scan Pro, and Cardio-Scan, outlining its intended use, technological characteristics comparison to a predicate device, and the regulatory approval process.
However, based on the limited information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design intent satisfaction | "actual device performance satisfies the design intent." |
| Conformance to system performance specifications | "Actual device performance as tested internally conforms to the system performance specifications." |
| Software testing and validation (module and system level) | "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." |
| Functionality (Acquire, store, retrieve, analyze digital ultrasound and Color Doppler images; 3D/4D image processing; import 2D/3D formats for reconstruction and rendering) | The device description and intended use implicitly claim these functionalities. |
Missing Information:
- Specific quantifiable acceptance criteria: The document uses general statements like "satisfies design intent" and "conforms to system performance specifications" without providing measurable metrics (e.g., specific accuracy, processing speed, image quality standards).
- Quantifiable reported performance: No actual data or results are reported against any specific criteria.
2. Sample size used for the test set and the data provenance
The document mentions "Software testing and validation were done at the module and system level," but does not explicitly state the sample size of the test set (e.g., number of images, number of cases).
Missing Information:
- Sample size for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). It is implied that the testing was internal to TomTec.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states, "Test results were reviewed by designated technical professionals."
Missing Information:
- Number of experts: Not specified.
- Qualifications of experts: Only generally referred to as "designated technical professionals." No specific medical or technical expertise (e.g., radiologist with X years of experience) is provided.
4. Adjudication method for the test set
The document states, "Test results were reviewed by designated technical professionals."
Missing Information:
- Adjudication method: Not specified (e.g., 2+1, 3+1 consensus). It only mentions a review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The testing described appears to be internal software validation, not a clinical effectiveness study.
Missing Information:
- MRMC study: Not performed or not reported.
- Effect size of human reader improvement with AI: Not applicable as no MRMC study was reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "Test Discussion" refers to "Software testing and validation at the module and system level," which implies standalone testing of the software's functionality. However, it's not explicitly stated that this was a "standalone performance" study in the context of diagnostic accuracy.
Missing Information:
- Explicit standalone performance study: While internal software testing was done, it's not detailed as a separate standalone diagnostic performance study with specific metrics.
7. The type of ground truth used
The document does not explicitly define the "ground truth" used for testing. Given the nature of the device (image acquisition and processing), the "ground truth" would likely involve the expected output or behavior of the software based on its design, rather than a clinical ground truth like pathology for diagnosis.
Missing Information:
- Type of ground truth: Not specified. It's likely based on internal software specifications and expected technical outputs.
8. The sample size for the training set
The document does not mention any "training set." This type of device, which focuses on image acquisition, storage, retrieval, and 3D/4D processing (rather than automated diagnosis), typically undergoes traditional software testing and validation rather than machine learning training.
Missing Information:
- Sample size for the training set: Not applicable based on the provided information, as there's no indication of machine learning.
9. How the ground truth for the training set was established
Not applicable as no training set is mentioned or implied.
Missing Information:
- How ground truth for training set was established: Not applicable.
Summary of Study Details:
Based on the provided text, the "study" was an internal software testing and validation process carried out by TomTec Imaging Systems GmbH.
- Acceptance Criteria: General statements about satisfying design intent and conforming to system specifications. Specific quantifiable criteria are not provided.
- Reported Device Performance: Conclusions state that performance "satisfies the design intent" and "conforms to the system performance specifications," without reporting specific data.
- Sample Size (Test Set): Not specified.
- Data Provenance (Test Set): Internal testing conducted by TomTec (implied to be in Germany given the company address). The nature (retrospective/prospective) is not specified.
- Number and Qualifications of Experts (Ground Truth): "Designated technical professionals" reviewed test results, but their number and specific qualifications are not detailed.
- Adjudication Method: Not specified beyond a general review.
- MRMC Study: No MRMC comparative effectiveness study was reported.
- Standalone Performance Study: Internal software testing was done, but not explicitly framed as a standalone diagnostic performance study.
- Type of Ground Truth: Most likely based on internal software specifications and expected technical outputs, not clinical ground truth like pathology.
- Training Set Sample Size: Not applicable/not mentioned, as the device's function suggests traditional software development rather than machine learning.
- Training Set Ground Truth: Not applicable/not mentioned.
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MAY 09 2002
1020561
Image /page/0/Picture/2 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" is the phrase "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
December 21, 2001
Special 510(k) Summary
Sono-Scan Sono-Scan Pro Cardio-Scan
Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
Contact Person
Florian Eisenberger Director, Regulatory 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 Sono-Scan Sono-Scan Pro Cardio-Scan
Predicate Device
TomTec Echo-Scan K993394
Device Description
The TomTec acquisition software products Sono Scan and Cardio Scan are combining 3D and 4D Acquisition 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 transdacers for the addition of 2 = "M" 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 Sono Scan™ is a software module for the high performance computer system Compact High or Professional based on Microsoft Windows 2000/XP™ operating system standards.
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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. The word "TOMTEC" is in large, bold letters, with the letters "O" and "M" connected. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters.
Intended Use
Sono Scan/Cardio Scan™ is intended to acquire, store, retrieve and analyze digital ultrasound images and Color Doppler images for computerized 3dimensional and 4-dimensional (dynamic 3D) image processing.
Sono Scan/Cardio 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 Sono Can/Cardio Scan is a modified version of the filed Echo-Scan system, which has been transferred to Windows 2000/XP operating system standards.
The graphic user interface has been improved for faster and easier application. Sono Scan/Cardio 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.
December 21, 2001
Florian Eisenberger
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Florian Eisenberger Manager, Regulatory Affairs TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim Bavaria, GERMANY
Re: K020561
Trade/Device Name: TomTec Sono-Scan, Sono-Scan Pro, Cardio-Scan Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: April 8. 2002 Received: April 16, 2002
Dear Mr. Eisenberger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
TOMTEC Sono-Scan, Sono-Scan Pro, Cardio-Scan Device Name:_
Indications For Use
Sono-Scan/Cardio-Scan™ is intended to acquire, store, retrieve and analyze digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4dimensional (dynamic 3D) image processing.
Sono-Scan/Cardio-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.
(PLEASE DO NOT WRITE BELOW LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Frogdon
(Division Sign-Offm
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K020561
OR
Prescription Use (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.