SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

K020561 · Tomtec Imaging Systems GmbH · IYO · May 9, 2002 · Radiology

Device Facts

• Record ID: K020561
• Device Name: SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
• Applicant: Tomtec Imaging Systems GmbH
• Product Code: IYO · Radiology
• Decision Date: May 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 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.

Device Story

Sono-Scan/Cardio-Scan is a software-based digital ultrasound image analysis system. It acquires, stores, retrieves, and processes 2D ultrasound image slices to generate 3D and 4D (dynamic 3D) reconstructions. The system controls transducer position/movement for data acquisition and performs tomographic reconstruction and surface rendering. It operates on Windows 2000/XP platforms. Used in clinical settings (cardiology, radiology, etc.) by healthcare professionals to visualize anatomical structures. Output is viewed by clinicians to assist in diagnostic imaging workflows. Benefits include enhanced visualization of 3D/4D ultrasound data for clinical assessment.

Clinical Evidence

No clinical data. Bench testing only; software validation and verification performed at module and system levels according to internal protocols.

Technological Characteristics

Software-based image processing system; operates on Windows 2000/XP; performs 3D/4D tomographic reconstruction and surface rendering; imports digital 2D/3D image formats; provides GUI for image analysis; intended as add-on for existing ultrasound imaging systems.

Indications for Use

Indicated for general purpose acquisition and processing of digital ultrasound and Color Doppler images for 3D/4D tomographic reconstruction and surface rendering in cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics, and gynecology.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TomTec Echo-Scan (K993394)

Submission Summary (Full Text)

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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