ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X

K022824 · Tomtec Imaging Systems GmbH · LLZ · Oct 17, 2002 · Radiology

Device Facts

• Record ID: K022824
• Device Name: ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X
• Applicant: Tomtec Imaging Systems GmbH
• Product Code: LLZ · Radiology
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Review Software products Echo-View 5.x, Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x, and Surgical View 1.x are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View 5.x, Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.

Device Story

Software suite for analysis, storage, retrieval, and reconstruction of digitized ultrasound B-mode and Color Doppler images. Inputs: digital 2D/3D image files from TomTec acquisition stations or 3D-capable ultrasound systems. Processing: 3D tomographic reconstruction and surface rendering of 3D/4D data sets; 2D/3D measurements. Output: reconstructed 3D volumes and processed images for clinical review. Used in clinical settings (cardiology, radiology, etc.) by healthcare professionals. Facilitates visualization and quantification of anatomical structures to support clinical decision-making and diagnosis.

Clinical Evidence

No clinical data. Bench testing only. Software testing and validation performed at module and system levels according to internal company protocols.

Technological Characteristics

Software-based digital ultrasound image analysis system. Operates on Microsoft Windows 2000/XP platforms. Features include 3D tomographic reconstruction, surface rendering, and 2D/3D measurement tools. Modular architecture with subsets of core Echo-View functionality. No specific hardware materials or energy sources defined as it is a software-only product.

Indications for Use

Indicated for use as a general purpose digital 3D ultrasound image processing tool for patients undergoing diagnostic imaging in cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics, and gynecology.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• TomTec Echo-View (K993398)

Submission Summary (Full Text)

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KD22824

Image /page/0/Picture/1 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.

July 318t , 2001

# Special 510(k) Summary

Echo-View 5.x Easy-View 2.x Omni-View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x

OCT 1 7 2002

#### 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(s): Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System Echo-View 5.x Easy-View 2.x Omni-View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x

#### Predicate Device

TomTec Echo-View K993398

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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 and features the word "Tomtec" in a bold, sans-serif font. Below the word "Tomtec" is the phrase "Imaging Systems" in a smaller, sans-serif font. The logo is simple and modern.

# Device Description

The Review Software products

- . Echo-View 5.x
- Easy-View 2.x ●
- Omni-View 2.x
- Cardio-View 1.x ●
- LV Analysis 1.x .
- Surgical View 1.x ●

are software modules for high performance computer systems based on Microsoft Windows 2000/XP™ operating system standards. These Review Software products are proprietary software for the analysis, storage, retrieval and reconstruction of digitized ultrasound B-mode images and Color Doppler images. The data can be acquired by a TomTec acquisition station or by a 3D capable ultrasound system. The result of acquired images allows a 3-dimensional volume to be reconstructed by Echo-View. The digital 3D / 4D data set can be used for 2D and 3D measurements.

# Intended Use

The Review Software products

- Echo-View 5.x .
- Easy-View 2.x .
- Omni-View 2.x .
- Cardio-View 1.x .
- LV Analysis 1.x .
- . Surgical View 1.x

are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Echo-View 5.x , Easy-View 2.x. Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surqical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and aynecology.

# Technological Characteristics Comparison

Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x are modified version and follow-up products of the filed Echo-View / Easy-View system, which has been transferred to Windows 2000/XP ™ operating system standards. The graphic user interface has been improved for faster and easier application.

While Echo-View includes the full functionality the products Cardio-View, LV Analysis, Surgical View, Easy-View and Omni-View are subsets of the Echo-

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Image /page/2/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The word "Tomtec" is in large, bold, black letters. Below that, in smaller letters, are the words "Imaging Systems."

View Software where the functionality is limited for easier software handling with respect to the software application.

# 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.

July 31st , 2002

Florian Eisenberger

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Image /page/3/Picture/1 description: The image shows a circular logo with a stylized eagle in the center. The eagle is depicted with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper half of the circle, following its curvature. The logo appears to be a seal or emblem, possibly representing a government agency.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Florian Eisenberger Manager Regulatory Affairs TomTec Imaging System Edisonstrasse 6 D-85716 Unterschleissheim Germany

Re: K022824

Trade/Device Name: TomTec Echo-View 5.x, Fasy-View 2.x. Omni-View 2.x. Cardio-View 1.x. LV Analysis 1.x, and Surgical View 1.x Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 LLZ and IYO Dated: September 16, 2002 Received: September 24, 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 adultcration.

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. Snogdon

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):

Device Name: . TomTec Echo-View 5.x, Easy-View 2.x, Omni-View 2,x Cardio-View 1.x, LV Analysis 1.x, Surgical-View 1.x

### Indications For Use

The products:

- Echo-View 5.x ●
- Easy-View 2.x
- Omni View 2.x
- Cardio-View 1.x ●
- LV Analysis 1.x ●
- Surgical View 1.x ●

are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose 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 (ODF)

Trink M. Segmen

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022824
OR
Over-The-Counter Use

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use