K Number
K993398
Device Name
ECHO VIEW, EASY VIEW, OMNI VIEW
Date Cleared
1999-11-05

(28 days)

Product Code
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Echo-View™ 4.X is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View™ 4.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 Description
The Echo-Viewis a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Echo-Viewis 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.
More Information

No
The summary describes standard digital image processing and reconstruction techniques, with no mention of AI or ML algorithms.

No
Explanation: The device is described as a software module for processing and analyzing ultrasound images, not for providing therapy. It retrieves, analyzes, and stores digital ultrasound images for computerized 3D and 4D image processing and reconstruction.

No
The device is described as an "image processing tool" that retrieves, analyzes, and stores digital ultrasound images for 3D and 4D processing. While used with diagnostic imaging, its intended use is to process images, not to make a diagnosis itself.

Yes

The device description explicitly states that Echo-View is a "software module" and "proprietary software" for image processing and reconstruction, running on a standard computer system. It does not include or require any specific hardware components beyond the computer itself and the source of the digital images.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that Echo-View™ 4.X is for retrieving, analyzing, and storing digital ultrasound images for computerized 3D and 4D image processing. It's described as a "general purpose digital 3D ultrasound image processing tool." This focuses on image manipulation and analysis, not on testing samples taken from the human body.
  • Device Description: The description reinforces that it's software for processing digitized ultrasound images. Ultrasound is an imaging modality that visualizes structures within the body, not a method for analyzing in vitro samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Echo-View™ 4.X's function is centered around processing and visualizing medical images acquired directly from the patient.

N/A

Intended Use / Indications for Use

Echo-ViewTM 4.X is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-ViewTM 4.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.

Product codes

90 IYO, 90 LLZ

Device Description

The Echo-Viewis a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Echo-Viewis 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound B-mode images and Color Doppler images

Anatomical Site

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K934139

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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.

August 30, 1999

Special 510(k) Summary EchoView 4.x

Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

Contact Person

Florian Eisenberger Director, Regulatory Affairs & Quality Assurance Phone ++49-89-32175-830 ++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-View Easy-View Omni-View

Predicate Device

TomTec Echo-View K934139

Device Description

The Echo-Viewis a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Echo-Viewis 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.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Florian Eisenberger Manager Regulatory Affairs TomTec Imaging Systems Edisonstrasse 6 857176 Unterschleissheim, Germany

Re:

K993398 Echo-View 4.x. Easy-View 1.x. Omni-View 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 III (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/cdch/dsma/dsmamain.html".

Sincerely yours,

$\tau$

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

2

510(k) Number (if known): K993398

Device Name: TOMTEC Echo View

Indications For Use

Echo-View™ 4.X is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View™ 4.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.

(PLEASE DO NOT WRITE BELOW LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Sagem

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 3348 510(k) Number

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use