ECHOTECH 3D FREESCAN

K980308 · Echotech 3D Imaging Systems GmbH · IYO · May 6, 1998 · Radiology

Device Facts

• Record ID: K980308
• Device Name: ECHOTECH 3D FREESCAN
• Applicant: Echotech 3D Imaging Systems GmbH
• Product Code: IYO · Radiology
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.

Device Story

EchoTech 3D FreeScan is an add-on computer system for existing diagnostic ultrasound machines; facilitates 3D image reconstruction. Input: sequential 2D ultrasound images and spatial transducer position data. Operation: magnetic field sensor (attached to probe via plastic holding plate) tracks transducer in six degrees of freedom; system digitizes 2D slices and converts them into 3D data volumes. Output: 3D ultrasound image volumes for analysis, storage, and retrieval. Used in clinical settings by healthcare providers to assist in diagnostic imaging. Benefits: enables 3D visualization of anatomy from standard 2D ultrasound equipment.

Clinical Evidence

Bench testing only. Software validation performed at module and system levels per internal protocols. Additional system testing conducted by a third-party standards test house. Results confirmed device performance conforms to design intent and system specifications.

Technological Characteristics

Computer system based on Intel motherboard; Microsoft DOS/Windows OS. Includes image digitizer circuit board. Spatial tracking via electromagnetic sensor (pulsed magnetic field). Connectivity: add-on accessory for ultrasound systems. Software: proprietary image processing.

Indications for Use

Indicated for patients requiring 3D reconstruction of diagnostic ultrasound images across various clinical specialties including cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, 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 (K963807)

Submission Summary (Full Text)

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6 1998 MAY

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January 23, 1998

# 510(k) Summary EchoTech 3D FreeScan

# Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 218 Indian Hills, CO 80454

# Submitter (Consultant) Contact Person

Kevin Morningstar, Senior Consultant phone [phone] fax: call first

## Manufacturer Name and Address

EchoTech 3D Imaging Systems GmbH Zeppelinstr. 4 D-85399 Hallbergmoos Germany

## Manufacturer Contact Person

Peter Wiczek, Product Line Manager Phone [phone] fax [phone]

## Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name:

Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System EchoTech 3D FreeScan

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#### Predicate Device

TomTec Echo-Scan K963807 dated December 18, 1996.

#### Device Description

The EchoTech 3D FreeScan is a high performance computer system based on Intel motherboard and Microsoft DOS/Windows standards. It incorporates a commercially available image digitizer circuit board and proprietary software for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.

2D ultrasound images are acquired sequentially in a series of steps as the ultrasound transducer is swept across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume.

#### Intended Use

The ECHOTECH 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is an add-on accessory for existing ultrasound imaging systems, and is intended to record position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, orthopedics, oncology, obstetrics and gynecology.

#### Technological Characteristics Comparison

The EchoTech 3D FreeScan is nearly identical in performance and intended use to the TomTec EchoScan, except that the EchoScan features an assortment of computer controlled probe carriage devices and incorporates respiration gating.

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## 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. Additional system testing was done by a third party standards test house.

### Test Conclusions

Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the system performance specifications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C 1398 MAY

EchoTech 3D Imaging Systems GmbH c/o Kevin Morningstar, Senior Consultant Morningstar Consulting Group, Inc. P.O. Box 218 Indian Hills, CO 80454

Re:

K980308 EchoTech 3D FreeScan Dated: April 4, 1998 Received: April 6, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Morningstar:

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 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). 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 (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 (OS) 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 [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 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. 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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K 980308

510(k) Number (if known):

ECHOTECH 3D FreeScan Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jamil A. Segerson

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)