VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

K980959 · Ge Medical Systems F.I. Haifa · KPS · Jun 4, 1998 · Radiology

Device Facts

• Record ID: K980959
• Device Name: VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Jun 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

To obtain attenuation corrected Nuclear Medicine images.

Device Story

VTransACT is an add-on hardware and software system for Apex VariCam and Millennium VG gamma cameras. It utilizes two scanning line sources attached to camera heads to acquire data for an attenuation correction map. This map is processed to generate attenuation-corrected nuclear medicine images, compensating for non-uniform attenuation across the field of view. The system is operated by nuclear medicine technologists or physicians in a clinical setting. The resulting corrected images provide improved uniformity compared to standard SPECT imaging, assisting clinicians in diagnostic interpretation by reducing artifacts caused by photon attenuation.

Clinical Evidence

Bench and clinical data provided. Comparison of VTransACT-corrected images to standard SPECT images demonstrated improved image uniformity. Comparison to the predicate TransACT system showed no significant difference in image quality.

Technological Characteristics

System comprises hardware (two scanning line sources) and software for attenuation map generation. Integrates with Apex VariCam and Millennium VG gamma cameras. Operates by acquiring transmission data to calculate a correction map for non-uniform attenuation. Connectivity is internal to the gamma camera system.

Indications for Use

Indicated for patients undergoing nuclear medicine imaging requiring attenuation correction to produce more uniform images, particularly when attenuation coefficients are non-uniform over the field of view.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• TransACT option for the Apex CardiaL Gamma Camera (K952674)

Reference Devices

• Apex VariCam and Millennium VG gamma cameras (K953801)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date JUN 4 1998 and the word "ELGEMS" in a stylized font. The word "ELGEMS" is written in all capital letters, and the "G" has a curved line extending from the bottom of the letter. The date is written in a simple font, with the month abbreviated to "JUN".

EMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL. 2-4-8310335/420 • FAX: [phone]

K980959

# 9. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)

#### Device Name

VTransACT: Attenuation Correction System for the VariCam Gamma Camera.

# Establishment Name and Registration Number of Submitter

Name: Registration Number: Corresponding Official: ELGEMS Ltd. 9613299 Yair Friedman ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

## Device Classification

Classification Code: 90 IYX Classification Class: Class II Product Panel Identification: Nuclear Medicine

#### Reason for 510(k) Submission

Modification of legally marketed device.

## Identification of Legally Marketed Equivalent Devices

TransACT option for the Apex CardiaL Gamma Camera K952674

#### Device Description

The VTransACT attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation.

## Description of Change or Modification

The VariCam (K953801) gamma camera has been modified to accommodate for the VTransACT attenuation correction system, by including an additional correction map for attenuation, obtained by two scanning line sources attached to the heads of the camera. This map is used to create an attenuation-corrected image.

#### Intended Use of Device

The intended use of the device is to produce attenuation-corrected NM images, even when attenuation coefficients are not uniform over the FOV.

#### Summary of Studies

Bench data and Clinical data show that the VTransACT option for the VariCam delivers more uniform images than regular SPECT without attenuation correction. Comparison to TransACT images shows no significant difference.

# Conclusion

In the opinion of ELGEMS Ltd., the VTransACT is substantially equivalent in terms of safety and effectiveness to the TransACT option for the CardiaL (K952674). The VTransACT has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a caduceus-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1998

Yair Friedman VP- Quality and Regulatory Affairs Elgems Ltd. P.O. Box 170 Tirat Hacarmel 30200 Israel

K980959 Re:

> VTransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera March 12, 1998 Dated: Received: March 16, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Friedman:

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 Ouality 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 result in reculatory 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 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 beein 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/odri/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D.

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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510(k) Number (if known): UNKNOWN VTransACT: Attenuation Correction System Device Name: Indications For Use:

To obtain attenuation corrected Nuclear Medicine images.

(Please do not write below this line - continue on another page if needed)

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

David A. Segmen
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Prescription Use_ -(Per 21 CFR 801.109)

OR Over-the-Counter Use