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

K991896 · Ge Medical Systems F.I. Haifa · KPS · Aug 23, 1999 · Radiology

Device Facts

• Record ID: K991896
• Device Name: MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Aug 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

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

Device Story

MG ATC is an optional hardware/software upgrade for the Millennium MG gamma camera; utilizes two scanning line sources attached to camera head supports to acquire attenuation data; generates an attenuation correction map; transforms raw SPECT data into attenuation-corrected nuclear medicine (NM) images; used in clinical settings by radiology staff; output viewed by clinicians to improve image uniformity; assists in diagnostic decision-making by correcting for non-uniform attenuation artifacts.

Clinical Evidence

Bench and clinical data provided. Comparison of MG ATC-corrected images to uncorrected SPECT showed improved image uniformity. Comparison to V TransACT predicate showed no significant difference in image quality.

Technological Characteristics

Hardware includes two scanning line sources attached to gamma camera head supports. Software generates attenuation correction maps. System is an add-on to the Millennium MG gamma camera. Connectivity is integrated with the host camera system.

Indications for Use

Indicated for improving the quality of emission SPECT images obtained on the Millennium MG dual-head camera via attenuation correction.

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

• V TransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera (K980959)

Reference Devices

• Millennium MG gamma camera (K962738)

Submission Summary (Full Text)

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ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: [phone] • FAX: [phone]

K991896

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

#### Device Name

:

AUG 23

MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera.

## Establishment Name and Registration Number of Submitter

ELGEMS Ltd.

Name: Registration Number: Corresponding Official:

9613299 Laor Dan ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

#### Device Classification

Classification Code: 90 KPS Classification Class: Class II Product Panel Identification: Radiology

### Reason for 510(k) Submission

Modification of legally marketed device.

### Identification of Legally Marketed Equivalent Devices

V TransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera - K980959.

#### Device Description

The MG ATC attenuation correction system is an optional addition to the Millennium MG gamma camera (K962738). It comprises additional hardware and software to generate a correction map and corrected NM images for non-uniform attenuation.

#### Description of Change or Modification

The Millennium MG gamma camera (K962738) gamma camera has been modified to accommodate for the MG ATC attenuation correction system, by including an additional correction map for attenuation, obtained by two scanning line sources attached to the heads supports 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 MG ATC option delivers better uniformed images than regular SPECT without attenuation correction. Comparison to V TransACT images shows no significant difference.

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ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: [phone] • FAX: [phone]

#### Conclusion

加法规划。

In the opinion of ELGEMS Ltd., the MG ATC is substantially equivalent in terms of safety and effectiveness to the V TransACT option for the Varicam (K980959). The MG ATC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three lines extending from the head, possibly representing ideas or communication.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Laor Quality and Requlatory Affairs ELGMENS, Ltd. P.O. Box 170 Tirat Hacarmel 30200

Re:

K991896 MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera Requlatory Class: II (two) Product Code: 90 KPS 21 CFR 892.1200 Dated: June 1, 1999 Received: June 3, 1999

Dear Mr. Laor:

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 (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 (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 [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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CART David C. Stahl, M.D.

APT 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

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510(k) Number (if known): DEVICE NAME: MG ATC: Attenuation correction system for dualhead variable-angle Gamma Camera

INDICATION FOR USE: MG ATC is indicated to improve the quality of emission SPECT images obtained on the Millennium MG dual head camera by attenuation correction. : : :

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| | (Concurrence of CDRH, Office of Device Evaluation (ODE)) |
|------------------|----------------------------------------------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K991896 |
| Prescription Use | <span style="text-decoration: overline;">✓</span> OR Over-the-Counter Use ______<br>(Per 21 CFR 801.109) |