HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

K991841 · Ge Medical Systems F.I. Haifa · KPS · Aug 26, 1999 · Radiology

Device Facts

• Record ID: K991841
• Device Name: HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Aug 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.

Device Story

Hawkeye Option is a hardware/software add-on for Apex VariCam/Millennium VG gamma cameras. It integrates an X-ray generation and detection system onto the rotating gantry. The system acquires transmission data to generate attenuation maps, which are used to correct nuclear medicine (NM) emission images for non-uniform attenuation. The device also facilitates the registration and display of anatomical (X-ray) and physiological (NM) images. Used in clinical settings by radiology/nuclear medicine staff, the output provides clinicians with more uniform images and improved anatomical localization of NM activity, aiding in diagnostic interpretation.

Clinical Evidence

Bench testing and clinical data provided. Results demonstrate that Hawkeye attenuation-corrected images exhibit higher uniformity compared to uncorrected NM images. Data also confirms the device's capability to facilitate the localization of emission activity within patient anatomy.

Technological Characteristics

Hardware add-on for gamma camera gantry; includes X-ray generation and detection system for transmission data acquisition. Software performs attenuation correction and image registration. Operates as an integrated subsystem of the Apex VariCam/Millennium VG gamma cameras.

Indications for Use

Indicated for patients requiring nuclear medicine imaging where attenuation-corrected emission images and anatomical/physiological image registration are necessary to facilitate localization of emission activity.

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

• VTransACT option for the VariCam Gamma Camera (K980959)
• Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model (K941223/S1)

Submission Summary (Full Text)

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K991841

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

#### Device Name

13.00

Proprietary Device Name : Hawkeye Option for Dual-Head Variable Angle Gamma Camera.

#### Establishment Name and Registration Number of Submitter

| Name: | |
|-------------------------------------------------|--|
| Registration Number:<br>Corresponding Official: | |

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

Device Classification

Classification Code: Panel Identification: Classification Name: Common Name: Classification Class:

90 KPS Radiology ECT system (per 21CFR 892.1200 ) Nuclear Medicine Imaging system Class II Product

### Reason for 510(k) Submission

Modification of legally marketed device.

# Identification of Legally Marketed Equivalent Devices

VTransACT option for the VariCam Gamma Camera - K980959 Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model - K941223/S1

#### Device Description

The Hawkeye Option is an addition to the Apex VariCam / Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation and to facilitate localization of the emission images in the patient anatomy.

#### Description of Change or Modification

The VariCam (K953801) gamma camera has been modified to accommodate for the Hawkeye transmission subsystem, by including an additional correction map for attenuation, obtained by an X-ray generation and detection system attached to the rotating frame of the gantry.

#### Intended Use of Device

The intended use of the device is to produce attenuation-corrected NM images. The attenuation maps are also displayed with the NM images to facilitate the localization of the NM activity in the patient anatomy.

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# Summary of Studies

- * Sench and clinical data show that Hawkeye attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the Hawkeye.
## Conclusion

In the opinion of ELGEMS Ltd., the Hawkeye is substantially equivalent in terms of safety and effectiveness to the VTransACT (K980959) for purposes of attenuation correction, and to the Advanced Analysis Software (K941223/S1) for purposes of facilitating localization of emission activity in the patient anatomy.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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AUG 26 1999

Quality and Regulatory Affairs

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re:

K991841 Hawkeve Option for Dual-Head Variable Angle Gamma Camera Requiatory Class: Il (two) Product Code: 90 KPS 21 CFR 892.1200 Dated: May 28, 1999 Received: May 28, 1999

Dear Mr. Laor:

Mr. Dan Laor

P.O. Box 170

ISRAEL

ELGMENS, Ltd.

Tirat Hacarmel 30200

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,
Dan Setiz

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

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K991841 510(k) Number (if known): Hawkeye option for dual head variable angle gamma Device Name: camera

Indications For Use:

To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.

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

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

Javid a. hayom

ivision Sign-Off) vision of Reproductive, Abdominal, ENT, and Radiological Devices 191841 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________