HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

K052434 · GE Medical Systems · KPS · Sep 27, 2005 · Radiology

Device Facts

• Record ID: K052434
• Device Name: HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
• Applicant: GE Medical Systems
• Product Code: KPS · Radiology
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitation of the NM activity in the patient anatomy.

Device Story

Hawkeye 4 Option is a functional anatomical mapping and attenuation correction module for the GE Infinia SPECT system. It integrates an X-ray source, high-voltage power supply, collimation assembly, and a multi-slice X-ray detector (four 5mm slices, 20mm total axial coverage) into the existing gamma camera gantry. The device utilizes helical CT scanning to generate attenuation maps, which are overlaid with NM images to improve image quality, shorten acquisition time, and enhance dose efficiency. Operated by clinicians in a clinical setting, the system uses the same acquisition station and patient table as the host SPECT system. The output provides clinicians with attenuation-corrected images and anatomical maps to assist in localizing NM activity, thereby aiding diagnostic decision-making.

Clinical Evidence

Bench testing only. The device was evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards (21 CFR 1020.30, 21 CFR 1020.33). No clinical data was required for this 510(k) submission.

Technological Characteristics

Multi-slice X-ray detector (four 5mm slices, 20mm axial coverage); helical CT scanning; X-ray generator power range 350W-700W; integrated with SPECT gamma camera via slip-ring gantry; conforms to 21 CFR 1020.30/1020.33; ISO 9001 and ISO 13485 quality systems.

Indications for Use

Indicated for patients undergoing nuclear medicine (NM) imaging to produce attenuation-corrected NM images and facilitate localization of NM activity within patient anatomy.

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

• Hawkeye Option for Dual-Head Variable Angle Gamma Camera (K991841)

Reference Devices

• GE Quasar Nuclear Medicine System (Infinia) (K022960)

Submission Summary (Full Text)

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K052434

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SEP 2 7 2005

GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

# Attachment B:

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are decorative swirls or flourishes around the letters, adding a stylized touch to the design.

### GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

| Submitter: | GE Medical Systems<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
|------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laurence Bigio<br>Quality, Safety and Regulatory Manager<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | August 25, 2005 |
| Device Name: | "Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera"<br>, Radiological, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" -K991841<br>Radiological, 21 CFR 892.1200, 90-KPS |

### Device Description:

The "Hawkeye 4 Option" is a modification of the "Hawkeye" option (K991841). "Hawkeye 4 Option" is a Functional Anatomical Mapping and Attenuation Correction option, designed to be used on SPECT system "GE Quasar Nuclear Medicine System" (K022960 trade name "Infinia"). The X-Ray system consists of an X-ray source, High voltage power supply, collimation assembly, X-ray detection unit for 4- detectors, and data collection and processing SW. The X-ray unit is completely integrated with the Infinia (K022960) gamma camera, using the same acquisition station, patient table, and slip-ring gantry. The "Hawkeye 4 Option" provides additional features to optimize radiation dose to the patient up to 700W. The "Hawkeye 4 Option" features a multi-slice X-Ray detector, with four 5mm slices and total axial coverage of 20mm. The "Hawkeye 4 Option" also utilizes helical CT scanning to further improve the image quality, shorten the acquisition time, and enhance dose efficiency. The "Hawkeye 4 Option" provides additional features to optimize radiation dose to the patient using a range of X-ray generator power from 350W to 700W. The system conforms to the USA regulation covered under

Code of Federal Regulations Title 21 Subchapter J- Radiological Health -21CFR1020.30, 21CFR 1020.33.

#### Indications for Use:

The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitation of the NM activity in the patient anatomy.

### Comparison with Predicate Device:

The GE "Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera" is a modification of, and is comparable and substantially equivalent to the currently marketed "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" - K991841 This system has the same Special 510(k) Premarket Notification

Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. There are decorative swirls around the letters, adding a touch of elegance to the design. The logo is black and white.

### GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.

### Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

### Conclusion:

Intended use and fundamental scientific technology are the legally marketed GE "Hawkeye" option (K991841). The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the "Hawkeve 4 Option for Dual-Head Variable Angle Gamma Camera" is substantially equivalent to the currently cleared "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" - K991841.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

SEP 2 7 2005

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. E. Werner Safety and Regulatory Engineering GE Medical Systems F.J. Haifa 4 Hayozma St., P.O. Box 170 Tirat HaCarmel 30200 ISRAEL

Re: K052434

Trade/Device Name: Hawkeye 4 Option for Dual Head Variable Angle Gamma Camera Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 31, 2005

Received: September 6, 2005

Dear Ms. Werner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we nave leviewed your becaon 510(tr) prohestantially equivalent (for the indications for use stated in above and nave determined the all needicate devices marketed in interstate commerce prior to the encrosure) to regally maneled production of the Medical Devices that have been May 26, 1970, the clacinent date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premiums approvisions of the Act. The general controls provisions of the Act device, subject to the general controls proon, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classilled (500 above) hitional controls. Existing major regulations affecting your Apploval), it may oc subject to aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FICASC oc advised mater 221 ৳ 135amiles with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I caral statues and regulations and limited to registration and listing (21 CFR Part 807); labeling Act s requirements, modaling, but not as active requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 Jagar This letter will anow you to ocgin makemig your antial equivalence of your device to a legally premarket notification. The PDA midnig of Sacolantial equive and thus, permits your device to proceed to the market.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our lasting of the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Wisotanants of the sunder the Act from the 807.97). You may obtain other general information on 50. John March Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GE Medical System, F.I. | Haifa dical System, F.i. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

## STATEMENT OF INTENDED USE-

510(k) Number (if known): __ K 052434

Device Name: "Hawkeye 4 Option for Dual Head Variable Angle Gamma Camera "

# Indications for Use

The Intended use of the device is to produce attenuation- corrected NM Images. The The intended use of the dovies to to proh the NM images to facilitate the localization of the NM activity in the patient anatomy.

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

OR

Over-The-Counter Use_

Nancy C. boydon

(Division Division of Reproductive and Rx 510k) Nu