HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

{0}------------------------------------------------ K052434 Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are in black, set against a white background. 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). {1}------------------------------------------------ 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: +972-4-856-3663; Fax: +972-4-857-7664 | | 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 {2}------------------------------------------------ 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. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments. Public Health Service SEP 2 7 2005 11 11 11 11 11 人 - 上一 . : . 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. {4}------------------------------------------------ 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 (800) 638-2041 or (301) 443-6597 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are three decorative swirls around the letters, positioned at the top, bottom left, and bottom right of the circle. 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