D-SPECT CARDIAC SCANNER SYSTEM

{0}------------------------------------------------ ### 510(K) SUMMARY ## D-SPECT SYSTEM # 510(k) Number K_062450 OC1 20 2006 、 : . | Applicant's Name: | Spectrum Dynamics Ltd. | |----------------------|---------------------------------------------------------------| | | 2 Haetgar St. | | | Carmel Building P.O.Box 2026 | | | Tirat Hacarmel 39120 | | | Israel | | | Tel: +972-4-8580774 | | | Fax: +972-4-8580776 | | | e-mail: info@spectrum-dynamics.com | | Contact Person: | Ahava Stein/ Ofer Hornick | | | A. Stein - Regulatory Affairs Consulting | | | 20 Hata'as St. | | | Kfar Saba 44425 | | | Israel | | | Tel. + 972-9-7670002 | | | Fax. +972-9-7668534 | | | e-mail: asteinra@netvision.net.il or oh_asra@netvision.net.il | | Date Prepared: | August 2006 | | Trade Name: | D-Spect™ Cardiac Scanner System | | Classification Name: | CFR Classification section 892.1200 (Product code KPS) | | Classification: | Class II medical Device | . {1}------------------------------------------------ The D-Spect™ Cardiac Scanner System is substantially equivalent Predicate Device: to a combination of the following predicate devices: - Virgo (K031825) manufactured by 3D, Danish Diagnostic Development A/S (device a.k.a C.Cam, owned by Siemens Medical). Virgo is a Gamma Camera system (SPECT) which is intended to detect the location and distribution of gamma ray radionuclides similar to the D-Spect™ device. - Cardiarc (K053062) manufactured by Cardiarc Ltd. Cardiarc is a SPECT imaging device which is intended for production of SPECT clinical images of the heart in nuclear medicine applications similar to the D-Spect™ device. - Predicate devices for device accessory used for identifying patient: - a) SmartBand (Class 1 510(k) exempt), provides patient identification - b) CareCheck (BK040053)- used in blood banks; provides patient and product identification. - c) VeriChip implantable RFID Transponder (K033440). Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a Device Description: SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radio-pharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed {2}------------------------------------------------ detector head. The special scanning geometry and detector technology, enable shorter scan times. Intended Use / Indication for Use: D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV. ### Comparison of Technological Characteristics with the predicate device: D-Spect as other SPECT devices uses arrays of collimators, crystals, and position detection circuits to obtain clinical from patients injected with gamma emitting information radionuclide materials. The operating principle is the same basic principle and the same basic technology is used in all SPECT devices, including the Virgo and Cardiarc predicate devices. Although the design of detector boards (10 boards rotating on their vertical axis) is different compared to conventional SPECT cameras (with two crystals moving around the patient), the principle of photon detection is identical and the resulting images are identical to those of other devices. All of the above features are similar to these features in the predicate devices. Performance Standards: None. The design of the D-Spect™ Cardiac Scanner System conforms to the following voluntary standards: {3}------------------------------------------------ IEC/EN-60601-1: Medical Electrical Equipment; Part 1: General Requirements for Safety. Second edition (1990), including amendments #1(1993), #2(1995), #13(1996). IEC/EN 60601-1-2: Medical Electrical Equipment; Part 1-2: Collateral Standard: Electromagnetic Compatibility- Requirements and Tests (2001) NEMA NU 1: Performance Measurements of Scintillation Cameras (1994) (relevant sections). The D-Spect™ Cardiac Scanner System has been subjected Non-Clinical Test Data: to extensive safety testing, performance testing, and validation before release. These tests included EMC and Safety testing according to international standards IEC/EN-60601-1 and IEC/EN 60601-1-2, testing according to the relevant sections of the NEMA NU 1 standard, and software validation testing. Clinical Performance Data: Sample images from three clinical cases using the D-SPECT device. Conclusions Drawn from Non-Clinical and Clinical Tests: The performance tests demonstrate that D-SPECT device may be safely and effectively used myocardial perfusion imaging. The software validation and performance validation tests for scintillation cameras (NEMA NU 1), as well as the clinical images provided, demonstrate that the D-SPECT device meets its design and performance specifications and is substantially equivalent to the predicate devices. The intended use of the D-Spect™ Cardiac Scanner System Substantial Equivalence: is substantially equivalent to the currently distributed predicate Cardiac SPECT systems intended for cardiac nuclear imaging {4}------------------------------------------------ applications. Furthermore, the basic technological characteristics of the D-Spect™ Cardiac Scanner System are similar to the predicate devices. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Furthermore, the performance data support the safety and effectiveness of the new device. Consequently, the D-Spect™ Cardiac Scanner System is substantially equivalent to the Virgo and Cardiarc predicate devices. {5}------------------------------------------------ Image /page/5/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" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing health, hope, and well-being. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Spectrum Dynamics Ltd. % Ms Ahava Stein A. Stein Regulatory Consulting 20 Hata'as St. Kfar Saba 44425 ISRAEL OCT 2 0 2006 Re: K062450 Trade/Device Name: D-Spect™ Cardiac Scanner System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 17, 2006 Received: August 22, 2006 Dear Ms. Stein: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/5/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top and the letters "PA" in the center. Below the letters "PA" is the word "Centennial" and three stars. The logo appears to be a commemorative emblem for a centennial celebration. Promoting and Promoting Public Health. {6}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Dri-s issualited our device complies with other requirements of the Act that I Dri has made a deceimnulations administered by other Federal agencies. You must of any I cacal statutes and regarations sincluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fatt 807), laochilg (21 OF N F at 800), go and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I his icher will anow you've cogin maing of substantial equivalence of your device to a legally premarket notification. The President 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), please If you desire specific advice to: your are of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |----------------|---------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21GI IT Fall 607.97). - 10d may of all Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Nancy C Hodgdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number (if known): `K062450 Device Name: D-Spect™ Cardiac Scanner System Indications for Use: D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports, radionuclides within the energy range of 40 -170 ke V. Prescription Use V (Per 21 C.F.R. 801 Subpart D) C) OR . Over-The-Counter Use (Optional Format Subpart (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Broadon (División Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K06245