MR FIBER OPTIC ECG GATING SYSTEM

{0}------------------------------------------------ Ko 3 1731 510(k) Summary JUL 3 0 2003 ## Summary of Safety and Effectiveness | Submitter: | SA Instruments, Inc. | |-----------------------------|---------------------------------------------------------------------------------------| | Address: | 65 Main Street<br>Stony Brook, NY, 11790 | | Telephone: | (631) 689-0408 | | Contact: | President | | Prepared: | May 28, 2003 | | Proprietary Name: | MR Fiber Optic ECG Gating System | | Common/Classification Name: | Gating system | | Predicate Devices: | Gating cable provided by General Electric for the<br>1.0 T and 1.5 T Signa MR systems | New Device Description: · The MR Fiber Optic ECG Gating System measures and digitizes the patient's electrocardiogram, detects the presence of an R-wave and provides a trigger to the Signa MR system. The gating system provides for operator control of parameters used in the R-wave detection algorithms and control of gate delay. The electrocardiogram waveform is displayed along with the gate, heart rate and the measured R to R interval. Intended Use: The MR Fiber Optic ECG Gating System is intended to be used when it is necessary to svnchronize the MR scanner's data acquisition with the patient's electrocardiogram. Performance Testing: The MR Fiber Optic ECG Gating System meets IEC 601-1-2, IEC 601-1-2, IEC 601-2-27, IEC 801-2. -3. 4. -5. CISPR 11. In addition, tests were performed to establish that the Gating system operated in the MRI environment substantially equivalent to the predicate device. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central symbol appears to be a stylized representation of an eagle or bird, with three curved lines forming its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 3 0 2003 G. Ronald Morris, Ph.D. President SA Instruments, Inc. P.O. Box 740 STONY BROOK NY 11790 Re: K031731 Trade/Device Name: MR Fiber Optic ECG Gating System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: May 30, 2003 Received: June 4, 2003 Dear Dr. Morris: 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 (PMA). it may be subject to 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050, {2}------------------------------------------------ Page 2 This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE 510 (k) NUMBER (IF KNOWN) Ko 3 / 7 3 / DEVICE NAME: MR Fiber Optic ECG Gating System INDICATIONS FOR USE: The MR Fiber Optic ECG Gating System would be used when it is necessary to synchronize the MR scanner's data acquisition with the patient's electrocardiogram. David R. Lyon productive, Abdominal, Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96)