VIEWCATH 3-D CATHETER PULLBACK

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for Quinton Imaging. The word "Quinton" is in a bold, sans-serif font, with the "Q" being a large, open circle. Below "Quinton" is the word "imaging" in a smaller, sans-serif font. The text is black on a white background. AUG 25 1997 1971397 ## SUMMARY OF SAFETY AND EFFECTIVENESS July 30, 1997 | Contact Person: | Roy A Smith, Manager of Manufacturing | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Catheter Pullback device | | Proprietary Name: | ViewCath™™ Catheter Pullback | | Product Classification: | Product Code: CV 74 DQX<br>Wire, Guide, Catheter,<br>Regulatory Class II | | Applicant: | Quinton Imaging Division<br>Quinton Instrument Company<br>1043 Kiel Court<br>Sunnyvale, California 94089<br>Telephone: (408) 752-8555<br>Fax: (408) 752-8544 | | Predicate Device: | Cardiovascular Imaging Systems, Inc.<br>Catheter Pullback Device, K921879 and K933517 | The ViewCath™ Catheter Pullback is a medical Description of Device: Ultrasound Intravascular transducer catheter pullback device used in conjunction with Intravascular Ultrasound system devices. The ViewCath™ Catheter has a cradle that firmly holds various catheter transducer drive motors. Upon actuation, the device pulls the motor cradle at one of two selected speeds. A medical Intravascular Ultrasound catheter attached to the drive motor is pulled back at a consistent speed to obtain multiple 2-D ultrasound images. It is similar in design to other such catheter pullback devices. It has a motor driven mechanical screw mechanism, Intravascular Ultrasound catheter motor drive cradle, control switch and travel readout scale. The ViewCath™ Catheter Pullback is a device used for Statement of intended use: motorized pullback of medical Ultrasound intravascular imaging catheters to assist in consistent, selectable speed, 2-D image acquisition for use by medical imaging software for longitudinal view display or 3-D reconstruction and rendering and volumetric presentation of 3-D images for diagnostic review. ViewCath™ Statement of technological characteristics: The Quinton Imaging 6. Catheter Pullback has no significant change in design, materials, energy source or other July 30 revision, Page 00019 {1}------------------------------------------------ technological characteristics when compared to the predicate device. It is housed in a molded plastic enclosure, 3.5" wide by 6.25" long by 1.875" (2.25" at cradle) high, with scribed metal readout scale and applied Mylar labels. The housing contains a high torque motor with step-down gear mechanism attached to a machined stainless steel drive screw, speed selection/power switch and LED indicator lights. The power source is four AA alkaline batteries. There are only minor configuration differences between the ViewCath™ Catheter Pullback and the predicate device. These minor differences do not alter the intended use or affect the safely and effectiveness of the ViewCath™ Catheter Pullback when used as labeled. The intended use and the technological characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it. Special Controls: Although there are no performance standards established by the FDA, or official industry standards for these devices, the ViewCath™ Catheter Pullback has been designed with FDA recommended development processes, within a Quality System including design and development procedures and manufactured in a GMP Quality System compliant facility. Performance tests were conducted by testing the system to the requirements of the design specifications and comparison to the predicate devices. The performance evaluations indicated that the system consistently performed within its design parameters, and equivalently to the predicate devices. This data is summarized in the submission, and supports the safety and efficacy of the Quinton Imaging ViewCath™ Catheter Pullback. July 30 revision, Page 00020 {2}------------------------------------------------ Image /page/2/Picture/18 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of thick, curved lines, giving it a modern and abstract appearance. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Roy A. Smith Manager of Manufacturing Quinton Imaging Division Quiton Instrument Company 1043 Kiel Court Sunnyvale, California 94089 Re: K971397 ViewCath™ Catheter Pullback Dated: July 30, 1997 Received: August 5, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX AUG 25 1997 Dear Mr. Smith: 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 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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 yitte diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours h.Jliau Lillian Yiu, Ph.D. Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ 510(k) Number (if known): ViewCath™ Catheter Pullback Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: Statement of intended use: The ViewCath™ Catheter Pullback is a device used for motorized pullback of medical Ultrasound intravascular imaging catheters to assist in consistent, selectable speed, 2-D image acquisition for use by medical imaging software for longitudinal view display or 3-D reconstruction and rendering and volumetric presentation of 3-D images for diagnostic review. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Seymore (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number. Prescription Use V (Per 21 CFR 801.109) OR Over - The - Counter - Use (Optional Format 1-2-96) July 30 revision, Page 00014