ISIGHT IMAGING CATHETER, MODEL 38986

{0}------------------------------------------------ MAR 2 4 2006 K060175 Boston Scientific Corporation, iSight™ Imaging Catheter Special 510(k) Notification # Attachment VI # Summary of Safety and Effectiveness . {1}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### Boston Scientific Corporation (BSC) iSight™ Imaging Catheter Boston Scientific Corporation Submitted by: IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538 Contact Person: Veronica M. Kocken Regulatory Affairs Specialist II Tel: (510) 624-1431 Fax: (510) 624-1449 kockenv@bsci.com Date prepared: January 20, 2006 Proprietary Name: BSC iSight™ Imaging Catheter Common Name(s): Ultrasound Diagnostic Imaging Catheter Diagnostic Intravascular Catheter (74DQQ) Diagnostic Ultrasonic Transducers (90ITX) Classification Name(s): Diagnostic Intravascular Catheter, 21 CFR Part 870.1200 (74DQO) Diagnostic Ultrasonic Transducer, 21 CFR Part 892.1570 (90ITX) #### Predicate Device(s): The BSC iSight™ Imaqinq Catheter is substantially equivalent to the following device: | Product | 510(k) | Clearance<br>Date | |---------------------------------------------------|---------|-------------------| | Atlantis™ SR Pro2<br>Coronary Imaging<br>Catheter | K050577 | March 30,<br>2005 | {2}------------------------------------------------ #### Description of the Device The iSight™ imaging catheter consists of two subassemblies: - Catheter body . - . Imaging core The catheter body is comprised of three sections: - . Distal section - Guidewire lumen and Imaging Core lumen - . Proximal section - Imaging Core lumen only - . Telescoping section - Imaging Core lumen only The distal section of the iSight™ catheter body has a guidewire lumen and an imaging core lumen. The 1.3 cm long guidewire lumen with tapered entry profile provides access into the femoral artery via a 0.36 mm (0.014") guidewire. To enhance pushability and trackability, the guidewire lumen is lined with polytetrafluoroethylene (PTFE) and a hydrophilic coating [Bioslide™ BL] is applied to the distal section of the catheter body. For fluoroscopic visibility within the vasculature, a radiopaque (RO) marker is embedded in the catheter tip at 0.5 cm from the distal tip. To enhance flexibility, the catheter sheath gradually tapers from 2.5F at the proximal bond, to 1.5F at the distal section. The proximal section is comprised of a single lumen tube with attached molded strain relief. For navigational purposes, an insertion depth indicator is located on the proximal section 100 cm from the distal tip and corresponds to the length of a 100 cm quide catheter. The working length of the iSight™ catheter assembly is comprised of the distal and proximal sections and measures 135 cm. The iSight™ catheter is 5F quide catheter compatible. The telescoping section remains outside of the guide catheter and allows for 15 cm of linear translation of the imaging core within the catheter body. It also contains a flush port with a one-way valve, which is used to displace air near the {3}------------------------------------------------ transducer prior to insertion into the patient. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use. The telescope section has 16 gold marks, spaced at 1-cm increments, to indicate imaging core position during manual pullback of the imaging core. The imaging core is composed of a flexible, rotating drive cable with an outward looking 40 MHz ultrasonic transducer at the distal end. The transducer, in the fully advanced position, is located 1.7 cm from the catheter distal tip. An electromechanical connector interface at the proximal end of the imaging core makes the connection to the Motor Drive Unit (MDU). The MDU-Catheter interface consists of an integrated mechanical drive hub and electrical connection. The iSight™ catheter is compatible with the MD-4 and MD-5 Motor Drive Units. The iSight™ catheter is compatible with the ClearView Ultra™, Galaxy™ , Galaxy 2 ™ , and iLAB™ systems. #### Intended Use/Indications for Use: The iSight™ Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. #### Device Technology Characteristics an Comparison to Predicate Device: The BSC iSight™ Imaging Catheter utilizes the same basic catheter design as the predicate device, the BSC Atlantis SR Pro2 Coronary Imaging Catheter, (cleared in March 30 2005). This device has the same intended use, the same operating principal, incorporates the same basic catheter design, and is packaged using the same materials and processes as the predicate device. The modifications to the iSight™ Imaging Catheter include, a change to the hydrophilic coating, reduction to the imaqing window profile, distal housing profile, entry profile, crossing profile, and guidewire lumen. Material change to {4}------------------------------------------------ the male telescope tubing, quidewire lumen lining and hub O-ring. Reduction in distance from transducer to catheter tip. Addition of qold marks on the telescoping section, and a new molded strain relief. In addition, the shelf life will be 11 months, and the iSight™ catheter will be sterilized using Ethylene Oxide (EO) sterilization method. These modifications are made to enhance the performance of the catheter. #### Non-clinical Test Results: Bench testing, biosafety testing, and package validation, demonstrate that the iSight™ Imaging Catheter exceeds the performance requirements, and is safe and effective for its intended use. #### Bench Testing: Bench testing was performed to evaluate the physical integrity, functionality, and performance of the catheter. Testing included dimensional testing, bond tensile testing, and a variety of performance testing of the sheath and telescoping assembly, the imaging core assembly, and of the final sterile device. #### Biological Safety Testing: The iSight™ Imaging Catheter was subjected to a series of biocompatibility tests per EN ISO 10993, and microbiological assessment, which included bioburden, pyrogen/endotoxin, sterility assurance, and latex testing. The results of the biosafety testing demonstrate that the catheter is acceptable for its intended use. #### Acoustic Output Testing: The iSight™ Imaging Catheter was tested for acoustic output as described in the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 30, 1997). Acoustic Output test results for the iSight™ Imaging Catheter are below the FDA Track 1 limits. {5}------------------------------------------------ ### Packaging Validation: Package validation was performed on the catheter package design per EN 868, to validate the integrity of the packaging system. Test results demonstrate that the packaging met all of the pre-determined acceptance criteria. #### Conclusion: The BSC iSight™ Imaging Catheter utilizes the same design features and has the same intended use/indications for use as its predicate device, the Atlantis™ SR Pro2 Coronary Imaging Catheter. The tests support a determination of substantial equivalence of the modified device, the iSight™ Imaging Catheter to its predicate device. {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three flowing lines representing the body and head. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the figure in the center. MAR 2 4 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Boston Scientific Corporation c/o Mr. Robert Z. Phillips Manager, Regulatory Affairs IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538 Re: K060175 Trade Name: iSight™ Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: February 22, 2006 Received: February 23, 2005 Dear Mr. Phillips: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreases of the enactment date of the Medical Device Amendments, or to conninered pror to May 2011/2017 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmoule For (110) that the device, subject to the general controls provisions of the Act. The r ou may, merces, while 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 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. {7}------------------------------------------------ Page 2 – Mr. Robert Z. Phillips Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dri brisean that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I cacal statutes and regulations ancluding, but not limited to: registration and listing (21 Compry with an the 11ct 31equirements)01); good manufacturing practice requirements as set CFK in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quarty bysellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro note of provide (evice as described in your Section 510(k) I mis letter will and in you've organ finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific arraniance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. . Whooranting of reference to proxresponsibilities under the Act may be obtained from the Other general mionnation on pers, 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, impeachment Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Boston Scientific Corporation, iSight™ Imaging Catheter Special 510(k) Notification ### Indications for Use Statement | 510(k) Number: | | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Boston Scientific Corporation, iSight™ Imaging Catheter | | Indications for Use: | The iSight™ Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | | Prescription Use | X | | AND/OR | Over the counter Use | #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Part 21 CFR 807 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE.) Mefasman (Division Sign-Off) (Part 21 CFR 801 Subpart D) (Division Sign-Off) Division of Cardiovascular Devices **510(k) Number** K060175