ATLANTIS PVIMAGING CATHETER, MODEL H749364560

{0}------------------------------------------------ K080272 ### CONFIDENTIAL MAR 1 1 2008 # 510(k) Summary of Safety and Effectiveness ## Boston Scientific Corporation # Atlantis™ PV Imaging Catheter | Submitted By | Boston Scientific Corporation<br>49700 Bayside Parkway<br>Fremont, CA 94538 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Person | Janice Brown<br>Director, Regulatory Affairs<br>Tel: (510) 624-2582<br>Fax: (510) 624-2569<br>janice.brown@bsci.com | | Date Prepared | January 31, 2008 | | Proprietary Name | AtlantisTM PV Imaging Catheter | | Common Name(s) | Ultrasonic Diagnostic Transducer<br>Ultrasonic Intravascular Catheter | | Classification<br>Name(s) | 21 CFR 892.1570 (ITX)<br>Transducer, Ultrasonic, Diagnostic<br>21 CFR 870.1200 (OBJ)<br>Catheter, Ultrasound Intravascular | ### Predicate Device . The Atlantis™ PV Imaging Catheter is substantially equivalent to the following predicate device: | Name | Manufacturer | 510(k) Number | |----------------------------------|-------------------------------|---------------| | Atlantis™ PV Imaging<br>Catheter | Boston Scientific Corporation | K050684 | {1}------------------------------------------------ #### Description of the Device The Atlantis™ PV imaging catheter (H749364560) is a sterile, single use, over-the-wire (OTW) imaging catheter with a 8F distal crossing profile and a transducer capable of producing a frequency of 15MHz and a 8F distal crossing profile. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound Imaging Systems: iLab™ (K072517), Galaxy2/Galaxy™ (K980851), and Clearview™ Ultra (K921750). The Atlantis™ PV catheter consists of two main assemblies: - . Catheter body - Imaging Core . The catheter body is comprised of two sections: - . Dual lumen - Telescoping section (shaft) . The dual lumen section is the "working length" of the catheter. The dual lumen is an over-the-wire (OTW) design containing an imaging core lumen and a guidewire lumen. The telescoping section remains outside of the introducer sheath. The telescoping shaft allows the imaging core to be advanced and retracted for 25 cm of linear movement. The corresponding movement of the transducer occurs inside the imaging core lumen. The catheter body is attached to the telescope shaft via a y-manifold with male/female luer connection. The straight leg of the y-manifold is the guidewire exit port with a female luer thread. The luer thread allows flushing of the guidewire lumen. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking ultrasonic transducer at the distal tip. The distal ends of the imaging core and the catheter body are radiopaque for visualization of the imaging plane and the catheter tip. An electro-mechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) / Instrument. The MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection. #### Intended Use/Indications for Use The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. #### Device Technology Characteristics and Comparison to Predicate Device The Atlantis™ PV Imaging Catheter and its predicate device are comprised of a catheter body and an imaging core. They are similar in terms of their intended use, fundamental technology, operating principle, and catheter design. Modifications to the Atlantis™ PV {2}------------------------------------------------ #### Boston Scientific Corporation Imaging Catheter, the subject of this submission, include design, material, and labeling changes. #### Non-Clinical Test Results The performance test results for bench, biocompatibility and sterility testing of the Atlantis™ PV Imaging Catheter demonstrate that the device meets or exceeds the performance requirements for the specified intended use. #### Conclusion The modified Atlantis™ PV Imaging Catheter is substantially equivalent to its predicate device. The test results support the determination that the two devices are substantially equivalent, and confirm the device is safe and effective for its intended use. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 1 2008 Boston Scientific Corporation c/o Ms. Janice Brown Director, Regulatory Systems IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538-6515 Re: K080272 Atlantis PV Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound Transducer Regulatory Class: Class II (two) Product Code: ITX, OBJ Dated: January 31, 2008 Received: February 1, 2008 Dear Ms. Brown: We have reviewed your Section 510(k) premarket 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 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). 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. This determination of substantial equivalence applies to the following transducers intended for use with the iLab™, Galaxy2/Galaxy™, and Clearview™™ Ultra Intravascular Ultrasound Imaging Systems, as described in your premarket notification: Atlantis TM PV Imaging Catheter, Model H749364560 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 {4}------------------------------------------------ Page 2 -- Ms. Janice Brown 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. This determination of substantial equivalence is granted on the condition that prior to shipping the first device, vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your 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 market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small 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/cdrh/industry/support/index.html {5}------------------------------------------------ Page 3 – Ms. Janice Brown If you have any questions regarding the content of this letter, please contact Lisa E. Leveille at (240) 276-4095. Sincerely yours, Pam D. Zuckerman, M.D. am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number: Ko80272 Device Name: Atlantis™ PV Imaging Catheter Indications for Use: The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. Prescription Use ਨ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Devices 51000 Numbe Traditional 510(k) Atlantis ™ PV Imaging Catheter January 31, 2008 {7}------------------------------------------------ #### Attachment 2.0 Diagnostic Indications for Use Form Atlantis™ PV Imaging Catheter Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows: | Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|---------------------------|-----------------------|--------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(specify) | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | P | | | | | | | | | | Peripheral<br>Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = New indication; P = Previously cleared by FDA; E = Added under Appendix E Additional Comments: Cleared under K022860 (November 21, 2002), K041727 (cleared July 23, 2004) and K050684 (cleared May 20, 2005) #### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED #### Concurrence of CDRH, Office of Device Evaluation (ODE) Traditional 510(k) Atlantis ™ PV Imaging Catheter January 31, 2008