Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2016 Boston Scientific Corporation Ka Zoua Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566 Re: K163200 Trade/Device Name: Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II (Special Controls) Product Code: LOX Dated: November 14, 2016 Received: November 15, 2016 Dear Ka Zoua Xiong: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Brian D. Pullin -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K163200 Device Name Maverick™ XL Percutaneous Transluminal Coronary Angioplasty Monorail™ Dilatation Catheter Indications for Use (Describe) The Maverick XL balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents. Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |--------------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary # Per 21 CFR §807.92 | Common or Usual<br>Name | PTCA Dilatation Catheter | | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Trade Name(s) | Maverick™ XL Percutaneous Transluminal Coronary Angioplasty<br>Monorail™ Dilatation Catheter | | | Product Code | LOX - Catheters, Transluminal Coronary Angioplasty,<br>Percutaneous | | | Classification of<br>Device | Class II (special controls) - 21 CFR 870.5100 | | | Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 | | | Contact Name and<br>Information | Ka Zoua Xiong<br>Regulatory Affairs Specialist<br>Phone: 763-494-2970<br>Fax: 763-494-2222<br>Email: Kazoua.Xiong@bsci.com | | | Date Prepared | 11 November 2016 | | | Section 514 of the<br>Act Performance<br>Standards | The special control for this device is FDA's "Class II Special<br>Controls Guidance Document: Percutaneous Transluminal<br>Coronary Angioplasty (PTCA) Catheters" | | | Establishment<br>Registration<br>Numbers | Owner /Operator: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>ERN: 9912058 | | | Manufacturing<br>Facility: | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>ERN: 2134265 | | | Sterilization<br>Facilities: | BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA | | Predicate Devices | P860019 - Maverick™ XL Percutaneous Transluminal Coronary<br>Angioplasty Monorail™ Dilatation Catheter, date reclassified | 08 October 2010 | {4}------------------------------------------------ | Device Description | The Maverick XL Percutaneous Transluminal Coronary Angioplasty<br>PTCA (Maverick XL) dilatation catheter is a Monorail catheter with a<br>balloon near the distal tip. The distal catheter segment is dual<br>lumen and coaxial, characteristic of all monorail style catheters. The<br>balloon is located at the distal end of the catheter and is designed<br>to provide an inflatable segment of known diameter and length at<br>recommended pressures. | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/<br>Indications for Use | The Maverick XL balloon catheter is indicated for balloon dilatation<br>of the stenotic portion of a coronary artery or bypass graft for the<br>purpose of improving myocardial perfusion. The Maverick XL<br>balloon catheter is also indicated for the post delivery expansion of<br>balloon expandable stents. | | Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Maverick XL is substantially equivalent to the existing<br>Maverick XL approved under premarket approval P860019, which<br>have since been down-classified by FDA on 08Oct2010. Maverick<br>XL has the same intended use, scientific technology, design (with<br>the exception of the corewire design), materials, sterilization<br>method, and packaging materials as the applicable predicate<br>device. | | Summary of Non-<br>Clinical Test<br>Summary | Bench testing and first article testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device with the<br>modified corewire has been designed and tested to assure<br>conformance to the requirements for its intended use. No new<br>safety or performance issues were raised during the device testing. | | Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed Maverick XL with the<br>modified corewire has been shown to be appropriate for its<br>intended use and is considered to be substantially equivalent to its<br>predicate (P860019). |