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.

Device Description

The Maverick XL Percutaneous Transluminal Coronary Angioplasty PTCA (Maverick XL) dilatation catheter is a Monorail catheter with a balloon near the distal tip. The distal catheter segment is dual lumen and coaxial, characteristic of all monorail style catheters. The balloon is located at the distal end of the catheter and is designed to provide an inflatable segment of known diameter and length at recommended pressures.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter." It is a regulatory filing with the FDA, not a clinical study report. Therefore, it does not contain information about acceptance criteria for device performance based on a study, nor does it provide details about patient data, expert ground truth, or multi-reader multi-case studies.

The document is primarily focused on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. This is typically achieved through bench testing and, if applicable, comparison to existing clinical data for the predicate device, rather than new clinical trials specifically designed to set and meet acceptance criteria for a novel AI algorithm.

However, I can extract the information that is present in the document related to testing for regulatory purposes:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense of a clinical study (e.g., sensitivity, specificity thresholds). Instead, it states that "Bench testing and first article testing were performed to support a determination of substantial equivalence." The acceptance criteria would be for the physical and functional aspects of the catheter to meet pre-defined engineering and design specifications for safety and performance, which are not explicitly detailed here.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to requirements	Bench testing and first article testing confirmed conformance to requirements for intended use. No new safety or performance issues were raised.
Substantial Equivalence	Proposed device is substantially equivalent to the predicate device (P860019) in terms of intended use, scientific technology, design (with one minor modification), materials, sterilization, and packaging.

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. This document refers to bench testing and first article testing, not a clinical test set with patient data. The "sample" would be the number of catheters tested in various bench tests (e.g., burst pressure, fatigue, trackability), but these numbers are not specified.
Data Provenance: Not applicable, as no patient data is mentioned. The testing is described as "bench testing and first article testing," implying laboratory-based testing of the physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. There is no mention of expert-established ground truth because this is not a study involving diagnostic accuracy with human interpretation.

4. Adjudication Method:

Not applicable. There is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not done. This submission is for a physical medical device (catheter), not an AI algorithm for image interpretation or diagnosis.

6. Standalone (Algorithm Only) Performance Study:

No. This is not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" for a physical device like a catheter would be its adherence to engineering specifications and performance standards through physical and functional testing, not a diagnostic pathology or outcome.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a training set as it's not an AI model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K163200

Device Name

Maverick™ XL Percutaneous Transluminal Coronary Angioplasty Monorail™ Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Per 21 CFR §807.92

Common or UsualName	PTCA Dilatation Catheter
Trade Name(s)	Maverick™ XL Percutaneous Transluminal Coronary AngioplastyMonorail™ Dilatation Catheter
Product Code	LOX - Catheters, Transluminal Coronary Angioplasty,Percutaneous
Classification ofDevice	Class II (special controls) - 21 CFR 870.5100
Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566
Contact Name andInformation	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	11 November 2016
Section 514 of theAct PerformanceStandards	The special control for this device is FDA's "Class II SpecialControls Guidance Document: Percutaneous TransluminalCoronary Angioplasty (PTCA) Catheters"
EstablishmentRegistrationNumbers	Owner /Operator:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058
	ManufacturingFacility:	Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265
	SterilizationFacilities:	BSC Coventry8 Industrial DriveCoventry, RI 02816USA
Predicate Devices	P860019 - Maverick™ XL Percutaneous Transluminal CoronaryAngioplasty Monorail™ Dilatation Catheter, date reclassified	08 October 2010

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Device Description	The Maverick XL Percutaneous Transluminal Coronary AngioplastyPTCA (Maverick XL) dilatation catheter is a Monorail catheter with aballoon near the distal tip. The distal catheter segment is duallumen and coaxial, characteristic of all monorail style catheters. Theballoon is located at the distal end of the catheter and is designedto provide an inflatable segment of known diameter and length atrecommended pressures.
Intended Use/Indications for Use	The Maverick XL balloon catheter is indicated for balloon dilatationof the stenotic portion of a coronary artery or bypass graft for thepurpose of improving myocardial perfusion. The Maverick XLballoon catheter is also indicated for the post delivery expansion ofballoon expandable stents.
Comparison ofRequiredTechnologicalCharacteristics	The proposed Maverick XL is substantially equivalent to the existingMaverick XL approved under premarket approval P860019, whichhave since been down-classified by FDA on 08Oct2010. MaverickXL has the same intended use, scientific technology, design (withthe exception of the corewire design), materials, sterilizationmethod, and packaging materials as the applicable predicatedevice.
Summary of Non-Clinical TestSummary	Bench testing and first article testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device with themodified corewire has been designed and tested to assureconformance to the requirements for its intended use. No newsafety or performance issues were raised during the device testing.
Conclusion	Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Maverick XL with themodified corewire has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to itspredicate (P860019).

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.