GLADIATOR ELITE PTA BALLOON DILATATION CATHETER

K132810 · Boston Scientific Corp · LIT · Feb 28, 2014 · Cardiovascular

Device Facts

• Record ID: K132810
• Device Name: GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gladiator Elite Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Gladiator Elite Balloon Dilatation Catetatheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Story

Over-the-wire balloon dilatation catheter; dual lumen shaft design. One lumen for 0.035" guidewire passage; second lumen for balloon inflation/deflation via proximal Y-connector manifold. Radiopaque marker bands under balloon shoulders for positioning; tapered tip for stenosis advancement; balloon coating for insertion/withdrawal performance. Used by physicians in clinical settings for peripheral angioplasty and stent post-dilatation. Device facilitates vessel opening/stent expansion, potentially improving blood flow and treating obstructive lesions.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (sensitization, reactivity, hemocompatibility, pyrogenicity, mutagenicity, cytotoxicity) and in-vitro performance (balloon compliance, burst pressure, burst mode, tensile strength, crossing profile, particulate release, and sheath interaction).

Technological Characteristics

Over-the-wire balloon catheter; dual lumen shaft; radiopaque marker bands; coated balloon. Materials are substantially equivalent to predicate. Sterilization via established method. No software or electronic components.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries) or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae; also indicated for post-dilatation of balloon-expandable and self-expanding stents.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Gladiator PTA Balloon Dilatation Catheter (K113681)

Submission Summary (Full Text)

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K132810

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# 510(k) Summary

per 21 CFR §807.92

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Name<br>and<br>Information | Beth Torok<br>Principal Regulatory Affairs Specialist | |
| | Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Date Prepared | 06 September 2013 | |
| Proprietary<br>Name | Gladiator™ Elite PTA Balloon Dilatation Catheter | |
| Common Name | Percutaneous Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal | |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter | |
| Predicate<br>Device(s) | Gladiator PTA Balloon Dilatation<br>K113681<br>11 January 2012<br>Catheter | |
| Device<br>Description | Gladiator Elite is an over-the-wire balloon catheter with a dual lumen shaft<br>design. One lumen is used to pass the catheter over 0.035" guidewires.<br>The second lumen communicates with the balloon and is used to inflate<br>and deflate the balloon during the procedure. The guidewire lumen and the<br>balloon lumen terminate at the proximal end of the catheter in a Y-<br>connector manifold with luer lock fittings. There are radiopaque marker<br>bands located under the balloon shoulders to aid in positioning the system<br>during the procedure. A coating is applied to the balloon to enhance<br>insertion and withdrawal performance. The tip of the catheter is gradually<br>tapered to facilitate advancement of the catheter through the stenosis. | |
| Intended<br>Use/Indications<br>for Use | The Gladiator Elite Balloon Dilatation Catheter is indicated for<br>Percutaneous Transluminal Angioplasty (PTA) in the peripheral<br>vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian,<br>and renal arteries and for the treatment of obstructive lesions of native or<br>synthetic arteriovenous dialysis fistulae.<br>The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-<br>dilatation of balloon expandable and self-expanding stents in the peripheral<br>vasculature. | |
| Comparison of<br>Technological<br>Characteristics | The Gladiator Elite PTA Balloon Dilatation Catheter incorporates<br>substantially equivalent device materials, catheter configuration, packaging,<br>fundamental technology, manufacturing processes, sterilization process<br>and intended use as those featured in the Boston Scientific predicate<br>device. | |
| | | |
| Characteristic | Proposed compared to Predicate | |
| Components | Same components, configuration, design and function. | |
| Materials | Same materials. Balloon contains an additional material<br>not new to the device. | |
| Packaging | Same packaging materials and configuration. | |
| Sterilization<br>Method/SAL | Same method and level of assurance. | |
| Guidewire<br>Compatibility | Same compatibility. | |
| Balloon Diameters &<br>Lengths | Same sizes. | |
| Effective Length | Same length catheters. | |
| Rated Burst<br>Pressure (RBP) | Same RBP. | |

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### Comparison to Predicate Device:

Performance Data

Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.

The following biocompatibility tests support the Gladiator Elite PTA Balloon Dilatation Catheter;

| Guinea Pig Maximization<br>Sensitization | Intracutaneous Reactivity |
|-----------------------------------------------|------------------------------------------|
| In vitro Hemocompatibility Assay | Acute Systemic Injection |
| Hemolysis Assay: Direct Contact<br>Method | Materials Mediated Rabbit<br>Pyrogen |
| Complement Activation C3a and<br>SC5b-9 Assay | Ames Mutagenicity |
| Mouse Lymphoma | In vitro Cytotoxicity: MEM Elution |
| Partial Thromboplastin Time<br>(PTT) | USP Physicochemical Test for<br>Plastics |
| Natural Rubber Latex | |

K132810

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| The following in-vitro performance tests were completed; | | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Balloon Compliance | Balloon Multiple Inflation | |
| Balloon Nominal Diameter | Burst in a Stent | |
| Rated Burst Pressure | Balloon Multiple Inflation in a<br>Stent | |
| Balloon Burst Mode | Initial Sheath Insertion Force | |
| Proximal Bond Tensile | Sheath Withdrawal | |
| Balloon Protector (Wingtool) Removal<br>Force | Crossing Profile | |
| Particulate Release | | |
| Conclusion | Based on the indications for use, technological characteristics, safety and<br>performance testing, the Gladiator Elite PTA Balloon Dilatation Catheter<br>has been shown to be appropriate for its intended use and is considered to<br>be substantially equivalent to the Gladiator PTA Balloon Dilatation Catheter<br>as submitted in K113681. | |

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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2014

Boston Scientific Corporation c/o Ms. Anne V. Rossi Regulatory Affairs Fellow One Scimed Place Maple Grove, MN 55311-1566

Re: K132810

Trade/Device Name: Gladiator 19 Elite PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 24, 2014 Received: January 27, 2014

Dear Ms. Rossi,

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 gencral 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 complics 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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Page 2 - Ms. Anne V. Rossi

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -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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# K132810

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

.

Gladiator™ Elite Over-the-Wire PTA Balloon Dilatation Catheter Device Name:

Indications for Use:

The Gladiator Elite Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illiac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Prescription Use X (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 IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Boston Scientific Corporation