Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter

K163314 · Boston Scientific Corporation · DQY · Mar 23, 2017 · Cardiovascular

Device Facts

• Record ID: K163314
• Device Name: Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Guidezilla™ II Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Device Story

Guidezilla II and II LONG are guide extension catheters used in coronary/peripheral vasculature. Device enters through parent guide catheter; extends 15 cm beyond distal end to provide additional support for interventional device delivery. Comprised of proximal stainless steel hypotube with handle and distal guide catheter segment (25 cm or 40 cm). Radiopaque platinum iridium collar connects segments; radiopaque marker band at distal tip aids positioning. Hydrophilic coating on distal 20 cm. Used by physicians in clinical settings during interventional procedures. Output is a physical conduit for interventional devices; assists in navigating complex anatomy. Benefits include enhanced support and trackability for interventional devices, potentially improving procedural success in challenging vascular regions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including corrosion resistance, tensile strength, kink resistance, torque, radiopacity, coating integrity, and biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity, hemolysis, thrombogenicity, and complement activation).

Technological Characteristics

Proximal stainless steel hypotube; distal guide catheter segment (25/40 cm); radiopaque platinum iridium collar; radiopaque marker band. Hydrophilic coating on distal 20 cm. Sterile, single-use. Conforms to EN ISO 10555-1:2013. Mechanical device; no energy source or software.

Indications for Use

Indicated for use in patients requiring access to discrete regions of the coronary and/or peripheral vasculature to facilitate the placement of interventional devices.

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

• Guidezilla™ Guide Extension Catheter (K123765)

Reference Devices

• GuideLiner V2 Catheter (K112082)
• GuideLiner XL Catheter (K091750)

Submission Summary (Full Text)

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Public Health Service

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

March 23, 2017

Boston Scientific Corporation Nikki Wahlberg Sr. Regulatory Affairs Specialist Two Scimed Place Maple Grove, Minnesota 55311-1566

Re: K163314

Trade/Device Name: Guidezilla™ II Guide Extension Catheter; Guidezilla™ II LONG Guide Extension Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 17, 2017 Received: February 21, 2017

Dear Ms. Wahlberg:

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 [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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel
Fernando Aguel-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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| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | K163314 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Guidezilla™ II Guide Extension Catheter |
| | Guidezilla™ II LONG Guide Extension Catheter |
| Indications for Use (Describe) | The Guidezilla II Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input 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> |

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# 510(k) Summary
per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name and<br>Information | Nikki M Wahlberg<br>Two Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | | |
| Prepared | 22 November 2016 | | |
| Proprietary Name | Guidezilla™ II Guide Extension Catheter<br>Guidezilla™ II LONG Guide Extension Catheter | | |
| Common Name | Guide Catheter | | |
| Product Code | DQY | | |
| Classification | Class II, 21 CFR Part 870.1250 | | |
| Primary Predicate<br>Device | Guidezilla™ Guide<br>Extension Catheter | K123765 | 19 March 2013 |
| Reference<br>Device(s) | GuideLiner V2 Catheter | K112082 | 01 December 2011 |
| | GuideLiner XL Catheter | K091750 | 04 November 2009 |

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## Device Description

The Boston Scientific Guidezilla™ II and Guidezilla™ II LONG Guide Extension Catheters act as extensions to traditional guide catheters. The Guidezilla II Guide Extension Catheter enters through the parent guide catheter and extends an additional 15 cm out the distal end of the parent guide catheter, providing physicians with additional support to advance interventional devices into the vasculature. The Guidezilla II Guide Extension Catheter consists of a proximal stainless steel hypotube, which includes a handle used for device identification, and a distal guide catheter segment (25 cm or 40 cm) through which interventional devices may be delivered. The proximal hypotube is connected to the distal guide catheter segment by a small collar. The collar is made of radiopaque platinum iridium material that provides support and a smooth transition from the offset hypotube to the distal guide catheter segment. The distal quide catheter segment incorporates one radiopaque marker band located 2 mm from the distal tip of the device. The radiopaque collar and marker band aid in positioning the device during the procedure. A hydrophilic coating is applied to the distal 20 cm of the device.

## Indications for Use / Intended Use Guide Wire

The Guidezilla™ II Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

## Comparison of Technological Characteristics

The Guidezilla™ II and Guidezilla™ II LONG Guide Extension Catheter incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate, Guidezilla™ Guide Extension Catheter K123765.

#### Performance Data

Design verification testing was performed to support a determination of substantial equivalence according to Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 2010. Guidezilla II also conforms to relevant sections of EN ISO 10555-1: 2013, Sterile, single-use intravascular catheters; Part 1: General Requirements. The results of the tests provide reasonable assurance that the proposed devices have 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.

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The following device performance tests were completed:

| Corrosion Resistance | Withdrawing an Interventional Device Through<br>Guidezilla |
|---------------------------------------------------------|------------------------------------------------------------|
| Average Outer Diameter | Minimum Inner Diameter |
| Device Length | Entering an Interventional Device into<br>Guidezilla |
| Deliverability | Dye Flow |
| Tip Deflection | Withdrawal of Guidezilla Device |
| Full Unit Tensile | Particulates |
| Post-Radius Tensile | Torque |
| Radiopacity | Coating Integrity |
| Proximal Markers | Kink Resistance |
| Tracking an Interventional Device Through<br>Guidezilla | |

The following package performance tests were completed:

| Pouch Seal Strength | Sterile Barrier Integrity |
|----------------------------------|----------------------------------|
| Shelf Carton Condition | Visual Sterile Barrier Integrity |
| Label Adhesion and Print Quality | Device Removal from Carrier Tube |
| Master Shipping Carton/Condition | |

The following biocompatibility tests were completed:

| Cytotoxicity | Materials Mediated Pyrogenicity |
|--------------------------------------|---------------------------------|
| Sensitization | Hemolysis Direct Contact |
| Intracutaneous Reactivity | Hemolysis Extract Method |
| Acute Systemic Toxicity | In Vivo Thrombogencity |
| Complement Activation C3a and SC5b-9 | |

# Clinical Testing

Clinical evaluation was not required for this device.

#### Conclusion

Based on the indications for use, technological characteristics, safety and performance testing, the Guidezilla™ II and Guidezilla™ II LONG Guide Extension Catheters are appropriate for the stated intended uses and are considered to be substantially equivalent to the Guidezilla™ Guide Extension Catheter K123765.