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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Guidezilla™ II and Guidezilla™ II LONG Guide Extension Catheters. It describes the device, its intended use, and a comparison to a predicate device. However, it does not describe an AI/ML-driven device or study that provides acceptance criteria and performance metrics for such a device. The document details performance testing for a physical medical device (catheter) to establish substantial equivalence to a predicate device, as required for FDA clearance.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or ground truth details) because the document does not pertain to an AI/ML device study.

The document indicates:

Clinical Testing: "Clinical evaluation was not required for this device." This further confirms that no study of the type requested (MRMC, standalone AI performance, etc.) was conducted or is applicable here.
Performance Data: The performance data section lists various device performance tests (e.g., Corrosion Resistance, Deliverability, Radiopacity), package performance tests (e.g., Pouch Seal Strength, Sterile Barrier Integrity), and biocompatibility tests (e.g., Cytotoxicity, Sensitization). These are physical and biological tests of the catheter itself, not evaluations of an AI algorithm.
Ground Truth: The concept of "ground truth" as it relates to expert consensus or pathology for an AI model is not relevant to this document. The "truth" for this device is its physical and biological performance against established engineering and medical device standards.
Sample Size: Sample sizes are not explicitly mentioned for these physical/biological tests, but they would refer to the number of catheters tested, not patient data.

Summary

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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 (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,

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)
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

Sponsor:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Nikki M WahlbergTwo Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2381Fax: 763-494-2981e-mail: Nikki.Wahlberg@bsci.com
Prepared	22 November 2016
Proprietary Name	Guidezilla™ II Guide Extension CatheterGuidezilla™ II LONG Guide Extension Catheter
Common Name	Guide Catheter
Product Code	DQY
Classification	Class II, 21 CFR Part 870.1250
Primary PredicateDevice	Guidezilla™ GuideExtension Catheter	K123765	19 March 2013
ReferenceDevice(s)	GuideLiner V2 Catheter	K112082	01 December 2011
	GuideLiner XL Catheter	K091750	04 November 2009

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Device Description

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 ThroughGuidezilla
Average Outer Diameter	Minimum Inner Diameter
Device Length	Entering an Interventional Device intoGuidezilla
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 ThroughGuidezilla

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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).