(120 days)
No
The device description and performance studies focus on the mechanical and material properties of a guide extension catheter, with no mention of AI or ML capabilities.
No
The device is intended to facilitate the placement of interventional devices, acting as an extension to guide catheters, but it does not directly treat a condition or restore a function itself.
No
The device is described as an extension catheter to facilitate the placement of interventional devices, providing support to advance them. Its purpose is therapeutic/interventional, not diagnostic.
No
The device description clearly outlines physical components such as a hypotube, handle, distal guide catheter segment, collar, and marker band, indicating it is a physical medical device, not software-only.
Based on the provided information, the Guidezilla II Guide Extension Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to access and facilitate placement of interventional devices within the coronary and/or peripheral vasculature. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. This is consistent with an in vivo medical device, not a device used to test samples outside the body.
- Anatomical Site: The specified anatomical site is the coronary and/or peripheral vasculature, which are internal body structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures in the way a guide extension catheter does.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The following device performance tests were completed:
Corrosion Resistance
Average Outer Diameter
Device Length
Deliverability
Tip Deflection
Full Unit Tensile
Post-Radius Tensile
Radiopacity
Proximal Markers
Tracking an Interventional Device Through Guidezilla
Withdrawing an Interventional Device Through Guidezilla
Minimum Inner Diameter
Entering an Interventional Device into Guidezilla
Dye Flow
Withdrawal of Guidezilla Device
Particulates
Torque
Coating Integrity
Kink Resistance
The following package performance tests were completed:
Pouch Seal Strength
Shelf Carton Condition
Label Adhesion and Print Quality
Master Shipping Carton/Condition
Sterile Barrier Integrity
Visual Sterile Barrier Integrity
Device Removal from Carrier Tube
The following biocompatibility tests were completed:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Complement Activation C3a and SC5b-9
Materials Mediated Pyrogenicity
Hemolysis Direct Contact
Hemolysis Extract Method
In Vivo Thrombogencity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. The logo is black and white.
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
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,
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
2
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 |
3
510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name and
Information | Nikki M Wahlberg
Two Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2381
Fax: 763-494-2981
e-mail: Nikki.Wahlberg@bsci.com | | |
| Prepared | 22 November 2016 | | |
| Proprietary Name | Guidezilla™ II Guide Extension Catheter
Guidezilla™ II LONG Guide Extension Catheter | | |
| Common Name | Guide Catheter | | |
| Product Code | DQY | | |
| Classification | Class II, 21 CFR Part 870.1250 | | |
| Primary Predicate
Device | Guidezilla™ Guide
Extension Catheter | K123765 | 19 March 2013 |
| Reference
Device(s) | GuideLiner V2 Catheter | K112082 | 01 December 2011 |
| | GuideLiner XL Catheter | K091750 | 04 November 2009 |
4
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.
5
The following device performance tests were completed:
| Corrosion Resistance | Withdrawing an Interventional Device Through
Guidezilla |
|---------------------------------------------------------|------------------------------------------------------------|
| Average Outer Diameter | Minimum Inner Diameter |
| Device Length | Entering an Interventional Device into
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
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.