(102 days)
Not Found
No
The summary describes a mechanical guide extension catheter and does not mention any AI/ML components or capabilities. The performance studies are limited to bench testing and biocompatibility, with no mention of data-driven performance metrics typically associated with AI/ML.
No
The device facilitates the placement of interventional devices, it does not directly treat or diagnose a condition.
No
The device is described as an "extension to a traditional guide catheter" designed to "facilitate placement of interventional devices," which are tools used for treatment, not diagnosis. The text does not mention any diagnostic capabilities like sensing or imaging.
No
The device description clearly outlines physical components like a stainless steel hypotube, a distal guide catheter segment with radiopaque marker bands, and a hydrophilic coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical catheter designed to extend a guide catheter for delivering other devices. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing being performed by the device.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The GUIDEZILLA™ Guide Extension Catheter does not fit this description.
N/A
Intended Use / Indications for Use
The GUIDEZILLA™ 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
DQY
Device Description
The Boston Scientific GUIDEZILLA™ Guide Extension Catheter acts as an extension to a traditional guide catheter. GUIDEZILLA consists of a proximal stainless steel hypotube with a tab used for device identification and a distal guide catheter segment through which interventional devices may be delivered. The guide catheter segment incorporates two radiopaque marker bands to aid in positioning the device during the procedure. A hydrophilic coating is applied to the distal polymer segment of the device. GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter. The effective length of the device is 145 cm.
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)
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.
The following biocompatibility tests were completed on the GUIDEZILLA™ Guide Extension Catheter:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated Pyrogenicity
USP Physicochemical
Direct Contact Hemolysis
Hemolysis Extract
Complement Activation
Partial Thromboplastin Time
In Vitro Hemocompatibility
Latex
The following in-vitro performance tests were completed of the GUIDEZILLA™ Guide Extension Catheter:
Effective Length
Outer Diameter
Inner Diameter
Full Unit Tensile
Kink Resistance
Tip Deflection
Torque Strength
Radiopacity
Dye Flow
Coating Integrity
Particulate Evaluation
Corrosion Resistance
Device Compatibility
Packaging Integrity
Clinical Evaluation was not required for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: 上
Traditional 510(k) Submission . GUIDEZILLA™ Guide Extension Catheter
.
:
:
| | 510(k) Summary
per 21 CFR §807.92 | | MAR 1 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | |
| Contact Name
and Information | Holly Ramirez
Phone: 763-494-2113
Fax: 763-494-2222
e-mail: Holly.Holmes@BSCI.com | | |
| Prepared | 06 December 2012 | | |
| Proprietary
Name | GUIDEZILLA™ Guide Extension Catheter | | |
| Common Name | Guide Catheter | | |
| Product Code | DQY | | |
| Classification | Class II, 21 CFR Part 870.1250 | | |
| Predicate
Devices | GuideLiner® V2 Catheter | K112082 | 01 December 2011 |
| Device
Description | The Boston Scientific GUIDEZILLA™ Guide Extension Catheter acts as an
extension to a traditional guide catheter. GUIDEZILLA consists of a proximal
stainless steel hypotube with a tab used for device identification and a distal
guide catheter segment through which interventional devices may be
delivered. The guide catheter segment incorporates two radiopaque marker
bands to aid in positioning the device during the procedure. A hydrophilic
coating is applied to the distal polymer segment of the device.
GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter. The
effective length of the device is 145 cm. | | |
| Intended Use /
Indications for
Use | The GUIDEZILLA™ 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™ Guide Extension Catheter incorporates substantially
equivalent device materials and design, packaging materials and design,
fundamental technology, manufacturing processes, sterilization process and
intended use as the GuideLiner® V2 (K112082). | | |
9 2013
1
Traditional 510(k) Submission GUIDEZILLA™ Guide Extension Catheter
| 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. | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|
| | The following biocompatibility tests were completed on the GUIDEZILLA™
Guide Extension Catheter: | | |
| | Cytotoxicity | Direct Contact Hemolysis | |
| | Sensitization | Hemolysis Extract | |
| | Intracutaneous Reactivity | Complement Activation | |
| | Acute Systemic Toxicity | Partial Thromboplastin Time | |
| | Materials Mediated Pyrogenicity | In Vitro Hemocompatibility | |
| | USP Physicochemical | Latex | |
| | The following in-vitro performance tests were completed of the GUIDEZILLA™
Guide Extension Catheter: | | |
| | Effective Length | Radiopacity | |
| | Outer Diameter | Dye Flow | |
| | Inner Diameter | Coating Integrity | |
| | Full Unit Tensile | Particulate Evaluation | |
| | Kink Resistance | Corrosion Resistance | |
| | Tip Deflection | Device Compatibility | |
| | Torque Strength | Packaging Integrity | |
| Clinical Testing | Clinical Evaluation was not required for these devices. | | |
| Conclusion | Based on the indications for use, technological characteristics, and safety and
performance testing, the GUIDEZILLA™ Guide Extension Catheter has been
shown to be appropriate for its intended use and is considered to be
substantially equivalent to the GuideLiner® V2 (K112082). | | |
. . .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
March 19, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation C/O Holly Ramirez One Scimed Place Maple Grove, MN 55311
Re: K123765
Trade/Device Name: Guidezilla™ Guide Extension Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 15, 2013 Received: February 19, 2013
Dear Ms. Ramirez:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Matthew G. Hillebrenner
for Bram Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K123765
GUIDEZILLA™ Guide Extension Catheter Device Name:
Indications for Use:
The Guidezilla 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.
Prescription Use × (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)