(102 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the GUIDEZILLA™ Guide Extension Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria with specific threshold values (e.g., "radiopacity must be X or better"). Instead, it lists the types of tests performed. The "Reported Device Performance" column reflects that these tests were "completed" and their results provided "reasonable assurance" of conformance.
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility Tests: | - All tests completed successfully, providing reasonable assurance of safety. No new safety concerns were identified. |
| Cytotoxicity | Completed |
| Sensitization | Completed |
| Intracutaneous Reactivity | Completed |
| Acute Systemic Toxicity | Completed |
| Materials Mediated Pyrogenicity | Completed |
| USP Physicochemical | Completed |
| Direct Contact Hemolysis | Completed |
| Hemolysis Extract | Completed |
| Complement Activation | Completed |
| Partial Thromboplastin Time | Completed |
| In Vitro Hemocompatibility | Completed |
| Latex | Completed (Likely testing for presence/absence of latex, or reactivity to latex) |
| In-Vitro Performance Tests: | - All tests completed successfully, providing reasonable assurance of performance. No new performance issues were identified. |
| Effective Length | Completed |
| Outer Diameter | Completed |
| Inner Diameter | Completed |
| Full Unit Tensile | Completed |
| Kink Resistance | Completed |
| Tip Deflection | Completed |
| Torque Strength | Completed |
| Radiopacity | Completed |
| Dye Flow | Completed |
| Coating Integrity | Completed |
| Particulate Evaluation | Completed |
| Corrosion Resistance | Completed |
| Device Compatibility (with 6F guide catheter) | Completed (Stated in device description: "GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter.") |
| Packaging Integrity | Completed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units/samples) used for each individual bench or biocompatibility test. It broadly states that "bench testing and biocompatibility testing were performed."
- Data Provenance: The data is likely from retrospective testing conducted by Boston Scientific Corporation, the manufacturer. The country of origin of the data is not specified, but given the submitter's address in Maple Grove, MN, USA, it is presumed to be conducted within the manufacturer's facilities or outsourced to labs in the US or other compliant regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the provided documentation describes a device/engineering performance study (bench testing and biocompatibility), not a clinical study involving experts to establish ground truth for a diagnostic device.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3. Adjudication is typically used in clinical studies or studies where subjective interpretation is involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. A MRMC comparative effectiveness study was not performed for this device. The documentation explicitly states: "Clinical Evaluation was not required for these devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
This question is not applicable as the GUIDEZILLA™ Guide Extension Catheter is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering specifications, industry standards, and established biocompatibility testing protocols. The tests performed (e.g., measuring effective length, outer diameter, kink resistance, cytotoxicity) have objective, measurable endpoints defined by these standards.
8. The Sample Size for the Training Set:
This information is not applicable. The GUIDEZILLA™ Guide Extension Catheter is a physical medical device and does not involve AI or machine learning, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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Traditional 510(k) Submission . GUIDEZILLA™ Guide Extension Catheter
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| 510(k) Summaryper 21 CFR §807.92 | MAR 1 | ||
|---|---|---|---|
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | ||
| Contact Nameand Information | Holly RamirezPhone: 763-494-2113Fax: 763-494-2222e-mail: Holly.Holmes@BSCI.com | ||
| Prepared | 06 December 2012 | ||
| ProprietaryName | GUIDEZILLA™ Guide Extension Catheter | ||
| Common Name | Guide Catheter | ||
| Product Code | DQY | ||
| Classification | Class II, 21 CFR Part 870.1250 | ||
| PredicateDevices | GuideLiner® V2 Catheter | K112082 | 01 December 2011 |
| DeviceDescription | The Boston Scientific GUIDEZILLA™ Guide Extension Catheter acts as anextension to a traditional guide catheter. GUIDEZILLA consists of a proximalstainless steel hypotube with a tab used for device identification and a distalguide catheter segment through which interventional devices may bedelivered. The guide catheter segment incorporates two radiopaque markerbands to aid in positioning the device during the procedure. A hydrophiliccoating is applied to the distal polymer segment of the device.GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter. Theeffective length of the device is 145 cm. | ||
| Intended Use /Indications forUse | The GUIDEZILLA™ Guide Extension Catheter is intended to be used inconjunction with guide catheters to access discrete regions of the coronaryand/or peripheral vasculature, and to facilitate placement of interventionaldevices. | ||
| Comparison ofTechnologicalCharacteristics | The GUIDEZILLA™ Guide Extension Catheter incorporates substantiallyequivalent device materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization process andintended use as the GuideLiner® V2 (K112082). |
9 2013
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Traditional 510(k) Submission GUIDEZILLA™ Guide Extension Catheter
| PerformanceData | Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew 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 andperformance testing, the GUIDEZILLA™ Guide Extension Catheter has beenshown to be appropriate for its intended use and is considered to besubstantially equivalent to the GuideLiner® V2 (K112082). |
. . .
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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.
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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
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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)
Matthew GJ Willebrenner
§ 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).