(56 days)
The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a lubricious coating. The inner lumen of the Sherpa Guide Catheters is an HDPE liner.
This document is a 510(k) summary for Medtronic's 5F and 6F Launcher® Guide Catheters and 5F and 6F Sherpa® Guide Catheters. It describes the device, its intended use, and its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | No new safety or effectiveness issues during evaluation and testing, demonstrating substantial equivalence to predicate devices. | "No new safety or effectiveness issues were raised during the evaluation and testing. Current testing demonstrates that the 5F and 6F Launcher and Sherpa Guide Catheters are safe, effective and are substantially equivalent to the predicate devices." |
| Biocompatibility | Modified devices remain biocompatible and compliant to ISO 10993. | "The current biocompatibility testing supports the biological safety, as no new materials or processes are being introduced into the design, and no additional biocompatibility tests were deemed necessary. Therefore, the modified 5F and 6F Launcher and Sherpa Guide Catheters remain biocompatible and compliant to ISO 10993." |
| Technological Characteristics | Technological characteristics are identical to predicate devices (Luer hub, outer jacket, wire braided shaft, distal segments, soft tip). | "The technological characteristics of the subject medical devices 5F and 6F Launcher and Sherpa Guide Catheters are identical to the predicate devices." (Details provided for each characteristic like Luer hub, outer jacket, etc.) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical investigation has been performed on the modified device." This indicates that there was no "test set" in the traditional sense for clinical performance. The evaluation for this 510(k) was based on non-clinical data and a comparison of technological characteristics to predicate devices. The data provenance is not applicable as no human-subject testing occurred.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As stated above, no clinical investigation was performed, and therefore no ground truth was established by human experts for a test set.
4. Adjudication Method for the Test Set
Not applicable. No clinical investigation or test set requiring adjudication occurred.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a guiding catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related improvement metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not a software algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering testing and established standards, primarily demonstrating that the modified device's characteristics and performance are substantially equivalent to existing, legally marketed predicate devices. This includes:
- Non-clinical performance data: Indicating no new safety or effectiveness issues.
- Biocompatibility testing: Compliance to ISO 10993.
- Technological characteristics comparison: Verification that features like the Luer hub, outer jacket, wire braided shaft, distal segments, and soft tip are identical to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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OCT 22 2013
Special 510(k) Summary
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923-5186 |
|---|---|
| Contact Person: | Heather MoroseRegulatory Affairs SpecialistPhone: (978) 739-3187Fax: (978) 750-8204Email: heather.p.morose@medtronic.com |
| Alternate Contact: | Fred BoucherDirector of Regulatory AffairsPhone: (978) 739-3116Fax: (978) 750-8204Email: fed.boucher@medtronic.com |
| Date Prepared: | August 23, 2013 |
| Trade Name: | 5F Launcher® Guide Catheter6F Launcher® Guide CatheterSF Sherpa® Active NX Guide Catheter6F Z4 (Sherpa) Guiding Catheter |
| Common Name: | Guiding Catheter |
| Classification Name: | Catheter, Percutaneous21CFR 870.1250, Product Code DQY |
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| Device | 510(k) | Clearance Date | |
|---|---|---|---|
| Predicate Devices: | 5F Launcher®Guide Catheter | K103386 | 02/11/2011 |
| 6F Launcher®Guide Catheter | K021256 | 05/17/2002 | |
| 5F Sherpa® GuideCatheter | K062420 | 09/08/2006 | |
| 6F Sherpa® (Z4)Guiding Catheter | K042489 | 12/13/2004 | |
| DeviceDescription: | The Medtronic Launcher Guide Catheter isconstructed with an inner liner, stainless steel braid,outer shaft jacket, sleeve, marker band and a softdistal tip. The inner lumen of the Launcher GuideCatheter has a lubricious coating. The inner lumen ofthe Sherpa Guide Catheters is an HDPE liner. | ||
| Statement of IntendedUse: | The Medtronic Guide Catheter is designed to providea pathway through which therapeutic devices areintroduced. The guiding catheter is intended for usedin the coronary or peripheral vascular system. | ||
| Summary ofTechnologicalCharacteristics: | The technological characteristics of the subjectmedical devices 5F and 6F Launcher and SherpaGuide Catheters are identical to the predicate devices. | ||
| Luer hub: The luer hub allows interfacing of thecatheter with other devices. | |||
| Outer jacket: The outer jacket provides the catheterwith its ability to retain its curve, and also providessupport and contributes to the shaft stiffness and kinkresistance. | |||
| Wire braided shaft: The wire braided shaftprovides the catheter with torque response and crushresistance. |
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| Distal segments: The distal segments allow atransition of catheter stiffness from the proximalcatheter shaft to the soft distal tip. | ||
|---|---|---|
| i.Soft tip: The soft tip minimizes thepotential for vessel trauma when thecatheter is advanced in the vasculaturesystem. | ||
| Summary of Non-clinical Data: | No new safety or effectiveness issues were raisedduring the evaluation and testing. Current testingdemonstrates that the 5F and 6F Launcher and SherpaGuide Catheters are safe, effective and aresubstantially equivalent to the predicate devices. | |
| BiocompatibilityTesting: | The current biocompatibility testing supports thebiological safety, as no new materials or processesare being introduced into the design, and noadditional biocompatibility tests were deemednecessary. Therefore, the modified 5F and 6FLauncher and Sherpa Guide Catheters remainbiocompatible and compliant to ISO 10993 | |
| Summary ofClinical Data: | No clinical investigation has been performed on the modifieddevice. | |
| Conclusion fromData: | Medtronic Vascular has demonstrated that the modified 5Fand 6F Launcher and Sherpa Guide Catheters are substantiallyequivalent to the predicate device. |
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 22, 2013
Medtronic Inc. C/O Heather Morose Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, MA 01923 US
Re: .K 132673
Trade/Device Name: 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 5F Sherpa Guide Catheter and 6F Sherpa Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 20, 2013 Received: September 23, 2013
Dear Ms. Morose:
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 (2 l 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
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Page 2 - Heather Morose
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.
M.A. Stillemann
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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Indications for Use
K132673 510(k) Number (if known): _
Device Name: Medtronic SF and 6F Launcher™ Guide Catheters and Medtronic 5F and 6F Sherpa™ Guide Catheter.
Indications for Use: The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
ਨਾ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Zillerman
PAGE 1 OF __
§ 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).