(85 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 thin lubricious coating.
Acceptance Criteria and Device Performance Study for Medtronic Vascular Guide Catheters
This document outlines the acceptance criteria and the study conducted to demonstrate that the modified Medtronic Vascular 5F and 8F Launcher Guide Catheters meet these criteria and perform similarly to their predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bench Testing | 1. Visual Analysis (Sink Mark, Flash, Short Shot, Discoloration) | No significant visual defects (e.g., sink marks, flash, short shots, discoloration) on the luer hub that would affect function or aesthetics. | Met: Bench testing included visual analysis for sink mark, flash, short shot, and discoloration on the luer hub (due to new material change). The summary states that "no new safety or effectiveness issues were raised during the testing," implying acceptable visual quality. |
| 2. Visual Analysis (Luer Taper ISO 594-1 Gauge) | Luer taper dimensions meet ISO 594-1 standards. | Met: Bench testing included visual analysis of the luer taper using ISO 594-1 gauge. The summary states that "no new safety or effectiveness issues were raised during the testing," implying compliance with the luer taper standard. | |
| 3. Dimensional Analysis (Hub Shaft ID) | Hub shaft inner diameter within specified tolerance. | Met: Bench testing included dimensional analysis of the hub shaft ID. The summary states that "no new safety or effectiveness issues were raised during the testing," implying acceptable dimensions. | |
| 4. Hub/Shaft Tensile | Hub-to-shaft bond strength exceeds a specified minimum tensile force. | Met: Bench testing included hub/shaft tensile strength tests. The summary implies sufficient tensile strength, as "no new safety or effectiveness issues were raised during the testing." | |
| 5. Leak | No leakage at specified pressure or vacuum. | Met: Bench testing included leak tests. The summary implies no significant leakage, as "no new safety or effectiveness issues were raised during the testing." | |
| 6. Luer Hub Leak and Aspiration Test | No leakage or aspiration when connected to other devices, at specified pressures/vacuums, demonstrating secure connection. | Met: Bench testing included luer hub leak and aspiration tests. The summary implies no significant leakage or aspiration, as "no new safety or effectiveness issues were raised during the testing." | |
| 7. Visual Analysis (Hub Inside Inspection for Exposed Wires) | No exposed wires inside the hub that could compromise device integrity or patient safety. | Met: Bench testing included visual analysis of the hub inside for exposed wires. The summary implies no exposed wires, as "no new safety or effectiveness issues were raised during the testing." | |
| Biocompatibility | Cytotoxicity Testing | No evidence of cytotoxic effects. | Met: "Cytotoxicity Testing was performed as a screening test for this device modification." The overall conclusion states that "no new safety or effectiveness issues were raised during the testing," indicating acceptable biocompatibility. |
| Overall Performance | Substantial Equivalence | The modified devices perform similarly to the predicate devices and raise no new safety or effectiveness issues. | Met: "Medtronic Vascular has demonstrated that the modified 5F Launcher and 8F Launcher Guide Catheters are substantially equivalent to the predicate devices," based on the nonclinical data. "No new safety or effectiveness issues were raised during the testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for each bench test conducted. However, the tests are implied to have been performed on a sufficient number of samples designated for quality and performance evaluation.
- Data Provenance: The data is presented as "Nonclinical Data," which includes bench and biocompatibility testing. The data is generated internally by Medtronic Vascular as part of their regulatory submission for a Special 510(k). The context strongly suggests this is prospective testing conducted specifically for this device modification. The country of origin for the data is not explicitly stated, but it is a US-based company submitting to the FDA, implying the tests were likely conducted in the US or under US regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "ground truth" in the diagnostic or image interpretation sense, which typically requires expert consensus for classification. Instead, the "ground truth" is primarily established by adherence to engineering specifications, recognized standards (e.g., ISO 594-1), and pre-defined acceptance criteria for physical and biological properties. Therefore:
- Number of Experts: Not applicable in the traditional sense of diagnostic expert consensus. The "ground truth" for the performance characteristics is derived from engineering and regulatory standards.
- Qualifications of Experts: The "experts" would be the engineers, technicians, and regulatory specialists within Medtronic Vascular responsible for designing, conducting, and interpreting these tests, ensuring compliance with relevant standards and internal specifications. Their qualifications would typically include degrees and experience in biomedical engineering, materials science, quality assurance, and regulatory affairs, but these specific qualifications are not detailed in the summary.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly those involving human readers interpreting medical images or clinical outcomes, to resolve discrepancies. For bench and biocompatibility testing, the results are objectively measured against predefined acceptance criteria. Any inconclusive or borderline results would likely lead to re-testing or deeper investigation by the testing team, rather than an adjudication process involving multiple independent reviewers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
- Reason: The device under review is a guide catheter, a physical medical device, not a diagnostic imaging algorithm, and the study focuses on changes to its physical characteristics (luer hub material). MRMC studies are designed to assess the performance of diagnostic systems where multiple human readers interpret multiple cases, often with and without AI assistance. This study is a nonclinical, bench, and biocompatibility study.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted, and the device is a physical catheter, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" performance evaluation was done, as the testing assessed the intrinsic physical and biological properties of the modified catheter without human intervention in its analysis or interpretation. However, this isn't an "algorithm only" study, as the device is mechanical, not an algorithm. The bench tests and biocompatibility tests evaluate the device's inherent characteristics.
7. The Type of Ground Truth Used
The ground truth used for this study is a combination of:
- Expert Consensus (Engineering/Regulatory Standards): The acceptance criteria themselves are established based on industry standards (e.g., ISO 594-1 for luer taper), regulatory guidance from the FDA, and internal engineering specifications for device functionality and safety. These standards and specifications represent the "ground truth" for successful device performance.
- Objective Measurements: The test results (e.g., dimensional measurements, tensile strength, leak test pressures, cytotoxicity readings) are objective measurements compared against these predefined numerical or qualitative criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The nonclinical testing performed (bench and biocompatibility) is analogous to verification and validation testing for a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set exists for this type of device.
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| FEB 1 1 2011Special 510(k) Summary | |
|---|---|
| Submitter: | Medtronic Vascular35-37A Cherry Hill DriveDanvers, MA 01923-5186 |
| Contact Person: | Anu GaurRegulatory Affairs SpecialistPhone: (978) 739-3080Fax: (978) 739-7380 |
| Alternate Contact | Fred BoucherDirector of Regulatory AffairsPhone: (978) 739-3116Fax: (978) 750-8204 |
| Date Prepared: | November 17th, 2010 |
| Trade Name: | Medtronic Vascular 5F Launcher® Guide CatheterMedtronic Vascular 8F Launcher® Guide Catheter |
| Common Name: | Guiding Catheter |
| ClassificationName: | Catheter, Percutaneous21CFR 870.1250, Product Code DQY |
| Predicate Devices: | K030779 - 5F Launcher® Guide Catheter.K023402 - 8F Launcher® Guide Catheter |
| DeviceDescription: | The Medtronic Launcher Guide Catheter is constructed with aninner liner, stainless steel braid, outer shaft jacket, sleeve,marker band and a soft distal tip. The inner lumen of theLauncher Guide Catheter has a thin lubricious coating. |
| Statement ofIntended Use: | The Medtronic Guide Catheter is designed to provide a pathwaythrough which therapeutic devices are introduced. The guidingcatheter is intended for used in the coronary or peripheralvascular system. |
| Summary ofTechnologicalCharacteristics: | The technological characteristics of the subject medical devices5F and 8F Launcher Guide Catheters are identical to thepredicate devices.Luer hub: The luer hub allows interfacing of the catheter withother devices.Outer jacket: The outer jacket provides the catheter with itsability to retain its curve, and also provides additional support. |
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Wire braided shaft: The wire braided shaft provides the catheter with torque response and crush resistance.
Inner liner: The inner liner provides sufficient lumen lubricity for therapeutic device to pass through.
Distal segments: The distal segments allow a transition of catheter stiffness from the proximal catheter shaft to the soft distal tip.
Soft tip: The soft tip minimizes the potential for vessel trauma when the catheter is advanced in the vasculature system.
Summary of Nonclinical Data:
The bench and biocompatibility testing were conducted in accordance with the recommendations from the relevant FDA guidance to demonstrate that the modified 5F and 8F Launcher Guide Catheters met the acceptance criteria and performed similarly to the predicate devices.
Bench Testing performed was specific to the luer hub due to the new material change. The tests performed included:
-
- Visual Analysis Sink Mark, Flash, Short Shot and Discoloration.
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- Visual Analysis Luer Taper ISO 594-1 Gauge.
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- Dimensional Analysis Hub Shaft ID.
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- Hub/Shaft Tensile.
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- Leak
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- Luer Hub Leak and Aspiration Test
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- Visual Analysis Hub Inside Inspection for Exposed Wires.
Biocompatibility Testing: Cytotoxicity Testing was performed as a screening test for this device modification.
No new safety or effectiveness issues were raised during the testing.
No clinical investigation has been performed for these devices.
Summary of Clinical Data:
Conclusion from Data:
Medtronic Vascular has demonstrated that the modified 5F Launcher and 8F Launcher Guide Catheters are substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 4 2011
Medtronic Vascular c/o Anupama Gaur, Ph.D., MBA, MSRA Regulatory Affairs Specialist 35-37 A Cherry Hill Drive Danvers, MA 01923
Re: K103386
Trade/Device Name: Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher® Guide Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: January 11, 2011 Received: January 12, 2011
Dear Dr. Gaur:
This letter corrects our substantially equivalent letter of February 11, 2011.
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.
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Page 2 - Dr. Anu Gaur
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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" (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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely youns.
Bram D. Zuckerman, M.D.
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
510(k) Number: K10386
Device Names: Medtronic Vascular 5F Launcher Guide Catheter and 8F Launcher 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.
Prescription Use X (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)
Sign-Off
on of Cardiovascular Device:
mber K103386
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§ 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).