(21 days)
The Medtronic 5F Sherpa Active NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 5F Sherpa Active NX Guiding Catheter is intended for use in the coronary or peripheral vascular system.
The 5F Sherpa Active NX Guiding Catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary segment, a primary segment, tungsten marker band, a segment sleeve and a soft tip.
The 5F Sherpa Active NX Guide Catheter design is based on a four layer design with an inner liner of polyethylene.
The provided text is related to a 510(k) submission for the Medtronic 5F Sherpa Active NX Guide Catheter, a medical device. This document describes the device, its intended use, and its substantial equivalence to predicate devices based on technological characteristics and performance testing.
However, the provided text does not contain any information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance.
The document is a regulatory submission for a physical medical device (a catheter), not a software or AI-based device that would typically have the kind of performance metrics you are asking about (e.g., accuracy, sensitivity, specificity, expert adjudication).
Therefore, I cannot fulfill your request with the input provided. The requested information pertains to studies typically conducted for AI/machine learning medical devices, which this document is not about.
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Ko62420
Medtronic Vascular 37 A Cherry Hill Drive Danvers, MA-01923 ww.medtronic.com
16! 978.777 004.2 Fax 978.777.0390
510(k) Summary
SEP - 8 2006
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923USA |
|---|---|
| Contact Person: | Mark PuopoloSr. Regulatory Affairs Specialist978.739.3108978.777.0390mark.puopolo@medtronic.com |
| Date Prepared: | August 16, 2006 |
| Trade Name: | 5F Sherpa® Active NX Guide Catheter |
| Common Name: | Percutaneous Catheter |
| ClassificationName: | Percutaneous Catheter |
| Predicate Device: | 8F Sherpa NX Guide Catheter (K060418)5F Launcher Guide Catheter (K030779) |
| DeviceDescription: | The 5F Sherpa Active NX Guiding Catheter consists of a luerhub, strain relief, a shaft (outer jacket, braid wire, anintermediate layer, and inner liner), a secondary segment, aprimary segment, tungsten marker band, a segment sleeve anda soft tip.The 5F Sherpa Active NX Guide Catheter design is based ona four layer design with an inner liner of polyethylene. |
| Statement ofIntended Use: | Provide a pathway through which therapeutic devices areintroduced. The guiding catheter is intended to be used in thecoronary or peripheral vascular system |
| Summary of | In addition to being technologically equivalent to the |
| Technological | predicate devices, the 5F Sherpa Active NX Guiding Catheter |
| Characteristics: | has been subjected to performance testing and it has beendetermined that the 5F Sherpa Active NX Guiding Catheter issuitable for its intended use. |
| Summary of Non-clinical Data: | The 5F Sherpa Active NX Guiding Catheter is manufacturedunder the same conditions, using the similar processes andequivalent materials, as the 8F Sherpa NX Guiding Catheter;and 5F Launcher Guiding Catheter, the legally marketedpredicate devices. In addition to being technologicallyequivalent, the indications for use have not changed. |
When Life Depends on Medical Technology
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and the comments of the comments of the comments of
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2006
Medtronic, Inc c/o Mr. Mark Puopolo Sr. Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923
Re: K062420
Medtronic® Vascular 5F Sherpa® Active NX Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: August 16, 2006 Received: August 18, 2006
Dear Mr. Puopolo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
Vana R. Wehner
Office of Device Evaluation Center for Devices and Radiological Health
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices
Enclosure
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Indications for Use
510(k) Number (if known):
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Device Name: Medtronic® 5F Sherpa Active NX Guiding Catheter
Indications For Use: The Medtronic 5F Sherpa Active NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 5F Sherpa Active NX Guiding Catheter is intended for use in the coronary or peripheral vascular system.
Prescription Use _ X (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)
Page 1 of _ /
una R. Vuchner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko62420
§ 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).