(90 days)
The Medtronic 6F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.
The 6F Z4 Guide Catheter consists of a luer hub, a strain relief, inner liner, a braided wire, an outer jacket, a sleeve, a tungsten/nylon band, and a soft tip.
The 6F Z4 Guide Catheter design is based on an inner lumen liner of polyethylene material. The new shaft will be comprised of an inner liner of polyethylene, an intermediate layer of Pebax, stainless steel braid wire and a Vestamid outer jacket. The braided wire, intermediate layer and outer jacket materials have been previously used in others Medtronic Guide Catheters.
This document describes a 510(k) submission for the Medtronic 6F Z4 Guiding Catheter, comparing it to a predicate device, the 6F Launcher Guide Catheter (K021256).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not list specific numerical acceptance criteria or detailed performance metrics. It states that the device has been "subjected to performance testing and it has been determined that the 6F Z4 Guiding Catheter is suitable for its intended use."
The comparison is primarily qualitative, focusing on technological equivalence and manufacturing processes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device | "In addition to being technologically equivalent to the predicate devices...""The 6F Z4 Guiding Catheter design is based on an inner lumen liner of polyethylene material. The new shaft will be comprised of an inner liner of polyethylene, an intermediate layer of Pebax, stainless steel braid wire and a Vestamid outer jacket. The braided wire, intermediate layer and outer jacket materials have been previously used in others Medtronic Guide Catheters." |
| Suitability for Intended Use | "...it has been determined that the 6F Z4 Guiding Catheter is suitable for its intended use." |
| Manufacturing Processes Equivalence | "The 6F Z4 Guiding Catheter is manufactured under the same Summary of Non-The of 24 Galling Catalonian (sic) processes and equivalent clinical Data, as the 6F Launcher Guiding Catheter; the legally marketed predicate device." |
| Equivalent Indications for Use | "In addition to being technologically equivalent, the indications for use have not changed." (Indications for Use for the 6F Sherpa NX, likely a typo for Z4, are "Provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.") |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI device. The submission focuses on device design, materials, and manufacturing process equivalency to a predicate device, along with performance testing (without specifying the nature or scale of this testing). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of data is not provided for a "test set."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The device is a physical medical device (guiding catheter), not an AI algorithm requiring expert-established ground truth from a dataset. The evaluation is based on engineering principles and comparison to a predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no "test set" or associated "ground truth" to adjudicate in the context of an AI device evaluation.
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:
This information is not applicable. The document describes a physical medical device (a guiding catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical guiding catheter, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. For this type of device submission, "ground truth" would be established through engineering specifications, material testing standards, and predicate device equivalence.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical device.
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DEC 1 3 2004
Appendix 2. 510(k) Summary
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923USA |
|---|---|
| Contact Person: | Fred BoucherDirector, Regulatory Affairs978.739.3116978.777.0390Fred.Boucher@Medtronic.com |
| Date Prepared: | August 17, 2004 |
| Trade Name: | 6F Z4 Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| ClassificationName: | Percutaneous Catheter |
| Predicate Device: | 6F Launcher Guide Catheter K021256 |
| DeviceDescription: | The 6F Z4 Guide Catheter consists of a luer hub, a strain relief, inner liner, a braided wire, an outer jacket, a sleeve, a tungsten/nylon band, and a soft tip.The 6F Z4 Guide Catheter design is based on an inner lumen liner of polyethylene material. The new shaft will be comprised of an inner liner of polyethylene, an intermediate layer of Pebax, stainless steel braid wire and a Vestamid outer jacket. The braided wire, intermediate layer and outer jacket materials have been previously used in others Medtronic Guide Catheters. |
| Statement ofIntended Use: | Provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system |
| Summary ofTechnologicalCharacteristics: | In addition to being technologically equivalent to the predicate devices, the 6F Z4 Guiding Catheter has been subjected to performance testing and it has been determined that the 6F Z4 Guiding Catheter is suitable for its intended |
:
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use.
The 6F Z4 Guiding Catheter is manufactured under the same Summary of Non-The of 24 Galling Catalonian processes and equivalent clinical Data: conditions, as the 6F Launcher Guiding Catheter; the legally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2004
Medtronic Inc. c/o Mr. Fred Boucher Director, Regulatory Affairs 37A Cherry Hill Drive Danvers, MA 01923
K042489 Re:
Trade/Device Name: 6F Z4 Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 22, 2004 Received: November 23, 2004
Dear Mr. Boucher:
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.
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
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Page 2 - Mr. Fred Boucher
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) Byevisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I mis letter will and in your of substantial equivalence of your device of your device to a legally prematics noticeation. The 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 n you don't 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 other gotting s, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blimmermoser
R. 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: | K042489 |
|---|---|
| Device Name: | Medtronic 6F Sherpa NX Guiding Catheter |
| Indications for Use: | The Medtronic 6F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Sherpa NX guiding catheter is intended for used 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)
minutes in and the may
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number Joseph 2489
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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).