(26 days)
The Medtronic 8F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 8F Sherpa NX guiding catheter is intended for use in the coronary or peripheral vascular system.
The 8F Sherpa NX guide catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary (transition) segment, a primary segment, primary (transition) segment, tungsten marker band. a segment sleeve and a soft tip. The 8F Sherpa NX Guide Catheter design is based on a four layer design with an inner liner of polyethylene.
This submission K060418 is for a guiding catheter, not an AI device. Therefore, the questions related to AI device performance are not applicable.
The 510(k) summary indicates that the device's substantial equivalence is based on:
- Technological equivalence to predicate devices (7F Sherpa NX Guide Catheter K042489 and 8F Launcher Guide Catheter K023402).
- Performance testing to demonstrate suitability for its intended use.
- Manufacturing conditions, processes, and materials being similar to predicate devices.
- Indications for use remaining unchanged from predicate devices.
Since this is a traditional medical device and not an AI-powered one, the requested information about acceptance criteria for AI devices, test set details, expert ground truth, MRMC studies, standalone performance, training set, etc., are not presented in this document.
The document states: "The 8F Sherpa NX Guiding Catheter has been subjected to performance testing and it has been determined that the 8F Sherpa NX Guiding Catheter is suitable for its intended use. Summary of Non-The 8F Sherpa NX Guiding Catheter is manufactured under clinical Data: the same conditions, using the similar processes and equivalent materials, as the 7F Sherpa NX Guiding Catheter; and 8F Launcher Guiding Catheter, the legally marketed predicate devices."
This implies that the acceptance criteria for this device would have been related to the physical and functional performance of the catheter (e.g., burst pressure, tensile strength, kink resistance, lubricity, torqueability, trackability, etc.) to ensure it is safe and effective for its intended purpose of providing a pathway for other therapeutic devices. However, the specific acceptance criteria and the detailed results of these performance tests are not provided in this 510(k) summary. The summary only states that such testing was performed and confirmed suitability for use, consistent with predicate devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circle with a figure inside that appears to be in motion. Below the circle is the word "Medtronic" in a bold, sans-serif font.
Medironic Vascular 37 A Cherry Hitl Dave Danvers, MA 01924 www.medironices.o
16| 978,"77V,0047 שירות שירות אתר אתר אתר
510(k) Summary
| Submitter: | Medtronic Vascular37A Cherry Hill DriveDanvers, MA 01923USA |
|---|---|
| Contact Person: | Mark PuopoloSr. Regulatory Affairs Specialist978.739.3108978.777.0390mark.puopolo@medtronic.com |
| Date Prepared: | February 8, 2006 |
| Trade Name: | 8F Sherpa NX Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| ClassificationName: | Percutaneous Catheter |
| Predicate Device: | 7F Sherpa NX Guide Catheter (K042489)8F Launcher Guide Catheter (K023402) |
| DeviceDescription: | The 8F Sherpa NX guide catheter consists of a luer hub, strainrelief, a shaft (outer jacket, braid wire, an intermediate layer,and inner liner), a secondary (transition) segment, a primarysegment, primary (transition) segment, tungsten marker band.a segment sleeve and a soft tip.The 8F Sherpa NX Guide Catheter design is based on a fourlayer 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 |
page 1 of 2
<0035
{1}------------------------------------------------
K060418
In addition to being technologically equivalent to the Summary of Technological predicate devices, the 8F Sherpa NX Guiding Catheter has been subjected to performance testing and it has been Characteristics: determined that the 8F Sherpa NX Guiding Catheter is suitable for its intended use. Summary of Non-The 8F Sherpa NX Guiding Catheter is manufactured under clinical Data: the same conditions, using the similar processes and equivalent materials, as the 7F Sherpa NX Guiding Catheter; and 8F Launcher Guiding Catheter, the legally marketed predicate devices. In addition to being technologically equivalent, the indications for use have not changed.
Page 2 of 2
0026
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Medtronic Vascular c/o Mr. Mark Puopolo Sr. Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923
Re: K060418 8F Sherpa NX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: February 15, 2006 Received: February 17, 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 Found, Trug, 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.
{3}------------------------------------------------
Page 2 - Mr. Mark Puopolo
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Abimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Medtronic® 8F Sherpa NX guiding Catheter
Indications For Use: The Medtronic 8F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 8F Sherpa 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
Bhumman
h Slan-Off Division of Cardiovascular Devices
§ 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).