(29 days)
No
The summary describes a physical medical device (a guide catheter) and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as providing a pathway for other therapeutic devices, not performing therapy itself.
No
Explanation: The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway for therapeutic devices and is not described as being used for diagnosis.
No
The device description clearly outlines physical components like a luer hub, shaft, marker band, and soft tip, indicating it is a hardware device, not software-only.
Based on the provided information, the Medtronic 7F Sherpa NX Guide Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" within the coronary or peripheral vascular system. This describes a device used in vivo (within the body) for a therapeutic procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details the physical components of a catheter designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Medtronic 7F Sherpa NX Guide Catheter is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 7F Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.
Product codes
DQY
Device Description
The 7F 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, tungsten marker band, a segment sleeve and a soft tip. The 7F Sherpa NX Guide Catheter design is based on a four layer design with an inner linner of polyethylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The 7F Sherpa NX Guiding Catheter has been subjected to performance testing and it has been determined that the 7F Sherpa NX Guiding Catheter is suitable for its intended use. The 7F Sherpa NX Guiding Catheter is manufactured under the same conditions, using the similar processes and equivalent materials, as the 6F Sherpa NX Guiding Catheter; the legally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
.
AUG 5 - 2005
510(k) Summary
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923
USA |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fred Boucher
Director, Regulatory Affairs
978.739.3116
978.777.0390
Fred.Boucher@Medtronic.com |
| Date Prepared: | July XX, 2005 |
| Trade Name: | 7F Sherpa NX Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| Classification
Name: | Percutaneous Catheter |
| Predicate Device: | 6F Sherpa NX Guide Catheter (K042489) |
| Device
Description: | The 7F 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, tungsten marker band, a segment sleeve and a soft
tip.
The 7F Sherpa NX Guide Catheter design is based on a four
layer design with an inner linner of polyethylene. |
| Statement of
Intended 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 of
Technological | In addition to being technologically equivalent to the
predicate devices, the 7F Sherpa NX Guiding Catheter has |
1
- been subjected to performance testing and it has been Characteristics: determined that the 7F Sherpa NX Guiding Catheter is suitable for its intended use.
- The 7F Sherpa NX Guiding Catheter is manufactured under Summary of Nonthe same conditions, using the similar processes and clinical Data: equivalent materials, as the 6F Sherpa NX Guiding Catheter; the legally marketed predicate device. In addition to being technologically equivalent, the indications for use have not changed.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
Medtronic Vascular c/o Mr. Fred Boucher Director Regulatory Affairs 37A Cherry Hill Drive Danvers, CA 01923
Re: K051846
Medtronic® 7F Sherpa NX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II (Two) Product Code: DQY Dated: July 6, 2005 Received: July 7, 2005
Dear Mr. Boucher:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(t) per levice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it itgains and ment date of the Medical Device Amendments, or to Conninered prior to May 20, 2017) in accordance with the provisions of the Federal Food, DINE, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, chereleve, mains of the Act include requirements for annual registration, listing of general obtired provisions 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 If your device is elabilition (osmal controls. Existing major regulations affecting your device can may oe subject to back as a subjections, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Fred Boucher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DTT 3 iboastes of our device complies with other requirements of the Act that I DA has made a acterimaliations administered by other Federal agencies. You must of ally it cach statures and regalations and and limited to: registration and listing (21 Comply with an the 11et 6 requirements (1); good manufacturing practice requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro no begin marketing your device as described in your Section 510(k) I mis icher will and w you'll begin finding of substantial equivalence of your device to a legally premarket notification: "The Province of and this, permits 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 If you desire specific at (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Compunations on the time (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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,
Duna R. Vadines
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): | K051846 |
|---|---|
| --------------------------- | --------- |
Device Name: Device name: Medtronic® 7F Sherpa NX guiding Catheter
Indications For Use: The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 7F 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)
Dwna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko5184(c
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