(26 days)
Not Found
No
The description focuses on the physical components and intended use of a guide catheter, with no mention of AI or ML capabilities.
No
The device is described as providing a pathway for other therapeutic devices, not as a therapeutic device itself.
No
This device is a guide catheter designed to provide a pathway for therapeutic devices, not to diagnose conditions.
No
The device description clearly outlines physical components like a luer hub, shaft, marker band, and soft tip, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Medtronic 8F Sherpa NX Guide Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed 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 test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the physical components of a catheter designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. The Sherpa NX Guide Catheter's function is purely mechanical and procedural, facilitating the delivery of other devices within the body.
N/A
Intended Use / 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.
Product codes
DQY
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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 Vascular
37A Cherry Hill Drive
Danvers, MA 01923
USA |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark Puopolo
Sr. Regulatory Affairs Specialist
978.739.3108
978.777.0390
mark.puopolo@medtronic.com |
| Date Prepared: | February 8, 2006 |
| Trade Name: | 8F Sherpa NX Guiding Catheter |
| Common Name: | Percutaneous Catheter |
| Classification
Name: | Percutaneous Catheter |
| Predicate Device: | 7F Sherpa NX Guide Catheter (K042489)
8F Launcher Guide Catheter (K023402) |
| Device
Description: | 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. |
| 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 |
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