(164 days)
Not Found
No
The summary describes a physical catheter device and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a guide catheter for delivering contrast media or other devices, and not for directly treating a condition. Its function is to facilitate other procedures rather than providing a therapeutic effect itself.
Yes
The device is designed for the delivery of contrast media, which is used to enhance the visibility of structures during X-ray imaging for diagnostic purposes (e.g., visualizing the coronary venous system). While it also delivers Biotronik devices, its explicit function for contrast media delivery makes it a diagnostic device at least in part.
No
The device description clearly details a physical catheter with a shaft, tip, hub, and other hardware components intended for insertion into the body. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- ScoutPro Inner Catheter Function: The ScoutPro Inner Catheter is a medical device used inside the body (in vivo) to deliver contrast media or other devices directly into the coronary venous system. It is a tool for accessing and navigating within the cardiovascular system.
The device's function is entirely focused on direct intervention within the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik devices into the left ventricular coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen.
Product codes
DQY
Device Description
The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The guide catheters serve as a conduit to guide devices, including guidewires, or to deliver contrast medium into specific branches of the coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. ScoutPro Inner Catheters come with a 50° to 90° tip angle. They are designed as single use devices and for short term application (
§ 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
K/0/0/5
510(k) SUMMARY
Submitter's Information: A.
Name:
Address:
Title:
SEP 2 3 2010
Thomas Medical Products - A GE Healthcare Company 65 Great Valley Parkway Malvern, PA 19355 Telephone Number: 610.651.5000 Facsimile: 610.651.5003 Contact Person: Tim Stoudt Manager, QA / RA Date Submission Prepared: February 26, 2010
B. Device Information:
| Trade name: | ScoutPro Inner Catheters |
|---|---|
| Classification Name(s): | Percutaneous Catheter (21 CFR §870.1250) |
| Common or usual name(s): | Guide catheters and accessories |
C. Legally marketed device to which equivalence is claimed:
Guidant Corporation Rapido™ Guiding Catheter (K021455) and Merit Medical Systems, Inc. Impress Radiology Catheter (K053171)
D. Description of the device:
The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The guide catheters serve as a conduit to guide devices, including guidewires, or to deliver contrast medium into specific branches of the coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. ScoutPro Inner Catheters come with a 50° to 90° tip angle. They are designed as single use devices and for short term application (