(209 days)
No
The device description focuses on the physical characteristics, materials, and mechanical function of the introducer kits. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies are limited to biocompatibility, simulated use, and physical/dimensional testing, which are typical for mechanical devices and do not involve AI/ML evaluation metrics.
No
The device is an introducer used to guide other therapeutic devices (e.g., pacemaker or defibrillator leads) into the coronary venous system, but it does not provide therapy itself.
No
Explanation: The device is intended to introduce various types of pacing or defibrillator leads and catheters, or to deliver contrast medium. It acts as a conduit for other devices and substances, but does not itself provide a diagnosis.
No
The device description clearly outlines physical components such as introducers, guidewires, dilators, needles, and syringes, and describes their material properties and physical characteristics. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of pacing or defibrillator leads and catheters into the coronary venous system. This is a surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical introducer designed to guide other medical devices into a specific anatomical location within the body. It is used in vivo (within the living body), not in vitro (in glass, i.e., outside the body).
- Lack of Diagnostic Function: The device itself does not perform any diagnostic testing or analysis of biological samples. Its function is purely mechanical and procedural.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not fit that description.
N/A
Intended Use / Indications for Use
For the introduction of various types of pacing or defibrillator leads and catheters.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to guide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short term application (
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
K120158 p.1. of 4
Coronary Sinus Guide & Lateral Vein Introducer Kits
Traditional 510(k
| SECTION 5: | 510(k) SUMMARY |
|---|---|
| ------------ | ---------------- |
.
E.
[as required by section 807.92(c)]
Submitter's Information: A.
AUG 1 4 2012
| Name: | Thomas Medical Products, Inc. |
|---|---|
| Address: | 65 Great Valley Parkway |
| Malvern, PA 19355 | |
| Telephone Number: | 610.651.5000 |
| Facsimile: | 610.651.5003 |
| Contact Person: | Tim Stoudt |
| Title: | Regulatory Affairs Manager |
| Date Submission Prepared: | January 11, 1012 |
в. Device Information:
Coronary Sinus Guide & Loteral Vein Introducer Kits Trade name: Classification Name(s): Cotheter Introducer (21 CFR §870.1340) Coronary Sinus Guide & Lateral Vein Introducer Kits Common or usual name(s):
C. Legally marketed device to which equivalence is claimed:
- (a) Thomas Medical Products, Inc. SafeSheath Coronary Sinus Guide & Lateral Vein Introducer Kits (K003731)
- (b) Merit Medical Systems, Inc. Impress Radiology Catheter (K053171)
- (c) Biotronik, Inc. ScoutPro ACS Coronary Sinus Lead Introducer System (K101776)
D. Description of changes:
The reason for this submission is due to improvements made to the SafeSheath Coronary Sinus Guide & Lateral Vein Introducer Kits designed to provide greater protection against environmental factors known to degrade polymers. The specific changes are:
| Element of
modification | Predicate device
K003731 | Modified
device | Reason for modification |
|----------------------------|-----------------------------|-------------------------------------|-------------------------------------------------------------------------------|
| UV Stabilization | None | 0.15 - 0.20%
Tinuvin 783
w/w | To provide UV stabilization. |
| Heat Stabilization | None | 0.08 - 0.12%
Irganox 1010
w/w | To provide long-term
thermal stabilization |
| RO tip material | Pebax 4033 w/
80% M10 W | Pebax MX-
1205 w/80%
C5 W | Material optimization to
provide greater stability
against degradation. |
Description of the device:
The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short
1
term application (