(27 days)
No
The summary describes a physical guiding catheter and its functional testing, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device, a guiding catheter, is used to introduce other therapeutic devices, but it is not therapeutic itself.
No
The device, a guiding catheter, provides a pathway for therapeutic devices and does not itself diagnose any condition. Its description and intended use focus on its function in delivering other devices, not on identifying diseases or conditions.
No
The device description clearly outlines physical components like an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band, and a soft distal tip, indicating it is a hardware device.
No, this device 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" and is used "in the coronary or peripheral vascular system." This describes a device used in vivo (within the body) for a therapeutic or interventional purpose.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body.
- Device Description: The description details the physical construction of a catheter, which is a device inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on biological materials, or providing diagnostic information based on laboratory analysis.
The Medtronic Launcher Guiding Catheter is a catheter used in interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.
Product codes
DQY
Device Description
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.
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)
Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (
§ 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
NOV 6 2002
Special 510(k) Notification Medtronic, Inc. 8F Launcher Guiding Catheter
Section 9
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
1. Identifying Information
| (a) Submitters Name: | Medtronic AVE, Inc.
37A Cherry Hill Drive
Danvers, MA 01923 |
|-------------------------------|-------------------------------------------------------------------|
| (b) Contact Person: | Fred L. Boucher R.A.C.
(978) 777-0042 |
| (c) Classification Name: | Percutaneous Catheter
(21 CFR Part 870.1250) |
| (d) Proprietary Name: | Medtronic 8F Launcher™ Guide Catheter |
| (e) Name of Predicate Devices | Medtronic® 7F Launcher™ Guide Catheter
K022764 |
2. Description
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.
3. Intended Use
The Medtronic Launcher Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.
4. Technological Characteristics
The 8F Launcher Guide Catheters are manufactured similar to the legally marketed predicate 7F Guide Catheters.
The manufacturing processes, materials and design are substantially equivalent to the 7F Launcher Guide Catheter.
1
Special 510(k) Notification Medtronic, Inc. 8F Launcher Guiding Catheter
-
- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (Labels | Values |
|-------------------------|-------------------------|
| Prescription Use | \checkmark |
| Over-The-Counter Use | |
- Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (Labels | Values |
(Per 21 CFR 801.109)