(43 days)
Edwards Lifesciences Arterial Perfusion Cannula
Not Found
No
The device description and performance studies focus on the physical characteristics and functional equivalence of a polymeric tube for blood return, with no mention of AI/ML technologies or data processing.
Yes
The device is used to return oxygenated blood to a patient during cardiopulmonary bypass procedures, which is a therapeutic intervention aimed at supporting patient health during surgery.
No
The device description clearly states its purpose is to return oxygenated blood to a patient during cardiopulmonary bypass procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a polymeric tube and describes physical characteristics like reinforcement and suture rings, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Edwards Lifesciences Arterial Perfusion Cannulae II are described as polymeric tubes used to return oxygenated blood to a patient during cardiopulmonary bypass procedures. This is a device used in vivo (within the body) to facilitate a medical procedure, not to analyze a sample in vitro (outside the body).
- Intended Use: The intended use is for arterial perfusion in an extracorporeal circuit, which is a surgical procedure involving the circulatory system. This is not a diagnostic test.
The description clearly indicates a device used directly on a patient during surgery, not a test performed on a biological sample.
N/A
Intended Use / Indications for Use
The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Submitter: | Edwards Lifesciences Research Medical, Inc. |
|---|---|
| Contact Person: | John W. Nicholson, Senior Regulatory Affairs Associate |
| 6864 South 300 West | |
| Midvale, UT 84047 | |
| 801-565-6282 | |
| Date Prepared: | December 18, 2007 |
| Trade Name: | Edwards Lifesciences Arterial Perfusion Cannula II |
| Classification Name: | Cardiovascular Diagnostic Devices, CFR 870.1300, Catheter |
| Cannula, Product Code DQR, Class II | |
| Predicate Device: | Edwards Lifesciences Arterial Perfusion Cannula |
Device Description: Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.
The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.
The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Intended Use: The Edwards Lifesciences Arterial Perfusion Cannula is indicated for arterial perfusion in the extracorporeal circuit for