(139 days)
Not Found
Not Found
No
The summary describes a mechanical device for blood perfusion and does not mention any computational or data-driven components indicative of AI/ML.
Yes.
The device is intended for the perfusion of blood to an ischemic area of the heart, directly addressing a medical condition (ischemia) and restoring physiological function (perfusion), which aligns with the definition of a therapeutic device.
No
The device is described as an "AortoCoronary Shunt" intended for "perfusion of anticoagulated arterial blood to an ischemic area of the heart" during "CABG procedures." This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly details physical components like cannulas and tubing, and the performance studies involve material biocompatibility and mechanical testing, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "perfusion of anticoagulated arterial blood to an ischemic area of the heart" and "from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures." This describes a surgical intervention and direct treatment of a patient's circulatory system.
- Device Description: The description details a physical device (cannulas, tubing, connector) used to divert blood flow within the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) outside of the body to provide diagnostic information about a patient's condition. IVDs are primarily used for testing samples to diagnose diseases or conditions.
The device is a surgical tool used to support blood flow during a specific medical procedure.
N/A
Intended Use / Indications for Use
These devices are intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart.
These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae (2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also available separately for user convenience. The user assembles the components into the final product configuration immediately prior to use. The assembled device diverts oxygenated, arterial blood from the patient's aorta directly to one or two coronary arteries, thereby providing perfusion of an ischemic area of the heart during cardiac surgical procedures
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, aorta, coronary arteries
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)
Summary of Non-Clinical Performance Data:
Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard the AortoCoronary Shunt and Arteriotomy Cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(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 stylized human figure inside, and the word "Medtronic" written in a bold, sans-serif font below the circle. The human figure appears to be in motion, with multiple overlapping outlines suggesting movement. The logo is black and white.
APR 2 7 2000
Medtronic c Surgical Products 620 Watson, S.W. Grand Rapids, MI 49504 U.S.A. Phone (616) 643 5200
FAX (616) 643 1095
510(k) Summary [As Required by 21 CFR 807.92]
| Submitter: | James Balun
Medtronic Cardiac Surgical Products
620 Watson, S.W.
Grand Rapids, Michigan 49504 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | (616) 643 5283 |
| FAX Number: | (616) 643 5214 |
| Date Summary Prepared: | December 7, 1999 |
| Trade Name of Device: | Medtronic AortoCoronary Shunt and separately packaged Arteriotomy Cannulae |
| Common Name of Device: | Cardiovascular cannula and tubing |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula and tubing",
Class II at 21 CFR 870.4210 |
| Predicate Substantially Equivalent Devices: | Medtronic DLP Aortic Root Cannula
Class II at 21 CFR 870.4210
Medtronic DLP Y-Type Coronary Perfusion Adapter
Class II at 21 CFR 870.4210
Medtronic DLP Coronary Cannula
Class II at 21 CFR 870.4210 |
| Description of Device: | The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula
Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae
(2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also
available separately for user convenience. The user assembles the components
into the final product configuration immediately prior to use. The assembled
device diverts oxygenated, arterial blood from the patient's aorta directly to one
or two coronary arteries, thereby providing perfusion of an ischemic area of the
heart during cardiac surgical procedures |
| Intended Use of Device: | These devices are intended for the perfusion of anticoagulated arterial blood
to an ischemic area of the heart. |
Image /page/0/Picture/6 description: The image shows a sequence of numbers. The numbers are 000003. The numbers are written in a simple, sans-serif font.
1
Comparison to Predicate Devices:
The Aortic Root Cannula Assembly used in the new Medtronic AortoCoronary Shunt is identical to the predicate Medtronic DLP 10014 Aortic Root Cannula except for the substitution of a more flexible material that is used to fabricate the cannula body. The Y-Tubing Connector Assembly used in the new Medtronic AortoCoronary Shunt is very similar to the predicate Medtronic DLP 10004 Y-Type Coronary Perfusion Adapter except for material substitutions. which permit increased flexibility of this assembly as well. Finally the Arteriotomy Cannula Assemblies used in the new Medtronic AortoCoronary Shunt are substantially equivalent to the predicate Medtronic DLP 30010 and 30012 Coronary Cannula in that both the new and predicate devices are intended to deliver protective fluid (blood or cardioplegia solution) to myocardial tissue via direct cannulation of the coronary arteries.
Summary of Non-Clinical Performance Data:
Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard the AortoCoronary Shunt and Arteriotomy Cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (