(88 days)
Not Found
No
The summary describes a physical modification to a cannula tip to alter blood flow patterns. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the perfusion of the ascending aorta during cardiopulmonary bypass, which is a medical procedure used to support heart and lung function during surgery. This direct involvement in supporting a vital bodily function qualifies it as a therapeutic device.
No
Explanation: The device, Medtronic DLP Arterial Cannulae, is described as being for "perfusion of the ascending aorta during short-term cardiopulmonary bypass" and involves "baffled tip design into the 22 Fr. cannula" to "impart a more diffuse pattern of blood flow." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly describes a physical medical device (cannulae) with a modified tip design, not a software-only product. The performance studies also focus on material biocompatibility and hemolytic properties, which are relevant to a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "perfusion of the ascending aorta during short-term cardiopulmonary bypass." This is a procedure performed on a patient's body, not on a sample taken from a patient's body.
- Device Description: The device is a cannula, which is a tube inserted into the body. This is a surgical/interventional device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents or instruments for diagnostic purposes.
- Performance Studies: The performance studies focus on biocompatibility and hemolytic properties, which are relevant to devices that come into contact with blood within the body, not for analyzing blood outside the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta
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)
Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard these 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
KU13013
DEC 0 4 2001
Summary of Safety and Effectiveness Information
1
DEC 0 4 2001
510(k) Summary [As Required by 21 CFR 807.92]
Submitter: Roger Brink Medtronic Cardiac Surgical Products 620 Watson SW Grand Rapids, MI 49504
| Telephone: | (616) 643-7337 |
|---|---|
| Fax: | (616) 643-1044 |
September 4, 2001 Date Summary Prepared:
- Medtronic DLP Arterial Cannulae modified Trade Name of Device: with 3D Tip - 22 Fr.
- Cardiovascular cannula Common Name of Device:
- Classification Name of Device: "Cardiopulmonary bypass vascular cannula," Class II at 21 CFR 870.4210
Predicate Substantially Medtronic DLP Arterial Cannulae, Class II at Equivalent Devices: 21 CFR 870.4210, Curved Tip Models cleared under 510(k) Number K840002, and 24 Fr. 3D Tip Models cleared under 510(k) Number K000776.
- The Medtronic DLP Arterial Cannulae with 3D Tip Description of Device: represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. This baffled tip imparts a more diffuse cannula. pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.
- Intended Use of Device: These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.
| Special 510(k) Notification | 22 Fr. Arterial Cannulae with 3D Tip | Confidential |
|---|---|---|
| Medtronic, Inc. | ||
| Medtronic Cardiac Surgical Products | 9/4/01 | 33 |
2
Comparison to Existing Predicate Devices
The Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr. are substantially equivalent to existing Medtronic DLP Arterial Cannulae. The existing cannulae have been modified to include a baffled tip, which features side exit holes and scoop-shaped exit ports on the outside of the tip surface. The indications for use for both the existing and modified devices are identical, and the addition of a baffled tip feature does not represent a change to the fundamental scientific technology of the devices.
Summary of Non-Clinical Performance Data
Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard these cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (✓ | OR | Over-The-Counter-Use |
| -------------------------------------- | -------------------------------------------- | ---- | ---------------------- |
|---|
| Special 510(k) Notification | 22 Fr. Arterial Cannulae with 3D Tip | Confidential |
|---|---|---|
| Medtronic, Inc. | ||
| Medtronic Cardiac Surgical Products | 9/4/01 | 35 |