(177 days)
Not Found
No
The device description and performance studies focus on material properties and mechanical modifications, with no mention of AI or ML technologies.
No
The device is described as being for "collection of venous blood" during surgery, not for treating a disease or condition. Its purpose is to facilitate a surgical procedure (cardiopulmonary bypass), acting as a conduit rather than providing therapy.
No
Explanation: The device is described as a cannula intended for collecting venous blood during cardiopulmonary bypass surgery. Its function is to facilitate blood collection, not to identify, monitor, or examine a health condition or disease.
No
The device description clearly states it is a physical cannula with a malleable wire/tube assembly, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of venous blood from the heart during surgery. This is a procedure performed on the patient's body, not a test performed on a sample of the patient's body outside of the body.
- Device Description: The device is a cannula designed to be inserted into the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing a sample of blood or other bodily fluid in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for a disease.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical tool for collecting a sample from the body, not for analyzing that sample.
N/A
Intended Use / Indications for Use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.
Product codes
DWF
Device Description
The Medtronic DLP Malleable Single Stage Venous Cannulae represent modified versions of existing Medtronic Single Stage Venous Cannulae. The proposed change involves the incorporation of a malleable wire/tube assembly embedded within the wall of the cannula. This malleable wire/tube assembly allows the cannula body to be shaped into a surgeon preferred position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right side of the heart via the superior and inferior vena cava
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)
Non-Clinical Performance Data: Material biocompatibility 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
KO22272
Section 2: 510(k) Summary and Certification
JAN 0 8 2003
510(k) Summary
> Medtronic
Medtronic Cardiac Surgical Products
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 |
| Date Summary Prepared: | July 11, 2002 |
| Trade Name of Device: | Medtronic DLP Malleable Single Stage Venous
Cannula |
| Common Name of Device: | Cardiovascular cannula |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula,"
Class II at 21 CFR 870.4210 |
| Predicate Substantially
Equivalent Devices: | Medtronic DLP Single Stage Venous Cannulae,
Class II at 21 CFR 870.4210, cleared under 510(k)
Number K845045 |
| Description of Device: | The Medtronic DLP Malleable Single Stage Venous
Cannulae represent modified versions of existing
Medtronic Single Stage Venous Cannulae. The proposed
change involves the incorporation of a malleable wire/tube
assembly embedded within the wall of the cannula. This
malleable wire/tube assembly allows the cannula body to
be shaped into a surgeon preferred position. |
| Intended Use of Device: | These cannulae are intended for collection of venous
blood from the right side of the heart via the superior and
inferior vena cava during cardiopulmonary bypass surgery. |
| Comparison to Existing Predicate Devices | The Medtronic DLP Malleable Single Stage Venous Cannulae are substantially
equivalent to existing Medtronic DLP Single Stage Venous Cannulae. The existing |
| 510(k) Premarket Submission | Malleable Single Stage Venous Cannulae
Confidential |
| Medtronic, Inc. | |
7/11/02
6
1
cannulae have been modified to include a malleable wire/tube assembly embedded within the cannula body. The indications for use for both the existing and modified devices are identical, and the addition of wire / tube assembly does not represent a change to the fundamental scientific technology of the devices.
Summary of Non-Clinical Performance Data
Material biocompatibility 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 (