(57 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of a physical cannula with an inflatable balloon. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is intended for use in cardiovascular surgery procedures requiring cardiopulmonary bypass (CPB), which is a medical procedure used to temporarily take over the function of the heart and lungs. It also delivers cardioplegia solution to protect the heart during surgery. These are direct interventions aimed at treating a medical condition or supporting bodily functions.
No
The device is described as a perfusion cannula intended for use in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass. Its function is to deliver arterial blood, cardioplegia solution, and vent the aortic root, and it is used to occlude the ascending aorta. These are therapeutic and supportive functions, not diagnostic ones.
No
The device description clearly indicates it is a physical, disposable medical device made of polyurethane with lumens, a balloon, and insertion depth marks. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB)." This describes a surgical intervention and support system, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical cannula with lumens and a balloon for delivering fluids and occluding the aorta during surgery. This is a medical device used in vivo (within the body) during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing of a sample.
The device is a surgical tool used to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (
§ 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
OCT 2 2 2003
ਤ ਤੋਂ ਜਾਣ ਦੀ ਜ
510(k) Summary
A. Submitter / 510(k) Sponsor: ESTECH, Inc. 4135 Blackhawk Plaza Circle Suite 150 Danville, CA 94506 Tel: 925-648-3500 Fax: 925-648-3507 Contact: Arthur Bertolero Date Prepared: 2002-09-05
B. Device Name:
Remote Access Perfusion Cannula Left Axillary 21 French
Common/Generic Device Name: Cannula
Classification Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass under 21 CFR 870.4210
C. Predicate Device(s)
| Predicate Device Name: | ESTECH Remote Access
Perfusion Cannula | Axillary Access Arterial
Cannula |
|-------------------------------------------|-------------------------------------------|-------------------------------------|
| Manufacturer: | ESTECH | Edwards Lifesciences |
| 510(k) Number: | K990573 | K002578 |
| Substantial Equivalence
Decision Date: | 1999-03-11 | 2002-04-11 |
D. Device Description
The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is a disposable 31 cm long flexible polyurethane tube with three (3) lumens with an inflatable polyurethane balloon at the distal end of the cannula. The inflatable balloon has elastomeric properties designed to provide aortic occlusion in a range of aorta sizes with internal diameters from 22 mm to 34 mm. The outside diameter of the cannula is 21 Fr. (7 mm). The cannula has a central lumen for the delivery of arterial blood through multiple distal outlets at flow rates of 1.0 to 5.0L/min, a lumen that communicates with the aorta in the area of the aortic root for delivery of cardioplegia solution and left ventricle venting, and a small lumen for control of the distal balloon. Radio-opaque arch segment of cannula and insertion depth marks aid in positioning the device. The Cannula are provided sterile in individual packages for single use.
1
Image /page/1/Picture/0 description: The image contains the word "ESTECH" in a bold, sans-serif font inside a black oval. Below the oval, the words "LEAST INVASIVE CARDIAC SURGERY" are printed in a smaller, sans-serif font. The text is arranged in a way that suggests a logo or branding for a medical company specializing in minimally invasive heart surgery.
E. Indications for Use
The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (