(118 days)
Not Found
No
The device description and intended use describe a mechanical cannula for blood flow during surgery, with no mention of AI or ML capabilities.
No.
The device facilitates extracorporeal cardiopulmonary bypass during surgery, which is a supportive function rather than directly treating a disease or condition.
No
Explanation: The device is a cannula used for perfusion during cardiovascular surgery, which is a therapeutic intervention, not a diagnostic process. It facilitates the circulation of blood rather than gathering information about a patient's condition.
No
The device description clearly states it is a sterile, single-use, physical device made of a polymer tube with wire-wrapping and perforations, intended for surgical insertion. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass. This is a surgical procedure involving the direct manipulation of the patient's circulatory system.
- Device Description: The device is a cannula designed to be inserted into the aorta to facilitate blood flow during surgery. It is a physical device used in vivo (within the body).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the ESTECH Aortic Easy Flow Cannula is a surgical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
Product codes
DWF
Device Description
The Estech Aortic Easy Flow Cannula is a sterile, single-use, device. The single-lumen polymer tube incorporates wire-wrapping with multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Biocompatibility testing consistent with ISO 11193 is presented in Section 15. The ESTECH Aortic Easy Flow Cannula met the criteria for biocompatibility.
Preclinical performance data was supplied to demonstrate that the ESTECH Aortic Easy Flow Cannula can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
| Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Estech |
| 2603 Camino Ramon | |
| Suite 100 | |
| San Ramon, CA 94583 | |
| Tel: 925-866-7111 | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Device Classification & Code: | Class II, DWF (21 CFR 870.4210) |
| Device Classification Name: | Cardiopulmonary bypass vascular catheter, cannula |
| or tubing | |
| Device Proprietary Name: | ESTECH Aortic Easy Flow Cannula |
Section 5: 510(k) Summary
Predicate Device Information:
| Predicate Devices: | Low Jetting Aortic Arch Cannula (K934127)
ESTECH Remote Access Perfusion FV
Cannula (K052081) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Sarns a division of Terumo
ESTECH, Inc. |
| Predicate Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Predicate Device Classification: | 21 CFR 870.4210 |
| Predicate Device Classification & Code: | Class II, DWF |
b. Date Summary Prepared
6 January 2006
c. Description of Device
The Estech Aortic Easy Flow Cannula is a sterile, single-use, device. The single-lumen polymer tube incorporates wire-wrapping with multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula.
1
d. Intended Use
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures reguiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
e. Comparison to Predicate Device
The ESTECH Aortic Easy Flow Cannula is identical in intended use, technology, design, to that of the Low Jetting Aortic Arch Cannula (K934127). The ESTECH Aortic Easy Flow Cannula is identical in materials, manufacture, and packaging to the ESTECH Remote Access Perfusion FV Cannula (K052081).
Estech concludes that the ESTECH Aortic Easy Flow Cannula is substantially equivalent to the predicate devices.
f. Summary of Supporting Data
Biocompatibility testing consistent with ISO 11193 is presented in Section 15. The ESTECH Aortic Easy Flow Cannula met the criteria for biocompatibility.
Preclinical performance data was supplied to demonstrate that the ESTECH Aortic Easy Flow Cannula can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 10 2005
Endoscopit Technologies, Incorporated c/o Mr. Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, California 94501
Re: K060101
Trade/Device Name: ESTECH Arotic Easy Flow Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: April 17, 2006 Received: April 28, 2006
Dear Mr. Coombs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Craig Coombs
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Signature
Bram D. Zuckerman, M.D. Director / Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ESTECH Aortic Easy Flow Cannula Premarket Notification
Section 4: Indications for Use Statement
510(k) Number (if known):
ESTECH Aortic Easy Flow Cannula Device Name:
Indications For Use:
The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __
(Division/Sign-Off:
Division of Cardiovascular Devices
510(k) Number
CONFIDENTIAL
Section 4