ESTECH AORTIC EASY FLOW CANNULA

K060101 · Endoscopic Technologies, Inc. · DWF · May 10, 2006 · Cardiovascular

Device Facts

Record IDK060101
Device NameESTECH AORTIC EASY FLOW CANNULA
ApplicantEndoscopic Technologies, Inc.
Product CodeDWF · Cardiovascular
Decision DateMay 10, 2006
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4210
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

Sterile, single-use cardiopulmonary bypass vascular cannula; single-lumen polymer tube with wire-wrapping; distal end features multiple perforations for diffuse blood flow; barbed proximal end connects to bypass tubing; includes flexible obturator for placement/positioning. Used in clinical settings during stopped-heart surgical procedures; operated by surgeons/perfusionists. Facilitates extracorporeal circulation of blood during surgery; diffuse flow pattern minimizes jetting effects. Benefits patient by providing stable perfusion during bypass.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility testing per ISO 11193. Preclinical performance data supplied to demonstrate device meets labeled performance claims and is substantially equivalent to predicates.

Technological Characteristics

Single-lumen polymer tube; wire-wrapped construction; distal end with multiple perforations; barbed proximal connector; includes flexible obturator. Biocompatibility per ISO 11193. Non-electronic, mechanical device.

Indications for Use

Indicated for patients undergoing cardiovascular surgery requiring extracorporeal cardiopulmonary bypass (CPB) for up to 6 hours.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ | Device Information: | | |---------------------------------------|----------------------------------------------------------------| | Category | Comments | | Sponsor: | Estech | | | 2603 Camino Ramon | | | Suite 100 | | | San Ramon, CA 94583 | | | Tel: 925-866-7111 | | Correspondent Contact<br>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<br>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)<br>ESTECH Remote Access Perfusion FV<br>Cannula (K052081) | |-----------------------------------------|-----------------------------------------------------------------------------------------------------| | Predicate Device Manufacturers: | Sarns a division of Terumo<br>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
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