(16 days)
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No
The document describes a mechanical device (cannula) and its physical characteristics and performance testing. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used in extracorporeal cardiopulmonary bypass procedures to deliver arterial blood and cardioplegia solution, which are therapeutic interventions.
No
Explanation: The device is an arterial cannula used for delivering arterial blood, cardioplegia, and venting during cardiopulmonary bypass. It is a therapeutic device, not a diagnostic one, as it does not gather information about a patient's condition for diagnosis.
No
The device description clearly outlines a physical, sterile, disposable cannula with multiple lumens, an inflatable balloon, and radiopaque markers. This 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 "arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB)." This describes a device used in vivo (within the body) during a surgical procedure to support physiological function.
- Device Description: The description details a physical cannula with lumens and a balloon designed for insertion into blood vessels and manipulation within the circulatory system. This is consistent with a surgical device, not a device used to test samples in vitro (outside the body).
- Performance Studies: The performance studies described (Occlusion Balloon tests, Hemolysis Testing, Flow Testing, Biocompatibility Testing, Animal Testing, Clinical Investigation) are all relevant to evaluating the safety and performance of a device used in vivo during surgery. IVD performance studies would typically involve evaluating the accuracy and reliability of tests performed on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on biological samples.
N/A
Intended Use / Indications for Use
The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.
Product codes
74 DXC, 74 DWF
Device Description
The ESTECH Arterial Remote Access Perfusion Cannula is a sterile, disposable, flexible polyurethane tube with three integrated lumens and an inflatable polyurethane balloon at the distal end of the cannula. The outside diameter of the cannula is 21 French. The cannula has a central lumen for delivery of arterial blood through multiple distal outlets at a flow rate up to 5 liters per minute, a small lumen for delivery of cardioplegia or venting at the aortic root, and an additional smaller lumen for control of the distal balloon. The blood outlet ports are multiple elongated openings along the cannula proximal to the occlusion balloon. Radiopaque balloon markers and insertion depth marks aid in positioning the device. The cannulas are provided sterile in individual packages for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aorta, femoral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
- Occlusion Balloon Volume/Pressure/Diameter: This test was performed to document the inflation characteristics of the balloon up to burst. The pressure and diameter data as a function of inflation volume were collected.
- Occlusion Balloon Repeat Inflation Test: This test was performed to demonstrate that the balloon can be inflated repeatedly if necessary.
- Occlusion Balloon Inflation Hold Test: This test was performed to demonstrate that the balloon can withstand at least 6 hours of inflation.
- Hemolysis Testing: This test was performed to evaluate the cellular damage produced by the system when used during cardiac bypass procedures. An in vitro test was used to evaluate the relative effect of the ESTECH cannula in the circuit.
- Flow Testing: The pressure drop was measured for a range of arterial perfusion flow rates of 0-5 liters per minute. In additional testing, the pressure/flow characteristics of the Heartport cannula were measured.
- Biocompatability Testing: Biocompatability Testing was performed on all critical components of the Cannula to verify biocompatability.
- Animal Testing: Animal studies of the ESTECH Arterial Remote Access Cannula to evaluate the handling characteristics and to verify performance of all intended functions. The ESTECH perfusion cannula was used in all functional modes. The conclusion of this study was that complete function of the ESTECH Arterial Remote Access Perfusion Cannula and ease of use were demonstrated.
- Clinical Investigation: A Clinical Investigation was conducted to verify the safety. efficacy, and performance of the device.
Key Metrics
Not Found
Predicate Device(s)
Heartport Arterial Perfusion Systems
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
510(k) Summary
ESTECH Arterial Remote Access Perfusion Cannula
Common/Classification Name: Cardiopulmonary Bypass vascular catheter, cannula or tubing as classified under 21 CFR 870.4210
ESTECH 4115 Blackhawk Plaza Circle, Suite 100 Danville, CA 94506 925-648-2033 (Tel), 925-648-2034 (Fax)
Prepared: February 19, 1999
Legally Marketed Predicate Device A.
The ESTECH Arterial Remote Access Perfusion Cannula is substantially equivalent to perfusion cannulae currently marketed in the U.S. The ESTECH cannula is specifically equivalent to the Heartport Arterial Perfusion Systems have the same intended use, which is to provide arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass. Both systems provide occlusion of the ascending aorta with an inflatable balloon and may be used for delivery of cardioplegia through an internal lumen of the device. Additional similarities between the ESTECH Arterial Perfusion Cannula and the Heartport Cannula are the ability to monitor Aortic Root Pressure and the capability to provide Left Ventricle Venting. The ESTECH cannula is 21 French in diameter and the Heartport system is offer in 21 and 23 French diameters.
The primary difference between the systems is that the Heartport Arterial Perfusion System requires the use of the Femoral Artery Cannula and an Aortic Occlusion cannula, which must be inserted through the Femoral Artery Cannula. These functions are combined in the single device ESTECH Arterial Remote Access Perfusion Cannula. The ESTECH device delivers blood into the Aorta "Antegrade Flow" and the Heartport device delivers blood into the femoral artery "Retrograde Flow".
B. Device Description
The ESTECH Arterial Remote Access Perfusion Cannula is a sterile, disposable, flexible polyurethane tube with three integrated lumens and an inflatable polyurethane balloon at the distal end of the cannula. The outside diameter of the cannula is 21 French. The cannula has a central lumen for delivery of arterial blood through multiple distal outlets at a flow rate up to 5 liters per minute, a small lumen for delivery of cardioplegia or venting at the aortic root, and an additional smaller lumen for control of the distal balloon. The blood outlet ports are multiple elongated openings along the cannula proximal to the occlusion balloon. Radiopaque balloon markers and insertion depth marks aid in positioning the device. The cannulas are provided sterile in individual packages for single use.
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C. Indications for Use
The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.
D. Substantial Equivalence Summary
The ESTECH Arterial Remote Access Perfusion Cannula has the same intended use as the 510(k) cleared Heartport Perfusion System. Both systems provide arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass.
The primary difference is that the Heartport Arterial Perfusion System requires the use of a Femoral Artery Cannula and an Aortic Occlusion cannula, which must be inserted through the Femoral Artery Cannula. These functions are combined in the single device ESTECH Perfusion Cannula to simplify the procedure.
Another difference is the perfusion flow pattern of each system. The multiple holes along the length of the ESTECH cannula produce a normal antegrade flow pattern similar to physiological conditions of flow. Heartport produces retrograde flow from a single outlet port of the Heartport femoral cannula. Testing was performed to demonstrate that the ESTECH cannula does not induce a higher degree of hemolysis or pressure drop than expected during bypass procedures.
All materials used in the ESTECH cannula have a safe history of use in medical devices and are used by the manufacturer to produce similar 510(k) cleared devices.
The ESTECH Arterial Remote Access Perfusion Cannula is therefore substantially equivalent to currently marketed devices.
E. Technological Characteristics
See Device Description, above.
F. Testing
The laboratory testing adhered to Good Laboratory Practices guidelines.
The occlusion balloon has been tested to demonstrate that it meets performance and safety specifications as follows:
Occlusion Balloon Volume/Pressure/Diameter: This test was performed to document the inflation characteristics of the balloon up to burst. The pressure and diameter data as a function of inflation volume were collected.
Occlusion Balloon Repeat Inflation Test: This test was performed to demonstrate that the balloon can be inflated repeatedly if necessary.
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Occlusion Balloon Inflation Hold Test: This test was performed to demonstrate that the balloon can withstand at least 6 hours of inflation.
Hemolysis Testing: This test was performed to evaluate the cellular damage produced by the system when used during cardiac bypass procedures. Since all cardiac bypass procedures produce some degree of hemolysis which may be at least partially compensated for in human or animal testing, an in vitro test was used to evaluate the relative effect of the ESTECH cannula in the circuit.
Flow Testing: The pressure drop was measured for a range of arterial perfusion flow rates of 0-5 liters per minute. In additional testing, the pressure/flow characteristics of the Heartport cannula were measured. While the pressure drop was determined to be within ESTECH specifications, the outlet blood velocity of the Heartport device was determined to be unacceptable.
Biocompatability Testing: Biocompatability Testing was performed on all critical components of the Cannula to verify biocompatability.
Animal Testing: Animal studies of the ESTECH Arterial Remote Access Cannula to evaluate the handling characteristics and to verify performance of all intended functions. The ESTECH perfusion cannula was used in all functional modes. The conclusion of this study was that complete function of the ESTECH Arterial Remote Access Perfusion Cannula and ease of use were demonstrated.
Clinical Investigation: A Clinical Investigation was conducted to verify the safety. efficacy, and performance of the device.
G. Conclusions
ESTECH has demonstrated through its comparison of characteristics with predicate device and comparison of performance testing with the predicate device that the ESTECH Arterial Remote Access Perfusion Cannula is substantially equivalent to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR I I 1999
Mr. Arthur A. Bertolero Estech, Inc. 4115 Blackhawk Plaza Circle, Suite 100 Danville, CA 94506
Re : K990573 Estech Arterial Remote Access Perfusion Cannula Requlatory Class: II (Two) Product Code: 74 DXC, 74 DWF Dated: February 22, 1999 Received: February 23, 1999
Dear Mr. Bertolero:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Arthur A. Bertolero
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Allelson
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): _ K 9005 73 ________________________________________________________________________________________________________________________________________
Device Name: ESTECH Arterial Remote Access Perfusion Cannula
Indications for Use:
The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use __________________
(Optional Format 1-2-96)
M. Page.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_