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.

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.

AI/ML Overview

The provided S510(k) summary for the ESTECH Arterial Remote Access Perfusion Cannula focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of its performance against explicit acceptance criteria. The document describes various tests performed but does not explicitly state quantitative acceptance criteria or report specific performance values from these tests that can be directly compared in a table.

Therefore, many of the requested sections below cannot be fully answered due to the nature of the provided document, which is a regulatory submission for substantial equivalence based on a predicate device, rather than a standalone performance study with defined criteria.

Here's an analysis of the provided information, addressing what can be inferred and highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the tests performed, nor does it provide specific numerical performance results for the ESTECH Arterial Remote Access Perfusion Cannula that would allow for a direct comparison in a table format.

The document implicitly suggests that the acceptance criterion for most tests was to demonstrate performance comparable or superior to the predicate device or within "ESTECH specifications." However, these specifications are not detailed or quantified.

Test Performed	Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Quantified in Document)
Occlusion Balloon Volume/Pressure/Diameter	Not explicitly stated; "document the inflation characteristics up to burst"	Not quantified; states data was "collected"
Occlusion Balloon Repeat Inflation	Not explicitly stated; "demonstrate that the balloon can be inflated repeatedly"	Not quantified
Occlusion Balloon Inflation Hold	Not explicitly stated; "demonstrate that the balloon can withstand at least 6 hours of inflation"	Not quantified
Hemolysis Testing	Not explicitly stated; "not induce a higher degree of hemolysis...than expected"	Not quantified; "in vitro test was used to evaluate the relative effect"
Flow Testing (Pressure Drop)	"within ESTECH specifications" (specifications not provided)	Not quantified for ESTECH; predicate's "outlet blood velocity...unacceptable"
Biocompatibility Testing	Not explicitly stated; "verify biocompatibility"	States "performed on all critical components"
Animal Testing	Not explicitly stated; "evaluate handling characteristics and verify performance of all intended functions"	"complete function...and ease of use were demonstrated"
Clinical Investigation	Not explicitly stated; "verify the safety, efficacy, and performance of the device"	States "conducted to verify the safety, efficacy, and performance"

2. Sample Size Used for the Test Set and the Data Provenance

The document does not provide specific sample sizes for the test sets used in any of the described tests (Occlusion Balloon, Hemolysis, Flow, Biocompatibility, Animal Testing, Clinical Investigation).

Animal Testing: Mentioned as "Animal studies." No number of animals or specifics provided.
Clinical Investigation: Mentioned as "A Clinical Investigation." No number of participants or specifics provided.

The data provenance is generally implied as laboratory testing conducted by ESTECH. The country of origin for the studies is not specified but the company location is in Danville, CA, USA, and the submission is to the FDA. The studies are prospective in nature, as they were conducted to test the performance of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The tests described (e.g., balloon inflation, hemolysis, flow) appear to be objective engineering and biological tests that do not typically rely on expert consensus for ground truth but rather on measured physical or chemical properties. For animal and clinical studies, the evaluation would be performed by veterinarians and clinicians, respectively, but their numbers and qualifications are not disclosed.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests described are not of a nature that would typically involve an adjudication method like 2+1 or 3+1 (which are common in image interpretation studies).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable to the provided document. The ESTECH Arterial Remote Access Perfusion Cannula is a medical device (a cannula), not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study or the effect of AI assistance on human readers is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the various tests would be based on:

Engineering Measurements: For occlusion balloon characteristics and flow testing (e.g., pressure, diameter, volume, burst pressure, flow rate).
Laboratory Assays: For hemolysis testing (e.g., free hemoglobin levels).
Standardized Biocompatibility Tests: For biocompatibility (e.g., cytotoxicity, irritation, sensitization).
Clinical Observations/Outcomes: For animal and clinical testing (e.g., successful cannulation, adequate perfusion, absence of adverse events, physiological parameters).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for a physical medical device.

Summary

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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

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C. Indications for Use

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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned within a circle that contains the text "HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.

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:

(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)

Over-The-Counter Use __________________

(Optional Format 1-2-96)

M. Page.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_

Regulation Number and Section

§ 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).