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 (< 6 hours). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

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.

AI/ML Overview

The provided 510(k) summary for the ESTECH Remote Access Perfusion Cannula Left Axillary 21 French describes non-clinical performance data and a comparison to predicate devices to establish substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets specific performance thresholds in a clinical or analytical efficacy study with human or expert-based ground truth.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative, pass/fail format typical for clinical or standalone efficacy studies. Instead, it describes various performance tests conducted and generally states that the device "meets performance and safety specifications" or that results were "within specification." The comparison with predicate devices serves as the primary means of demonstrating equivalence rather than meeting independent quantitative acceptance criteria.

Feature Tested/Evaluated	Acceptance Criteria (Implied)	Reported Device Performance
Occlusion Balloon Restricted Burst Test	Demonstrate inflation characteristics up to burst in a restricted environment.	Pressure data as a function of inflation volume were collected. (Implied: Data were acceptable and did not indicate premature or uncontrolled burst within intended use pressure range.)
Occlusion Balloon Volume/Pressure/Diameter	Characterize inflation characteristics up to burst.	Pressure and diameter data as a function of inflation volume were collected. (Implied: Data were acceptable and demonstrated consistent, predictable inflation across the specified ranges, including aortic occlusion in 22mm to 34mm aorta sizes).
Occlusion Balloon Repeat Inflation Test	Demonstrate balloon can be inflated repeatedly.	Performed to demonstrate the balloon can be inflated repeatedly if necessary. (Implied: Test confirmed successful repeated inflation without failure or degradation.)
Occlusion Balloon Sustained Inflation Test	Withstand at least 6 hours of inflation.	Performed to demonstrate that the balloon can withstand at least 6 hours of inflation. (Implied: Test confirmed successful sustained inflation for at least 6 hours.)
Hemolysis Testing	Evaluate cellular damage produced by the system compared to predicate.	In-vitro test used to evaluate the relative effect of the device in the circuit as compared to the predicate devices. (Implied: Hemolysis levels were comparable to or better than predicate devices, or within acceptable limits). Note: "all cardiac bypass procedures produce some degree of hemolysis which may be at least partially compensated for in human and animal testing" suggests a comparative standard was used.
Flow Testing - Arterial Perfusion	Pressure drop across cannula for 0-5 L/min flow rates to be within specification.	Pressure drop across the cannula was measured for a range of arterial perfusion flow rates from 0-5 L/min and was within specification.
Flow Testing - Cardioplegia Delivery	Minimum cardioplegia delivery flow rates for a given pressure to be within specification.	Minimum cardioplegia delivery flow rates for a given pressure were also within specification.
Biocompatibility Testing	Materials to be biocompatible.	Completed for the currently marketed predicate device, and all materials used in the current device are identical. (Implied: The device shares the same biocompatibility profile as the predicate.)
Animal Testing	Suitable for intended use (insertion via axillary artery, placement, performance).	Performed to demonstrate that the device was suitable for its intended use in terms of insertion via axillary artery and placement. Performance of the device, including the occlusion balloon and perfusion/cardioplegia flow, are known to be safe and effective for its intended use. (Implied: Successful insertion, placement, and functional performance were observed in animal models.)

The study that proves the device meets the (implied) acceptance criteria:

The "study" consists of a series of non-clinical laboratory and animal tests, designed to demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices. These are described in Section G: "Summary of Non-Clinical Performance Data" and Section III: "Device Specifications" (though Section III is not provided in the input).

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify exact sample sizes for each test (e.g., number of balloons tested, number of flow tests performed, number of animals used). It reports results generally.
Data Provenance: All data referenced are from "laboratory testing" and "animal testing." This indicates in-vitro (bench testing) and in-vivo (animal) studies. No human data or external (country of origin) data provenance is explicitly stated, which is typical for 510(k) submissions that rely on predicate device equivalence. It explicitly states "The laboratory testing adhered to Good Laboratory Practices guidelines."

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 performed are primarily engineering and simulated physiological tests, not requiring clinical expert ground truth in the way an AI diagnostic device would. For animal testing, veterinary experts would likely be involved in assessing outcomes, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The testing described is objective, physical/physiological performance measurement, not subjective expert assessment requiring adjudication.

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 information is not applicable and therefore not provided. The device is a medical instrument (cannula) and not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable and therefore not provided. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

Bench Test Performance: For tests like burst pressure, flow rates, and sustained inflation, the "ground truth" is established by the specified engineering and material performance standards relevant to the device's function and safety. These would refer to predefined acceptable ranges or limits established by engineering design, regulatory standards, or comparison to predicate devices.
Biocompatibility: Established by adherence to material standards and previous testing on identical materials used in predicate devices.
Animal Testing: The "ground truth" is the observed physiological and mechanical performance in an animal model, validated against expected outcomes for successful device operation (e.g., proper insertion, placement, perfusion, and balloon occlusion without adverse events).

8. The sample size for the training set:

This information is not applicable and therefore not provided. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The "training" in the context of this device refers to "On-site customized training" for users, which is not a data set.

9. How the ground truth for the training set was established:

This information is not applicable and therefore not provided. As mentioned above, there is no "training set" in the context of an AI algorithm.

Summary

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K032632

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 AccessPerfusion Cannula	Axillary Access ArterialCannula
Manufacturer:	ESTECH	Edwards Lifesciences
510(k) Number:	K990573	K002578
Substantial EquivalenceDecision Date:	1999-03-11	2002-04-11

D. Device Description

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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

F. Summary of Technological Characteristics Comparison

For complete detail regarding comparison of the proposed device with predicate devices please see Section IIb of this 510(k) application. The following table lists the feature comparison of the three devices:

ESTECH RAP CannulaLeft Axillary 21Fr	ESTECH RAP Cannula(Femoral)	Edwards Axillary AccessArterial Cannula
Intended for use in arterialperfusion via axillaryartery	Intended for use in arterialperfusion via femoralartery	Intended for use in arterialperfusion via axillaryartery
Intended for short-termCPB (<6hrs)	Intended for short-termCPB (<6hrs)	Intended for short-termCPB (<6hrs)
Multi-channel, multi-function integratedcannula	Multi-channel, multi-function integratedcannula	Single-channel, single-function cannula
Single step insertion	Single step insertion	Single step insertion
Facilitates AntegradeBlood Flow	Facilitates AntegradeBlood Flow	Facilitates AntegradeBlood Flow
Low pressure/velocityblood flow system("soaker hose") viamultiple blood outlet ports	Low pressure/velocityblood flow system("soaker hose") viamultiple blood outlet ports	Higher pressure/velocityblood flow system("nozzle") via singleblood outlet port
Rated for blood flow rates1.0-5.0L/min	Rated for blood flow rates1.0-5.0L/min	Rated for blood flow rates1.0-5.0L/min
Flat-sided distal aorticocclusion balloon - moreanatomical, easierplacement, better stability	Flat-sided distal aorticocclusion balloon - moreanatomical, easierplacement, better stability	No aortic clamping.Perfusion only.
Designed to provide aorticocclusion in a range ofaorta sizes with internaldiameters from 22 mm to34 mm	Designed to provide aorticocclusion in a range ofaorta sizes with internaldiameters from 22 mm to34 mm	No aortic clamping.Perfusion only.
Usable Length = 31cm(designed for axillary	Usable Length = 81cm(designed for femoral	Usable Length = 33 cm(designed for axillary

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Outside diameter of thecannula is 21 Fr. (7 mm)Advanced over guidewireto insure accurateplacementInternal obturator toprevent kinkingRadio-opaque archsegment of cannula andinsertion depth marks aidin positioning the deviceDelivers cardioplegia andfacilitates aortic rootventingProvided sterile. Singleuse device.On-site customizedtraining	Outside diameter of thecannula is 21 Fr. (7 mm)Advanced over guidewireto insure accurateplacementInternal obturator toprevent kinkingRadio-opaque archsegment of cannula andinsertion depth marks aidin positioning the deviceDelivers cardioplegia andfacilitates aortic rootventingProvided sterile. Singleuse device.On-site customizedtraining	Outside diameter of thecannula is 22 Fr. (7.3 mm)Does not advance overguidewireWire-wrapped to preventkinkingNo radio-opaque materialsor insertion depth marksNo cardioplegia deliveryor venting. Perfusiononly.Provided sterile. Singleuse device.Unknown trainingprogram

G. Summary of Non-Clinical Performance Data

The laboratory testing adhered to Good Laboratory Practices guidlelines. All test protocols and results can be found in Section III Device Specifications of this 510(k) applications. Below is a bried summary of tests conducted.

The occlusion balloon has been tested to demonstrate that it meets performance and safety specifications as follows:

Occlusion Balloon Restricted Burst Test: This test was performed to characterize the inflation characteristics of the balloon up to burst in a restricted environment. The pressure data as a function of inflation volume were collected.

Occlusion Balloon Volume/Pressure/Diameter: This test was performed to characterize 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 Sustained Inflation Test: This test was performed to demonstrate that the balloon can withstand at least 6 hours if inflation.

Hemolysis Testing: This test was performed to evaluate the cellular damage produced by the system when used during the cardiac bypass procedures. Due to the

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Image /page/3/Picture/0 description: The image shows the logo for ESTECH Least Invasive Cardiac Surgery. The word "ESTECH" is written in large, bold, white letters inside a black oval. Below the oval, the words "LEAST INVASIVE CARDIAC SURGERY" are written in a smaller font.

fact that all cardiac bypass procedures produce some degree of hemolysis which may be at least partially compensated for in human and animal testing, an in-vitro test was used to evaluate the relative effect of the device in the circuit as compared to the predicate devices.

Flow Testing: The pressure drop across the cannula was measured for a range of arterial perfusion flow rates from 0-5 liters per minute and was within specification. Minimum cardioplegia delivery flow rates for a given pressure were also within specification.

Biocompatibility Testing: Biocompatibility testing has been completed for the currently marketed predicate device, ESTECH Remote Access Perfusion Cannula. All materials used in the manufacture of the current device are identical and thus testing will not be repeated.

Animal Testing: Animal testing was conducted to demonstrate that the device was suitable for its intended use in terms of insertion via axillary artery and placement. Performance of the device, including the occlusion balloon and perfusion/cardioplegia flow, are known to be safe and effective for its intended use as these features have either remained unchanged from the predicate device or have been demonstrated to be adequate based on the tests described above.

H. Substantial Equivalence Summary

The proposed device is an adaptation of the currently marketed remote access perfusion cannula, designed for femoral artery access. The only design changes to the current device included reducing the length of the cannula to facilitate insertion via axillary artery and changing the outlet blood port configuration to suit the new length of the device.

The proposed device has a modified indication for use statement. The new indication. for arterial perfusion by cannulation of the axillary artery, versus femoral artery, does not change the intended use of the device, which is arterial perfusion during cardiopulmonary bypass. The proposed device, therefore is substantially equivalent . to the predicate device in intended use.

ESTECH has demonstrated through its comparison of characteristics with predicate device and comparison of performance testing with predicate device that the Remote Access Perfusion Cannula LA 21 Fr is substantially equivalent to the predicate device in technology, material, manufacture and design.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

ESTECH, Inc. c/o Mr. Arthur Bertolero 4135 Blackhawk Plaza Circle, Suite 150 Danville, CA 94506

Re: K032632

Remote Access Perfusion Cannula Left Axillary 21 French Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: August 25, 2003 Received: August 29, 2003

Dear Mr. Bertolero:

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. Iisting 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.

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Page 2 – Mr. Arthur Bertolero

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) 594-4648. 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,

Q. M. Ellis

Image /page/5/Picture/4 description: The image shows a close-up of a handwritten symbol or character. It appears to be a combination of curved and straight lines, possibly representing a letter or a stylized design. The lines are thick and dark, creating a bold and distinct shape against the white background. The symbol has a loop at the top and a stroke extending downwards.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K032632

Page 1 of 1

Device Name: Remote Access Perfusion Cannula Left Axillary 21 French

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANTOHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	X
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Over-The-Counter Use
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(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K032632
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Regulation Number and Section

§ 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).