The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.

Device Description

The ESTECH EasyFlow Cannula with Guidewire is a sterile, single-use device. The single-lumen wire reinforced polymer tube incorporates 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 and an optional stylet which inserts into the obturator to provide additional column strength for insertion. The product also comes with a 0.035" diameter guidewire, up to 3 vessel dilators, an 18 gauge. needle, and scalpel for introduction

AI/ML Overview

The provided text describes the ESTECH EasyFlow Cannula with Guidewire and its premarket notification for substantial equivalence, but it does not contain information related to acceptance criteria, specific device performance numbers, or a study design with sample sizes, ground truth establishment, or expert involvement.

The document states:

"Bench testing has demonstrated that the device meets the proposed product specifications."
"Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993"

However, it does not provide details on:

A table of acceptance criteria and the reported device performance: The document mentions "proposed product specifications" and "compliance with ISO 10993" but does not detail what these specifications or the outcome of the compliance testing were.
Sample size used for the test set and the data provenance: No sample sizes or data provenance are mentioned for any testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth creation process is described.
Adjudication method for the test set: Not applicable as no ground truth creation process is described.
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: Not applicable. This device is a medical cannula, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical cannula, not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" for a medical device like this would typically involve engineering specifications, material properties, and functional performance metrics, not diagnostic "ground truth."
The sample size for the training set: Not applicable as there is no mention of a "training set" for this type of device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on establishing substantial equivalence to predicate devices based on design, materials, manufacturing, packaging, and intended use, along with general statements about bench testing and biocompatibility. It does not present a detailed study with specific acceptance criteria and performance data in the format requested.

Summary

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KC091542

ESTECH EasyFlow Cannula with Guidewire Premarket Notification

Section 5: 510(k) Summary of Safety and Effectiveness

Device Information:

OCT 20 2009

Category	Comments
Sponsor:	ESTECH, Inc.2603 Camino RamonSuite 100San Ramon, CA 94583Tel: 925-543-2110
Correspondent:	Tamer Ibrahim
	Vice President, R&D, QA/RA2603 Camino RamonSan Ramon, CA 94523
Contact Information:	Tel: 925-543-2110Fax: 925-866-7117
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 EasyFlow Cannula with
	Guidewire

Predicate Device Information:

Predicate Device:	ESTECH Aortic EasyFlow Cannula
	(K060101)
Predicate Device Manufacturer:	ESTECH, Inc.
Predicate Device Common Name:	Cardiopulmonary bypass vascular cannula
Predicate Device Classification:	21 CFR 870.4210
Predicate Device Classification & Code:	Class II, DWF
Predicate Device:	Medtronic EOPA Elongated One-PieceArterial Cannula with Guidewire (K000274)
Predicate Device Manufacturer:	Medtronic, Inc.
Predicate Device Common Name:	Cardiopulmonary bypass vascular cannula
Predicate Device Classification:	21 CFR 870.4210
Predicate Device Classification & Code:	Class II, DWF

Predicate Device:	Edwards Lifesciences Venous Flex IIPeripheral And Intra-Operative AccessVenous Return Cannulae (K974259)
Predicate Device Manufacturer:	Edwards Lifesciences, Inc.
Predicate Device Common Name:	Cardiopulmonary bypass vascular cannula
Predicate Device Classification:	21 CFR 870.4210

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Endoscopic Technologies, Inc.

ESTECH EasyFlow Cannula with Guidewire Premarket Notification

Predicate Device Classification & Code:	Class II, DWF
-----------------------------------------	---------------

Predicate Device:	ESTECH Percutaneous Insertion Dilator Kit(K070749)
Predicate Device Manufacturer:	ESTECH, Inc
Predicate Device Common Name:	Vessel dilator for percutaneouscatheterization
Predicate Device Classification:	21 CFR 870.1310
Predicate Device Classification & Code:	Class II, DRE

b. Date Summary Prepared

19May09

c. Description of Device

d. Intended Use

The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.

e. Comparison to Predicate Device

The ESTECH EasyFlow Cannula with Guidewire is identical in technology, design, materials, manufacture, and packaging to the ESTECH Aortic EasyFlow Cannula (K060101) with the addition that it is packaged with a guidewire and accessory introduction components including scalpel, needle, and dilators. A small hole has been added to the cannula and obturator tips to facilitate pass through of the guidewire. The ESTECH EasyFlow Cannula with Guidewire is similar in intended use to the Medtronic EOPA Elongated One-Piece Arterial Cannula with Guidewire that it is intended for use with cardiopulomonary bypass as an arterial return cannula. The ESTECH EasyFlow Cannula with Guidewire is similar in intended use to the Edwards Lifesciences Venous Flex II Peripheral

Section 5, Page 2

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Endoscopic Technologies, Inc.

And Intra-Operative Access Venous Return Cannulae which are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e right atrial appendage and right atriotomy access is desired.

ESTECH concludes that the ESTECH EasyFlow Cannula with Guidewire is substantially equivalent to the predicate devices.

f. Summary of Supporting Data

Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993

Bench testing has demonstrated that the device meets the proposed product specifications.

CONFIDENTIAL

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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 circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding a stylized image of an eagle. The eagle is depicted with its wings spread, and its body is formed by three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

OCT 20 2009

Endoscopic Technologies, Inc. c/o Mr. Tamer Ibrahim Vice President 2603 Camino Ramon, Suite 100 San Ramon, CA 94583

K091542 Re:

ESTECH EasyFlow Cannula with Guidewire Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: September 21, 2009 Received: September 23, 2009

Dear Mr. Ibrahim:

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 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.

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

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Page 2 -- Mr. Tamer Ibrahim

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Dovices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Section 4: Indications for Use

510(k) Number (if known): Ke99542

Device Name: ESTECH EasyFlow Cannula with Guidewire

Indications For Use:

The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for 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 1
	Cardiovascular Devices
510(k) number	K091542

CONFIDENTIAL

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).