The ELITE-i Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

Device Description

The Elite-i (RA) Dual Lumen (short lengths), Elite-i (Bi) Dual Lumen (standard) and Elite-i (BiX) Dual Lumen (extra-long lengths) are wire-reinforced catheters with a one-piece, dual lumen construction. The Dual Lumen Catheter is a single catheter with two separate lumens within the catheter body to collect and to return the blood. The product is offered in a range of sizes to address varying patient size requirements. The catheters are intended to be inserted via the internal jugular vein into the superior vena cava, the right atrium and the inferior vena cava (except for the short lengths which only reach the right atrium). The catheter's dual lumen construction allows for both venous drainage and reinfusion of blood during extracorporeal life support procedures. The catheters are designed for use by physicians trained in and experienced with venous catheterization and extracorporeal life support in a hospital setting. Each catheter is supplied with a tapered tip introducer to facilitate placement into the vasculature using a guide wire and following normal access techniques. In addition to the standard introducer, the Elite-i (RA) Dual Lumen Catheter (short lengths) is supplied with an extra, blunt tip introducer to accommodate user preference for placement into the right atrium. Both the catheter and introducers are radiopaque and include depth or location marks. The standard introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) guide wire (which is not included). The blunt tip introducers do not require or accommodate a guide wire. The device is supplied sterile and non-pryogenic in a peel pouch and carton. It is intended for single use.

AI/ML Overview

A table of acceptance criteria and the reported device performance:

The document describes a medical device, the Elite-i Dual Lumen Catheter family, which is a modification of a previously cleared predicate device. Instead of acceptance criteria and reported device performance in the traditional sense of AI/software performance metrics, this submission focuses on demonstrating substantial equivalence through nonclinical testing.

Here's a table based on the provided text, outlining the tests performed and the general performance conclusions:

Acceptance Criteria (Test Performed)	Reported Device Performance
Pressure/Burst	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. (Implies performance met original criteria).
Simulated Use	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. (Implies performance met original criteria).
Kink Resistance	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, design verification of spring and reinforcement modifications included kink resistance testing (Implies performance met original and new criteria).
Tensile Strength	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, design verification of spring and reinforcement modifications included tensile strength testing (Implies performance met original and new criteria).
Flow Characteristics (Flow Curves)	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, flow curves for the new configurations were generated. "Flow curves for the modified devices will be consistent with the flow-curves of the predicate devices."
Hemolysis	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. (Implies performance met original criteria).
Biocompatibility	Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable. Additionally, verification of biocompatibility for the colored caps and tantalum dots was performed. "Biocompatibility was confirmed to be acceptable."
Sterilization (for blunt tipped introducers and modified lengths)	Verification of Sterilization for blunt tipped introducers and modified lengths performed. (Implied successful verification).

Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a nonclinical testing program, building upon the original 510(k) submission for the predicate device. The core argument for substantial equivalence is that the new devices utilize the "same technological characteristics (design and materials)" as the predicate device.

For modifications, additional testing was conducted:

Flow curves for the new configurations: These were generated to confirm consistency with the predicate device.
Verification of Biocompatibility for the colored caps and tantalum dots: This addressed new materials.
Verification of Sterilization for blunt tipped introducers and modified lengths: This addressed new components and lengths.
Design verification of spring and reinforcement modifications including kink resistance and tensile strength testing: This addressed minor structural changes.

The conclusion is that the modified catheters are "equivalent to the predicate devices in all key areas of features and performance that affect safety and effectiveness based on a Risk Assessment of the modifications made."

The subsequent questions (2-9) are typically relevant for AI/ML device submissions, where statistical performance of an algorithm against a ground truth is evaluated. This document describes a traditional medical device (catheter) and its 510(k) submission based on substantial equivalence to a predicate device, not an AI/ML device. Therefore, questions 2 through 9 are not directly applicable to this particular submission.

Here's why each question is not applicable in this context:

Sample size used for the test set and the data provenance: This relates to data used to test an algorithm's performance. No such "test set" of data (e.g., images, patient records) is mentioned for this physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no diagnostic or interpretive "ground truth" being established by experts for algorithmic performance.
Adjudication method: Not applicable as there's no expert review of algorithmic outputs.
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 is specific to AI-assisted diagnostic devices. There is no AI component mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no algorithmic output to compare against a ground truth. The "ground truth" for the catheter's performance is adherence to engineering specifications and safe physiological function shown through nonclinical tests.
The sample size for the training set: Not applicable as there is no AI model requiring a training set.
How the ground truth for the training set was established: Not applicable as there is no AI model requiring a training set.

Summary

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MAY 1 6 2013

510(k) Summary

Elite-i (RA) Dual Lumen Catheter, Elite-i (Bi) Dual Lumen Catheter and Elite-i (BiX) Dual Lumen Catheter - K130639

Prepared: May 13, 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I.	Submitter Information	MAQUET Cardiopulmonary AGKehler Strasse 3176437 RastattGermany
	Contact Person:	Katrin Schwenkglenks
		Phone: 011 49 7478 921 151
		Fax: 011 49 7478 921 8667
		e-mail: Katrin.Schwenkglenks@maquet.com
	Summary Date:	May 13, 2013

II. Device Name

Proprietary:	Elite-i (RA) Dual Lumen Catheter
	Elite-i (Bi) Dual Lumen Catheter
	Elite-i (BiX) Dual Lumen Catheter
Common:	Cardiopulmonary Bypass Vascular Catheter
Classification:	Class II
Product Code:	DWF
CFR Section:	21 CFR 870.4210

Predicate Device: Avalon Elite® Bi-Caval Dual Lumen Catheter - K081820 111.

Device Description IV.

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The catheters are intended to be inserted via the internal jugular vein into the superior vena cava, the right atrium and the inferior vena cava (except for the short lengths which only reach the right atrium). The catheter's dual lumen construction allows for both venous drainage and reinfusion of blood during extracorporeal life support procedures. The catheters are designed for use by physicians trained in and experienced with venous catheterization and extracorporeal life support in a hospital setting.

Each catheter is supplied with a tapered tip introducer to facilitate placement into the vasculature using a guide wire and following normal access techniques. In addition to the standard introducer, the Elite-i (RA) Dual Lumen Catheter (short lengths) is supplied with an extra, blunt tip introducer to accommodate user preference for placement into the right atrium. Both the catheter and introducers are radiopaque and include depth or location marks. The standard introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) guide wire (which is not included). The blunt tip introducers do not require or accommodate a guide wire.

The device is supplied sterile and non-pryogenic in a peel pouch and carton. It is intended for single use.

V. Intended Use

The intended use of the dual lumen catheters remains the same as the predicate device.

The Elite-i Dual Lumen Catheter is intended for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

The catheters are intended for use by physicians trained and experienced with venous catheterization and extracorporeal life support which are both done in a hospital setting.

VI. Comparison of Technological Characteristics to Predicate Device

The Elite-i (RA) Dual Lumen Catheters and Elite-i (BiX) Dual Lumen Catheters all utilize the same technological characteristics (design and materials) as the original Bi-Caval Dual Lumen Catheter. The Bi-Caval Catheter line is simply being expanded to include a short version for users who prefer to only access the right atrium and not the inferior vena cava and an extra-long version for those patients whose anatomy requires extra length to access the inferior vena cava adequately.

Embedded, radiopaque tantalum markers are being added to the drainage and infusion ports on all catheter models to enhance radiographic visualization of the catheters. To accommodate the markers, the basket (where the infusion and drainage ports are located) configuration has been slightly modified. For the Elite-i (RA) Dual Lumen Catheter, the hole placement on the catheter has been slightly modified to accommodate placement in the right atrium as opposed to the inferior vena cava. There is a small modification to the hole configuration for the extra-long Elite-i (BiX) Dual Lumen

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Catheters. Flow curves for the modified devices will be consistent with the flow-curves of the predicate devices.

A blunt tipped introducer is being added to the short length catheters. This introducer is made from the same material and design as the existing taper tipped introducer. The tip is blunted and closed rather than tapered and open based on customer preference during placement in the right atrium.

Color is being added to the previously clear hemostasis caps (blue for drainage and red for infusion) to address customer and marketing preference. These are non-patient contact parts. However, biocompatibility was confirmed to be acceptable.

VII. Nonclinical Data

Substantial equivalence testing performed and presented in the original Avalon Elite® Bi-Caval Dual Lumen Catheter 510(k) is applicable for the devices included in this submission. These tests included Pressure/Burst. Simulated Use. Kink Resistance. Tensile Strength, Flow Characteristics, Hemolysis and Biocompatibility.

The modified devices were subjected to additional testing based on the Risk Analysis performed relative to the modifications made to the design. Additional testing included:

. Flow curves for the new configurations
. Verification of Biocompatibility for the colored caps and tantalum dots
Verification of Sterilization for blunt tipped introducers and modified lengths .
Design verification of spring and reinforcement modifications including kink . resistance and tensile strength testing.

VIII. Clinical Data

Clinical results were not submitted to support substantial equivalence.

IX. Conclusions

The intended use of the modified Elite-i Dual Lumen Catheters is identical to the previously cleared Avalon Elite® Bi-Caval Dual Lumen Catheters. The design and materials are also substantially the same. The modified catheters are equivalent to the predicate devices in all key areas of features and performance that affect safety and effectiveness based on a Risk Assessment of the modifications made. Therefore, the Elite-i (RA) Dual Lumen Catheters (short lengths) and the Elite-i (BiX) Dual Lumen Catheters (extra-long length) are substantially equivalent to the predicate device, the Avalon Elite® Bi-Caval Dual Lumen Catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with flowing lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 16, 2013

Maquet Cardiopulmonary AG C/O Ms. Katrin Schwenkglenks Regulatory Affairs Manager Neue Rottenburger Strasse 37 72379 Hechingen Germany

Re: K130639

Trade/Device Name: Elite-I (Bi 100XX; RA 400XX; BiX 300XX) Dual Lumen Catheters Regulation Number: 21 CFR 870.4210 · Regulation Name: Cardiopulmonary Bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF. Dated: April 30, 2013

Received: May 2, 2013

Dear Ms. Katrin Schwenkglenks:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - Ms. Katrin Schwenkglenks

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Matthew G. Hillebrenner

for

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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Indications for Use

510(k) Number (if known): K130639

ELITE-i Dual Lumen Catheter Family (ELITE-i (Bi) Dual Lumen Device Name: Catheter, ELITE-i (RA) Dual Lumen Catheter, ELITE-i (BiX) Dual Lumen Catheter)

Indications for Use: The ELITE-i Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G. Hillebrenner

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).