The OriGen Reinforced Dual Lumen cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

Device Description

The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.

AI/ML Overview

This is not an AI/ML medical device. It is a dual-lumen catheter used for extracorporeal life support. Therefore, the questions related to AI/ML device studies are not applicable.

However, I can extract the acceptance criteria and the summary of the study performed for this device:

1. Table of acceptance criteria and the reported device performance:

Test Classification - Title	Acceptance Criteria	Reported Device Performance
Physical/mechanical - structural integrity	Pass	Pass
Physical/mechanical - burst testing	Pass	Pass
Physical/mechanical - kink testing	Pass	Pass
Functional/Performance - flow testing	Pass	Pass

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

Sample Size: Not explicitly stated. The document mentions "applicable tests were carried out," but does not specify the number of units tested for each in vitro test.
Data Provenance: The tests were conducted "in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum." These are non-clinical, in-vitro tests, not involving human data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a medical device (catheter), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data. The "ground truth" for this device's performance is established by objective engineering and material science standards as per ISO 10993-1 and FDA guidelines.

4. Adjudication method for the test set:

Not applicable. As this is not an AI/ML device assessing patient data, no adjudication method for a test set by human experts is relevant.

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:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

For this device, the "ground truth" can be considered the established engineering and performance specifications and safety standards defined by ISO 10993-1 and FDA guidance for medical device biocompatibility, structural integrity, and functional performance (e.g., flow rates). These are objective, measurable criteria.

8. The sample size for the training set:

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

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

Not applicable. This is a physical medical device, not an AI/ML model.

Summary

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510(k) SUMMARY

JUL 26 2012

Submitter:	OriGen Biomedical, Inc7000 Burleson Rd, Bldg DAustin, TX 78744
Contact Person:	Richard MartinPhone +1 512 474 7278dmartin@origen.com
Date Prepared:	25 July 2012
Device Trade Name:	OriGen Reinforced Dual Lumen cannula
Common Names:	ECMO catheterECLS catheterVeno-Venous catheter
Classification Names:	Catheter, vascular access
Predicate Device:	OriGen Dual Lumen cannula

Device Description:

Indications for Use:

The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

Technological Characteristics:

The OriGen RDLC catheter has the same fundamental technological characteristics, principles of operation and manufacturing processes as the predicate device. The new device has an added wire reinforcement layer and a smooth protective sheath over that. This extra material adds approximately 1 French size over the existing catheter. However, the polyurethane material of the original OriGen Dual Lumen Catheter was not compatible with this process and Pebax is now used. Pebax has excellent biocompatibility and a long history of use in medical applications in catheters and central lines.

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As the internal geometry and manufacturing practices have not changed, the flow characteristics of the device are unchanged.

Non Clinical Test Results:

Applicable tests were carried out in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum on the use of that standard for biocompatibility testing of materials.

In Vitro Test Results:

In vitro testing was carried out to demonstrate both substantial equivalence with the predicate device and to demonstrate the safety and effectiveness of the new catheter test results supplied in the 510(k) premarket notification include performance and mechanical integrity tests which all demonstrated both safety and effectiveness. The tests which were performed are listed in the following summarizing table:

Test Classification - Title	Test results
Physical /mechanical - structural integrity	Pass
Physical /mechanical - burst testing	Pass
Physical /mechanical - kink testing	Pass
Functional/Performance - flow testing	Pass

Conclusions:

The results of the in vitro studies demonstrate that the Origen Dual Lumen Reinforced Catheter performs in a manner substantially equivalent to the predicate device, the Origen Dual Lumen Catheter. Test results of this study demonstrate that the two devices function with substantially equivalent performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized lines that resemble a human figure.

Public Health Service

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

JUL 26 2012

Origen Biomedical c/o Mr. Richard Martin President 7000 Burleson Road, Building D Austin, TX 78744

Re: K113869

Trade/Device Name: Origen Reinforced Dual Lumen Catheter Regulation Number: 21 CFR 870.1300 Regulation Name: Catheter cannula Regulatory Class: Class II Product Code: DWF Dated: July 24, 2012 Received: July 25, 2012

Dear Mr. Martin:

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.

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Page 2 - Mr. Richard Martin

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 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 Devices 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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510 (k) NUMBER (IF KNOWN) : _K113869

OriGen Reinforced Dual Lumen Cannula DEVICE NAME :

INDICATIONS FOR USE :

The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

(Division Sign-Off)

invision of Cardiovascular Devices 1300 5 : Olki Number

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).