ORIGEN REINFORCED DUAL LUMEN CATHETER

K113869 · Origen Biomedical, Inc. · DWF · Jul 26, 2012 · Cardiovascular

Device Facts

• Record ID: K113869
• Device Name: ORIGEN REINFORCED DUAL LUMEN CATHETER
• Applicant: Origen Biomedical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The OriGen Reinforced Dual Lumen Cannula (RDLC) is a vascular access catheter designed for extracorporeal life support (ECLS). It functions as a single-cannula system for simultaneous venous drainage and arterial re-infusion of blood via the internal jugular vein. The device features dual lumens of unequal area. Compared to the predicate OriGen Dual Lumen Cannula, the RDLC incorporates a wire reinforcement layer at the tip, secured by a heat-shrunk protective sheath, to enhance structural integrity. The material composition has been updated from polyurethane to Pebax. The device is intended for short-term use (six hours or less). It is used by clinicians in a clinical setting to facilitate extracorporeal circulation. The design maintains the internal geometry and flow characteristics of the predicate, ensuring equivalent performance in blood transport.

Clinical Evidence

Bench testing only. In vitro studies evaluated structural integrity, burst pressure, kink resistance, and flow performance. All tests passed, demonstrating safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Dual lumen catheter; Pebax construction; wire reinforcement layer at tip with heat-shrunk protective sheath; approximately 1 French size larger than predicate; internal geometry and flow characteristics unchanged from predicate; biocompatibility per ISO 10993-1.

Indications for Use

Indicated for venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support (ECLS) procedures lasting six hours or less.

Regulatory Classification

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.

Predicate Devices

• OriGen Dual Lumen cannula

Submission Summary (Full Text)

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#### 510(k) SUMMARY

## JUL 26 2012

| Submitter: | OriGen Biomedical, Inc<br>7000 Burleson Rd, Bldg D<br>Austin, TX 78744 |
|-----------------------|------------------------------------------------------------------------|
| Contact Person: | Richard Martin<br>Phone [phone]<br>[e-mail] |
| Date Prepared: | 25 July 2012 |
| Device Trade Name: | OriGen Reinforced Dual Lumen cannula |
| Common Names: | ECMO catheter<br>ECLS catheter<br>Veno-Venous catheter |
| Classification Names: | Catheter, vascular access |
| Predicate Device: | OriGen Dual Lumen cannula |

#### 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.

#### 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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