OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120

K083814 · Cordis Corp., A Johnson & Johnson Co. · PDU · Jan 13, 2009 · Cardiovascular

Device Facts

• Record ID: K083814
• Device Name: OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
• Applicant: Cordis Corp., A Johnson & Johnson Co.
• Product Code: PDU · Cardiovascular
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

Device Story

Outback LTD Re-Entry Catheter is a sterile, single-use percutaneous catheter; used to facilitate placement and positioning of guidewires and catheters within peripheral vasculature. Device operates by providing a mechanism for re-entry into the true lumen during endovascular procedures. Used by physicians in clinical settings. Output is the physical positioning of guidewires/catheters to assist in navigating peripheral vascular anatomy. Benefits include improved procedural success in complex peripheral interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use percutaneous catheter. Sterilized via Ethylene Oxide. Class II device under 21 CFR 870.1250.

Indications for Use

Indicated for facilitating placement and positioning of guidewires and catheters within the peripheral vasculature. Contraindicated for use in coronary or cerebral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Outback LTD Re-Entry Catheter (K043534)

Submission Summary (Full Text)

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K083814

Cordis Corporation, a Johnson & Johnson Company Outback LTD Re-Entry Catheter

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510(k) Premarket Notification .

## 510(k) Summary

## JAN 1 3 2009

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| Proprietary Name | Common or Usual Name |
|---------------------------------|----------------------------------------------------------------|
| Outback® LTD™ Re-Entry Catheter | Catheter, percutaneous<br>21 CFR 870.1250<br>Product Code: DQY |

| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>Outback LTD Re-Entry Catheter (510(k) # K043534) | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Classification | Class II | |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Food, Drug and Cosmetic Act. | |
| Indication for<br>Use | The Outback LTD Re-Entry Catheter is intended to facilitate placement and<br>positioning of guidewires and catheters within the peripheral vasculature. The<br>Outback LTD Re-Entry Catheter is not intended for use in the coronary or<br>cerebral vasculature. | |
| Device<br>Description | The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxide<br>sterilization) device and is intended for single use only. | |
| Summary of<br>Substantial<br>Equivalence | The Outback LTD Re-Entry Catheter is substantially equivalent to the<br>predicate device. The substantial equivalence to the predicate device has been<br>demonstrated via data collected from non-clinical in-vitro bench testing. | |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of an abstract human figure. The figure is composed of three curved lines that form the shape of a person in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

Cordis Corporation Ms. Karen Wilk Regulatory Affairs Manager 7 Power Horn Drive Warren, NJ 07059

Re: K083814

Trade/Device Name: Outback LTD Re-Entry Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: December 19, 2008 Received: December 22, 2008

SEP 1 8 2013

Dear Ms. Wilk:

This letter corrects our substantially equivalent letter of January 13, 2009.

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

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Page 2 - Ms. Karen Wilk

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 (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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Zhn.Z

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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510(k) Premarket Notification

1 of

Cordis Corporation, a Johnson & Johnson Company Outback LTD Re-Entry Catheter

## Indications for Use

510/k) Number (if known): 1083814

Device Name: Outback LTD Re-Entry Catheter

Indication for Use: The Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

Prescription Use _X (Part 21 CFR 801 Subpart D)

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

(PLRASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Bvaluation (ODE)

Dummer R. V. Holmes
(Division or Office)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k o 8 38 | 4

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