OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER

K091077 · Cordis Corp., A Johnson & Johnson Co. · DTK · Feb 4, 2010 · Cardiovascular

Device Facts

• Record ID: K091077
• Device Name: OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
• Applicant: Cordis Corp., A Johnson & Johnson Co.
• Product Code: DTK · Cardiovascular
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OPTEASE Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations: Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic disease, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava. The Cordis OPTEASE Retrieval Catheter is has been designed for retrieval of an implanted OPTEASE Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by femoral approach.

Device Story

System comprises flexible, self-expanding vena cava filter, 6F sheathed introduction kit, and retrieval catheter. Filter deployed in infra-renal inferior vena cava to trap large emboli while maintaining caval patency. Angiographic vessel dilator provides visualization and linear measurement of vasculature using radiopaque contrast media. Retrieval catheter allows removal of filter via femoral approach when no longer needed. Used in clinical settings by physicians. Device benefits patients by preventing recurrent pulmonary embolism in high-risk populations where anticoagulation is not viable.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use similarities to predicate devices.

Technological Characteristics

Self-expanding vena cava filter; 6F sheathed introduction kit; includes angiographic vessel dilator, directional filter storage tube, catheter sheath introducer, and obturator. Mechanical device; no energy source or software. Sterilization and biological evaluation performed per ISO-10993 and FDA guidance.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism via percutaneous inferior vena cava placement when anticoagulants are contraindicated, anticoagulant therapy has failed, or in emergency cases of massive pulmonary embolism. Retrieval indicated for patients no longer requiring the filter via femoral approach.

Regulatory Classification

Identification

A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”

Predicate Devices

• Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter (K034050)
• G2 EXPRESS Filter System, Bard Peripheral Vascular, Inc. (K082305)

Submission Summary (Full Text)

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K091077
FEB - 4 2010

# 510(k) Summary

| Applicant | Cordis Corporation, a Johnson & Johnson Company<br>430 Rt. 22 East<br>Bridgewater, New Jersey 08807<br>Telephone: [phone]<br>Fax: [phone] | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Contact | Joan Martin, Manager, Regulatory Affairs | |
| Date | April 13, 2009 | |
| Subject Device | Trade Name: | OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter |
| | Common or Usual Name: | Cardiovascular Intravascular Filter (per 21 CFR 870.3375) |
| | Classification: | Class II |
| | Classification Panel | Cardiovascular |
| Name of Predicate Devices | The device is substantially equivalent to:<br>Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter (ref. 510(k) K034050) G2 EXPRESS Filter System, Bard Peripheral Vascular, Inc. (ref. 510(k) K082305) | |
| Performance Standards | As per 21 CFR 870.3375, the following special controls were established for cardiovascular intravascular filters:<br>Use of International Standards Organization's ISO-10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing, FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final Guidance for Industry and FDA, August 30, 2002 and FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions, dated November 26, 1999 | |

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| Indications for<br>Use for Filter | The OPTEASE Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations: <ul><li>Pulmonary thromboembolism when anticoagulants are contraindicated,</li><li>Failure of anticoagulant therapy in thromboembolic disease,</li><li>Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced,</li><li>Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.</li></ul> The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava. |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use for<br>Retrieval<br>Catheter | The Cordis OPTEASE Retrieval Catheter is has been designed for retrieval of an implanted OPTEASE Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by femoral approach. |
| Device<br>Description | The subject device is a system that consists of a flexible, self-expanding vena cava filter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introduction kit. The filter is designed to trap large, life threatening emboli and therefore prevent recurrent pulmonary embolism, while maintaining caval patency. The OptEase Permanent Vena Cava Filter is packaged with a filter introduction kit that includes the Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter. |
| Summary of<br>Substantial<br>Equivalence | The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices, the OPTEASE Vena Cava Filter and the G2 EXPRESS Filter System in terms of intended use, application and user application. The change to the predicate devices, OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter, only affects the labeling. |

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

FEB - 4 2010

Cordis Corporation c/o Ms. Joan Martin 430 Rt. 22 East Bridgewater, NJ 08807

Re: K091077

OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: January 4, 2010 Received: January 5, 2010

Dear Ms. 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 use in the prevention of recurrent pulmonary embolism 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 resporancing 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.

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### Page 2 - Ms. Joan 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/ReportalProblem/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,

Dina R. Lehner

E
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Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cordis Corporation, a Johnson & Johnson Company OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter

SPECIAL 510(k) Premarket Notification

#### Indications for Use

510(k) Number (if known): K091077

## Device Name: OPTEASE® Vena Cava Filter and OPTEASE Retrieval Catheter

Indication for Use:

The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulants are contraindicated, .
- Failure of anticoagulant therapy for thromboembolic disease, �
- Emergency treatment following massive pulmonary embolism where anticipated benefits of . conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is . contraindicated

The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval.

The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopague contrast media to the vena cava.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Vihunen

(Division Sign-Off) (Division Sign of Cardiovascular Devices

510(k) Number_10 9 10 7