CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B

K023116 · Cordis Corp. · DTK · Oct 18, 2002 · Cardiovascular

Device Facts

• Record ID: K023116
• Device Name: CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
• Applicant: Cordis Corp.
• Product Code: DTK · Cardiovascular
• Decision Date: Oct 18, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OptEase™ is indicated for the prevention of recurrent pulmonary embolism via permanent, percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, and chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Device Story

System consists of flexible, self-expanding vena cava filter deployed via 6F sheathed introduction kit; includes VisEase Angiographic Vessel Dilator for visualization/measurement. Filter traps large, life-threatening emboli in infra-renal inferior vena cava to prevent pulmonary embolism while maintaining caval patency. Used by physicians in clinical settings. Design modifications include adjusted fixation hook configuration and addition of caudal filter extension. Output is physical entrapment of emboli; clinical benefit is reduction of recurrent pulmonary embolism risk in patients where anticoagulation is contraindicated or failed.

Clinical Evidence

No human clinical data provided. Evidence based on bench testing and animal studies. In-vitro testing included visual/dimensional inspections, pull strength/friction tests, simulated deployment, kink resistance, and migration resistance. In-vivo testing consisted of two animal study parts: filter implantation with and without simulated thrombo-embolic load.

Technological Characteristics

Self-expanding vena cava filter; 6F sheathed introduction kit; includes VisEase Angiographic Vessel Dilator. Materials and design equivalent to predicate. Complies with ISO-10993 for biological evaluation. Sterilization per FDA guidance. No software or electronic components.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism via permanent inferior vena cava placement, specifically those with contraindications to anticoagulants, failure of anticoagulant therapy, or emergency treatment for massive pulmonary embolism.

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 TrapEase Permanent Vena Cava Filter and Introduction Kit
• Cordis TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator
• Günther Tulip Vena Cava MReye™ Filter set
• Cook Incorporated, Vena Tech LGM 30 CJ/U & 30 D/U Vena Cava Filter

Submission Summary (Full Text)

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## OCT 1 8 2002

## 510(k)

## Summary of Safety and Effectiveness

| Submitter: | Bert Roossien, Ph.D.<br>Manager, Regulatory Affairs<br>Cordis Europa, N.V., a Johnson & Johnson Company<br>Oosteinde 8<br>NL-9301-LJ Roden<br>The Netherlands<br>Telephone: [phone]<br>Fax [phone]<br>e-mail address [e-mail] |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Karen Wilk<br>Manager, Regulatory Affairs<br>Cordis Corporation, a Johnson & Johnson Company<br>7 Powder Horn Drive<br>Warren, New Jersey 07059<br>USA<br>Telephone: [phone]<br>Fax [phone]<br>e-mail address [e-mail] |
| Date<br>Prepared: | September 18, 2002 |
| General<br>Provisions: | |
| | Trade Name Cordis OptEase™ Permanent Vena Cava Filter<br>Common Name Permanent Vena Cava Filter and Introduction Kit<br>Classification Name Cardiovascular Intravascular Filter (per 21 CFR 870.3375)<br>Device-classification Class II |
| Predicate<br>Devices: | The subject Cordis OptEase Permanent Vena Cava Filter is substantially equivalent to:<br>Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit, Cordis TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator, Günther Tulip Vena Cava MReye™ Filter set, Cook Incorporated, Vena Tech LGM 30 CJ/U & 30 D/U Vena Cava Filter. |
| Performance<br>Standards | As per 21 CFR 870.3375, the following special controls were established for<br>cardiovascular intravascular filters:<br>• Use of International Standards Organization's ISO-10993 'Biological Evaluation of<br>Medical Devices Part I: Evaluation and Testing,<br>• FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final Guiance for<br>Industry and FDA, August 30, 2002 , and<br>• FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions |
| Indications<br>for Use | The Cordis OptEase Permanent Vena Cava Filter is indicated for the prevention of<br>recurrent pulmonary embolism via percutaneous placement in the inferior vena cava<br>in the following situations:<br>• Pulmonary thromboembolism when anticoagulants are contraindicated,<br>• Failure of anticoagulant therapy in thromboembolic diseases,<br>• Emergency treatment following massive pulmonary embolism, where anticipated<br>benefits of conventional therapy are reduced; and<br>• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or<br>is contraindicated. |
| | This is the same intended use as for the filter featured with the predicate devices:<br>TrapEas, Günther Tulip Vena Cava MReye Filter set, and Vena Tech LGM Vena<br>Cava Filter.<br>The VisEase Angiographic Vessel Dilator is designed to provide angiographic<br>visualization and linear measurement of the vasculature when combined with the<br>delivery of radiopaque contrast media to the Vena Cava.<br>This is the same intended use as for the VisEase Angiographic Vessel Dilator<br>featured with the predicate device. |
| Device<br>Description | The subject device is a system that consists of a flexible, self-expanding vena cava<br>filter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introduction<br>kit. The filter is designed to trap large, life threatening emboli and therefore prevent<br>recurrent pulmonary embolism, while maintaining caval patency. The OptEase<br>Permanent Vena Cava Filter is packaged with a filter introduction kit that includes the<br>VisEase Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath<br>introducer and obturator for safe and accurate deployment of the filter.<br>The modification to the design of the OptEase Vena Cava Filter with respect to the<br>number and configuration of the fixation hooks and the introduction of a filter<br>extension at the caudal end of the filter basket, do not affect the intended use or basic<br>fundamental technology of the device. The subject device is substantially equivalent<br>to the predicate devices, i.e., TrapEase permanent Vena Cava Filter, Günther Tulip<br>Vena Cava MReye Filter and the Vena Tech LGM Vena Cava Filter. |

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The safety and effectiveness of the Cordis OptEase Permanent Vena Cava Filter Performance have been demonstrated via data collected from in-vitro and in-vivo testing and Data: analyses conducted on the OptEase Permanent Vena Cava Filter.

> The following in-vitro tests have been performed on the OptEase Permanent Vena Cava Filter:

- -Visual Inspection: Storage Tube
- -Visual Inspection: Filter position in Storage tube
- Visual Inspection: Filter -
- -Dimensional Inspection: Marker position obturator
- Dimensional Inspection Storage Tube -
- Dimensional Inspection: Measurement of expanded filter diameter -
- Suitability: Pull strength / Friction test Storage Tube -
- Simulated Deployment & Introducer / sheath Suitability incl. Kink resistance
- Resistance to Migration in-vitro-test Subject and Predicate Devices -

The following in-vivo have been performed:

- -Animal Study - Part I: Filter implantation with simulated thrombo-embolic load.
- Animal Study Part II: Filter implantation without simulated thrombo-embolic load.

Summary of The design, material, components, fundamental technology and intended use featured with the Cordis OptEase Permanent Vena Cava are substantially equivalent Substantial to those featured with the predecessor Cordis TrapEase Permanent Vena Cava Filter Equivalence and Introduction Kit and the Cordis TrapEase Permanent Vena Cava with the VisEase Angiographic Vessel Dilator. In addition, the design of the OptEase Permanent Vena Cava Filter is substantially equivalent with the Günther Tulip Vena Cava MReye Filter set and the Vena Tech LGM Vena Cava Filter.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2002

Bert Roossien, Ph.D. Manager, Regulatory Affairs Cordis Europa, N.V. Oosteinde 8 NL-9301-LJ Roden The Netherlands

Re: K023116

Trade/Device Name: Cordis OptEase™ Permanent Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II (two) Product Code: DTK Dated: September 18, 2002 Received: September 19, 2002

Dear Dr. Roossien:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions section of the device's labeling and promotional materials:

The safety and effectiveness of the OptEase™ Filter for use as a retrievable or temporary filter have not been established.

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

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Page 2 - Bert Roossien, Ph.D.

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); 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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

David C. Sabol, M.D.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_K203116

Device Name: Cordis OptEase™ Permanent Vena Cava Filter

FDA's Statement of the Indications For Use for device: The OptEase™ is indicated for the prevention of recurrent pulmonary embolism via permanent, percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, and chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Division of Cardiovascular & Respiratory Devices
510(k) Number K023116

Prescription Use_ X_ (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________