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 the radiopaque contrast media to the vena cava.

Device Description

The Cordis OPTEASE® Vena Cava Filter (Filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC). The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. The constrained filter is supplied in a unidirectional storage tube that is loaded as a system into the hemostasis valve of the sheath introducer. The subject device is comprised of the filter packaged within a unidirectional storage tube, introduction kit that includes angiographic vessel dilator, catheter sheath introducer and obturator. The OPTEASE® Retrieval catheter is packaged separately.

AI/ML Overview

The Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are devices designed for the prevention of recurrent pulmonary embolism. The 510(k) submission K140286 describes design verification and validation testing performed to demonstrate substantial equivalence to a predicate device (K034050 and K091077).

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Human Factor Assessment	Safer use, mitigated incorrect insertion risk	The proposed product configuration was safer to use and better at mitigating the risk of incorrect insertion.
Transfer filter into CSI	Meets Acceptance Criteria	Meets Acceptance Criteria
Filter release from storage tube	Meets Acceptance Criteria	Meets Acceptance Criteria
Fixation on mounting card	Meets Acceptance Criteria	Meets Acceptance Criteria
Fixation in storage tube	Meets Acceptance Criteria	Meets Acceptance Criteria
Dimensional Analysis	Meets Acceptance Criteria	Meets Acceptance Criteria
Visual inspection and verification of packaging and labeling	Meets Acceptance Criteria	Meets Acceptance Criteria

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for each of the tests (Human Factor Assessment, Transfer filter into CSI, Filter release from storage tube, Fixation on mounting card, Fixation in storage tube, Dimensional Analysis, Visual inspection and verification of packaging and labeling).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. These appear to be laboratory-based engineering and performance tests conducted internally by Cordis Corporation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. For tests like "Human Factor Assessment," it implies an evaluation, but the specifics of who conducted it and their expertise are not detailed. For the other performance tests, "ground truth" would likely refer to engineering specifications and performance standards.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. Given the nature of the tests (engineering and performance benchmarks), it's likely that a pass/fail determination was made based on meeting predetermined specifications, rather than a consensus among multiple reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is typically associated with diagnostic imaging devices or AI-assisted interpretation, where human reader performance is a key metric. This 510(k) concerns a medical device (vena cava filter) and its associated retrieval catheter, focusing on design verification and validation against established standards and a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The device is a physical medical device (vena cava filter) and its retrieval catheter, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant to this submission.

7. The Type of Ground Truth Used:

For the performance tests, the "ground truth" implicitly refers to the engineering specifications, design requirements, and performance characteristics established for the device. These are derived from its intended function, safety considerations, and comparison to the predicate device. For the Human Factor Assessment, the ground truth would be ergonomic and safety principles related to user interaction.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The tests described are for a physical medical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

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K140286 1/3 MAR - 7 2014

510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92 in order to gain clearance to market the OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. The OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are identical in design and intended use to the predicate OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. The change is to provide unique catalog numbers for the femoral-only, jugular-only, and jugular/antecubital-only approaches with dedicated OPTEASE® Vena Cava Filter packaged within a unidirectional storage tube according to the site specific deployment approach.

APPLICANT	Cordis CorporationA Johnson & Johnson Company6500 Paseo Padre ParkwayFremont, CA 94555Tel.: 510-248-2961Fax: 510-248-2533
OFFICIALCORRESPONDENT	Shamsa KarimiManager, Regulatory AffairsPhone:(510) 248-2896Fax: (510) 248-2533e-mail: SKarimi@ITS.JNJ.com
DATE PREPARED	February 04, 2014
TRADE NAME	OPTEASE® Vena Cava Filter and OPTEASE®Retrieval Catheter
COMMON NAME	Vena Cava Filter and Introduction Kit
CLASSIFICATION NAME	Filter, Intravascular, Cardiovascular
DEVICE CLASSIFICATION	21 CFR §870.3375
PRODUCT CODES	DTK
PREDICATE DEVICE	OPTEASE® Vena Cava Filter and OPTEASE®Retrieval CatheterPreviously cleared under K034050 and again underK091077

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SUBSTANTIALLY EQUIVALENT TO:

The Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are substantially equivalent to the predicate Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter, previously cleared under K034050 and again under K091077.

The OPTEASE® Vena Cava Filter (Filter) is identical in design and intended use to the . predicate OPTEASE® Filter.
The packaging components of the Cordis OPTEASE® Vena Cava Filter and . OPTEASE® Retrieval Catheter are substantially equivalent to the predicate packaging components.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS 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".

TECHNICAL CHARACTERISTICS:

The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. Six straight struts connect the baskets. A single row of fixation barbs is present at the cranial end of the struts. These barbs are intended for the fixation to the vessel wall, and are extensions of the parallel struts. A hook is centrally

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located at the caudal basket extremity. The constrained filter is supplied in a unidirectional storage tube that is to be loaded as a system into the valve of the sheath introducer. The constrained filter is flexible and achieves its unconstrained diameter upon deployment in the inferior vena cava (IVC). Upon deployment, the filter imparts an outward radial force on the luminal surface of the Vena Cava to ensure proper positioning and stability.

The OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter is packaged with an Introduction Kit that contains the following components:

. Filter packaged within unidirectional storage tube (containing the constrained OPTEASE Filter)
. 6F BRITE TIP® Catheter Sheath Introducer
VisEase™ Angiographic Vessel Dilator ●
. Obturator.

The OPTEASE® Retrieval catheter is packaged separately.

Performance Data:

Design verification and validation testing data confirms that the Optease® Vena Cava Filter in a unidirectional storage tube performs according to its intended use and is equivalent in performance to the predicate device. Specifically, the following tests were performed on the proposed device to demonstrate substantial equivalence with the predicate device.

Test	Conclusion
Human Factor Assessment	The proposed productconfiguration was safer to useand better at mitigating therisk of incorrect insertion.
Transfer filter into CSI	Meets Acceptance Criteria
Filter release from storagetube
Fixation on mounting card
Fixation in storage tube
Dimensional Analysis
Visual inspection andverification of packaging andlabeling

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technical comparison and design verification and validation testing demonstrate that the subject OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are substantially equivalent to the predicate.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a person with outstretched arms.

Public Health Service

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

March 7, 2014

Cordis Corporation, A Johnson & Johnson Co. Ms. Shamsa Karimi Manager, Regulatory Affairs 6500 Paseo Padre Parkway Fremont, CA 94555 US

Re: K140286

Trade/Device Name: OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter Regulation Number: 21 CFR 870.3375 Regulation Name: Vena Cava Filter and Introduction Kit, Filter, Intravascular, Cardiovascular Regulatory Class: Class II Product Code: DTK Dated: February 4, 2014 Received: February 5, 2014

Dear Ms. Karimi,

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh - S

for

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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INDICATIONS FOR USE STATEMENT

..............................................................................................................................................................................

510(k) Number (if known): K140286

Device Name: Cordis OPTEASE® Vena Cava Filter and Optease Retrieval Catheter

Indications 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".

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

of Page

Regulation Number and Section

§ 870.3375 Cardiovascular intravascular filter.

(a)
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.(b)
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.”