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 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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. It is a request for substantial equivalence to previously cleared devices. Therefore, the device does not provide specific acceptance criteria or an explicit study proving performance against those criteria in the same way a new, de novo device or a PMA submission might.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, application, and user application. The regulatory review process for a 510(k) primarily assesses whether the new device is as safe and effective as a legally marketed predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission seeking substantial equivalence to predicate devices, there are no explicit "acceptance criteria" in the form of specific performance metrics with target values that a study was designed to meet for the subject device. The "reported device performance" is essentially the claim of substantial equivalence to the predicate devices.

Acceptance Criteria Category	Specific Criteria (Implicit via Substantial Equivalence Claim)	Reported Device Performance (Claim)
Intended Use	Must be same as predicate device(s).	"The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices... in terms of intended use."
Application	Must be same as predicate device(s).	"The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices... in terms of... application."
User Application	Must be same as predicate device(s).	"The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices... in terms of... user application."
Safety and Effectiveness	Must be at least as safe and effective as predicate device(s).	Implied through the assertion of substantial equivalence based on the above categories and adherence to general controls and special controls (e.g., ISO-10993, sterility guidance, specific filter guidance). The FDA's clearance letter confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent for use in the prevention of recurrent pulmonary embolism to legally marketed predicate devices..."

Regarding the "Study that proves the device meets the acceptance criteria":

The document does not describe a new clinical or performance study for the subject device to prove specific performance metrics. Instead, the "proof" is based on demonstrating that the modified device (the current OPTEASE Vena Cava Filter and Retrieval Catheter) is fundamentally unchanged from its predicate, except for labeling:

"The change to the predicate devices, OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter, only affects the labeling."

This statement is critical. It implies that no new significant performance data was required because the physical device and its mechanism of action were not altered. The "study" here is essentially a comparison to predicate devices and a declaration of labeling changes only, rather than a full-scale performance study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission states only labeling was changed, implying no new clinical or performance test data was generated for a "test set" to establish equivalence. The equivalence is based on the previously cleared predicate device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment is described in the provided text, as the change was only to labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a vena cava filter and retrieval catheter, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical medical implant and retrieval system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. As noted earlier, the submission states that only the labeling was changed, implying no new performance data was generated for the subject device beyond what existed for the predicate devices. The "ground truth" for the predicate devices' performance would have been established through clinical trials, bench testing, and potentially post-market surveillance associated with their initial clearances.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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K091077
FEB - 4 2010

510(k) Summary

Applicant	Cordis Corporation, a Johnson & Johnson Company430 Rt. 22 EastBridgewater, New Jersey 08807Telephone: 908-541-4888Fax: 908-541-4559
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: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: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 forUse 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: 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.
Indications forUse forRetrievalCatheter	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.
DeviceDescription	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 ofSubstantialEquivalence	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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services. The symbol consists of a series of curved lines that form a wing-like shape, suggesting care and protection.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dina R. Lehner

E
L

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

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.”