The Option* Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
Failure of anticoagulant therapy in thromboembolic diseases; ●
Emergency treatment following massive pulmonary embolism when anticipated . benefits of conventional therapy are reduced;
Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated

The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

Device Description

The Rex Medical Option Vena Cava Filter System consists of a self-centering vena cava filter made from nickel-titanium alloy (Nitinol). The filter consists of shape memory nitinol struts emanating from a central location and designed for clot capture. Retention anchors are located at the caudal portion of the filter. These anchors are intended for filter fixation into the cava wall. The Option Filter is intended for use in cava diameters up to 30mm.

The delivery system consists of the filter preloaded in a filter cartridge, a 5French catheter sheath introducer, an openended angiographic vessel dilator which may be used for infusion of contrast solution during placement and a pusher with deployment marker.

AI/ML Overview

The provided text describes the Rex Medical Option Vena Cava Filter System. Here's an analysis of the acceptance criteria and supporting studies based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance metrics for the device itself. Instead, it states that "Substantial equivalence is based upon not only descriptive characteristics of the various devices but also upon the safety and performance testing completed."

However, it does mention that the device underwent certain types of testing and adhered to specific standards and guidance documents. These implicitly serve as acceptance criteria for regulatory clearance.

Acceptance Criteria Category	Specific Criteria (Implicit from Document)	Reported Device Performance (Summary from Document)
Biocompatibility	Adherence to ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing	"Testing was also performed in accordance with... ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing" (Implies successful completion)
Sterility	Adherence to FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final Guidance for Industry and FDA, August 30, 2002	"Testing was also performed in accordance with... FDA's Updated 510(k) Sterility Review Guidance" (Implies successful completion)
Functional/Mechanical Performance	Adherence to FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions. (Implicitly includes design and performance of filter for clot capture, fixation, and retrieval)	"Mechanical bench testing, in vivo animal testing and clinical testing were performed." "The Option Filter is intended for use in cava diameters up to 30mm." "Substantial equivalence... upon the safety and performance testing completed." (Implies successful performance against these criteria to demonstrate substantial equivalence to predicate devices).
Intended Use	Prevention of recurrent pulmonary embolism (PE) in specified conditions (e.g., contraindication to anticoagulation, failure of anticoagulant therapy, emergency treatment, chronic/recurrent PE).	The device is indicated for these uses. (Implies the testing supported these indications).
Retrieval Capability	Ability to be retrieved by jugular approach according to instructions.	"The filter may be retrieved according to the instructions supplied in section entitled 'Optional Procedure for Filter Retrieval' in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach." (Implies successful demonstration of retrieval capabilities).

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

The document states: "Mechanical bench testing, in vivo animal testing and clinical testing were performed." However, it does not specify the sample sizes for the test sets used in these studies, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for clinical or animal studies.

It does mention that "In some instances, legally marketed vena cava filters were tested as control devices for the purpose of comparison with the Option Vena Cava Filter System," which suggests a comparative study design.

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not mention any MRMC comparative effectiveness study involving human readers with or without AI assistance. The device is a physical medical implant, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a physical vena cava filter, not an algorithm or AI. The performance discussed is the device's functional and safety performance, not algorithmic performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the mechanical bench testing and in vivo animal testing, the "ground truth" would likely be derived from:

Mechanical measurements: e.g., filter strength, deployment accuracy, clot capture efficiency, migration resistance, retrieval force.
Physiological observations (animal studies): e.g., absence of organ damage, successful deployment and retrieval, lack of significant adverse events, patency of the vena cava.
Histopathology (animal studies): Tissue response around the filter.
Clinical outcomes (clinical testing): Successful prevention of PE, successful deployment, no significant adverse events, successful retrieval.

However, the document does not explicitly detail the specific ground truth methodologies for the clinical or animal studies, beyond broadly stating "safety and performance testing."

8. The Sample Size for the Training Set

The document does not mention a training set as this information is relevant for machine learning algorithms, which is not the type of device being described.

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

This question is not applicable as the device is not an AI/ML algorithm.

Summary

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K081410

JUN - 4 2009

Section 5

・

510(k) Summary : Rex Medical Option Vena Cava Filter System

Submitter:	Rex Medical1100 East Hector Street, Suite 245Conshohocken, PA 19428Phone: 610-940-0665Fax: 610-940-1590
Contact Person:	Leo Basta, PartnerBoston Biomedical Associates, LLCOffice: 508.351.8632
Date Prepared:	June 2, 2009
Trade Name:	Option* Vena Cava Filter System
Classification Name:	Cardiovascular Filter
Classification Number:	21 CFR 870.3375
Product Code:	DTK
Predicate Devices:	Boston Scientific Corporation's SS Greenfield Vena CavaFilter - K964284, determined substantially equivalent onJanuary 6, 1997 (also K955396, K951508)
	Cordis Optease Vena Cava Filter - K023116 determinedsubstantially equivalent on October 18, 2002.
	Cordis Trapease Vena Cava Filter - K000062 determinedsubstantially equivalent on July 7, 2000
	Bard Recovery Vena Cava Filter - K022236 determinedsubstantially equivalent on November 27, 2002
	Recovery G2 Filter - K073090 determined substantiallyequivalent on January 15, 2008
	Gunther-Tulip Vena Cava Filter Set -- K032426 determinedsubstantially equivalent on October 31, 2003.
Device Description:	The Rex Medical Option Vena Cava Filter System consists ofa self-centering vena cava filter made from nickel-titanium

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alloy (Nitinol). The filter consists of shape memory nitinol struts emanating from a central location and designed for clot capture. Retention anchors are located at the caudal portion of the filter. These anchors are intended for filter fixation into the cava wall. The Option Filter is intended for use in cava diameters up to 30mm.

The Option* Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

. Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
. Failure of anticoagulant therapy in thromboembolic diseases;
Emergency treatment following massive pulmonary . embolism when anticipated benefits of conventional therapy are reduced;
. Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated

Mechanical bench testing, in vivo animal testing and clinical testing were performed. In some instances, legally marketed vena cava filters were tested as control devices for the purpose of comparison with the Option Vena Cava Filter System.

In addition, testing was also performed in accordance with the following Special Controls for Cardiovascular Intravascular Filters (21 CFR 870.3375):

. International Standards Organization's ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing,

Intended Use:

Functional Testing:

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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

Summary of Substantial Equivalence:

The design, material, components, fundamental technology and intended use of the Rex Medical Option Vena Cava Filter System for the permanent indication with the option for removal are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon not only descriptive characteristics of the various devices but also upon the safety and performance testing completed. Based upon this information, the Rex Option Vena Cava Filter System has been shown to be substantially equivalent to the predicate devices for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

N - 4 2009

Rex Medical c/o Mr. Leo L. Basta Boston Biomedical Associates, LLC 386 West Main Street, Suite #7 Northboro, MA 01532

Re: K081410

Trade/Device Name: Option Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II (Two) Product Code: DTK Dated: April 6, 2009 Received: April 7, 2009

Dear Mr. Basta:

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.

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 - Mr. Leo L. Basta

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 (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 go to http://www.fda.gov/cdrl/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Duna D. Vuhner

Image /page/4/Picture/6 description: The image shows a handwritten symbol or character that appears to be a stylized letter or abstract design. It consists of curved and angular lines, with a prominent loop at the top and a diagonal stroke extending downwards to the left. The symbol is positioned to the left of some blurred text, which is unreadable due to the image quality or focus.

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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INDICATION FOR USE

KO81410 Not Assigned

510(k) Number (if known):

Device Name:

Option* Vena Cava Filter System

Indications for Use:

The Option* Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
Failure of anticoagulant therapy in thromboembolic diseases; ●
Emergency treatment following massive pulmonary embolism when anticipated . benefits of conventional therapy are reduced;
Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is � contraindicated

Prescription Use:

AND/OR

Over-The Counter Use:

(Per 21 CFR 801 Subpart D) ...................................................................................................................................................

(Per 21 CFR 801 SubpartC)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

P. V. huse

sion of Cardiovascular Devices

Page 1 of 1

510(k) number K081460

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.”