The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent 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.
ECLIPSE™ Filter may be removed according to the instructions supplied under . the section labeled: Optional Procedure for Filter Removal.

Device Description

The ECLIPSE™ Filter consists of twelve electropolished shape-memory nitinol wires emanating from a central electropolished nitinol filter hook. These 12 wires form two levels of embolic filtration: the legs provide the lower level of filtration and the arms. provide the upper level of filtration. The ECLIPSE™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.

The ECLIPSE™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the ECLIPSE™ Filter and pusher system. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The storage tube and pusher system attach to the introducer and allow for delivery and deployment of the ECLIPSE™ Filter.

The ECLIPSE™ Filter System - Jugular/Subclavian Delivery Kit consists of a 10 French 1.D. introducer catheter and dilator set and a delivery device preloaded with the ECLIPSE™ Filter. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and has a delivery mechanism to deploy the ECLIPSE™ Filter.

AI/ML Overview

This document describes a 510(k) premarket notification for the ECLIPSE™ Filter System. As such, it is focused on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria and performance metrics for a new device. Therefore, the information typically found in a study proving acceptance criteria for a new AI/software device is not present.

However, I can extract the information provided about the device's "acceptance criteria" and "study" in the context of a 510(k) submission, acknowledging that this is a different type of evaluation than a clinical trial for an AI diagnostic.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

This phrasing indicates that there were internal acceptance criteria for design verification and validation, but the specific metrics are not detailed in this public summary. The "reported device performance" is summarized as meeting these criteria, implying successful completion of these tests.

Therefore, a table with specific performance metrics cannot be constructed from the provided text. The evaluation was primarily a comparison of technological characteristics to a predicate device to establish substantial equivalence.

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

The document does not describe a "test set" in the context of an AI or diagnostic study evaluating performance on data. The "study" mentioned is the design verification and validation process.

Sample Size: Not applicable/not specified in terms of patient data. The "acceptance criteria" relate to engineering and design testing.
Data Provenance: Not applicable in the context of patient data. The process focuses on the device itself.

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

Not applicable. The document does not describe a study involving expert review of patient data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication of a test set based on expert review.

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. This document is for a medical device (intravascular filter), not an AI algorithm requiring such a study.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of an AI/diagnostic study. The "ground truth" for this submission would be defined by engineering specifications, device functionality, and adherence to industry standards, rather than clinical outcomes or pathology from patient data.

8. The Sample Size for the Training Set

No training set is mentioned as this is a physical medical device, not an AI algorithm.

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

Not applicable. No training set is mentioned.

Summary regarding the "Study that Proves the Device Meets the Acceptance Criteria" from the 510(k) document:

The "study" referenced in the document is the design verification and validation process for the ECLIPSE™ Filter System. This process ensures the device meets its predetermined specifications and performance requirements through various engineering tests and evaluations.

Key points from the document regarding this process:

Acceptance Criteria: These were "predetermined… as specified by applicable standards, guidance, test protocols and/or customer inputs." While the exact criteria (e.g., filtration efficiency, deployment success rate, material integrity under stress) are not detailed in this summary, the submission asserts that the device met all of them.
Proof: The success in meeting these criteria is the "proof."
Nature of the Device: The device is a physical intravascular filter, not a diagnostic algorithm. Therefore, the "studies" and "acceptance criteria" are related to mechanical, material, and functional performance of the device in a controlled environment, not clinical trial outcomes or AI performance metrics.
Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices (G2® EXPRESS Filter System). The "study" (design verification/validation) supports this by showing the modified device performs comparably to the predicate and meets safety and effectiveness requirements.

In essence, the document claims that the device met its acceptance criteria through a design verification and validation process, which is standard for medical device development, but it does not provide the specific details of those tests or their quantitative results in this summary.

Summary

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K093659 page 1 of 3

JAN 1 4 2010

ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc
	1625 West 3rd Street
	PO Box 1740
	Tempe, Arizona 85280
Phone:	480-638-2906

Fax: 480-449-2546

Joni Creal Contact: Regulatory Affairs Associate

Subject Device:

Device Trade Name:	ECLIPSE™ Filter System – Femoral Delivery Kit and
	ECLIPSE™ Filter System – Jugular/SubclavianDelivery Kit

Common or Usual Name: Filter, Intravascular, Cardiovascular

Classification: Class II

Classification Panel: Cardiovascular

Predicate Devices:

G2 EXPRESS® Filter System - Femoral Delivery Kits (K082305)

G2 EXPRESS® Filter System -Jugular/Subclavian Delivery Kits (K082305)

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K093659 pag 2 of 3

Summary of Change:

The primary modification from the predicate device, the G2® EXPRESS Filter System -Femoral and Jugular/Subclavian Delivery System, to the subject device, the ECLIPSE™ Femoral Filter System and Jugular/Subclavian Delivery System, was an improvement of the surface finish of the filter raw material wire by electropolishing the wire prior to forming the filter. A cosmetic colorant modification to some of the molded components of the delivery kits was also made.

Device Description:

Indications for Use of Device:

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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.
ECLIPSE™ Filter may be removed according to the instructions supplied under . the section labeled: Optional Procedure for Filter Removal.

Technological Comparison to Predicate Device:

The technological characteristics of the subject device, the ECLIPSE™ Filter System -Femoral and Jugular/Subclavian Delivery Kits, are substantially equivalent to those of the predicate devices, the G2® EXPRESS Filter System - Femoral and Jugular/Subclavian Delivery System (K082305), in terms of intended use, indications for use, application, user population, same operating principle, basic design, fundamental scientific technology, performance, packaging configuration and sterilization method.

Conclusions:

The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits is substantially equivalent to the legally marketed predicate device, the G2® EXPRESS Filter System - Femoral and Jugular/Subclavian Delivery System Kits (K082305 - cleared October 31, 2008).

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

BARD

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 4 2010

Bard Peripheral Vascular, Inc. c/o Ms. Joni Creal Regulatory Affairs Associate 1625 West Third Street Tempe, AZ 85280-1749

Re: K093659

Trade/Device Name: ECLIPSE Filter System, Femoral and Jugular/Subclavian Delivery Kits Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II (two) Product Code: DTK Dated: December 17, 2009 Received: December 18, 2009

Dear Ms. Creal:

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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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/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/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.

Dmith R. Vachner

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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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page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits

Indications for Use:

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.
ECLIPSE™ Filter may be removed according to the instructions supplied under . the section labeled: Optional Procedure for Filter Removal,

Prescription Use / (Part21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. kchner

n Sion-Off Division of Cardiovascular Devices

510(k) Number_

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

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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.”