The MERIDIAN™ Filter System - Femoral Delivery Kit is 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.
MERIDIAN™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

Device Description

The MERIDIAN™ 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 six legs provide the lower level of filtration and the six arms provide the upper level of filtration. The legs contain hooks and the arms contain anchors to resist filter movement. The MERIDIAN™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The MERIDIAN™ Filter System - Femoral Delivery Kit consists of a 8 French inner diameter (I.D.) introducer sheath and dilator set, a storage tube preloaded with the MERIDIAN™ 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 MERIDIAN™ Filter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MERIDIAN™ Filter System - Femoral Delivery Kit, based on the provided text:

Important Note: The provided document is a 510(k) Summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or safety through new clinical trials as would be the case for a novel device. Therefore, the "study" described here is primarily a series of in vitro and in vivo performance tests designed to show that the modified device performs comparably to the predicate. It does not involve human subjects as a traditional clinical trial would for evaluating primary outcomes.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative thresholds against which "reported device performance" is directly compared for each test. Instead, it states that the results from the performance tests "demonstrate that the technological characteristics and performance of the MERIDIAN™ Filter System – Femoral Delivery Kit is comparable to the predicate devices and that the subject device can perform in a manner substantially equivalent to the predicates devices with the same intended use."

The document lists the following performance tests conducted:

In Vitro Delivery System Testing:

Dimensional and Visual Inspection
Tensile
Torque
Flushability
Component compatibility
Attachment/Detachment
Filter Dislodgement
Pushability
Trackability
Removability
Filter Centering (Tilt)
Arm and Leg Entanglement (Filter Configuration)
Deployment Force
Deployment Accuracy
Liquid Leakage
Leakage during power injection
Burst
Air Aspiration
Biocompatibility per ISO 10993-1

In Vivo Delivery System Testing:

Delivery System Trackability and Pushability
Dilator and Introducer Sheath Trackability and Pushability
Ease of Deployment (Deployment Force)
Deployment Accuracy
Filter Centering (Tilt)
Arm and Leg Entanglement (Filter Configuration)
Dilator Marker Band Visibility Under Fluoroscopy
Introducer Sheath Tip Visibility Under Fluoroscopy

Summary of Reported Performance: The overall reported performance is that the device is "comparable to the predicate devices" and "substantially equivalent." Specific quantitative metrics for each test and their relation to defined acceptance criteria are not provided in this 510(k) summary. The FDA's clearance implies that the provided data (which likely included specific test reports and data that are not part of this public summary) met the agency's requirements for demonstrating substantial equivalence.

Study Details

Given this is a 510(k) summary focused on demonstrating substantial equivalence through performance testing of a modified device, many of the typical "study" parameters for clinical trials (like sample sizes for test sets, data provenance, expert ground truth, adjudication, MRMC studies) are not applicable or described in the same way.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. Performance tests typically involve a defined number of devices or components.
- Data Provenance: The tests were conducted "in vitro and in vivo." The "in vivo" testing would likely refer to animal models, not human subjects, given that this is a 510(k) for a modification (delivery kit components). The country of origin for the data is not specified but would typically be conducted by or for the manufacturer (Bard Peripheral Vascular, Inc. in Tempe, Arizona, USA). The study is prospective in the sense that these tests were performed specifically to support this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of device performance testing. Ground truth here is based on engineering specifications, material standards (e.g., ISO 10993-1 for biocompatibility), and comparison to the predicate device's established performance under those specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study requiring human expert assessment or consensus on clinical outcomes. Device performance tests are typically objective measurements.
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:
- This is not an AI-assisted diagnostic device, but rather a medical implant delivery system. Therefore, an MRMC comparative effectiveness study is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an algorithm or AI device. The performance tests are of the physical device and its components.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or standard of comparison) for these performance tests is based on:
  - Engineering specifications: Ensuring the components meet design tolerances and functional requirements (e.g., deployment force, trackability).
  - Material standards: Conformance to established standards, such as ISO 10993-1 for biocompatibility.
  - Predicate device performance: Demonstrating that the modified device performs comparably to the previously cleared predicate device in all relevant aspects.
The sample size for the training set:
- This is not an AI/machine learning device; hence, there is no "training set." The device is evaluated based on its physical and mechanical properties.
How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML model.

Summary

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OCT 24 2011 K112497
p. 1 of 4
Page 7

MERIDIAN™ Filter System - Femoral Delivery Kit 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 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-638-2906
Fax:	480-449-2546
Contact:	Joni Creal, Regulatory Affairs Specialist II
Date:	September 30, 2011

Subject Device Name:

Device Trade Name:	MERIDIAN™ Filter System - FemoralDelivery Kit (MD800F)
Common or Usual Name:	Filter, Intravascular, Cardiovascular
Classification:	Class II
Classification Panel:	Cardiovascular Devices
Product Code:	DTK
Predicate Devices:	ECLIPSE® Filter System - Femoral Delivery Kit (K101431;Clearance June 24, 2010)
	MERIDIAN™ Filter System - Jugular/Subclavian DeliveryKit (K102511; Clearance August 24, 2011)

Summary of Change:

The modifications from the predicate devices, compared to the subject MERIDIAN™ Filter System - Femoral Delivery System, are changes to the delivery system only. The following delivery system components were upsized to accommodate the addition of the

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filter arm anchors of the cleared MERIDIAN™ Filter (K102511, August 24, 2011): spline, introducer sheath, introducer hub, introducer hub cap, introducer valve, dilator hub, dilator marker bands, safety cap and storage tube. All materials are identical, with the exception of the storage tube, which is now polycarbonate tubing with ABS overmold (the predicate storage tube is only polycarbonate tubing). No changes have been made to the MERIDIAN™ Filter as cleared under K102511 on August 24, 2011. Minor changes have been made to the device labeling.

Device Description:

The MERIDIAN™ Filter System - Femoral Delivery Kit consists of a 8 French inner diameter (I.D.) introducer sheath and dilator set, a storage tube preloaded with the MERIDIAN™ 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 MERIDIAN™ Filter.

Indications for Use of Device:

The subject device, the MERIDIAN™ Filter System - Femoral Delivery Kit, is 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.

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K122497
P. 3 of 4

Page 9

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

Technological Comparison to Predicate Devices:

The technological characteristics of the subject device, the MERIDIAN™ Filter System -Femoral Delivery Kit, are substantially equivalent to those of the predicate devices, in terms of following:

Intended use (both predicates) .
Indications for use (both predicates) .
Target population (both predicates) .
Operating principle (both predicates) .
Delivery system design (ECLIPSE® Filter System Femoral Delivery Kit) ●
Filter design and material (MERIDIAN™ Filter System Jugular/Subclavian . Delivery Kit)
Fundamental scientific technology (both predicates) .
Packaging configuration (ECLIPSE® Filter System Femoral Delivery Kit) ●
Sterility Assurance and method of Sterilization (both predicates) .

Performance Testing Summary:

To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated using in vitro and in vivo testing performed as outlined below:

In Vitro Delivery System Testing

Dimensional and Visual Inspection .
Tensile .
Torque .
Flushability .
Component compatibility .
Attachment/Detachment .
Filter Dislodgement .

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K112497
p. 4 of 4

Page 10

. Pushability
Trackability ●
. Removability
Filter Centering (Tilt) �
Arm and Leg Entanglement (Filter Configuration) .
Deployment Force .
Deployment Accuracy .
. Liquid Leakage
Leakage during power injection .
. Burst
Air Aspiration .
. Biocompatibility per ISO 10993-1

In Vivo Delivery System Testing

. Delivery System Trackability and Pushability
Dilator and Introducer Sheath Trackability and Pushability .
Ease of Deployment (Deployment Force) .
Deployment Accuracy
Filter Centering (Tilt) .
Arm and Leg Entanglement (Filter Configuration) .
Dilator Marker Band Visibility Under Fluoroscopy .
Introducer Sheath Tip Visibility Under Fluoroscopy .

The results from these tests demonstrate that the technological characteristics and performance of the MERIDIAN™ Filter System – Femoral Delivery Kit is comparable to the predicate devices and that the subject device can perform in a manner substantially equivalent to the predicates devices with the same intended use.

Conclusion:

The MERIDIAN™ Filter System – Femoral Delivery Kit is substantially equivalent to the legally marketed predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

OCT 2 4 2011

Bard Peripheral Vascular, Inc. c/o Ms. Joni Creal Regulatory Affairs Associate 1625 West Third Street Tempe, AZ 85281

Re: K112497

Trade Name: Meridian Filter System - Femoral Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: September 30, 2011 Received: October 3, 2011

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. 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

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Page 2 - Ms. Joni Creal

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram 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

510(k) Number (if known): צו ו 2497

Device Name: MERIDIAN™ Filter System - Femoral Delivery Kit

Indications for Use:

The MERIDIAN™ Filter System - Femoral Delivery Kit is 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.

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

Prescription Use X (Part 21 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)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number

Bard Peripheral Vascular, Inc.

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.”