The MERIDIAN™ Filter System -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.
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 subject MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the MERIDIAN™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire, enables a contrast medium power injection up to 800 psi maximum pressure, and is fitted with two radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip for identification of the distal end of the sheath and a hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and delivery mechanism to deploy the MERIDIAN™ Filter.

AI/ML Overview

The provided text is a 510(k) summary for the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests rather than presenting a standalone study with acceptance criteria and reported device performance in the way a diagnostic AI device might.

Therefore, many of the requested categories for AI device studies (like sample size, ground truth establishment, expert qualifications, MRMC studies, and training set details) are not applicable to this submission.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a tabular format as would be expected for a diagnostic AI device. Instead, it lists various types of in vitro and in vivo tests conducted to demonstrate substantial equivalence to the predicate device. The conclusion states that the "results from these tests demonstrate that the technological characteristics and performance criteria of the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit is comparable to the predicate device and that the subject device can perform in a manner substantially equivalent to devices currently on the market for the same intended use."

The tests performed are:

Test Type	In Vitro Tests	In Vivo Tests
Mechanical/Physical	- Fatigue Resistance	- Retrievability
	- Anchor Weld Tensile Strength	- Fatigue Resistance
	- Cephalad Migration Resistance	- Cephalad Migration Resistance
	- Caudal Migration Resistance	- Caudal Migration Resistance
	- Removal Force	- Penetration Resistance
	- Delivery System Trackability	- Perforation
	- Delivery System Pushability	- Caval Patency
	- Deployment Accuracy	- Caval Damage
	- Filter Centering (Tilt)	- Caval Narrowing
	- Arm/Leg Entanglement (Configuration)	- Delivery System Trackability
		- Delivery System Pushability
		- Ease of Deployment (Deployment Force)
		- Deployment Accuracy
		- Filter Centering (Tilt)
		- Arm/Leg Entanglement (Configuration)
Material/Visibility	- MRI Compatibility	- Filter Visibility Under Fluoroscopy
	- Biocompatibility	- Delivery System Visibility Under Fluoroscopy
	- Corrosion Resistance

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

The document does not specify the sample sizes for the in vitro or in vivo tests. It only lists the types of tests performed. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the submission describes physical and material performance testing of a medical device, not a diagnostic AI system requiring expert-established ground truth from imaging data.

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

Not applicable for a physical device performance study.

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 is not an AI device or an imaging interpretation study.

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

Not applicable.

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

For a physical medical device, "ground truth" would refer to established engineering standards, material specifications, and biological responses. The tests performed (e.g., fatigue, migration, biocompatibility, perforation) implicitly rely on these standards and established clinical outcomes for similar devices, rather than expert consensus on interpretive data.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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K102511
P. 1 of 4
Page 19

MERIDIAN™ Filter System -Jugular/Subclavian Delivery Kit 510(k) Summary 21 CFR 807.92

AUG 2 4 2011

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 Associate
Date:	August 31, 2010

Subject Device Name:

Device Trade Name:	MERIDIAN™ Filter System –Jugular/Subclavian Delivery Kit (MD800J)
Common or Usual Name:	Filter, Intravascular, Cardiovascular
Classification:	Class II
Classification Panel:	Cardiovascular Devices
Product Code:	DTK
Predicate Devices:	ECLIPSE™ Filter System – Jugular/Subclavian DeliveryKit (K101431: Clearance June 25, 2010)

Summary of Change:

. .

The primary modification to the predicate device, the ECLIPSE™ Filter System -Jugular/Subclavian Delivery System (K101431), compared to the subject device, the MERIDIAN™ Jugular/Subclavian Delivery System, is the addition of one downward pointing titanium anchor which is laser welded to each filter wire arm (6 total). In

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addition, the Jugular delivery system has been modified to accommodate the filter design changes and minor changes have been made to the IFU.

Device Description:

The subject MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the MERIDIAN™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire, enables a contrast medium power injection up to 800 psi maximum pressure, and is fitted with two radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip for identification of the distal end of the sheath and a hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and delivery mechanism to deploy the MERIDIAN™ Filter.

Indications for Use of Device:

The subject device, the MERIDIAN™ Filter System - Jugular/Subclavian 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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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 -Jugular/Subclavian Delivery Kit, are substantially equivalent to those of the predicate device, the ECLIPSE™ Filter System -Jugular/Subclavian Delivery System (K101431), in terms of intended use, indications for use, application, user population, operating principle, delivery system design, filter bi-level design, fundamental scientific technology, packaging configuration, and sterilization method.

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

Fatigue Resistance .
Anchor Weld Tensile Strength .
Cephalad Migration Resistance .
Caudal Migration Resistance ●
Removal Force .
. MRI Compatibility
Delivery System Trackability .
. Delivery System Pushability
. Deployment Accuracy
Filter Centering (Tilt) .
Arm/Leg Entanglement (Configuration) .
Biocompatibility .
Corrosion Resistance .

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K102571
p. 4 of 4
Page 22

In Vivo

Retreivability .
Fatigue Resistance .
Cephalad Migration Resistance .
Caudal Migration Resistance .
Penetration Resistance ◆
Perforation .
Caval Patency .
Caval Damage .
Caval Narrowing .
Delivery System Trackability .
Delivery System Pushability .
Ease of Deployment (Deployment Force) t
Deployment Accuracy .
Filter Centering (Tilt) ●
Arm/Leg Entanglement (Configuration) ◆
Filter Visibility Under Fluoroscopy .
Delivery System Visibility Under Fluoroscopy .

The results from these tests demonstrate that the technological characteristics and performance criteria of the MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit is comparable to the predicate device and that the subject device can perform in a manner substantially equivalent to devices currently on the market for the same intended use.

Conclusions:

The MERIDIAN™ Filter System - Jugular/Subclavian Delivery Kit is substantially equivalent to the legally marketed predicate device, the ECLIPSE™ Filter System -Jugular/Subclavian Delivery System (K101431).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

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

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

AUG 2 4 2011

Re: K102511

Trade Name: MERIDIAN Filter System - Jugular/Subclavian Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: June 27, 2011 Received: June 28, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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.

Si-

Sincerely yours,

Bram Zuckerman, M.D.

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):

Device Name: MERIDIAN™ Filter System -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.

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

Prescription Use_X (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)
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	and the comments of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of the fir
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(Divis


	Division of Cardiovascular Devices

510(k) Number_K 10254

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.”