The Denali® Vena Cava Filter is a venous interruption device designed to prevent pulmonary embolism. The Denali® Filter can be delivered via the femoral and jugular/subclavian approaches. A separate delivery system is available for each approach. The Denali® Filter is designed to act as a permanent filter. When clinically indicated, the Denali® Filter may be percutaneously removed after implantation according to the instructions provided under the "Optional Procedure for Filter Removal" section.

The Denali® Filter of twelve shape-memory laser-cut nickel-titanium appendages. These twelve appendages form two levels of filtration with the legs providing the lower level of filtration and the arms providing the upper level of filtration. The Denal® Filter is intended to be used in the inferior vena cava (IVC) with a diameter less than or equal to 28mm.

The Denali®Vena Cava Filter System consists of a short, 15cm, 10 French dilator, an introducer sheath, a long, 55cm, 8 French dilator, and a preloaded Denall® Filter in a storage tube with a pusher. The 15cm, 10 French dilator accepts a 0.035" quidewire and is intended for pre-dilatation. The long, 55cm, 8 French dilator accepts a 0.035" quidewire and allows for an 800 psi maximum pressure contrast power injection. Radiopaque marker bands on the end of the dilator aid in measuring the maximum indicated IVC diameter. They are spaced at a distance of 28mm (outer-to-outer). The 55cm, 8.4 French I.D. introducer sheath contains a radiopaque marker and hemostasis valve with a side port. The pusher advances the filter through the introducer sheath to the predeployment mark and is then used to fix the filter in place while the filter is unsheathed.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Denali Filter System, structured according to your request:

Based on the provided document, the Denali Filter System is a medical device, and the submission is a 510(k) premarket notification. This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria like those for a novel drug or a high-risk de novo device. Therefore, the information you're asking for, particularly quantitative performance metrics and clinical study details (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance), is typically not included in this type of submission summary.

The document focuses on in vitro testing to show that the modified device (Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit) is substantially equivalent to its predicate.

Here's what can be extracted and inferred from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a substantial equivalence determination based on in vitro testing, explicit numerical acceptance criteria and performance metrics for clinical outcomes are not provided in the document. The "performance" is reported qualitatively as meeting the criteria for substantial equivalence.

Acceptance Criteria Category	Reported Device Performance
Mechanical/Physical	Qualitative statements: - "The results from these tests demonstrate that the technological characteristics and performance of the Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit is comparable to the predicate device." - "The subject Denali Filter System met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." Specific In-Vitro Tests Performed (implying criteria were met for these): - Dimensional and Visual Inspection - Delivery System Component Tensile Testing - Simulated Use Testing - Packaging Testing
Functional Equivalence	Qualitative statements: - "The technological characteristics of the subject device... are substantially equivalent to those of the predicate devices, in terms of the following: - Intended use - Indications for use - Target population - Delivery system design - Filter design and material - Fundamental scientific technology - Packaging configuration (with addition of the extra dilator) - Sterility Assurance and method of Sterilization" - "The subject device can perform in a manner substantially equivalent to the predicate device with the same intended use."

Acceptance Criteria Category

Reported Device Performance

Mechanical/Physical

Qualitative statements: - "The results from these tests demonstrate that the technological characteristics and performance of the Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit is comparable to the predicate device." - "The subject Denali Filter System met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." Specific In-Vitro Tests Performed (implying criteria were met for these): - Dimensional and Visual Inspection - Delivery System Component Tensile Testing - Simulated Use Testing - Packaging Testing

Functional Equivalence

Qualitative statements: - "The technological characteristics of the subject device... are substantially equivalent to those of the predicate devices, in terms of the following: - Intended use - Indications for use - Target population - Delivery system design - Filter design and material - Fundamental scientific technology - Packaging configuration (with addition of the extra dilator) - Sterility Assurance and method of Sterilization" - "The subject device can perform in a manner substantially equivalent to the predicate device with the same intended use."

Note: For a 510(k), "acceptance criteria" usually refers to successful completion of specific engineering tests to ensure the new device performs as intended and is safe and effective when compared to a predicate, rather than clinical performance metrics. The document confirms these engineering criteria were met.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided document. The performance testing section mentions "In Vitro Delivery System Testing." These are typically bench tests or simulated use tests, not clinical human subject trials.
Data Provenance: The document refers to "in vitro testing" without details on where these tests were conducted or the specific samples used. Given it's in vitro, there isn't human data provenance in the sense of country of origin or retrospective/prospective status for patients.

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

This information is not applicable and therefore not provided in the document. In vitro testing does not typically involve expert consensus for "ground truth" in the way clinical studies with image interpretation or pathology do. The "truth" for these tests would be defined by engineering specifications and measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, in vitro testing does not involve adjudication methods for human interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the equivalence was demonstrated via "in vitro testing."

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 (a vena cava filter) and its associated delivery system, not an algorithm or AI.

7. The type of ground truth used

For the in vitro performance testing, the "ground truth" would be the engineering specifications, established mechanical properties, and functional requirements against which the device's performance was measured. For example, for "Dimensional and Visual Inspection," the ground truth would be the design specifications and manufacturing tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device, so there is no "training set."

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

Not applicable. Since there is no training set, there's no ground truth for it to be established.

Summary

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Image /page/0/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 a stylized symbol of three human profiles facing to the right, stacked on top of each other.

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

December 9, 2014

C.R. Bard, Inc. % Laurie Sang Regulatory Affairs Specialist 1625 W. Third St. Tempe, Arizona 85281

Re: K143208

Trade/Device Name: Denali Filter System – Femoral. Jugular/Subclavian Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: November 7, 2014 Received: November 10, 2014

Dear Laurie Sang,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Kenneth J. Cavanaugh -S

for

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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Indications for Use

510(k) Number (if known) K143208

Device Name

Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit

Indications for Use (Describe)

The Denali® Filter is indicated for use in the prevent pulmonary embolism via 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 Denali® Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure for Filter Removal.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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DENALI® Filter System 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:	480-350-6069
Fax:	480-449-2546
Contact:	Laurie Sang, Regulatory Affairs Specialist
Date:	November 7, 2014

Subject Device Name:

Device Trade Name:	Denali® Filter System - Femoral andJugular/Subclavian Delivery Kit
Common or Usual Name:	Filter, Intravascular, Cardiovascular
Classification:	Class II
Classification Panel:	Cardiovascular Devices
Product Code:	DTK
Predicate Devices:	(K130366; Clearance May15, 2013)

Summary of Change:

The modification from the predicate device, compared to the subject Denalle Filter System - Femoral and Jugular/Subclavian Delivery Kit, is the device will include two introducers, a 10 French dilator and an 8 French dilator and pusher system. The new design will also incorporate a longer handle on the delivery system. Minor changes have been made to the device labeling.

Image /page/3/Picture/12 description: The image shows the word "BARD" in a stylized, bold font. The letters are thick and geometric, with a unique design for the letter "A" that resembles an upside-down "V" with a horizontal line connecting the two sides. The overall impression is a strong and modern logo or wordmark.

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Device Description:

Indications for Use of Device:

The Denali® Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

. Pulmonary thromboembolism when anticoaqulants are contraindicated
. Failure of anticoagulant therapy for thromboembolic disease
Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced

Image /page/4/Picture/13 description: The image shows the word "BARD" in a stylized, all-caps font. The letters are bold and outlined in black, giving them a three-dimensional appearance. The "A" in "BARD" is designed with a unique, angular shape, setting it apart from the other letters.

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. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The Denali® 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 Denali® Filter System -Femoral and Jugular/Subclavian Delivery Kit, are substantially equivalent to those of the predicate devices, in terms of the following:

Intended use
Indications for use
. Target population
. Delivery system design
Filter design and material .
. Fundamental scientific technology
. Packaging configuration (with addition of the extra dilator)
. Sterility Assurance and method of Sterilization

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 testing performed as outlined below:

In Vitro Delivery System Testing

. Dimensional and Visual Inspection
Delivery System Component Tensile Testing .
. Simulated Use Testing
. Packaging Testing

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The results from these tests demonstrate that the technological characteristics and performance of the Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit is comparable to the predicate device and that the subject device can perform in a manner substantially equivalent to the predicate device with the same intended use.

Conclusion:

The subject Denali Filter System met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit is substantially equivalent to the legally marketed predicate device.

Image /page/6/Picture/6 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. The letters are outlined in black, creating a strong visual impact. The design of the letters is somewhat geometric, with the "A" resembling a triangle and the "D" having a rounded, almost semi-circular shape.

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.”