The Crux Vena Cava Filter (VCF) System is indicated for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC) in the following situations:

pulmonary thromboembolism when anticoagulants are contraindicated:
failure of anticoagulant therapy in 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 Crux VCF may be removed according to the instructions contained in the section "Optional Retrieval of the Crux VCF" in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach.

Device Description

The Crux Vena Cava Filter (VCF) System is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The system is comprised of a self-expanding Nitinol filter delivered from a single-use, disposable 9Fr catheter, which can be used percutaneously to deploy the filter. The filter wireforms are composed of two opposing selfexpanding Nitinol spiral elements connected at each end with Nitinol crimps. One of each wireform is formed into a sinusoidal shaped retrieval tail to aid in retrieval of the filter using a snare. Each retrieval tail has an atraumatic plasma ball and a radiopaque tantalum marker band to facilitate visualization. There are five tissue anchors attached to the wireform elements with Nitinol tubing. The filter is designed to treat IVC diameters of 17 to 28mm.

The delivery catheter for the Crux VCF System is a disposable, 9Fr introducer-sheath-compatible, single-use delivery catheter. The filter is provided loaded in the Crux VCF System for jugular or femoral approach delivery. The delivery catheter is an over-the-wire system, 0.035" guidewirecompatible, and is comprised of a polycarbonate inner shaft and a nylon outer shaft. The polyimide inner shaft is comprised of the guidewire lumen, and a flexible radiopaque tracking tip with a radiopaque marker band. The outer shaft has a radiopaque marker band, a Touhy-Borst hemostasis valve, and a one-way check-valve for flushing.

The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Crux Vena Cava Filter System. The document focuses on regulatory approval based on substantial equivalence to a predicate device and addresses labeling changes, not on a study proving the device meets specific acceptance criteria in terms of clinical performance as an AI/CAD/imaging device.

Therefore, many of the requested details, such as a table of accuracy metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/CAD/imaging device performance, are not applicable to this submission.

However, the document does mention performance data related to device functionality.

Here's the information that can be extracted or deduced from the provided text:

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

Acceptance Criteria (General Description)	Reported Device Performance Statement
Proper blood flow with renal vein inflow (evaluated by CFD Modeling)	All tests met the pre-determined acceptance criteria.
Radial forces at pararenal placement (evaluated by VCF Radial Force Test)	All tests met the pre-determined acceptance criteria.
Catheter pressure integrity for power injection	All tests met the pre-determined acceptance criteria.
Clinical workflow of VCF deployment at pararenal location	All tests met the pre-determined acceptance criteria.
Power injection through the delivery catheter during simulated use	All tests met the pre-determined acceptance criteria.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The "tests" mentioned were bench and animal studies, not human clinical trials for endpoint efficacy.
Data Provenance: Not explicitly stated. The studies were described as "bench and animal device testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. The "tests" focused on device functionality (e.g., flow, radial force, pressure integrity, workflow) rather than clinical diagnostic or therapeutic outcomes requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

Not Applicable. This is not relevant for the type of device functionality tests described.

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:

No. This is not an AI/CAD/imaging device.

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

Not Applicable. This is not an AI/CAD/imaging device.

7. The type of ground truth used:

For the bench testing, the "ground truth" would be established by validated engineering principles, physical measurements, and computational models (e.g., CFD).
For the animal testing, the "ground truth" would be direct observation and measurement in the animal model.
Not pathology, outcomes data, or expert consensus in the context of diagnostic interpretation, as this is a device for mechanical intervention.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires "training sets."

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

Not Applicable. This is not a machine learning or AI device.

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 an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

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

April 3, 2015

Volcano Corporation Elaine Alan Senior Regulatory Affairs Specialist 1 Fortuna Drive Billerica, MA 01821

Re: K150262

Trade/Device Name: Crux Vena Cava Filter System, Femoral: Crux Vena Cava Filter System, Jugular Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: February 3, 2015 Received: February 4, 2015

Dear Ms. Elaine Alan:

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 device

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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 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) K150262

Device Name Crux Vena Cava Filter System

Indications for Use (Describe)

The Crux Vena Cava Filter (VCF) System is indicated for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC) in the following situations:

· pulmonary thromboembolism when anticoagulants are contraindicated:
· failure of anticoagulant therapy in 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Volcano Corporation. The logo features a stylized gray triangle next to the company name in bold, dark blue letters. Below the logo is the company's address at 1 Fortune Drive, Billerica, MA 01821, along with their main phone number +1 978-262-0049, fax number +1 978-262-0035, and website www.volcanocorp.com.

510(k) Summary

SPONSOR: Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670

CONTACT/

SUBMITTER: Elaine Alan Sr. Regulatory Affairs Specialist Volcano Corporation 1 Fortune Drive Billerica, Massachusetts 01821 Tel: 858-764-1281 Fax: 978-262-0035 Email: ealan@volcanocorp.com

DATE OF

SUBMISSION: February 3, 2015
DEVICE: Vena Cava Filter
TRADE NAME: CRUX Vena Cava Filter System

COMMON

NAME: Crux VCF System
PRODUCT CODE: DTK
CLASSIFICATION: 21 CFR 870.3375 Class II Device
PANEL: Cardiovascular
PREDICATE DEVICE: Crux Vena Cava Filter System, K122585

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DEVICE DECRISPTION:

The filter can be retrieved with commercially available snares and sheaths via either the jugular or femoral approach.

INTENDED USE:

The Crux Vena Cava Filter System is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard endovascular techniques for placement of vascular access sheaths, angiographic catheters and guidewires should be employed.

The intended use of the Crux VCF System is unchanged by the content of this submission.

INDICATIONS FOR USE:

The Crux® Vena Cava Filter System is indicated for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC) in the following situations:

pulmonary thromboembolism when anticoagulants are contraindicated;
failure of anticoagulant therapy in 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.

COMPARISON OF CHARACTERISTICS:

This submission is for labeling changes only. The devices are identical in terms of design, materials, specifications, principles of operation, and fundamental scientific technology.

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PERFORMANCE DATA:

Bench and animal device testing was conducted to confirm the performance of the device. There are no known recognized standards relevant to the proposed labeling changes. Bench testing relative to infusion of contrast media was conducted in accordance with FDA Guidance for Industry and FDA Staff "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty PPTCA) Catheters". Tests performed to assess the impact of the proposed labeling changes were:

Bench testing:

Flow Analysis using Computational Flow Dynamics (CFD) Modelling to examine blood flow past the Crux VCF with the inflow from the right and left renal veins
. VCF Radial Force Test to evaluate the effect of the proposed pararenal placement on radial forces
Catheter Pressure Integrity testing to show that the catheter is designed to perform power injection of contrast media

Animal testing:

. Work flow Evaluation of Placement to evaluate the clinical workflow of deploying the Crux VCF when placed in a pararenal location
Power Injection Testing to evaluate the use of a power injector to inject contrast media ● through the Crux VCF delivery catheter during simulated clinical use

All tests met the pre-determined acceptance criteria.

Biocompatibility testing was not conducted on the device as there were no changes made to materials or sterilization.

CONCLUSION:

Completion of these tests concluded that the proposed Crux VCF System is substantially equivalent to the predicate device.

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.”