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

Pulmonary thromboembolism when anticoagulants are contraindicated .
. Failure of anticoagulant therapy in thromboembolic diseases
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 Instructions for Use 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 VCF System is an endovascular medical device used in the prevention of recurrent pulmonary embolism (PE). The system consists 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 self-expanding Nitinol spiral elements connected at each end with Nitinol crimps. One end 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 wireforms elements with Nitinol tubing. The filter is designed to treat IVC diameters of 17 to 28mm.

The Delivery Catheter for the Crux VCF 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" guidewire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The polyimide inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip and 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

This document outlines the performance data for the Crux Vena Cava Filter System, as presented in its 510(k) submission.

Device: Crux Vena Cava Filter System

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to a predicate device through bench testing. The document states that "Bench test results demonstrate that the device meets the established specifications and is comparable to the predicate device supporting substantial equivalence." Specific performance metrics and criteria are not explicitly detailed in the provided text, but the tests conducted were:

Acceptance Criteria (Implied)	Reported Device Performance
Device meets established specifications.	"Bench test results demonstrate that the device meets the established specifications."
Device is comparable to the predicate device.	"Bench test results demonstrate that the... device is comparable to the predicate device supporting substantial equivalence." and "The results also are comparable to the established predicate device supporting substantial equivalence."
No adverse impact on safety and effectiveness compared to the predicate device due to design updates.	"Based on the design verification results, the updates in Delivery Catheter do not have an adverse impact on the safety and effectiveness of the VCF when compared to the predicate device."
Performance of the updated delivery catheter is not adversely affected compared to the predicate device.	"As demonstrated in the results of the bench testing, these differences in design do not adversely affect the performance when compared to the predicate device and the devices are substantially equivalent."

2. Sample Size for Test Set and Data Provenance

The provided text does not specify the sample sizes used for the in-vitro bench tests (Dimensional and Visual Inspection, Deployment Trackability, Bond Strength). The data provenance is assumed to be from Crux Biomedical, Inc.'s internal testing, as it's part of a 510(k) submission to the FDA. The testing is in-vitro, meaning it was conducted in a lab setting, not on human or animal subjects, so country of origin isn't relevant in the same way as clinical data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The study involved bench testing (in-vitro testing) of the device's physical properties and performance. There was no ground truth established by experts in a clinical context for a diagnostic output.

4. Adjudication Method for the Test Set

Not applicable, as this was bench testing, not a clinical study with subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes a 510(k) submission based on bench testing to demonstrate substantial equivalence of a medical device to a predicate device, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance Study (Algorithm Only)

No. This device is a physical medical device (vena cava filter system), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on established engineering specifications and performance benchmarks derived from the predicate device. The tests are designed to verify that the updated device components (specifically the delivery catheter) meet these physical and mechanical requirements and perform comparably to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning system that requires a "training set" of data.

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device submission.

Summary

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510(k) Summary Crux Vena Cava Filter System 21 CFR 807.92

JAN 1 7 2013

Device Common Name:

Vena Cava Filter

Elisa Hebb

Crux Biomedical, Inc.

Tel: 650-321-9903 Fax: 650-321-9904

1455 Adams Drive, #1170 Menlo Park, CA 94025

K122585

Applicant / Manufacturer:

Crux Biomedical, Inc. 1455 Adams Drive, #1170 Menlo Park, CA USA 94025 Tel: 650-321-9903 Fax: 650-321-9904

Correspondent Contact Information:

Device Classification Regulation & Name:

Device Classification & Product Codes:

Class II, DTK -

Panel:

Cardiovascular

K120402/S1 and S2

Prior FDA Document Numbers:

Device Proprietary Name:

Basis of Submission:

Kit Description:

Number of Devices in Submission:

Crux Vena Cava Filter System

Special 510(k) based on K120402

Crux Vena Cava Filter System consists of: Crux Vena Cava Filter Crux Delivery Catheter

7014 - Crux Vena Cava Filter System - Femoral 7015 - Crux Vena Cava Filter System - Jugular

RFI 20Sept2012 Crux Biomedical, Inc.

21 December 2012_Page 113 of 116

21 CFR 870.3375, Cardiovascular intravascular filters

Vice President, Clinical and Regulatory Affairs

Email: ehebb@cruxbiomedical.com

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Intended Use

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

Pulmonary thromboembolism when anticoagulants are contraindicated .
. Failure of anticoagulant therapy in thromboembolic diseases
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

Device Description - Crux Vena Cava Filter (VCF) System

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

Predicate Device Information

Predicate Device:
-------------------	--

Crux Vena Cava Filter System

510(k) Numbers:

K120402

K122585 RFI 20Sept2012 Crux Biomedical, Inc.

21 December 2012 Page 114 of 116

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Device Manufacturer:	Crux Biomedical, Inc.1455 Adams Drive, #1170Menlo Park, CA 94025 USA
Device Common Name:	Cardiovascular Filter
Device Classification Name:	21 CFR 876.3375, Cardiovascular intravascular filters
Device Classification &Codes:	Class II, DTK

Comparison to Predicate Device

Both the updated Crux VCF System and predicate device share similar designs, mode of operation and materials. The filters are the same in the subject and predicate devices. Both filters are delivered to the vena cava via transcatheter approach. When deployed, the nitinol material utilized in both the predicate and subject devices allows for self-centering of the filters are designed with anchors to secure the filter to vessel wall and both filters can be safely retrieved via catheterization.

The primary differences between the predicate and subject devices are the design updates for the Delivery Catheter in the subject device. The design updates include a smoother tracking tip, increased radiopacity of tracking tip, an additional radiopaque marker, and an updated manufacturing process for tubing. Based on the design verification results, the updates in Delivery Catheter do not have an adverse impact on the safety and effectiveness of the VCF when compared to the predicate device.

As demonstrated in the results of the bench testing, these differences in design do not adversely affect the performance when compared to the predicate device and the devices are substantially equivalent.

Other areas of substantial equivalence with predicate device:

Intended Use Indications for Use Target Patient Population Mode of Operations

Summary of Supporting Data

Crux conducted the applicable performance testing for the cited changes to the filter Delivery Catheter. Performance testing was conducted to establish substantial equivalence to the predicate device as outlined below:

In vitro testing

Dimensional and Visual Inspection Deployment Trackability Bond Strength

K122585 RFI 20Sept2012 Crux Biomedical, Inc.

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Conclusion

Bench test results demonstrate that the device meets the established specifications and is comparable to the predicate device supporting substantial equivalence.

The results for the updated Crux Vena Cava Filter System indicate safety and effectiveness for the proposed intended use. The results also are comparable to the established predicate device supporting substantial equivalence.

ਜੀ

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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 is circular and features the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem.

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

JAN 1 7 2013

Crux Biomedical, Inc. c/o Ms. Elisa Hebb Vice President, Clinical and Regulatory Affairs 1455 Adams Drive, # 1170 Menlo Park, CA 94025

Re: K122585

Trade/Device Name: Crux Vena Cava Filter System Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: December 21, 2012 Received: December 26, 2012

Dear Ms. Hebb:

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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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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Matthew G. Hillebrenner

for

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

Crux Vena Cava Filter System (Crux VCF System) Device Name:

Indications for Use:

The Crux 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 diseases, .
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.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Miller

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K122585

Page 1 of

Special 510(k)_22 August 2012 Crux Biomedical, Inc.

Page 20 of 145

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.”