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-sheathcompatible, 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-thewire system, 0.035" guidewire-compatible, and consists of a polycarbonate inner shaft and a nylon outer shaft. The inner shaft consists of the guidewire lumen and a flexible, radiopaque tracking tip. The outer shaft has a radiopaque distal marker band, a Touhy-Borst hemostasis valve and a one-way checkvalve for flushing.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Crux Vena Cava Filter System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Defined as "Primary Endpoint of Clinical Success")	Reported Device Performance
Technical success of deployment	98% (123/125)
Freedom from PE (Pulmonary Embolism)	2.4% recurrent PE
Freedom from filter migration	0 cases of migration
Freedom from device related adverse events requiring intervention	Not explicitly quantified, but overall Clinical Success was 96%
Overall Clinical Success: Expected to exceed 80% (91.8% lower one-sided 95% CL)	96% (91.8% lower one-sided 95% CL)
Retrieval success (Secondary Endpoint)	98% (53/54)

Note: The document explicitly states, "Clinical Success was 96% (91.8% lower one-sided 95% CL exceeding the 80)." This indicates that the acceptance criterion for overall clinical success was likely a lower bound of 80% with a 95% confidence interval.

Study Details

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

Test set sample size: 125 subjects (for clinical trial)
Data provenance: Prospective, single-arm, multinational clinical trial.

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

This information is not explicitly provided in the given text. Clinical trials often involve multiple clinicians for assessment, but the number and qualifications of experts specifically for establishing "ground truth" (e.g., confirming PE diagnoses, migration, etc.) are not detailed.

4. Adjudication method for the test set:

This information is not explicitly provided in the given text.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed. This document describes a clinical trial for a physical medical device (vena cava filter), not an AI-powered diagnostic tool.

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

No, this refers to a physical medical device, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The type of ground truth used:

The ground truth was established through clinical outcomes observed in the prospective clinical trial. This includes:
- Technical success of deployment (observed during procedure)
- Occurrence of recurrent PE (diagnosed clinically)
- Filter migration (diagnosed clinically/radiographically)
- Device-related adverse events requiring intervention (diagnosed clinically)
- Retrieval success (observed during removal procedure)
- Radiographic anomalies (e.g., IVC thrombus).

8. The sample size for the training set:

This information is not applicable as this describes a physical medical device and its clinical trial, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reasons as above.

Summary

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K120402

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

JUL 1 3 2012 1

Device Common Name:	Vena Cava Filter
Applicant / Manufacturer:	Crux Biomedical, Inc.1455 Adams Drive, #1170Menlo Park, CA USA 94025Tel: 650-321-9903Fax: 650-321-9904
Correspondent ContactInformation:	Elisa HebbVice President, Clinical and Regulatory AffairsCrux Biomedical, Inc.1455 Adams Drive, #1170Menlo Park, CA 94025Tel: 650-321-9903Fax: 650-321-9904Email: ehebb@cruxbiomedical.com
Device ClassificationRegulation & Name:	21 CFR 870.3375, Cardiovascular intravascular filter
Device Classification &Product Codes:	Class II, DTK
Panel:	Cardiovascular
Prior FDA DocumentNumbers:	G070035/S001 through G070035/S032
Device Proprietary Name:	Crux Vena Cava Filter System
Basis of Submission:	New Device
Kit Description:	Crux Vena Cava Filter System consists of:• Crux Vena Cava Filter• Crux Delivery Catheter
Number of Devices inSubmission	• 7014 – Crux Vena Cava Filter System - Femoral• 7015 – Crux Vena Cava Filter System - Jugular

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 .

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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:	Option Vena Cava Filter
510(k) Numbers:	K081410

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Device Manufacturer:	Rex Medical100 East Hector St. Suite 245Conshocken, PA 19428
Device Common Name:	Cardiovascular Filter
Device ClassificationName:	21 CFR 870.3375, Cardiovascular intravascularfilters
Device Classification &Codes:	Class II, DTK

Comparison to Predicate Device

Both the Crux VCF System and predicate device share similar designs, mode of operation and materials. 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 filter. Both 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 filter geometry and the addition of ePTFE filter web incorporated in the Crux VCF design. Based on the design verification and validation results, the variation in geometry and addition of the ePTFE filter web 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 clinical trial, these differences in design do not adversely affect the clinical outcomes 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

Performance testing was conducted to establish substantial equivalence to the predicate device as outlined below:

In vitro testing Biocompatibility Shipping and Packaging

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Dimensional and Visual Inspection Deployment Retrievability Trackability Deployment Radial Force Bond and Torque Strength MRI Compatibility Clot Trapping Fatigue Corrosion

In vivo testing (Pre-clinical) Deployment Retrieval Positional Stability IVC histopathology

Clinical Testing Summary:

A clinical trial was conducted under an approved IDE and IRB protocol to further establish the safety, effectiveness and substantial equivalence to the predicate device. One hundred and twenty-five (125) subjects with a temporary or permanent risk of recurrent pulmonary embolism were enrolled into a prospective, single arm, multinational clinical trial. Subjects were followed for 180 days or 30 days after filter retrieval. The primary endpoint of clinical success is defined as technical success of deployment and freedom from PE, filter migration, and device related adverse events requiring intervention. Secondary endpoints include retrieval success, filter migration, IVCF thrombosis, and device integrity.

The technical success rate was 123/125 (98%). There were 3 cases of recurrent PE (2.4%) and no cases of embolization, migration or fracture. There were 8 cases of asymptomatic, new inferior vena cava (IVC) thrombus including 5 observed at retrieval evaluation. Clinical Success was 96% (91.8% lower one-sided 95% CL exceeding the 80). Retrieval success was 53/54 (98%) at a mean of 83 ± 57 days (range 7 to 190) with 1 radiographic anomaly observed with no clinical sequelae.

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The clinical trial demonstrated the safe deployment, implant and retrieval of the filter. Technical and retrieval success are high, with a low rate of device related complications.

Conclusion:

Bench test, animal test and the clinical trial results demonstrate that the device meets the established success criteria and is substantially equivalent to the predicate device.

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Image /page/5/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 that resembles a caduceus, which is a traditional symbol of medicine. The symbol is composed of three abstract shapes that suggest a staff with two snakes coiled around it.

Public Health Service

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

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

Re: K120402

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: July 9, 2012 Received: July 10, 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

JUL 1 3 2012

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Page 2 - Ms. Hebb

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Or FC r ar bo 7) a created (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 1000 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,

M. G. Killeen

Gram 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 Statement

510(k) Number: This application

K190402

Crux Vena Cava Filter System Device Name:

Indications For 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

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 (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.G. Helleh

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K120402

K120402 RFI 23Mar2012 Crux Biomedical, Inc.

Page 488 of 581

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.”