(58 days)
Not Found
No
The device description and performance studies focus on the mechanical and hydraulic properties of the filter and delivery system, with no mention of AI or ML. The computational flow dynamics (CFD) modeling is a simulation technique, not an AI/ML application in this context.
Yes.
The device is used for the "prevention of recurrent pulmonary embolism," making it a therapeutic device aimed at treating or preventing a medical condition.
No
This device, a Vena Cava Filter, is used for the prevention of recurrent pulmonary embolism by physically filtering emboli in the inferior vena cava. It is a therapeutic device that acts on the body to treat a condition, not a diagnostic device that detects or identifies a disease or condition.
No
The device description clearly details physical components including a self-expanding Nitinol filter, a single-use disposable catheter, wireforms, crimps, retrieval tails, tissue anchors, and a delivery catheter with various parts. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC)". This is a therapeutic intervention performed within the patient's body.
- Device Description: The description details a physical implant (filter) and a delivery system (catheter) used to place the filter in the IVC. This is consistent with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
- 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.
Product codes
DTK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inferior vena cava (IVC)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Crux Vena Cava Filter System, K122585
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
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
2
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.
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.
| 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
4
DEVICE DECRISPTION:
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.
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.
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.
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.
5
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.