(30 days)
Not Found
No
The device description focuses on the mechanical design and materials of the filter and delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is clearly indicated for the "prevention of recurrent pulmonary embolism" and "emergency treatment following massive pulmonary embolism," which are therapeutic applications.
No
This device is a vena cava filter, which is an implantable medical device designed to prevent pulmonary embolism by physically trapping blood clots. It is a therapeutic device, not a diagnostic one. While it helps to physically prevent a medical condition, it does not diagnose, monitor, or detect a disease or condition. Radiopaque markers assist in deployment but are not for diagnostic imaging of the patient's condition.
No
The device description clearly details physical components made of nickel-titanium and other materials, including a filter, dilator, introducer sheath, and pusher, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Denali® Filter is a physical device (a vena cava filter) that is implanted in the body to prevent blood clots from traveling to the lungs. It does not analyze biological specimens.
- Intended Use: The intended use is to prevent pulmonary embolism by physically filtering the vena cava. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is an implantable medical device used for therapeutic purposes.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
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 in the Instructions for Use.
The Denali® Filter consists 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 Denali® 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 10 French dilator, an introducer sheath and long 8 French dilator, and a preloaded Denali® Filter in a storage tube with a pusher. The 15cm, 10 French dilator accepts a 0.035" guidewire and is intended for predilatation. The long 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No new operating principles have been introduced with the subject device. The subject Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit operates using the same fundamental scientific technology as the predicate Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit. Therefore, no performance testing was performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Bard Peripheral Vascular, Inc. Laurie Sang Regulatory Affairs Specialist 1625 W. Third St. Tempe, Arizona 85281
Re: K160866
Trade/Device Name: Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: March 29, 2016 Received: March 30, 2016
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 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.
1
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) K160866
Device Name
Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit
Indications for Use (Describe)
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 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, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-350-6069 |
| Fax: | 480-449-2546 |
| Contact: | Laurie Sang, Regulatory Affairs Specialist |
| Date: | March 18, 2016 |
Subject Device Name:
| Device Trade Name: | Denali® Filter System – Femoral anc
Jugular/Subclavian Delivery Kit |
|-----------------------|------------------------------------------------------------------------|
| Common or Usual Name: | Filter, Intravascular, Cardiovascular |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Product Code: | DTK |
Predicate Devices: (K143208; Clearance November 10, 2014)
Summary of Change:
No changes have been made to the subject Denali® Filter or Delivery System. The purpose of the submission is to update the IFU for inclusion of the 2-year clinical data.
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Device Description:
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 in the Instructions for Use.
The Denali® Filter consists 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 Denali® 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 10 French dilator, an introducer sheath and long 8 French dilator, and a preloaded Denali® Filter in a storage tube with a pusher. The 15cm, 10 French dilator accepts a 0.035" guidewire and is intended for predilatation. The long 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.
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:
- o 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
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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 identical to those of the predicate devices, in terms of the following:
- . Identical Intended use
- ldentical Indications for use
- ldentical target population ●
- . ldentical delivery system design
- ldentical filter design and material .
- Identical fundamental scientific technology ●
- ldentical packaging configuration .
- . Identical Sterility Assurance and method of Sterilization
Performance Testing Summary:
No new operating principles have been introduced with the subject device. The subject Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit operates using the same fundamental scientific technology as the predicate Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit. Therefore, no performance testing was performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption.
Conclusion:
The Denali® Filter System - Femoral and Juqular/Subclavian Delivery Kit is substantially equivalent to the legally marketed predicate device. No changes have been made to the device or delivery system. The only changes being made are to add the 2-year clinical data to the Instructions For Use on the subject device in place of the interim clinical data on the Instructions For Use for the predicate device.
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