(155 days)
No
The summary describes a mechanical device (vena cava filter) and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on mechanical integrity and clinical outcomes, not algorithmic performance.
Yes
The device is indicated for the prevention and treatment of pulmonary embolism, which is a medical condition, and it functions by filtering the vena cava.
No
Explanation: The device is a vena cava filter used for the prevention of pulmonary embolism; it does not diagnose a condition.
No
The device is a physical implantable medical device (vena cava filter) and associated delivery system, not a software-only device.
Based on the provided information, the VenaTech® Convertible™ Vena Cava Filter System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The VenaTech Convertible Vena Cava Filter is a physical implantable device designed to be placed directly into the vena cava within the body. Its purpose is to physically prevent blood clots from traveling to the lungs.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It is a therapeutic device that acts mechanically within the patient's circulatory system.
Therefore, the VenaTech Convertible Vena Cava Filter System falls under the category of a medical device (specifically, an implantable device), but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VenaTech® Convertible™ Vena Cava Filter System is indicated for 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 in thromboembolic diseases; ●
- Emergency treatment following massive pulmonary embolism where . anticipated benefits of conventional therapy are reduced; and
- . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the 'Conversion Procedure' in the Instructions for Use.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The VenaTech Convertible Vena Cava Filter is a flexible, symmetrical, cobalt-chromium metal alloy, self-expanding vena cava filter intended for permanent implantation into the infrarenal inferior vena cava to provide protection against pulmonary embolism. When clinically indicated, the clot-trapping features of the VenaTech Convertible filter can be deactivated by percutaneously converting the filter to an open configuration. The VenaTech Convertible filter is pre-loaded in a cartridge (syringe) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either using the femoral or jugular approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava, infrarenal inferior 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)
Non-clinical Evaluations (Bench):
The VenaTech Convertible system has been evaluated through ISO 14971-compliant risk analysis and design verification and validation (DV&V) testing in accordance with ISO 25539-3 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters and in consideration of the FDA guidance for cardiovascular intravascular filter 510(k) submissions. Results from the DV&V testing. which was completed both on the bench and in animals, shows the VenaTech Convertible filter is sufficiently robust for its intended use as a permanent vena cava filter and demonstrates the mechanical integrity and performance of the filter's convertible feature. The ISO 25539-3 compliant DVT included the below evaluations:
- Cavography ability ●
- Clot trapping test ●
- Conversion force
- Dilator spinlock resistance
- Dimension of introduction ● system
- Fatigue resistance (fracture, cracks, and corrosion)
- Filter dimension
- Filter head resistance ●
- Filter radio-opacity
- Filter welding resistance
- Head assembly resistance ●
- Hook crimping strength
- Introduction sheath radioopacity
- . Introduction system traction resistance
- Introduction sheath water tightness
- Migration resistance ●
- (Packaging) Transportation ●
- (Packaging) Fall (drop)
- Passage in sheath ●
- Radial force
- Radial pressure (contact ● pressure)
- Magnetic resonance (MR) testing
Additionally, the VenaTech Convertible filter was subjected to chemical characterization evaluations performed in accordance with ISO 10993 Biological Evaluation of Medical Devices - Part 18: Chemical characterization of materials.
Animal Studies:
Simulated use testing was performed in a sheep model. Results of this animal testing demonstrated that the VenaTech Convertible filter performed according to its intended use, and thus supports substantial equivalence.
Clinical Evaluation:
A multi-center, prospective, single-arm, historical (literature) controlled clinical study was performed to evaluate the VenaTech Convertible filter safety and performance in a minimum of 75 subjects in whom the filter has been implanted, converted and followed for 6-months. Converted subjects were followed at 30-days, 3-months, and 6-months post conversion. Subjects that were unable to undergo conversion (due to clinical condition based on investigator discretion) were followed at 6-months post filter implant (these subjects are referred to as 'permanent filtration subjects'). In this study, eleven (11) sites enrolled a total of 149 subjects. The VenaTech Convertible filter was successfully implanted in all 149 subjects. There were 96 attempted conversions of the filter, 93 actual conversions, and 89 successful conversions with no technical complications. The primary objective, technical success, was achieved in 92.7% of subjects, therefore the primary objective was met. Refer to the IFU for clinical study information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical study primary objective, technical success, was achieved in 92.7% of subjects.
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.
VenaTech LP Vena Cava Filter System (K010485, K063217)
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.
VenaTech LGM Vena Cava Filter System (K881604, K901454, K925679, K932921)
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.”
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
B.Braun Interventional Systems Inc. Peter Flosdorf Engineering Manager 824 Twelfth Avenue Bethlehem. Pennsylvania 18018
Re: K152765
Trade/Device Name: VenaTech Convertible Vena Cava Filter System Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: December 30, 2015 Received: December 31, 2015
Dear Mr. Flosdorf:
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
2
Indications for Use
510(k) Number (if known) K152765
Device Name
VenaTech® Convertible™ Vena Cava Filter System
Indications for Use (Describe)
The VenaTech® Convertible™ Vena Cava Filter System is indicated for 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 in thromboembolic diseases;
- · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced: and
- · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the 'Conversion Procedure' in the Instructions for Use.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
Date Prepared: February 25, 2016
| 510(k) Submitter | Contact | |
|---|---|---|
| B. Braun Interventional Systems Inc. | ||
| 824 Twelfth Avenue | ||
| Bethlehem, PA 18018 | ||
| FDA Est. Reg. #: 3006332832 | Contact: | |
| Peter Flosdorf, Engineering Manager | ||
| Tel: 610-997-4694; Fax: 610-849-5319 | ||
| Peter.Flosdorf@bbrauninterventional.com | ||
| General Information | ||
| Trade Name | VenaTech® Convertible™ Vena Cava Filter System | |
| Common Name | Vena cava filter system | |
| Classification | ||
| Information | Cardiovascular Intravascular Filter (21 CFR 870.3375; Class II) | |
| ProCode: DTK; Panel: Cardiovascular | ||
| Predicate | VenaTech LP Vena Cava Filter System (K010485, K063217) | |
| Reference Device | VenaTech LGM Vena Cava Filter System (K881604, K901454, K925679, K932921) |
Device Description
The VenaTech Convertible Vena Cava Filter is a flexible, symmetrical, cobalt-chromium metal alloy, self-expanding vena cava filter intended for permanent implantation into the infrarenal inferior vena cava to provide protection against pulmonary embolism. When clinically indicated, the clot-trapping features of the VenaTech Convertible filter can be deactivated by percutaneously converting the filter to an open configuration. The VenaTech Convertible filter is pre-loaded in a cartridge (syringe) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either using the femoral or jugular approach.
Intended Use / Indications
The VenaTech® Convertible™ Vena Cava Filter System is indicated for 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 in thromboembolic diseases; ●
- Emergency treatment following massive pulmonary embolism where . anticipated benefits of conventional therapy are reduced; and
- . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the 'Conversion Procedure' in the Instructions for Use.
4
B. Braun Interventional Systems Inc. VenaTech® Convertible™ Vena Cava Filter System
Substantial Equivalence Comparison
The VenaTech Convertible Vena Cava Filter System has substantially equivalent indications and principle of operation to the currently marketed VenaTech LP predicate system. The VenaTech Convertible filter design, materials, introducer accessories, sterile package configuration, and sterilization process are substantially similar when compared to the currently marketed predicate filter. The VenaTech Convertible system has design features that permit the filter elements to convert to an open configuration when clinically indicated to no longer trap emboli. Like the predicates, the VenaTech Convertible filter is intended for permanent implantation and is not to be removed following implantation.
Performance Data
Non-clinical Evaluations (Bench)
The VenaTech Convertible system has been evaluated through ISO 14971-compliant risk analysis and design verification and validation (DV&V) testing in accordance with ISO 25539-3 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters and in consideration of the FDA guidance for cardiovascular intravascular filter 510(k) submissions. Results from the DV&V testing. which was completed both on the bench and in animals, shows the VenaTech Convertible filter is sufficiently robust for its intended use as a permanent vena cava filter and demonstrates the mechanical integrity and performance of the filter's convertible feature. The ISO 25539-3 compliant DVT included the below evaluations:
- Cavography ability ●
- Clot trapping test ●
- Conversion force
- Dilator spinlock resistance
- Dimension of introduction ● system
- Fatigue resistance (fracture, cracks, and corrosion)
- Filter dimension
- Filter head resistance ●
- Filter radio-opacity
- Filter welding resistance
- Head assembly resistance ●
- Hook crimping strength
- Introduction sheath radioopacity
- . Introduction system traction resistance
- Introduction sheath water tightness
- Migration resistance ●
- (Packaging) Transportation ●
- (Packaging) Fall (drop)
- Passage in sheath ●
- Radial force
- Radial pressure (contact ● pressure)
- Magnetic resonance (MR) testing
Additionally, the VenaTech Convertible filter was subjected to chemical characterization evaluations performed in accordance with ISO 10993 Biological Evaluation of Medical Devices - Part 18: Chemical characterization of materials.
5
Animal Studies
Simulated use testing was performed in a sheep model. Results of this animal testing demonstrated that the VenaTech Convertible filter performed according to its intended use, and thus supports substantial equivalence.
Clinical Evaluation
A multi-center, prospective, single-arm, historical (literature) controlled clinical study was performed to evaluate the VenaTech Convertible filter safety and performance in a minimum of 75 subjects in whom the filter has been implanted, converted and followed for 6-months. Converted subjects were followed at 30-days, 3-months, and 6-months post conversion. Subjects that were unable to undergo conversion (due to clinical condition based on investigator discretion) were followed at 6-months post filter implant (these subjects are referred to as 'permanent filtration subjects'). In this study, eleven (11) sites enrolled a total of 149 subjects. The VenaTech Convertible filter was successfully implanted in all 149 subjects. There were 96 attempted conversions of the filter, 93 actual conversions, and 89 successful conversions with no technical complications. The primary objective, technical success, was achieved in 92.7% of subjects, therefore the primary objective was met. Refer to the IFU for clinical study information.
Conclusions
The VenaTech Convertible Vena Cava Filter System is similar in indications, principle of operation, and design to the currently marketed VenaTech LP Vena Cava Filter System predicate. The few design differences, which allow the filter to be converted to no longer trap emboli, were subjected to non-clinical and clinical performance evaluations in accordance with FDA guidance and industry standards. Based on the predicate comparison and performance evaluation information provided in this 510(k), it can be concluded that the VenaTech Convertible Vena Cava Filter System raises no new questions of safety or effectiveness compared to the predicate devices and is, therefore, substantially equivalent.
- End of 510(k) Summary -