(140 days)
No
The summary describes a mechanical device (an IVC filter) and its physical properties and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to prevent recurrent pulmonary embolism, which is a medical condition, making it a therapeutic device.
No.
The Sentry IVC Filter is a therapeutic device designed to prevent pulmonary embolism by trapping emboli in the inferior vena cava. It does not diagnose any condition.
No
The device description clearly details a physical implantable device (IVC filter) made of Nitinol and a bioabsorbable filament, along with a delivery system. The performance studies also focus on bench testing of the physical device's mechanical properties.
Based on the provided information, 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 percutaneous placement in the inferior vena cava". This describes a therapeutic intervention performed within the patient's body.
- Device Description: The description details a physical implantable device (a filter) designed to be placed in the inferior vena cava to trap emboli. This is an in-vivo device.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is an implantable medical device used for a therapeutic purpose within the patient's body.
N/A
Intended Use / Indications for Use
The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.
Product codes
DTK
Device Description
The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE.
The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr).
The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.
This 510(k) is submitted to support device and manufacturing process changes to the Nitinol frame and the Delivery System previously cleared under K162875.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Novate developed a design verification and validation program for the modified Sentry IVC Filter with reference to the FDA Guidance for Cardiovascular Intravascular Filter 510(k) Submissions and the international standard ISO 25539-3 Cardiovascular implants- Endovascular devices -Part 3: Vena cava filters. Bench studies were undertaken to demonstrate the performance and safety of the modified Sentry IVC Filter when used according to the Instructions for Use.
The design verification and validation program included the evaluations listed below:
- Delivery System visual & dimensional
- Delivery System integrity
- Filter visual and dimensional
- Fatigue resistance
- Filter Corrosion
- Migration resistance
- Radial Force
- Ease of device use
- Simulated Deployment
- Accuracy of Deployment
- Packaging Visual Inspection
- Labeling Visual Inspection
- Tyvek Pouch Peel
- Foil Pouch Peel
- Bubble Leak Testing
- Transportation testing
All tests met the pre-determined acceptance criteria. Results from the design verification and validation program demonstrate the mechanical integrity and performance of the modified device and that the modified Sentry IVC Filter achieves its intended use as a vena cava filter.
A biological safety assessment was performed to evaluate the biological risks associated with the modified Sentry IVC Filter per FDA's Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process". This risk assessment involved biocompatibility testing on the implant and delivery system/accessories. The modified Sentry IVC Filter was also subjected to chemical characterization and a toxicological evaluation performed in accordance with ISO 10993 Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances. The biocompatibility studies, required by ISO 10993 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing were performed in accordance with Good Laboratory Practices (GLP; 21 CFR Part 58).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2018
Novate Medical Ltd. Gordon Crowley Director of Regulatory & Quality Block 11, Galway Technology Park, Parkmore Galway, Ireland
Re: K173236
Trade/Device Name: Sentry Inferior Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: January 23, 2018 Received: January 25, 2018
Dear Gordon Crowley:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Nicole G. Ibrahim -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) K173236
Device Name Sentry Inferior Vena Cava Filter
Indications for Use (Describe)
The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.
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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510(k) Summary K173236
| Date Prepared: | October 02, 2017 | |
|---|---|---|
| 510(k) Submitter: | Novate Medical Ltd., Block 11, Galway Technology Park, | |
| Parkmore, Galway, Ireland. | ||
| Contact: | Gordon Crowley, Quality and Regulatory Director | |
| Tel: | +353 91 787716 | |
| Trade Name: | Sentry Inferior Vena Cava Filter | |
| Common Name: | Vena Cava Filter | |
| Classification | ||
| Information: | Cardiovascular Intravascular Filter (21 CFR 870.3375; Class | |
| II) | ||
| Product Code: | DTK | |
| Panel: | Cardiovascular | |
| Predicate Device: | Sentry IVC Filter (K162875) |
The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE.
The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr).
The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.
4
This 510(k) is submitted to support device and manufacturing process changes to the Nitinol frame and the Delivery System previously cleared under K162875.
Intended Use / Indications
The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.
Substantial Equivalence Comparison
The modified Sentry IVC Filter device is substantially equivalent in its intended use, principles of operation, design, materials, and sterile package configuration to the cleared Sentry IVC Filter (K162875). There is no change to the fundamental scientific technology or to the intended use.
The primary differences between the predicate and modified device are to the design of the delivery system and overall manufacturing process of the device.
Based on the design verification results, these modifications do not have an adverse impact on the safety and effectiveness of the modified device when compared to the predicate device.
Performance Data
Novate developed a design verification and validation program for the modified Sentry IVC Filter with reference to the FDA Guidance for Cardiovascular Intravascular Filter 510(k) Submissions and the international standard ISO 25539-3 Cardiovascular implants- Endovascular devices -Part 3: Vena cava filters. Bench studies were undertaken to demonstrate the performance and safety of the modified Sentry IVC Filter when used according to the Instructions for Use.
5
| • Delivery System visual & dimensional | • Simulated Deployment |
|---|---|
| • Delivery System integrity | • Accuracy of Deployment |
| • Filter visual and dimensional | • Packaging Visual Inspection |
| • Fatigue resistance | • Labeling Visual Inspection |
| • Filter Corrosion | • Tyvek Pouch Peel |
| • Migration resistance | • Foil Pouch Peel |
| • Radial Force | • Bubble Leak Testing |
| • Ease of device use | • Transportation testing |
The design verification and validation program included the evaluations listed below:
All tests met the pre-determined acceptance criteria. Results from the design verification and validation program demonstrate the mechanical integrity and performance of the modified device and that the modified Sentry IVC Filter achieves its intended use as a vena cava filter.
Biocompatibility Evaluations
A biological safety assessment was performed to evaluate the biological risks associated with the modified Sentry IVC Filter per FDA's Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process". This risk assessment involved biocompatibility testing on the implant and delivery system/accessories. The modified Sentry IVC Filter was also subjected to chemical characterization and a toxicological evaluation performed in accordance with ISO 10993 Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances. The biocompatibility studies, required by ISO 10993 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing were performed in accordance with Good Laboratory Practices (GLP; 21 CFR Part 58).
Conclusions
The modified Sentry IVC Filter is similar in indications, principle of operation, and design to the currently cleared Sentry IVC Filter (K162875) and does not raise different questions of safety and effectiveness. The changes were evaluated by bench testing and biocompatibility studies. Test results demonstrate that the modified device
6
meets the established specifications and is comparable to the predicate device supporting substantial equivalence. Based on the supportive data provided in this 510(k), it can be concluded that the modified Sentry IVC Filter does not raise new questions of safety or effectiveness compared to the predicate device and is, therefore, substantially equivalent.