(30 days)
None
No
The 510(k) summary describes a mechanical medical device (an IVC filter) and a change to its delivery system. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on the mechanical integrity of the device components.
Yes
The device is indicated for the prevention of recurrent pulmonary embolism and is designed to trap emboli, which are therapeutic functions aimed at preventing a medical condition.
No
The Sentry IVC Filter is an implanted medical device designed to prevent pulmonary embolism by trapping emboli in the inferior vena cava. It is a therapeutic device, not a diagnostic one, as it does not diagnose or detect medical conditions but rather treats or prevents them.
No
The device description clearly details a physical implantable device (IVC filter) and its delivery system, including hardware components like a Nitinol frame, Filter Cone, Loading Tool, and Introducer Sheath. The 510(k) is specifically for a change to the Introducer Sheath, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical implantable device (an IVC filter) designed to be placed within the inferior vena cava to trap emboli. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests
The device is a therapeutic implant, not a diagnostic tool.
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 six 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 a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.
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
Novate developed a design verification program for the modified Sentry IVC Filter. Bench studies were undertaken to demonstrate equivalent performance of the modified Sentry IVC Filter when used according to the Instructions for Use. The design verification program included the following evaluations:
- Introducer Sheath integrity
- Introducer Sheath patency
All tests met the pre-determined acceptance criteria. Results from the design verification program demonstrate the mechanical integrity and performance of the modified device.
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
June 6, 2018
Novate Medical Ltd. Gordon Crowley Director of Regulatory & Ouality Block 11, Galway Technology Park, Parkmore Galway, Ireland
Re: K181202
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: May 4, 2018 Received: May 7, 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 comprehensive regulatory information about mediation-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
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Indications for Use
510(k) Number (if known) K181202
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 K181202
| Date Prepared: | May 4, 2018 |
|---|---|
| 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 (K173236) |
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 six 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 a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.
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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 is substantially equivalent to the cleared Sentry IVC Filter (K173236). There is no change to the fundamental scientific technology or to the intended use.
The primary difference between the predicate and modified device is the design and manufacturing process for the Introducer Sheath of the Delivery System.
Based on a risk assessment and design verification results, the modification does not have an adverse impact on the safety or effectiveness of the modified device when compared to the predicate device.
Performance Data
Novate developed a design verification program for the modified Sentry IVC Filter. Bench studies were undertaken to demonstrate equivalent performance of the modified Sentry IVC Filter when used according to the Instructions for Use. The design verification program included the following evaluations:
- Introducer Sheath integrity .
- Introducer Sheath patency .
All tests met the pre-determined acceptance criteria. Results from the design verification program demonstrate the mechanical integrity and performance of the modified device.
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Conclusions
The modified Sentry IVC Filter is identical in intended use to the currently cleared Sentry IVC Filter (K173236). There is no change to the principles of operation or fundamental scientific technology. The change to the design and manufacturing process for the Introducer Sheath does not raise different questions of safety and effectiveness. Based on a risk assessment and design verification testing, the data supports that the modified Sentry IVC Filter is substantially equivalent to the predicate device.