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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Sentry Inferior Vena Cava Filter, specifically concerning a modification to its Introducer Sheath. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets clinical acceptance criteria for its intended use through human studies.

Therefore, the information required to answer your prompt, particularly regarding multi-reader multi-case (MRMC) studies, expert ground truth, and comprehensive performance data for an AI/algorithm-based device, is not available in this document. This document describes a medical device, an IVC filter, which is a physical implant used to prevent pulmonary embolism, not a diagnostic AI or imaging device that would typically undergo the types of studies you are asking about.

However, I can extract the acceptance criteria and performance data for the specific modification described in this 510(k) submission:

The acceptance criteria here pertain to the Introducer Sheath of the delivery system, not the filter itself or its clinical efficacy in preventing PE. The study proves the modified Introducer Sheath functions equivalently to the previous version.

Here's what can be extracted from the provided text regarding the Acceptance Criteria and the study for the modified Introducer Sheath:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Introducer Sheath integrity	All tests met the pre-determined acceptance criteria. Results from the design verification program demonstrate the mechanical integrity and performance of the modified device.
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.

Note: The document confirms that all tests "met the pre-determined acceptance criteria," but it does not specify the quantitative values for these criteria (e.g., specific pressure limits for integrity, flow rates for patency) or the exact numerical results obtained.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "Bench studies" and "design verification program," implying a laboratory setting with test articles.
Data Provenance: The studies were undertaken as part of Novate Medical Ltd.'s design verification program. Location is likely Ireland, where the submitter is based. The data is prospective in the sense that it was generated specifically for this submission to assess the design modification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device modification, and the "ground truth" for its performance (integrity, patency) would be established through engineering specifications and objective measurements, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Performance was assessed via objective bench testing against pre-determined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. This document describes a physical medical device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. Bench tests were performed on the device itself.

7. The Type of Ground Truth Used

The ground truth was based on engineering specifications and measurable physical properties (e.g., material strength, dimensions, fluid flow characteristics) of the Introducer Sheath.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical device modification and bench testing for substantial equivalence.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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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);

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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)

· 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
ClassificationInformation:	Cardiovascular Intravascular Filter (21 CFR 870.3375; ClassII)
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.

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

. 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.

Regulation Number and Section

§ 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.”