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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the VenaTech Convertible Vena Cava Filter System, based on your requested criteria:

The document (K152765) is a 510(k) summary for the VenaTech Convertible Vena Cava Filter System. It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for each tested characteristic. Instead, it lists evaluations performed and generally concludes that the device performed according to its intended use or was sufficiently robust. For the clinical study, a primary objective was defined.

Evaluation/Criterion	Reported Device Performance
Non-Clinical Evaluations (Bench) - General Statement	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.
ISO 25539-3 Compliant DV&V Test Areas:	(Implicitly met "sufficiently robust" criterion for each)
Cavography ability	Performed
Clot trapping test	Performed
Conversion force	Performed
Dilator spinlock resistance	Performed
Dimension of introduction system	Performed
Fatigue resistance (fracture, cracks, and corrosion)	Performed
Filter dimension	Performed
Filter head resistance	Performed
Filter radio-opacity	Performed
Filter welding resistance	Performed
Head assembly resistance	Performed
Hook crimping strength	Performed
Introduction sheath radioopacity	Performed
Introduction system traction resistance	Performed
Introduction sheath water tightness	Performed
Migration resistance	Performed
(Packaging) Transportation	Performed
(Packaging) Fall (drop)	Performed
Passage in sheath	Performed
Radial force	Performed
Radial pressure (contact pressure)	Performed
Magnetic resonance (MR) testing	Performed
Chemical Characterization (ISO 10993)	Performed
Animal Studies (Simulated Use in Sheep Model)	Demonstrated that the VenaTech Convertible filter performed according to its intended use and thus supports substantial equivalence.
Clinical Study - Primary Objective (Technical Success)	Achieved in 92.7% of subjects.
Details of Technical Success	96 attempted conversions, 93 actual conversions, and 89 successful conversions with no technical complications.

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

Clinical Study Test Set Sample Size: 149 subjects were enrolled and successfully implanted. 96 attempted conversions.
Data Provenance: Multi-center, prospective, single-arm clinical study. The country of origin of the data is not specified, but the submission is to the U.S. FDA. It's a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical study. It states that investigator discretion was used for subjects unable to undergo conversion.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It refers to "investigator discretion" for clinical decisions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, an MRMC comparative effectiveness study was not conducted. The clinical study was a single-arm study, not comparing human readers with and without AI assistance.

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

This device is a physical medical implant (vena cava filter), not a software algorithm. Therefore, the concept of "standalone algorithm performance" or "human-in-the-loop performance" as typically applied to AI/software devices is not relevant here and was not performed.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for the primary objective of "technical success" appears to be based on the direct observation and assessment of the procedure by the investigators (physicians/clinicians). For the adverse event reporting, it would be based on clinical outcomes.

8. The Sample Size for the Training Set

This product is a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and validation relied on engineering principles, bench testing, and animal studies.

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

As explained in point 8, there is no training set in the AI sense. The "ground truth" for the non-clinical and animal studies would be established through:

Bench Testing: Engineering specifications, standardized test methods (e.g., ISO standards), and physical measurements.
Animal Studies: Direct observation of device performance in a live biological model by trained veterinary and research staff.

Summary

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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.

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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) 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.

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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510(K) SUMMARY

Date Prepared: February 25, 2016

510(k) Submitter		Contact
B. Braun Interventional Systems Inc.824 Twelfth AvenueBethlehem, PA 18018FDA Est. Reg. #: 3006332832		Contact:Peter Flosdorf, Engineering ManagerTel: 610-997-4694; Fax: 610-849-5319Peter.Flosdorf@bbrauninterventional.com
General Information
Trade Name	VenaTech® Convertible™ Vena Cava Filter System
Common Name	Vena cava filter system
ClassificationInformation	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

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.

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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.

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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 -

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.”