The VenaTech™ LP Brachial Introducer System (Antecubital) allows for placement of the VenaTech LP Vena Cava Filter by an antecubital vein approach. The antecubital introducer system consists of an introducer sheath and dilator, guidewire, and pusher components. The introducer system is provided sterile.

AI/ML Overview

The provided text describes a 510(k) summary for the VenaTech™ LP Brachial Introducer System (Antecubital). This is a medical device accessory and its evaluation focuses on its ability to deliver an existing vena cava filter, rather than on AI/software performance. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Criteria	Reported Device Performance
Ability to reliably deliver and deploy the VenaTech LP Filter (This is the implicit acceptance criterion based on the "Summary of Non-Clinical Testing")	Confirmatory design verification testing was performed and demonstrates that the VenaTech LP Filter can reliably be delivered and deployed through the VenaTech™ LP Brachial Introducer System (Antecubital).

Study Information

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The study involved "confirmatory design verification testing," which typically involves engineering tests, not patient data in the sense of a test set for an AI model.
Data Provenance: Not applicable in the context of an AI model. The testing would have been conducted in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a physical device accessory, not an AI or diagnostic tool requiring expert ground truth for its performance evaluation in this context. The "ground truth" would be the successful physical delivery and deployment of the filter, evaluated by engineers or trained personnel during testing.

4. Adjudication method for the test set:

Not applicable. This concept applies to human interpretation of data for AI model validation, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an introducer system for a filter, not an AI-powered diagnostic tool. The concept of human readers improving with or without AI assistance is irrelevant here.

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

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for this type of device is successful physical deployment and delivery of the vena cava filter by the introducer system, as determined by engineering and performance testing. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather functional verification against design specifications.

8. The sample size for the training set:

Not applicable. This is not an AI model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI model.

Summary of the Study:

The study proving the device meets its acceptance criteria is summarized as "Confirmatory design verification testing." This testing demonstrated that the VenaTech LP Filter can "reliably be delivered and deployed through the VenaTech™ LP Brachial Introducer System (Antecubital)." The report states that this evaluation was performed through "risk analysis and design verification testing following established Design Control procedures." The focus was on ensuring that the dimensional changes (length) of the introducer, guidewire, and pusher to accommodate the antecubital delivery approach did not raise new questions of safety or effectiveness for the already cleared VenaTech LP Vena Cava Filter.

In essence, the study was an engineering verification to ensure the accessory functioned as intended for its specific purpose of delivering the known filter.

Summary

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510(k) Summary

as required by section 807.92(c)

JAN 1 2 2007

Date Prepared: October 17, 2006

1. Submitter's Name / Contact Person

Submitter Name	Contact Person
B. Braun Medical, Inc.	Paul O'Connell
824 Twelfth Avenue	Vice President, Vascular Interventional Products Group
Bethlehem, PA 18018	Tel: (847) 274-0097; Fax: (847) 733-1669

2. General Information

Trade Name	VenaTech™ LP Brachial Introducer System (Antecubital)for use with theVenaTech™ LP Vena Cava Filter
Common Name	Permanent Vena Cava Filter Introduction System
Classification Name	The VenaTech™ LP Vena Cava Filter is classified as a CardiovascularIntravascular Filter pursuant to 21 CFR 870.3375.The VenaTech™ LP Brachial Introducer System (Antecubital) is anaccessory to the VenaTech™ LP Vena Cava Filter.
Predicate Devices	B. Braun Medical Inc. – VenaTech LP Vena Cava FilterCordis Corporation – Cordis TrapEase™ Permanent Vena Cava Filter andIntroduction Kit

Device Description 3.

4. Intended Use / Indications

The VenaTech™ LP Brachial Introducer System (Antecubital) is intended for use with the B. Braun Medical VenaTech™ LP Vena Cava Filter.

Substantial Equivalence Comparison న్.

The addition of the VenaTech LP antecubital introducer system for use as an accessory with the VenaTech LP Vena Cava Filter has not changed the intended use of the previously cleared VenaTech LP Vena Cava Filter. The VenaTech LP Filter design, materials, sterile package configuration, and sterilization process are identical to the currently marketed VenaTech LP Filter

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predicate device. The fundamental scientific technology of the VenaTech LP Filter has not been altered nor have new questions of safety and effectiveness been raised. Dimensional changes in the length of the introducer, guidewire, and long pusher were made to accommodate the antecubital delivery approach.

Antecubital delivery of a vena cava filter is not new, the Cordis TrapEase™ Permanent Vena Cava Filter and Introduction Kit also accommodates an antecubital delivery approach.

The antecubital introducer system has been evaluated through risk analysis and design verification testing following established Design Control procedures. The addition of the VenaTech LP Brachial Introducer System (Antecubital) as an accessory to the VenaTech LP Vena Cava Filter raises no new questions of safety or effectiveness.

6. Summary of Non-Clinical Testing

Confirmatory design verification testing was performed and demonstrates that the VenaTech LP Filter can reliably be delivered and deployed through the VenaTech™ LP Brachial Introducer System (Antecubital).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2007

B. Braun Medical, Inc. c/o Paul O'Connell 824 Twelfth Avenue Bethlehem, PA 18018

Re: K063217

Trade/Device Name: VenaTech™ LP Brachial Introducer System (Antecubital) for use with the VenaTech™ LP Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II (two) Product Code: DTK Dated: October 17, 2006 Received: October 24, 2006

Dear Mr. O'Connell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Paul O'Connell

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); good 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Cofapap

Bram D. Zuckerman. N 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): __ K0632 17 ________________________________________________________________________________________________________________________________________

Device Name:

VenaTech™ LP Brachial Introducer System (Antecubital)

Indications for Use:

The VenaTech™ LP Brachial Introducer System (Antecubital) is intended for use with the B. Braun Medical VenaTech™ LP Vena Cava Filter.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Medaver
Bila

vascular Devices

510(k) Number

Page 1 of 1

(Posted November 13, 2003)

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.”