(80 days)
Not Found
Not Found
No
The summary describes a mechanical introducer system for a vena cava filter and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is an introducer system used to place a vena cava filter, which is a therapeutic device. The introducer itself facilitates the procedure but does not have a direct therapeutic effect.
No
This device is an introducer system for a vena cava filter, which is a therapeutic device used for placement, not diagnosis. It facilitates the delivery of another medical device.
No
The device description explicitly lists physical components (introducer sheath, dilator, guidewire, pusher components) and describes a physical delivery system for a vena cava filter, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- The VenaTech™ LP Brachial Introducer System is a medical device used in vivo (inside the body) to facilitate the placement of a vena cava filter. It is a delivery system for another implantable device.
The description clearly states its purpose is to introduce a filter into a vein, which is a procedure performed directly on the patient's body, not on a sample taken from the body.
N/A
Intended Use / Indications for Use
The VenaTech™ LP Brachial Introducer System (Antecubital) is intended for use with the B. Braun Medical VenaTech™ LP Vena Cava Filter.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
antecubital vein
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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 the
VenaTech™ LP Vena Cava Filter |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Permanent Vena Cava Filter Introduction System |
| Classification Name | The VenaTech™ LP Vena Cava Filter is classified as a Cardiovascular
Intravascular Filter pursuant to 21 CFR 870.3375.
The VenaTech™ LP Brachial Introducer System (Antecubital) is an
accessory to the VenaTech™ LP Vena Cava Filter. |
| Predicate Devices | B. Braun Medical Inc. – VenaTech LP Vena Cava Filter
Cordis Corporation – Cordis TrapEase™ Permanent Vena Cava Filter and
Introduction Kit |
Device Description 3.
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.
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
1
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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2
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.
3
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
4
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)