LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM

K081878 · LeMaitre Vascular, Inc. · DQY · Jan 27, 2009 · Cardiovascular

Device Facts

• Record ID: K081878
• Device Name: LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
• Applicant: LeMaitre Vascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The TT® Introducer is used to introduce balloon catheters, closed-end catheters, and other vascular devices.

Device Story

The TT® Tortuous Tracker Introducer Delivery System is a catheter-based device designed to facilitate the introduction of various vascular devices, such as balloon catheters and closed-end catheters, into the patient's vasculature. It is intended for use by clinicians in a clinical or surgical setting. The device functions as a conduit to navigate tortuous vascular anatomy, allowing for the safe placement of secondary therapeutic or diagnostic catheters. It does not involve electronic processing, software, or automated decision-making; it is a mechanical tool operated manually by the physician to assist in vascular access procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

The device is a catheter-based introducer system. It is a mechanical device with no electronic components, energy sources, or software. Materials and construction are consistent with standard vascular introducer catheters intended for navigation through tortuous anatomy.

Indications for Use

Indicated for use in patients requiring the introduction of balloon catheters, closed-end catheters, and other vascular devices into the vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LeMaitre Vascular c/o Ms. Erin Daly Regulatory Affairs Specialist 63 Second Avenue Burlington, MA 01803

# JAN 2-7 2009

Re: K081878

> Trade Name: TT® Tortuous Tracker Introducer Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Introducer Regulatory Class: II Product Code: DOY Dated: November 24, 2008 Received: November 26, 2008

Dear Ms. Daly:

We have reviewed your Section 510(k) premarket notification of intent-to-market-the devicereferenced 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.

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

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Page 2 - Ms. Erin Daly

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 i number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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 Statement

## 510(k) Number (if known): K081878

Device Name: LeMaitre TT® Tortuous Tracker Introducer Catheter Delivery System

Indications for Use: The TT® Introducer is used to introduce balloon catheters, closed-end catheters, and other vascular devices.

Prescription Use X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Vi. Vimer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K08 187 8