INTRODUCER ASSEMBLY WITH ROTATOR LOCK

K060519 · Teleflex Medical · DYB · May 5, 2006 · Cardiovascular

Device Facts

• Record ID: K060519
• Device Name: INTRODUCER ASSEMBLY WITH ROTATOR LOCK
• Applicant: Teleflex Medical
• Product Code: DYB · Cardiovascular
• Decision Date: May 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

Device Story

The Introducer Assembly with Rotator Lock is a medical device consisting of a dilator and a split sheath introducer. It is designed to facilitate access to the venous system for the subsequent entry of other percutaneous devices. The device is intended for use by healthcare professionals in a clinical setting. By providing a stable access point, it enables the safe insertion of secondary percutaneous instruments, thereby assisting in various venous procedures.

Clinical Evidence

Bench testing only. Materials were evaluated for safety per ISO 10993 Part 1 (Biological Evaluation of Medical Devices). No clinical data was required or provided.

Technological Characteristics

The device consists of a dilator and a split sheath introducer. Materials were tested for biocompatibility per ISO 10993-1. The device is a mechanical instrument for venous access; it does not utilize electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring venous access for the introduction of percutaneous devices.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• TFX Medical Introducer Assembly (1993191)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white. The word "Teleflex" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below the word "Teleflex."

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA 847-572-8002 Phone: [phone] Fax: www.teleflex.com

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Introducer Assembly with Rotator Lock

# A. Name, Address, Phone and Fax Number of Applicant

Kobosil

Teleflex Medical Group Headquarters 2345 Waukegan Road, Suite 140 Bannockburn, IL 60015 USA Phone: [phone] Fax:

-5 2006 MAY

### B. Contact Person

Lori Hays Senior Manager, Regulatory Affairs

### C. Date Prepared

February 24, 2006

#### D. Device Name

Trade Name: Introducer Assembly with Rotator Lock

Common Name: Catheter Introducer

Classification Name: Catheter Introducer

Product Code: DYB

Regulation Number: 870.1340

Class: II

#### E. Device Description

The Introducer Assembly with Rotator Lock consists of a dilator and a split sheath introducer that is used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous critry devices.

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### F. Intended Use

The Introducer Assembly with Rotator Lock is intended to provide access to the venous system The Introduct I LSSeniory with conjunction with additional percutaneous entry devices.

# G. Substantial Equivalence

The Introducer Assembly with Rotator Lock is substantially equivalent to the TFX Medical I he introducer Assembly (1993191) with respect to functionality, design, placement and use.

### H. Summary of Testing

All materials used in the fabrication of the Introducer Assembly with Rotator Lock were An matchals used in the faction safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed Bloogical Evaluation of rivelion design and materials were found to be acceptable for the intended use

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2006

Teleflex Medical Group Headquarters c/o Ms. Lori Hays Senior Manager, Regulatory Affairs 2345 Waukegan Road, Suite 140 Bannockburn, IL 60015

Re: K060519

> Introducer Assembly with Rotator Lock Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer -Regulatory Class: II Product Code: DYB Dated: April 6, 2006 Received: April 10, 2006

Dear Ms. Hays:

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 indivations for use stated in the enclosure) to legally marketed predicate devices marked 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, isting 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, TDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be devised and I Driv issualited your device complies with other requirements of the Act than Federal statutes and regulations administered by other Federal agencies. You must or any I odelui barees and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N i at 807), its ensigned (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 Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Wochner

\ 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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Image /page/4/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with the "T" stylized to look like a right angle. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.

Teleflex Medical Group Headquarter 2345 Waukegan Koad Bannockburn, IL, 60015 USA 847-572-8002 Phone: Fax: [phone] www.teleflex.com

## Indications for Use

Ko60519

510(k) Number (if known): K060519

Device Name: Introducer Assembly with Rotator Lock

Indications For Use:

The Introducer Assembly with Rotator Lock is intended to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lunes
(Division Sign-Off)
Cardiovascular Devices

(A) Number_1 (06

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