TFX MEDICAL INTRODUCER ASSEMBLY

K993191 · Tfx Medical, Inc. · DYB · Mar 24, 2000 · Cardiovascular

Device Facts

• Record ID: K993191
• Device Name: TFX MEDICAL INTRODUCER ASSEMBLY
• Applicant: Tfx Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The TFX Medical Introducer Assembly will be used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

Device Story

TFX Medical Introducer Assembly consists of a sheath and dilator; provides venous access for percutaneous device entry. Used by clinicians in clinical settings to facilitate insertion of other medical devices into the venous system. Device functions as a conduit; no active components or electronic processing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison.

Technological Characteristics

Sheath/dilator assembly; mechanical device for venous access. No 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

• Burron Tear-Away Sheath Introducers
• Daig Corporation Introducer Set

Submission Summary (Full Text)

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MAR 2 4 2000

K993191

# 510(k) Summary

## 1. Submitter Name, Address, and Date of Submission.

Mrs. Julie A. Beaumont Group Regulatory Affairs Technician TFX Medical Group Tall Pines Park Jaffrey, New Hampshire 03452

Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail]

Contact: Same as above

# 2. Name of the Device, Common, Proprietary (if Known), and Classification.

Classification Name: Catheter Introducer

Common Name: Introducer

Proprietary Name: TFX Medical Introducer Assembly

# 3. Identification of the legally marketed device to which the submitter claims equivalence.

The TFX Medical Introducer Assembly is substantially equivalent to the Burron Tear-Away Sheath Introducers and Daig Corporation Introducer Set.

### 4. Description of the Device.

The TFX Medical Introducer Assembly consists of a Sheath/Dilator Assembly.

Tall Pines Park Jaffrey, NH 03452 [phone] FAX [phone] or 6108

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#### 5. Intended Use of the Device.

The TFX Medical Introducer Assembly will be used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

#### 6. Summary of Technological Characteristics.

The TFX Medical Introducer Assembly is substantially equivalent to the predicate devices, since the basic features, designs and intended uses are the same. The differences between the TFX Medical, Incorporated devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.

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Public Health Service

MAR 2 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. Julie A. Beaumont TFX Medical, Inc. Tall Pines Park Jaffrey, NH 03452

Re : K993191 TFX Medical Introducer Assembley Regulatory Class: II (two) Product Code: DYB January 14, 2000 Dated: Received: January 18, 2000

Dear Mrs. Beaumont:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 - Mrs. Julie A. Beaumont

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Chistoph Mth for.

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TFX Medical Introducer Assembly

Indications for Use:

The TFX Medical Introducer Assembly will be used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use__________

(Per 21 CFR 801.109)

Chit. Auth. fr. Dillard.

(Divisioh Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number < 99319 |