TFX MEDICAL INTRODUCER KIT

K991647 · Tfx Medical Group · DYB · Jan 4, 2000 · Cardiovascular

Device Facts

• Record ID: K991647
• Device Name: TFX MEDICAL INTRODUCER KIT
• Applicant: Tfx Medical Group
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.

Device Story

TFX Medical Introducer Kit facilitates percutaneous vascular access. Components include sheath/dilator assembly, needle with indicator, syringe, and guide-wire tray. Device used by clinicians in clinical settings to assist placement of diagnostic or therapeutic instruments into vessels. Operation involves standard percutaneous techniques; output is the established vascular access path allowing subsequent device insertion. Benefits include simplified, reliable vessel entry for interventional procedures.

Clinical Evidence

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

Technological Characteristics

Kit includes sheath/dilator assembly, needle, syringe, and guide-wire. Mechanical device; no energy source, software, or electronic components. Materials and construction consistent with standard introducer kits.

Indications for Use

Indicated for patients requiring percutaneous access for the introduction of diagnostic or therapeutic devices into a vessel.

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 Sets

Submission Summary (Full Text)

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K991647

JAN - 4 2000

# 510 (k) Summary

- Submitter Name, Address, and Date of Submission. 1.
Mrs. Julie A. Beaumont Group Requlatory Affairs Technician TFX Medical Group Tall Pines Park Jaffrey, New Hampshire 03452

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

Contact: Same as above

- Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Introducer Kit

Common Name: TFX Medical Introducer Kit

Proprietary Name: TFX Medical Introducer Kit

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

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

#### 4 . Description of the Device.

The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray

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

This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.

### Summary of Technological Characteristics. 6.

The TFX Medical Introducer Kits are 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 4 2000

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

Re : K991647 Trade Name: TFX Medical Introducer Kit Requlatory Class: II Product Code: DYB Dated: October 29, 1999 November 2, 1999 Received:

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 leqally 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 against 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 Requlations, 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 regulation (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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Mrs. Julie A. Beaumont

under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (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" (21CFR 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,

Christopher

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_K99 1649

Device Name:

Indications for Use:

This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.

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)

Christopher for Witten