This 510(k) submission (K992664) for the TFX Medical Coated Catheter Stylet focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with acceptance criteria and measured performance.

Therefore, this document does not contain the requested information regarding acceptance criteria and a study that proves the device meets those criteria.

The submission is for a Class II medical device, and the FDA's clearance is based on the finding of "substantial equivalence" to a legally marketed predicate device (Lake Region Stylet), meaning the basic features, designs, and intended uses are the same, and the differences raise no new issues of safety and effectiveness.

To directly answer your request based on the provided text, the following information is NOT available:

A table of acceptance criteria and the reported device performance: Not present.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth described.
Adjudication method: Not applicable as no test set is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not performed or reported.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable as no study data is presented.
The sample size for the training set: Not applicable as no study data is presented.
How the ground truth for the training set was established: Not applicable as no study data is presented.

Summary

{0}------------------------------------------------

K992664

510 (k) Summary

1. Submitter Name, Address, and Date of Submission.
  Mrs. Julie A. Beaumont Group Regulatory Affairs Technician Willy Rüsch AG Group Tall Pines Park Jaffrey, New Hampshire 03452

Telephone: (603) 532-7706 Facsimile: (603) 532-6179 E-Mail: jbeaumont@tfx.com Contact: Same as above

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

Common Name: Catheter Stylet

Proprietary Name: TFX Medical Coated Catheter Stylet

1. Identification of the legally marketed device to which the submitter claims equivalence.
  The TFX Medical Coated Stylet is substantially equivalent to the Lake Region Stylet.

4 . Description of the Device.

The TFX Medical Hydrophilic Coated or Uncoated Stylet consists of a hub which is bonded to the flexible stainless steel shaft.

{1}------------------------------------------------

5. Intended Use of the Device.

The TFX Medical Hydrophilic Coated or Uncoated Stylet is intended for use with catheters or other devices, which require the aid of a stylet to render it stiff for placement.

6. Summary of Technological Characteristics.

TFX Medical Catheter Stylets 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 device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2000

Mrs. Julie A. Beaumont TFX Medical, Inc. Tall Pines Park 50 Plantation Drive Jaffrey, NH 03452

K992664 Re : TFX Medical Catheter Stylet Regulatory Class: II (two) Product Code: DRB March 7, 2000 Dated: Received: March 10, 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 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 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 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 requlation 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 under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Chitophm. Ronta

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

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

←

Device Name: TFX Medical Catheter Stylet

Indications for Use:

This product is intended for use in conjunction with catheters or other devices, which require the aid of a stylet to render it stiff for placement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K992664

Prescription Use	X	OR	Over-The-Counter Use
------------------	-----------------------------------------	----	----------------------

(Per 21 CFR 801.109)

Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108

A Subsidiary of Telefiex Incorporated (USA)

Regulation Number and Section

§ 870.1380 Catheter stylet.

(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).