(248 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (a stylet) and makes no mention of AI, ML, image processing, or any other computational technology.
No
The device, a stylet, is used to stiffen other devices like catheters for placement, which is an ancillary function to make another device therapeutic, but not therapeutic in itself.
No
The device description states it is a stylet used to stiffen catheters or other devices for placement, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description explicitly states it consists of a hub bonded to a stainless steel shaft, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the product as a stylet used to stiffen catheters or other devices for placement. This is a mechanical function performed in vivo (within the body) to aid in the insertion of other medical devices.
- Device Description: The device description details the physical components of the stylet (hub, stainless steel shaft).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are specifically designed to perform tests on samples taken from the body to diagnose or monitor conditions. This stylet's function is purely mechanical and related to the insertion of other devices into the body.
N/A
Intended Use / Indications for Use
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. 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.
Product codes (comma separated list FDA assigned to the subject device)
DRB
Device Description
The TFX Medical Hydrophilic Coated or Uncoated Stylet consists of a hub which is bonded to the flexible stainless steel shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Lake Region Stylet
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510 (k) Summary
-
- 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
- Submitter Name, Address, and Date of Submission.
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
-
- 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.
- Identification of the legally marketed device to which the submitter claims equivalence.
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)
| (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)