(236 days)
Not Found
Not Found
No
The summary describes a standard introducer kit with mechanical components and makes no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is used to assist in the introduction of diagnostic or therapeutic devices, but it is not explicitly stated to be therapeutic itself.
No
The product assists in the introduction of diagnostic or therapeutic devices, but it is not described as performing diagnostic functions itself.
No
The device description explicitly lists physical components like a Sheath/Dilator Assembly, Needle, Syringe, and Guide-wire Tray, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel." This describes a device used in vivo (within the body) for accessing blood vessels.
- Device Description: The components listed (Sheath/Dilator Assembly, Needle, Syringe, Guide-wire Tray) are all tools used for accessing and introducing devices into the circulatory system.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a procedural tool used for accessing the body, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.
Product codes
DYB
Device Description
The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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: | (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: 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
1
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.
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and connection.
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 (301) 594-4586. 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 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 (800) 638-2041 or (301) 443-6597 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