(183 days)
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.
The TFX Medical Introducer Assembly consists of a Sheath/Dilator Assembly.
The provided text is a 510(k) summary for the TFX Medical Introducer Assembly. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or groundbreaking truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document. The sections you asked for, such as a table of acceptance criteria and reported device performance, sample sizes, expert details, and ground truth information, are not present in this 510(k) submission.
This type of 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on similar technological characteristics and intended use, rather than presenting new performance study data against acceptance criteria.
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MAR 2 4 2000
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: (603) 532-7706 Facsimile: (603) 532-6179 E-Mail: ibeaumont@tfx.com
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 (603) 532-7706 FAX (603) 532-8211 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 (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 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 (800) 638-2041 or (301) 443-6597, 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 |
§ 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).