(236 days)
This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.
The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray
The provided text is a 510(k) summary for the TFX Medical Introducer Kit. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the way a novel AI or diagnostic device might.
Therefore, many of the requested data points (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not typically included in a 510(k) summary for a device like an introducer kit. The evaluation is based on comparison to existing devices with established safety and effectiveness.
Here's an analysis based on the provided text, addressing the points where information is available or explaining why it's not present:
Acceptance Criteria and Study for TFX Medical Introducer Kit (K991647)
This 510(k) summary for the TFX Medical Introducer Kit does not report specific quantitative acceptance criteria or a detailed study designed to measure the device's performance against such criteria. Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" in this context are implicitly met if the device has "basic features, designs and intended uses" that are the same as the predicate and the "differences... raise no new issues of safety and effectiveness."
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Equivalence to Predicate Device | The device's basic features, designs, and intended uses are the same as legally marketed predicate devices. Differences must not raise new issues of safety and effectiveness. | The TFX Medical Introducer Kits are "substantially equivalent" to the Burron Tear-Away Sheath Introducers and Daig Corporation Introducer Sets. The submitter explicitly states: "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. Sample size used for the test set and the data provenance
Not applicable. This 510(k) summary does not describe a clinical "test set" or a study involving human subjects or data collection for performance measurement. The submission is a comparison to predicate devices, focusing on design and intended use specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts for a test set is described, as the submission relies on substantial equivalence.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an introducer kit, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant or discussed in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an introducer kit, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance component.
7. The type of ground truth used
Not applicable. As discussed, the submission relies on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific "ground truth" derived from pathology, outcomes data, or expert consensus for the TFX Medical Introducer Kit itself. The "ground truth" is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This submission does not involve machine learning or AI models, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no corresponding ground truth to establish.
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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
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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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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
§ 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).