(72 days)
The Tamaryn I.V. Flow Regulator Extension Set is used to control the flow rate of administration infusion fluids to a patient during a gravity intravenous infusion.
Tamaryn I.V. Flow Regulator Extension Set
I am sorry, but based on the provided FDA letter for K971066, a submission for the "Tamaryn I.V. Flow Regulator Extension Set," I cannot provide the detailed information requested regarding acceptance criteria and study data.
This document is a 510(k) clearance letter, which indicates substantial equivalence to a predicate device. It does not contain the detailed study data, acceptance criteria, or performance metrics that would be part of a submission dossier. The letter confirms that the device can be marketed but does not elaborate on the specific tests or their results.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information would typically be found in the 510(k) summary or the full submission, which is not provided here.
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICE - USA" around the edge. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Mr. Jim Keane ·President Tamaryn Medical Systems, Incorporated 6539 South 2475 East Salt Lake City, Utah 84121
K971066 Re : Tamaryn I.V. Flow Requlator Extension Set Trade Name: Regulatory Class: II Product Code: FPA Dated: March 21, 1997 Received: March 24, 1997
Dear Mr. Keane:
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 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2 - Mr. Keane
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) 594-4618. 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) 630-2041 or at (301) 443-6597.
Sincerely yours,
Timothy R. Ulatowski
AVIV Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K97/066
INDICATIONS FOR USE
510(k) Number:
Device Name: Tamaryn I.V. Flow Regulator Extension Set
Indications For Use:
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The Tamaryn I.V. Flow Regulator Extension Set is used to control the flow rate of administration infusion fluids to a patient during a gravity intravenous infusion.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Pabara Cucentt
Division of Dental, Infection Control,
and General Hospital Devices
F Number K971066
OR
Prescription Use: (Per 21 CFR 801 109) Over-The-Counter Use:
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.