(81 days)
The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.
Primary I.V. Set with Backcheck Valve
This document is a 510(k) clearance letter from the FDA for a medical device called "Primary I.V. Set with Backcheck Valve." It does not contain information on acceptance criteria, device performance, an associated study, or any of the other specific details requested in the prompt (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).
The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices. It then outlines the regulatory framework and responsibilities for the manufacturer.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 1997
Mr. Thomas P. Sampogna Manager, Regulatory Affairs Hospital Products Division Abbott Manufacturinq, Incorporated 200 Hundred S. Abbott Park Road D 389, Building AP 30 Abbott Park, Illinois 60064-3500
K971293 Re : Primary I.V. Set With Backcheck Trade Name: Valve Requlatory Class: II Product Code: FPA Dated: April 4, 1997 Received: April 7, 1997
Dear Mr. Sampogna:
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 The general controls provisions of the Act 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 requirement, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Sampogna
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.
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) 594-4618. 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely Yours,
Timothy A. Ulatowski
Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number(if known):
Device Name: Primary I.V. Set with Backcheck Valve
Indications For Use:
The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Patricia Cucoreti |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K971293 |
Prescription Use_ (Per 21 CFR 301.109) OR
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.