(49 days)
The NFC Y-Site is for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The Needlefree side port of the y-site is swabbable and can be accessed multiple times using a male Luer for the purpose of administering general IV solutions or blood.
The Filtertek NFC Needlefree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.
The Filtertek NFC Needlefree Y-Site is a sterile, non-pyrogenic component packaged in a Twek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use.
The provided text is a summary of safety and effectiveness information for a medical device (Filtertek NFC Needlefree Y-Site) and an FDA clearance letter. It does not contain the kind of detailed information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment that would be required to complete the requested table and study description.
The document briefly mentions that:
- "The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use."
- "The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use."
- "The Filtertek NFC Needlefree Y-Site is sterilized per AAMI quidelines to a 10 sterility assurance level."
- "Each production lot is LAL tested per USP guidelines."
However, these are very high-level statements and do not provide specific acceptance criteria values, reported performance numbers, or details about the studies themselves (e.g., sample size, data provenance, expert involvement for ground truth).
Therefore, I cannot populate the table or provide the requested study details based on the provided text. The document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a detailed reporting of a performance study.
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June 11, 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92.
Trade Name: NFC Needlefree Y-Site Common Name: Y-Injection Site Classification Name: Intravascular Administration Set (accessory)
The Filtertek NFC Needlefree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.
The Filtertek NFC Needlefree Y-Site is a sterile, non-pyrogenic component packaged in a Twek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the NFC Needlefree Y-Site is the same or the equivalent of the predicate device named in this submission. The named predicate device in this submission is the Douglas Medical products Maxcess™ Needlefree Y-Site currently marketed by Douglas Medical Products under 510(k) #K970800. The Filtertek NFC Needlefree Y-Site is sterilized per AAMI quidelines to a 10 sterility assurance level. Each production lot is LAL tested per USP guidelines.
Based on the fact that the Fittertek NFC Needlefree Y-Site utilizes similar and equivalent designs and materials as currently legally marketed products, it is safe and effective when used as intended.
Sincerely,
Larry Larkin Regulatory Affairs Administrator
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three faces in profile, arranged in a row. The figure is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN | 8 1998
Mr. Larry Larkin 'Regulatory Affairs Administrator Filtertek, Incorporated 11411 Price Road P.O. Box 310 Hebron, Illinois 60034
Re : K981547 Trade Name: NFC Needlefree Y-Site, Model 69970 Regulatory Class: II Product Code: FPA Dated: April 17, 1998 Received: April 30, 1998
Dear Mr. Larkin:
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, Druq, 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 Regulations, Title 21, Parts 800 to 895. - A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, BOA 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
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Page 2 - Mr. Larkin
the Act for devices 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) 594-4692. 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 Other qeneral 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
Timothy A. Ulatows 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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To be assigned 510(K) Number (if known):
Device Name: NFC Needlefree Y-Site
Indications For Use:
The NFC Y-Site is for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The Needlefree side port of the y-site is swabbable and can be accessed multiple times using a male Luer for the purpose of administering general IV solutions or blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
(Division Sign-Off) /3. Bolki Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
U Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.