(189 days)
This device is connected between a patient and a container of administrated solution, and is used for gravity feed infusion into a patient's vascular system for medical use and is intended for single use only.
Vented I.V. Set
I am unable to provide the detailed information requested regarding acceptance criteria and study designs based on the provided text. The document is a 510(k) clearance letter from the FDA for a "Vented I.V. Set" and primarily focuses on the regulatory aspects of marketing the device.
Here's why the requested information cannot be extracted:
- No information on acceptance criteria or performance studies: The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not describe specific performance metrics, acceptance criteria, or the details of any studies conducted to demonstrate the device meets those criteria. Such details would typically be found in the 510(k) submission itself, not the FDA's clearance letter.
- Focus on regulatory compliance: The text discusses general controls, GMP regulations, labeling, and other regulatory obligations, but not the technical performance data that would be used to establish equivalence or safety and efficacy.
To answer your questions, I would require access to the actual 510(k) submission document, which would contain the performance data, testing methodologies, and clinical or non-clinical study results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Mr. Tetsukaru Hirose Manager, CQA and Regulatory Affairs JMS Company, LTD. 12,17 Kako-Machi, Naka-Ku Hiroshima 730 Japan
Re : K965027 Trade Name: Vented I.V. Set Regulatory Class: II Product Code: FPA Dated: April 23, 1997 Received: April 28, 1997
Dear Mr. Hirose:
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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your The general controls provisions of the Act include kit /tray. requirements for annual registration, listing of devices, good manufacturing practice, and 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
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Page 2 - Mr. Hirose
(GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (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.
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 the 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 "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Patrica Cucenta/10c
Timothy A. Ulatowski 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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INDICATION FOR USE
510(k) Number : K965027
Device Name : Vented I.V. Set
This device is connected between a patient and a container of administrated solution, Indications For Use : and is used for gravity feed infusion into a patient's vascular system for medical use and is intended for single use only.
(PLEASE DO NOT WRITE THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
(Division Sign-Off) Patricia Cucente
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K965027
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.