(42 days)
With drawal cannula for single use sterile transfer of liquid from a syrings vial and vice versa. Air enters and exits the through a hydrophobic membrane which avoide extraneous contamination of the vist and syringe contents and prevents liquid aerosols from escaping into the environment. The integrated fluid filter provides for reliable filtration o particles and ensures a high degree of safety patient.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Taky-Spike Plus". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it predates the widespread use of such detailed AI/ML study reporting in regulatory submissions.
Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on confirming the device's substantial equivalence to a legally marketed predicate device and outlining general regulatory obligations.
The device itself, "Taky-Spike Plus," is described as a "withdrawal cannula for single use sterile transfer of liquid from a syringe to a vial and vice versa." It features a hydrophobic membrane for air exchange and an integrated fluid filter. This description clearly indicates it is a physical medical device, not an AI/ML-driven software or diagnostic tool that would typically have the kind of performance metrics and study details you're asking for.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Reinhard Hopf Manager, Requlatory Affairs Clinico® Clinico Medical GmbH Robert-Koch-Straße 5 D-36222 Bad Hersfeld
വല്ല 2 2 1997
Re : K974198 Trade Name: Taky-Spike Plus Regulatory Class: II Product Code: LHI November 6, 1997 Dated: November 10, 1997 Received:
Dear Dr. Hopf:
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. ಕ್ಕೆ 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 - Dr. Hopf
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 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 leqally 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 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.qov/cdrh/dsmamain.html".
Sincerely Yours
Timothy A. Ulatowski
Timo 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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Indications For Use:
Page 1 of 1
510(k) Number (if known): K 974198 laky - Spike Plus Device Name:
With drawal cannula for single use sterile transfer of liquid from a syrings vial and vice versa. Air enters and exits the through a hydrophobic membrane which avoide extraneous contamination of the vist and syringe contents and prevents liquid aerosols from escaping into the environment. The integrated fluid filter provides for reliable filtration o particles and ensures a high degree of safety patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cucenotti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
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.