TAKY-SPIKE PLUS

K974198 · Clinico · LHI · Dec 22, 1997 · General Hospital

Device Facts

• Record ID: K974198
• Device Name: TAKY-SPIKE PLUS
• Applicant: Clinico
• Product Code: LHI · General Hospital
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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.

Device Story

Taky-Spike Plus is a withdrawal cannula for sterile liquid transfer between syringes and vials. Device features a hydrophobic membrane for air exchange, preventing contamination of vial/syringe contents and escape of liquid aerosols. Integrated fluid filter removes particles to enhance patient safety. Used in clinical settings for fluid handling; operated by healthcare professionals. Device facilitates safe, sterile medication preparation and administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Withdrawal cannula; includes hydrophobic membrane for air filtration and integrated fluid filter for particle removal; single-use; sterile.

Indications for Use

Indicated for the sterile transfer of liquids between syringes and vials for single use.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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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.

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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)