CODAN CHEMOSPIKE

K990711 · Codan US Corp. · LHI · Apr 13, 1999 · General Hospital

Device Facts

• Record ID: K990711
• Device Name: CODAN CHEMOSPIKE
• Applicant: Codan US Corp.
• Product Code: LHI · General Hospital
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The CODAN Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the withdrawar of modication aring reconstitution of the drug in the vial and withdrawal of the drug from the vial.

Device Story

CODAN Chemospike is a transfer pin system used for safe preparation and withdrawal of medications and cytotoxic agents. Device facilitates drug reconstitution and withdrawal from vials; prevents medication withdrawal during these processes. Used in clinical settings by healthcare professionals. Benefits include enhanced safety during handling of hazardous cytotoxic agents.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transfer pin system for medication/cytotoxic agent handling. Mechanical device; no energy source or software components.

Indications for Use

Indicated for the safe preparation and withdrawal of medication and cytotoxic agents from vials during reconstitution and withdrawal processes.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings forming three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1999

Fergie Ferguson Mr. Quality Assurance Manager CODAN US Corporation 3511 West Sunflower Avenue Santa Ana, California 92704-6944

Re : K990711 CODAN Chemospike Trade Name: Requlatory Class: II Product Code: LHI Dated: March 1, 1999 Received: March 4, 1999

Dear Mr. Ferguson:

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. ಗ್ 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 requlation may result in regulatory action. In addition, 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.

{1}------------------------------------------------

## Page 2 — Mr. Ferguson

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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
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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

thy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) NUMBER (IF KNOWN): CODAN Chemospike DEVICE NAME:

INDICATIONS FOR USE:

The CODAN Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the withdrawar of modication aring reconstitution of the drug in the vial and withdrawal of the drug from the vial.

Attachment 4

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

• .

Over-The-Counter-Use_ (Optional Format 1-2-96

Patricia Cuccenite

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K990711