CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER

K042504 · Myco Medical Supplies, Inc. · FOZ · Jan 19, 2006 · General Hospital

Device Facts

• Record ID: K042504
• Device Name: CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
• Applicant: Myco Medical Supplies, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids intravenously. Cathy IV Cannula may be used for with consideration of procedure.

Device Story

Cathy IV Cannula is an intravascular catheter used for intravenous fluid administration. Device is operated by healthcare professionals in clinical settings. It provides a conduit for fluid delivery to the patient's circulatory system. Device design facilitates venous access to support therapeutic fluid management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular catheter; Class II device; Product Code FOZ; Regulation 880.5200.

Indications for Use

Indicated for intravenous fluid administration in patients requiring vascular access.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Submission Summary (Full Text)

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Public Health Service

JAN 1 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sanjiv Kumar President Myco Medical Supplies, Incorporated 113 Centre West Court Cary, North Carolina 27513

Re: K042504

Trade/Device Name: Cathy IV Cannula Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 15, 2005 Received: September 19, 2005

Dear Mr. Kumar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Kumar

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisour mar 1 DT to learnination that your device complies with other requirements moun that 1 DT may made statutes and regulations administered by other Federal agencies. or the Act of ally 1 ederal base use - use - uirements, including, but not limited to: registration r ou inust comply while and 807; labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Fins reter will and in J . The FDA finding of substantial equivalence of your device to a premarket notifieddion. - The evice 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), rryou desire spleine acritics of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snytte y. Michieu Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): __K042504

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids As described in 21 CFR section 600.5200, Oakly IV ecanalian with consideration
intravenously. Cathy IV Cannula may be used for writtence of propoduce intravenously. Cathy IV Califiala may be accurity of the may of procedure.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Cita Ding

a of Actact raniclegy, Cieneral Hospits i Control, Control, Dental Devices

K042504

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