PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES

K041345 · Medix, Inc. · FOZ · Jul 22, 2004 · General Hospital

Device Facts

• Record ID: K041345
• Device Name: PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
• Applicant: Medix, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

A properly placed I.V. catheter provides access to a vein or artery. TThe I.V. catheter system is designed for single use and has a needlestick protection feature. The needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.

Device Story

Protectiv® Jelco® Safety I.V. Catheter is a single-use intravascular catheter featuring an integrated needle guard. During insertion, the guard automatically locks over the needle as the catheter is threaded into the vessel, protecting clinicians from accidental needlesticks. Used in clinical settings for venous or arterial access; operated by healthcare professionals. Device facilitates infusion therapy and power injection (16-24 gauge models). Benefit includes reduced risk of sharps injuries to medical staff.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular catheter with integrated needle guard mechanism. Gauge sizes 16-24. Compatible with power injectors up to 300 psi. Single-use, sterile.

Indications for Use

Indicated for any patient population requiring venous or arterial access, considering patient size, infusion solution, and therapy duration. 16-24 gauge catheters compatible with power injectors up to 300 psi.

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

JUL 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara Law Regulatory Affairs Manager Medex, Incorporated 6250 Shier-Rings Road Dublin, Ohio 43016

Re: K041345

Trade/Device Name: Protectiv® Jelco® Safety I.V. Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 17, 2004 Received: May 20, 2004

Dear Ms. Law:

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 - Ms. Law

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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 regulation (21 CFR Part 801), please contact the Office 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 Division 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/dsma/dsmamain.html

Sincerely yours,

Oul

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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K0413415

## Indications for Use Statement

510(k) Number (if known):

Protectiv® Jelco® Safety I.V. Catheter Device Name:

Indications for Use:

A properly placed I.V. catheter provides access to a vein or artery. TThe I.V. catheter system is designed for single use and has a needlestick protection feature. The needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cathy Ko. m

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental E

510(k) Number:

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