ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

K030571 · Ethicon Endo-Surgery, Inc. · FOZ · Mar 28, 2003 · General Hospital

Device Facts

• Record ID: K030571
• Device Name: ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ACUVANCE PLUS Safety IV Catheter: A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a selfblunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injectors up to 300 psi. PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi. OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.

Device Story

Single-use intravascular catheters provide venous or arterial access. ACUVANCE PLUS features automatic self-blunting needle mechanism; PROTECTIV PLUS features manual locking needle guard; OPTIVA is standard catheter. Devices used by clinicians for fluid/medication infusion. Modified catheter tube material formulation compared to predicates. Bench testing and biocompatibility data confirm equivalence.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility and bench testing demonstrate equivalence of the modified catheter tube material to the predicate material.

Technological Characteristics

Intravascular catheters; modified polymer tube material formulation. Features include self-blunting needle (ACUVANCE) or locking needle guard (PROTECTIV). Compatible with power injectors up to 300 psi (specific gauges). Single-use, sterile.

Indications for Use

Indicated for any patient population requiring venous or arterial access, considering patient size, infusion requirements, and therapy duration. Specific models include needlestick protection features (self-blunting or needle guard). Compatible with power injectors up to 300 psi for specific gauge ranges.

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.

Predicate Devices

• ACUVANCE PLUS Safety IV Catheter (K030571)
• PROTECTIV PLUS Safety IV Catheter (K030571)
• OPTIVA IV Catheter (K030571)

Submission Summary (Full Text)

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# ACUVANCE® PLUS Safety IV Catheter, PROTECTIV PLUS® Safety IV Catheter, OPTIVA® IV Catheter 510(k) Summary of Safety and Effectiveness

### Company

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

MAR 2 8 2003

### Contact

Katie Fordyce Regulatory Affairs Associate II

### Date Prepared:

February 21, 2003

### Name of Device

Trade Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter Classification Name: Catheter, Intravascular (short-term)

Predicate Devices: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter

Device Description: Intravascular catheters are single use devices which provide access to veins or arteries.

### Indications for Use:

ACUVANCE PLUS Safety IV Catheter: A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a selfblunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.

PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.

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OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.

Technological Characteristics: The catheter tube material has been modified for the IV Catheters. This new material is a different formulation of the material in the predicate devices. All other technological characteristics of the new device remain the same as those of the predicate device.

Performance Data: Bench testing and biocompatibility data demonstrate that the new material is equivalent to the current material.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.

#### Public Health Service

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Ms. Katie Fordyce Regulatory Affairs Associate II Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242

Re: K030571

Trade/Device Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 21, 2003 Received: February 24, 2003

Dear Ms. Fordyce:

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. Fordyce

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 vours.

Susan Bunner

Susan Runner, DDS, MA Interim 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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# 510(k) Number (if known): K 030571

## Device Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter

### Indications for Use:

### ACUVANCE PLUS Safety IV Catheter:

A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. 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. 14 to 22 gauge catheters may be used with power injector up to 300 psi.

### PROTECTIV PLUS Safety IV Catheter

The PROTECTIV PLUS Safety I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.

### OPTIVA IV Catheter:

The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

of CDRH, Office of Device Evaluation (ODE)

taltaux Vicente

(Optional Format 3-10-98)

(División Sign-On)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: