PROTECTIV ACUVANCE IV CATHETER SYSTEM

K012128 · Ethicon Endo-Surgery, Inc. · FOZ · Aug 1, 2001 · General Hospital

Device Facts

• Record ID: K012128
• Device Name: PROTECTIV ACUVANCE IV CATHETER SYSTEM
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

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 injectors up to 300 psi.

Device Story

Single-use intravascular catheter providing venous or arterial access. Features integrated needlestick protection via self-blunting needle mechanism that activates automatically during catheter threading. Used by clinicians in various healthcare settings. 14 to 22 gauge models support power injection up to 300 psi. Device reduces risk of accidental needlestick injuries to healthcare providers.

Clinical Evidence

Bench testing only. Testing demonstrated that 14 to 22 gauge ACUVANCE catheters are appropriate for use with power injectors up to 300 psi.

Technological Characteristics

Single-use intravascular catheter with automatic self-blunting needle mechanism. 14 to 22 gauge models compatible with power injectors up to 300 psi. No changes to materials, manufacturing, or sterilization processes compared to predicate.

Indications for Use

Indicated for any patient population requiring venous or arterial access, considering patient size, infusion solution, and therapy duration. 14-22 gauge catheters are indicated for use 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.

Predicate Devices

• PROTECTIV* ACUVANCE IV Catheter System (K012128)

Submission Summary (Full Text)

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Ethicon Endo-Surgery, Inc. Ethicon Blude Barger J, inci

K012/28

# PROTECTIV* ACUVANCE IV Catheter System 510(k) Summary of Safety and Effectiveness

### Company

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

## Contact

Katie Fordyce Regulatory Affairs Associate

# Date Prepared:

July 6, 2001

## Name of Device

Trade Name: PROTECTIV* ACUVANCE IV Catheter System Classification Name: Catheter, Intravascular (short-term)

Predicate Devices: PROTECTIV* ACUVANCE IV Catheter System

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

Intended Use: 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 injectors up to 300 psi.

Technological Characteristics: The technological characteristics of the new device are the same as those of the predicate device. No changes (materials, specifications, manufacturing or sterilization processes) have been made to the currently marketed catheters. The catheters differ from the currently marketed catheters only in the instructions for use which now include use of the 14 to 22 gauge catheters with power injectors up to 300 psi. The use with power injectors claim is the same as the claim on other Ethicon Endo-Surgery (previously Johnson & Johnson Medical) catheters with regard to use with power injectors.

Performance Data: Bench testing demonstrates that the 14 to 22 gauge ACUVANCE catheters are appropriate for use with power injectors up to 300 psi.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

AUG 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katie Fordyce Regulatory Affairs Associate Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839

K012128 Re : PROTECTIV ACUVANCE IV Catheter Trade/Device Name: System 880.5200 Regulation Number: Regulatory Class: II Product Code: FOZ Dated: July 6, 2001 Received: July 9, 2001

Dear Ms. Fordyce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marke is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate abe beaud 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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.

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Page 2 - Ms. Fordyce

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does curs response co figation 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.

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 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 compreated as (advertising of your device, please contact the office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

sincerely yours,

hy A. Ulatowski Time 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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510(k) Number (if known): K 012128

Device Name: PROTECTIV* ACUVANCE IV Catheter System_

Indications for Use:

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 injectors up to 300 psi.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

Pattria Cucenote

Division of Dental. and General Hospital 510(k) Number .