NEXIVA CLOSED IV CATHETER SYSTEM

K032843 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Feb 27, 2004 · General Hospital

Device Facts

• Record ID: K032843
• Device Name: NEXIVA CLOSED IV CATHETER SYSTEM
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.

Device Story

BD Nexiva is a closed, over-the-needle peripheral intravascular catheter system; features Vialon polyurethane catheter, integrated extension tubing with Y-adapter/clamp, BD Q-Syte luer access port, and passive needle-shielding mechanism. Device functions as a closed system to contain blood during insertion; needle withdrawal through a septum wipes blood from needle, reducing exposure risk. Used in clinical settings by healthcare providers for vascular access. 18-24 gauge models support power injection up to 300 psi when luer port is removed. Benefits include reduced needlestick injury risk and minimized blood exposure for clinicians.

Clinical Evidence

Bench testing only. Simulated use study compared Nexiva and Introcan catheters. Biocompatibility testing performed per ANSI/AAMI/ISO 10993-1 (1997).

Technological Characteristics

Vialon polyurethane catheter; integrated extension tubing with Y-adapter; passive needle-shielding mechanism; BD Q-Syte luer access port. Materials tested per ANSI/AAMI/ISO 10993-1. Supports power injection up to 300 psi (18-24 gauge).

Indications for Use

Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration, provided vascular anatomy and procedure are appropriate.

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

• BD Saf-T-Intima™ IV Catheter
• B. Braun Introcan® Safety™ IV Catheter

Submission Summary (Full Text)

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BD Medical Systems 9450 South State Street Sandy ! '1ah 84070 tel [phone] fax: [phone] www.bd.com

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32843

### PREMARKET NOTIFICATION

| Submitter: | Becton Dickinson<br>Infusion Therapy Systems Inc. |
|------------------------|------------------------------------------------------------------------|
| Address: | 9450 South State Street<br>Sandy, UT 84070 |
| Contact Person: | Leslie Wood<br>Manager, Regulatory Affairs |
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| Date Summary Prepared: | August 26, 2003 |
| Trade Name: | BD Nexiva™ Closed IV Catheter System |
| Common Name: | Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Predicate Devices: | BD Saf-T-Intima™ IV Catheter<br>B. Braun Introcan® Safety™ IV Catheter |

## Description of the BD Nexiva™ Closed IV Catheter System:

The BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needle-shielding mechanism.

The design of the Nexiva IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the Nexiva device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated

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extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or a BD Q-Syte luer access port.

#### Intended Use:

The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.

### Technological Characteristics Comparison:

The Nexiva catheter is similar to the Saf-T-Intima catheter in that both have Vialon polyurethane catheters, notched needles, integrated extension tubing with Y adapters, removable access ports, and a closed system.

The Nexiva catheter is similar to the Introcan Safety catheter in that a variation in the needle circumference 'traps' the needle tip within a shield and both can be used with power injectors with a maximum pressure setting of 300 psi.

#### Nonclinical Tests Support Substantial Equivalence:

The Nexiva catheter is composed of materials that have been tested in accordance with ANSI/AAMI/ISO 10993-1 (1997).

The Nexiva and Introcan catheters were compared in a simulated use study.

#### Conclusions from Nonclinical Tests:

The Nexiva IV catheter is substantially equivalent to the Introcan device.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2004

Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070

Re: K032843

Trade/Device Name: BD Nexiva Closed IV Catheter System Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 10, 2003 Received: December 11, 2003

Dear Ms. Wood:

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. Wood

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 (OS) 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.

Chiu Lin, Ph. D.

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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# K 032843

## INDICATIONS FOR USE

Device Proprietary Name:

BD Nexiva™ Closed IV Catheter System

Device Classification Name:

Intravascular Catheter (80 FOZ)

Indications for Use:

The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: __ X

OR

Coline Mr. Burdais

Over-The-Counter Use:

v. General Hospital,

510(k) Indications 9/3/03

510(k) Number: K032843