BD NEXIVA CLOSED IV CATHETER SYSTEM

K102520 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Jan 6, 2011 · General Hospital

Device Facts

• Record ID: K102520
• Device Name: BD NEXIVA CLOSED IV CATHETER SYSTEM
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 6, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a 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 needle-stick 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 18-22 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

Closed IV catheter system; consists of over-the-needle peripheral catheter (Vialon polyurethane), integrated extension tubing, Y-adapter, clamp, and passive needle-shielding mechanism. Used by clinicians for vascular access; protects against blood exposure via septum-sealed needle withdrawal and closed Y-adapter ports. Needle-shielding feature reduces needle-stick injury risk. Device allows blood sampling, pressure monitoring, and fluid administration. 18-22 gauge models support power injection (max 300 psi) upon direct connection. Modifications include refined adapter/tip shield geometry, cannula retention features, and packaging changes to improve performance and ergonomics.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included premature decouple force, pull force, burst strength, penetration force, drag, tip adhesion, seal integrity, flow rate, and ship testing. All tests met predefined acceptance criteria.

Technological Characteristics

Materials: Vialon polyurethane. Components: Over-the-needle catheter, integrated extension tubing, Y-adapter, passive needle-shielding mechanism. Standards: ANSI/AAMI/ISO 10993-1 2003 (E) for biocompatibility. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration. 18-22 gauge catheters are compatible with power injectors up to 300 psi when luer access port is removed.

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 Nexiva™ Closed IV Catheter System (K032843)

Submission Summary (Full Text)

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Becton Dickinson Infusion Therapy Systems, Inc. 9450 South State Street Sandy UT 84070 tel: [phone] fax: [phone] iustice [e-mail]

K102520/S2

Helping all people

live healthy lives

# SPECIAL PREMARKET NOTIFICATION [510(K)] Summary- BD NexivaTM Closed IV Catheter System

Submitter:

Becton Dickinson Infusion Therapy Systems, Inc.

Address:

9450 South State Street Sandy, UT 84070

Contact Person:

Trade Names:

Common Name:

Classification Name:

Justice Alder Specialist, Regulatory Affairs

Telephone Number: Fax Number:

801-565-2749

801-565-2662

August 30, 2010

Date Summary Prepared:

BD Nexiva™ Closed IV Catheter System

Intravascular Catheter

Intravascular Catheter (FOZ) 880.5200

Unmodified/Predicate Device: (K032843) BD NexivaTM Closed IV Catheter System

#### Description of the device:

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

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Intended Use of the BD Nexiva™ Closed IV Catheter System device: [21 CFR Part 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES; General Hospital and Personal Use Therapeutic Devices Sec. 880.5200]

The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a 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 needle-stick 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 18-22 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 BD NexivaTM Closed IV Catheter products have the same technological characteristics with no changes in intended use. The subject device has similar design features and materials as the predicate device. The table below shows the design features and material comparisons between the predicate and subject device.

| | Subject Device | Predicate Device |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Catheter adapter,<br>tip shield | Catheter Adapter -<br>Decreased adapter pocket<br>width to 0.075" for tighter<br>control of adapter retention<br>lock mechanism<br>Tip Shield -Decrease V-clip<br>pocket opening to 0.077" for<br>tighter control of V-clip<br>movement when engaged<br>with adapter<br>Tip Shield -Scaling of Internal<br>ID through holes to cannula<br>gauge to improve control of<br>cannula to tip shield<br>movement | Catheter Adapter -Adapter<br>pocket width set at 0.088"<br>Tip Shield -V-clip pocket<br>width set at 0.084"<br>Tip Shield -Internal ID holes<br>were generalized to<br>accommodate all cannula<br>gauge sizes |
| 2. Catheter material. | Catheter material -Vialon | Catheter material - Vialon |
| | | |
| Catheter adapter | X40, Radio opaque material<br>Catheter Adapter-24Ga ID<br>set to 0.0406" decreased by<br>0.0004" | X50, Radio opaque material<br>Catheter Adapter -24Ga ID<br>0.0410" |
| 3. Catheter adapter,<br>needle cover | Catheter Adapter -needle<br>cover modified to remove<br>bumps, have a straight<br>interference fit and a solid<br>stop feature<br>Needle Cover -Length set to<br>2.26" (0.040" shortened) | Catheter Adapter -needle<br>cover interface had 2 bump<br>interference features and a<br>tapered nose<br>Needle Cover -Length was<br>2.30" |
| 4. Extension tubing | Ext. Tubing -increased<br>diameters for 18,20 Ga<br>product | Ext. Tubing -all gauges<br>microbore tubing |
| 5. Clamp | Clamp -pinch clamp | Clamp -slide clamp |
| 6. Catheter adapter, Luer<br>adapter | Catheter Adapter -tubing<br>junction increased ID for<br>macrobore tubing,<br>optimized for adhesive<br>addition)<br>Luer Adapter -tubing<br>junction increased ID for<br>macrobore tubing,<br>optimized for adhesive<br>addition) | Catheter Adapter -<br>designed for microbore<br>tubing and solvent bond<br>joint<br>Luer Adapter -tubing<br>junction defined with a<br>swedge design |
| | 7. Leur adapter | Luer Adapter -PCTG "Y"<br>adapter |
| 8. Catheter adapter | Catheter Adapter -smaller<br>adapter wing structure<br>(confined within overmolded<br>soft wing) | Catheter Adapter -large<br>adapter wing structure<br>(confined within overmolded<br>soft wing) |
| 9. Tip shield | Tip Shield -improved<br>ergonomic gripping side wall<br>design to prevent user<br>applying force to catheter<br>adapter directly | Tip Shield -Straight side wall<br>design |
| 10. Packaging | Package -Rigid design | Package -Blister package of |
| | | |
| | constrained unit package<br>(dispenser, shipper scaled to<br>new unit package) | assembly |
| 11. Straight luer adapter | Straight Luer Adapter -<br>added new configuration | Straight Luer Adapter -did<br>not exist |
| 12. Vent plug | Vent Plug -placed in straight<br>adapter for air venting | Vent Plug -placed on "Y"<br>adapter for air venting |
| 13. Q-Syte, Q-Syte Dust<br>Cover, and End Cap | Q-Syte, Q-Syte Dust Cover<br>and End Cap -removed for<br>straight configuration | Q-Syte, Q-Syte Dust Cover<br>and End Cap -placed on "Y"<br>configuration |
| 14. Cannula | Cannula -bump indented into<br>cannula for tip shield retention | Cannula -ferrule bound to<br>cannula for tip shield retention |
| 15. Retaining feature | Retaining Feature -washer<br>retains cannula "bump" to<br>prevent tip shield removal | Retaining Feature -retention<br>plate retains cannula ferrule to<br>prevent tip shield removal |
| 16. V-Clip | V-Clip -flag for cannula tip<br>barrier | V-Clip -no cannula tip barrier<br>(barrier provided by retention<br>plate) |
| 17. Cannula, Catheter | Cannula -ID, OD gauge size<br>increase as ferrule removed<br>Catheter -tip resized to<br>cannula gauge increase | Cannula -smaller gauge size<br>to accommodate cannula<br>ferrule<br>Catheter -tip confirms to<br>cannula gauge size |
| 18. Wedge | Wedge -Improved reduced ID<br>wedge design as ferrule was<br>removed from cannula | Wedge -larger ID wedge to<br>accommodate cannula ferrule |
| 19. Tip shield | Tip Shield -internal ID holes<br>scaled to smaller cannula size | Tip Shield -internal ID<br>increased for larger cannula<br>size |
| 20. Grip | Grip -internal ID increased for<br>larger cannula size | Grip -internal ID holes scaled<br>to smaller cannula size |

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## Nonclinical Tests Support Substantial Equivalence:

The BD Nexiva™ Closed IV Catheter System is composed of material that have been tested in accordance with ANSI/AAMI/ISO 10993-1 2003 (E) standards. The design verification activities, acceptance criterion, and results have been summarized below which demonstrates safety and efficacy of the device.

.

| Associated<br>Modification | Product Performance Characteristics/Verification Testing | Acceptance Criteria for<br>Product Verification |
|----------------------------|-----------------------------------------------------------|-------------------------------------------------|
| 1 | Premature Decouple Force | DPPM < 280 |
| 2 | Catheter Pull Force | DPPM < 60 |
| 2 | Catheter Burst Strength | DPPM < 60 |
| 2 | Catheter Penetration Force | DPPM <1350 |
| 2 | Catheter Drag | DPPM <1350 |
| 2 | Tip Adhesion | DPPM <1350 |
| 1 | System Drag -Cannula Drag | DPPM < 500 |
| 1 | System Drag -Ferrule Retraction Force | DPPM < 500 |
| 1 | Adapter Release Force | DPPM < 500 |
| 3 | Needle Cover Removal | DPPM USL < 18000 |
| 3 | | DPPM LSL < 200000 |
| 3 | | -20%/+25%, DPPM < 5000 |
| 4 | Flow Rate Label Claim | -10%/+15%, DPPM < 5000 |
| 5 | Pinch Clamp Fluid Seal | DPPM < 10000 |
| 5 | Pinch Clamp Engagement Disengagement Force | DPPM < 2000 |
| 8 | Wing deflection force | DPPM USL < 2000 |
| 8 | | DPPM LSL < 500 |
| 6 | Bond Strength -Tubing Bond to Adapter | DPPM < 0.1 |
| 4 | Extension Tube Burst Pressure | DPPM < 60 |
| 10 | Unit Package Seal Peel Force | 1.33 Cpk |
| 10 | Seal Width | 1.33 Cpk |
| 10 | Unit PackageMaterial Thickness - Post Formed (Bottom Wed) | 1.33 Cpk |
| 10 | Package Integrity (Water Leak) | 0 out of 2301 |
| 10 | Ship Testing (Drop/Vibration) | 0 out of 2301 |
| 7 | Y-Adapter Wishbone Loading | DPPM < 0.1 |
| 7 | ISO Liquid Leakage | DPPM < 500 |
| 7 | ISO Air Leakage | DPPM < 500 |
| 7 | ISO Unscrewing Torque | DPPM < 500 |
| 7 | ISO Resistance to Overriding | DPPM < 500 |
| 7 | ISO Thread Separation | DPPM < 500 |
| 7 | Vent Plug Removal Force/Torque | DPPM USL < 6500 |
| 7 | | DPPM LSL <10000 |
| 7 | Q-Syte Removal Torque | DPPM USL < 6500 |
| 7 | | DPPM LSL <10000 |

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| Associated<br>modification | Product Performance Characteristics/Verification Testing | Acceptance Criteria for<br>Performance Testing | Result |
|----------------------------|----------------------------------------------------------|--------------------------------------------------|--------|
| 11 | ISO Thread Seperation -Both Y female luer | DPPM < 500 | Pass |
| 11 | ISO Thread Seperation -Straight female luer | DPPM < 500 | Pass |
| 11 | ISO Unscrewing Torque -Both Y female luer | DPPM < 500 | Pass |
| 11 | ISO Unscrewing Torque -Straight female luer | DPPM < 500 | Pass |
| 11 | ISO Resistance to Override -Both Y female luer | DPPM < 500 | Pass |
| 11 | ISO Resistance to Override -Straight female luer | DPPM < 500 | Pass |
| 11 | ISO Liquid Leakage | DPPM < 500 | Pass |
| 11 | ISO Air Leakage | DPPM < 500 | Pass |
| 12 | Vent Plug Torque Removal | DPPM USL < 10000<br>DPPM LSL< 20000 | Pass |
| 11 | Bond Strength - Tubing Bond to Adapter | DPPM < 60 | Pass |
| 11 | Flow Rate Label Claim | -10%/+15%, DPPM < 5000 | Pass |
| 14,15 | Proximal Re-exposure | DPPM < 100 | Pass |
| 17 | System Drag -Maximum Adhesion Force | DPPM < 1350 | Pass |
| 17 | System Drag - Average Drag Force | DPPM < 10,000 | Pass |
| 17 | System Drag - Offset Peak Force | DPPM < 2000 | Pass |
| 17 | Flow Rate Label Claim | -20%/+25%, DPPM < 5000<br>-10%/+15%, DPPM < 5000 | Pass |
| 17 | Minimum Flow | DPPM < 5000 | Pass |
| 17 | Flashback | DPPM < 1000 | Pass |
| 17 | Cannula Penetration | DPPM < 1350 | Pass |
| 17 | Catheter Penetration | DPPM < 1350 | Pass |
| 17,19 | Premature Decouple | DPPM < 280 | Pass |
| 20 | Needle Hub Pull | DPPM < 500 | Pass |

#### Conclusions from Nonclinical Tests:

The BD Nexiva™ Closed IV Catheter System modifications presented in this submission are substantially equivalent to the currently marketed predicate device (K032843). The intended use and technological characteristics of the BD Nexiva™ Closed IV Catheter System product modifications described in this submission have not been altered, and therefore have remained the same since receiving their original 510(k) approval from the FDA.

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

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construed as an admission against interest under the US Patent Laws or their application by the courts.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

C (a);

Ms. Justice Alder Specialist. Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070

Re: K102520

Trade/Device Name: BD Nexiva™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 6, 2010 Received: December 10, 2010

Dear Ms. Alder:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Alder

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

James J. Roberts
for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital.\ Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# K102520

## INDICATIONS FOR USE

Device Proprietary Name:

BD Nexiva™ Closed IV Catheter System

Device Classification Name:

Intravascular Catheter (80 FOZ)

Indications for Use:

As indicated in 21 CFR Part 880.5200, The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a 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 needle-stick 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 18-22 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 Over-The-Counter Use: **__**

Acting for
RICHARD CHAPMAN

(Sign Off)

(Phusion of Anesthesiology, General Hospital infection Control, Dental Devices

Special 510(k): Device Modification Indications for Use