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.

Device Description

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 Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the NexivaTM device during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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD Nexiva™ Closed IV Catheter System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The nonclinical tests compare the modified BD Nexiva™ Closed IV Catheter System to its predicate device (K032843). The reported device performance for all listed characteristics is "Pass," indicating that the device met the specified acceptance criteria.

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

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document specifies a sample size of 2301 units for "Package Integrity (Water Leak)" and "Ship Testing (Drop/Vibration)" tests. For other tests, specific sample sizes are not explicitly stated, but the acceptance criteria are generally expressed in "DPPM" (Defective Parts Per Million) or "Cpk" (Process Capability Index), suggesting statistical process control and quality assurance testing.
Data Provenance: The tests are described as "Nonclinical Tests" and "design verification activities," conducted by Becton Dickinson Infusion Therapy Systems, Inc. The data is retrospective in the sense that it was generated during device development and verification to support the 510(k) submission. There is no information on the country of origin of the data, but it can be assumed to be related to the manufacturer's testing facilities, potentially in the US (headquarters in Sandy, UT).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document primarily describes physical and mechanical performance testing of a medical device, not diagnostic or clinical performance involving expert interpretation of data (like radiology images). Therefore, the concept of "experts" establishing ground truth in this context doesn't directly apply as it would for a software device. The ground truth for these tests is based on established engineering standards (e.g., ANSI/AAMI/ISO 10993-1 2003 (E) for biocompatibility, and presumably other relevant engineering and ISO standards for mechanical performance), internal product specifications, and quality control methodologies.

4. Adjudication Method for the Test Set

Not applicable. As described above, these are physical and mechanical tests with quantitative acceptance criteria (e.g., DPPM, Cpk, force measurements). There is no "adjudication" in the sense of reconciling differing expert opinions or classifications. The results are objective measurements compared against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study. The submission relates to a physical medical device (intravascular catheter) and its modifications, not an AI or software device that would typically involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This concept is not applicable as the submission is for a physical medical device, not an algorithm or AI. The tests are focused on the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

Engineering Standards: Adherence to established industry and international standards (e.g., ANSI/AAMI/ISO 10993-1 2003 (E), ISO Liquid Leakage, etc.).
Product Specifications: Internal design requirements and performance targets defined by the manufacturer.
Predicate Device Performance: The modified device is benchmarked against its predicate device (K032843) to demonstrate "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such physical devices involves design, prototyping, and iterative testing processes, not data-driven algorithmic training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device.

Summary

{0}------------------------------------------------

Becton Dickinson Infusion Therapy Systems, Inc. 9450 South State Street Sandy UT 84070 tel: 801-565-2662 fax: 801-565-2749 iustice alder@hd.com

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:

{1}------------------------------------------------

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,tip shield	Catheter Adapter -Decreased adapter pocketwidth to 0.075" for tightercontrol of adapter retentionlock mechanismTip Shield -Decrease V-clippocket opening to 0.077" fortighter control of V-clipmovement when engagedwith adapterTip Shield -Scaling of InternalID through holes to cannulagauge to improve control ofcannula to tip shieldmovement	Catheter Adapter -Adapterpocket width set at 0.088"Tip Shield -V-clip pocketwidth set at 0.084"Tip Shield -Internal ID holeswere generalized toaccommodate all cannulagauge sizes
2. Catheter material.	Catheter material -Vialon	Catheter material - Vialon

Catheter adapter	X40, Radio opaque materialCatheter Adapter-24Ga IDset to 0.0406" decreased by0.0004"	X50, Radio opaque materialCatheter Adapter -24Ga ID0.0410"
3. Catheter adapter,needle cover	Catheter Adapter -needlecover modified to removebumps, have a straightinterference fit and a solidstop featureNeedle Cover -Length set to2.26" (0.040" shortened)	Catheter Adapter -needlecover interface had 2 bumpinterference features and atapered noseNeedle Cover -Length was2.30"
4. Extension tubing	Ext. Tubing -increaseddiameters for 18,20 Gaproduct	Ext. Tubing -all gaugesmicrobore tubing
5. Clamp	Clamp -pinch clamp	Clamp -slide clamp
6. Catheter adapter, Lueradapter	Catheter Adapter -tubingjunction increased ID formacrobore tubing,optimized for adhesiveaddition)Luer Adapter -tubingjunction increased ID formacrobore tubing,optimized for adhesiveaddition)	Catheter Adapter -designed for microboretubing and solvent bondjointLuer Adapter -tubingjunction defined with aswedge design
	7. Leur adapter	Luer Adapter -PCTG "Y"adapter
8. Catheter adapter	Catheter Adapter -smalleradapter wing structure(confined within overmoldedsoft wing)	Catheter Adapter -largeadapter wing structure(confined within overmoldedsoft wing)
9. Tip shield	Tip Shield -improvedergonomic gripping side walldesign to prevent userapplying force to catheteradapter directly	Tip Shield -Straight side walldesign
10. Packaging	Package -Rigid design	Package -Blister package of

	constrained unit package(dispenser, shipper scaled tonew unit package)	assembly
11. Straight luer adapter	Straight Luer Adapter -added new configuration	Straight Luer Adapter -didnot exist
12. Vent plug	Vent Plug -placed in straightadapter for air venting	Vent Plug -placed on "Y"adapter for air venting
13. Q-Syte, Q-Syte DustCover, and End Cap	Q-Syte, Q-Syte Dust Coverand End Cap -removed forstraight configuration	Q-Syte, Q-Syte Dust Coverand End Cap -placed on "Y"configuration
14. Cannula	Cannula -bump indented intocannula for tip shield retention	Cannula -ferrule bound tocannula for tip shield retention
15. Retaining feature	Retaining Feature -washerretains cannula "bump" toprevent tip shield removal	Retaining Feature -retentionplate retains cannula ferrule toprevent tip shield removal
16. V-Clip	V-Clip -flag for cannula tipbarrier	V-Clip -no cannula tip barrier(barrier provided by retentionplate)
17. Cannula, Catheter	Cannula -ID, OD gauge sizeincrease as ferrule removedCatheter -tip resized tocannula gauge increase	Cannula -smaller gauge sizeto accommodate cannulaferruleCatheter -tip confirms tocannula gauge size
18. Wedge	Wedge -Improved reduced IDwedge design as ferrule wasremoved from cannula	Wedge -larger ID wedge toaccommodate cannula ferrule
19. Tip shield	Tip Shield -internal ID holesscaled to smaller cannula size	Tip Shield -internal IDincreased for larger cannulasize
20. Grip	Grip -internal ID increased forlarger cannula size	Grip -internal ID holes scaledto smaller cannula size

{2}------------------------------------------------

{3}------------------------------------------------

{4}------------------------------------------------

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.

AssociatedModification	Product Performance Characteristics/Verification Testing	Acceptance Criteria forProduct 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

{5}------------------------------------------------

Associatedmodification	Product Performance Characteristics/Verification Testing	Acceptance Criteria forPerformance 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 < 10000DPPM 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 < 5000-10%/+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

{6}------------------------------------------------

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

{7}------------------------------------------------

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.

{8}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{9}------------------------------------------------

K102520

INDICATIONS FOR USE

Device Proprietary Name:

BD Nexiva™ Closed IV Catheter System

Device Classification Name:

Intravascular Catheter (80 FOZ)

Indications for Use:

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

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).