The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.

Device Description

The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle cover. A MaxZero™ needle-free connector with protective cover is provided in the package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). These devices are available with wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).

AI/ML Overview

This document (K231239) is a 510(k) Premarket Notification for the BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access. This submission aims to demonstrate substantial equivalence to a predicate device.

The provided text describes the regulatory aspects, technical characteristics, and the summary of performance testing for the device. However, it does not contain information regarding studies that establish a ground truth through expert consensus, MRMC studies, or training set details typically found in AI/ML device submissions. This is because the device in question is an IV catheter system, a physical medical device, not an AI/ML-driven diagnostic or therapeutic system. Therefore, the concepts of "ground truth for the test set," "number of experts," "adjudication method," "effect size of human readers improving with AI," "standalone algorithm performance," and "training set details" are not applicable in this context.

The acceptance criteria here pertain to engineering and biological performance standards for medical devices, rather than accuracy metrics for AI/ML models.

Here's a breakdown of the available information relevant to "acceptance criteria and the study that proves the device meets the acceptance criteria" for this physical medical device:

Acceptance Criteria and Reported Device Performance

The device manufacturer conducted various performance tests to ensure the Nexiva™ Closed IV Catheter System with NearPort™ IV Access meets predetermined design requirements and demonstrates substantial equivalence to its predicate device (BD Nexiva™ Closed IV Catheter System, K183399).

The document states that the subject devices met all predetermined acceptance criteria for the listed performance tests, demonstrating substantial equivalence. While specific numerical outcomes of these tests are not provided in this 510(k) summary, the overall statement of meeting acceptance criteria serves as the "reported device performance."

Table of Acceptance Criteria (based on stated tests and standards):

Performance Test Category	Specific Tests/Standards	Acceptance Criteria (Implied: Device meets all predetermined criteria as per standards)	Reported Device Performance
Biocompatibility	ISO 10993-1	Demonstrates biological safety for body contact (circulating blood, limited to prolonged duration).	Achieved.
Sterilization	ISO 10993-7 (Residuals), ISO 11135-1 (Validation)	Sterility Assurance Level (SAL) of $1 \times 10^{-6}$ and safe residual levels.	Achieved.
Packaging	ASTM D4169	Maintains integrity and sterility of the device until use.	Achieved.
Catheter Performance (ISO 10555-1 and ISO 10555-5)	Peak Tensile Force	Meets required tensile strength.	Achieved.
	Liquid Leakage	No unacceptable liquid leakage.	Achieved.
	Air Leakage	No unacceptable air leakage.	Achieved.
	Gravity Flow Rate	Achieves specified flow rates.	Achieved.
	Power Injection Flow Rate	Achieves specified flow rates under power injection conditions (up to 300 psi for 24-18 GA).	Achieved.
Needle Safety	ISO 23908	Demonstrates effective needle tip protection.	Achieved.
Luer Connections	ISO 594-1 and ISO 594-2	Ensures secure and leak-free Luer connections.	Achieved.
BD Internal Studies	Catheter tubing open flow pressure	Meets internal performance specifications.	Achieved.
	Catheter tubing rupture pressure	Withstands specified pressure without rupture.	Achieved.
	System burst	Withstands specified pressure without bursting.	Achieved.
	Catheter adapter separation force	Meets required separation force.	Achieved.
	Extension tubing detachment force	Meets required detachment force.	Achieved.
	Wing bending force	Withstands specified bending force.	Achieved.
	Needle cover removal force	Meets specified removal force.	Achieved.
	Needle cover retention	Meets specified retention.	Achieved.
	Flow control plug retention rate	Meets specified retention rate.	Achieved.
MR Compatibility	ASTM F2182-19, FDA Guidance for MR Environment Medical Devices (May 2021)	Demonstrates safety in MR environment.	Achieved.
Microbial Ingress	Intravascular Administration Sets Premarket Notification Submissions [510(k)] Guidance (July 2008)	Prevents unacceptable microbial ingress.	Achieved.
Usability	Applying Human Factors and Usability Engineering to Medical Devices Guidance (February 2016)	Demonstrated safe and effective use by intended users.	Achieved.

Study Details (as applicable to a physical medical device)

Sample sizes used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes (e.g., number of units tested) for each performance test. It refers to "performance tests completed on the subject devices."
- Data Provenance: The studies were conducted by Becton Dickinson Infusion Therapy Systems Inc., based in Sandy, Utah, USA. The data is from internal performance verification testing ("BD Internal Studies") and compliance testing to international (ISO, ASTM) and national (FDA guidance) standards. The studies would be considered prospective as they were conducted specifically for this submission to demonstrate compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device (IV catheter), not an AI/ML diagnostic. "Ground truth" in this context refers to engineering specifications and performance standards established by organizations like ISO, ASTM, and FDA. The "experts" involved would be engineers, scientists, and regulatory affairs professionals ensuring the device meets these pre-defined physical and functional requirements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in subjective interpretation tasks (e.g., radiology image review) to establish consensus ground truth. For objective physical performance tests (e.g., tensile strength, flow rate), the results are quantitative and do not require expert adjudication in this manner. Compliance is determined by meeting numerical or descriptive criteria within established standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is specifically designed for AI-assisted diagnostic devices where human readers interpret medical images. This document is for a physical IV catheter; AI assistance for human readers is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI algorithm. Its performance is tested as a standalone physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and quality standards, including:
  - International Standards (ISO 10993, ISO 10555, ISO 23908, ISO 594, ISO 11135, ISO 14971)
  - ASTM Standards (ASTM D4169, ASTM F2182)
  - FDA Guidance Documents (e.g., for Usability, Microbial Ingress, MR Compatibility)
  - Internal design requirements and specifications, which are based on the above standards and common medical device engineering principles.
- "Ground truth" is not based on expert consensus for subjective interpretation or pathology/outcomes data in the way it would be for a diagnostic tool.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for a non-AI/ML device, ground truth establishment for it is irrelevant.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 22, 2023

Becton Dickinson Infusion Therapy Systems Inc. Paul Holman Regulatory Affairs Manager 9450 South State Street Sandy, Utah 84070

Re: K231239

Trade/Device Name: Nexiva™ Closed IV Catheter System with NearPort™ IV Access Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: August 25, 2023 Received: August 25, 2023

Dear Paul Holman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K231239

Device Name

Nexiva™ Closed IV Catheter System with NearPort™ IV Access

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

bd.com

Image /page/3/Picture/2 description: The image shows the BD logo. The logo consists of two parts: a stylized orange sun-like symbol on the left and the letters "BD" in blue on the right. The sun-like symbol is a circle with rays emanating from it, and the letters "BD" are in a bold, sans-serif font.

K231239 510(k) Summary (21 CFR §807.92) Nexiva™ Closed IV Catheter System with NearPort™ IV Access

Submitter	Submitter Name:	Becton Dickinson Infusion Therapy Systems Inc.
Information	Submitter Address:	9450 South State Street, Sandy, Utah 84070
	Contact Person:	Paul Holman, Regulatory Affairs Manager
	Email Address:	paul.holman@bd.com
	Phone Number:	(801) 522-5000
	Date of Preparation:	September 22, 2023
Subject Device	Trade Name:	Nexiva™ Closed IV Catheter System with NearPort™ IV Access
	Common Name:	Peripheral Intravascular or IV Catheter
	510(k) Reference:	K231239
	Regulation Number:	21 CFR §880.5200
	Regulation Name:	Catheter, intravascular, therapeutic, short-term less than 30 days
	Regulatory Class:	II
	Product Code:	FOZ, FPA
	Classification Panel:	General Hospital
Predicate	Trade Name:	BD Nexiva™ Closed IV Catheter System
Device	Common Name:	Peripheral Intravascular or IV Catheter
	510(k) Reference:	K183399
	Regulation Number:	21 CFR §880.5200
	Regulation Name:	Catheter, intravascular, therapeutic, short-term less than 30 days
	Regulatory Class:	II
	Product Code:	FOZ, FPA
	Classification Panel:	General Hospital
Reason for		The purpose of this submission is to notify the FDA of the introduction of the Nexiva™
Submission	Closed IV Catheter System with NearPort™ IV Access, allowing for compatibility with aneedle-free blood draw device (e.g., PIVO™ Pro Needle-free Blood Collection Device).
Device	The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ cathetertubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp,Luer adapter, and vent plug. The needle and catheter tubing are protected by a needlecover. A MaxZero™ needle-free connector with protective cover is provided in thepackage.
bd.com
The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion.
Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood.
In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
These devices are available with wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
Indications for Use(21 CFR § 807.92(a)(5))	The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
TechnologicalCharacteristics	Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject device, Nexiva™ Closed IV Catheter System with NearPort™ IV Access, achieves its intended use based on the same technology and principles of operation as the predicate device. A comparison of the subject and predicate device technological characteristics is provided in the table below
	SUBJECT (K231239)	PREDICATE (K183399)	Comparison &

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

Attribute	SUBJECT (K231239)Nexiva™ Closed IV CatheterSystem with NearPort™ IVAccess	PREDICATE (K183399)BD Nexiva™ Closed IV CatheterSystem	Comparison &Discussion
	21 CFR 880.5200Class II	21 CFR 880.5200Class II
Classification	FOZ - Intravascular CatheterFPA - Intravascular AdministrationSet	FOZ - Intravascular CatheterFPA - Intravascular AdministrationSet	Same
Attribute	SUBJECT (K231239)Nexiva™ Closed IV CatheterSystem with NearPort™ IVAccess	PREDICATE (K183399)BD Nexiva™ Closed IV CatheterSystem	Comparison &Discussion
Indications forUse	The Nexiva™ Closed IV CatheterSystem with NearPort™ IV Access isintended to be inserted into apatient's peripheral venous systemfor short term use to administerfluids and/or medications and tosample blood. These devices may beused for any patient population withconsideration given to adequacy ofvascular anatomy, procedure beingperformed, fluids being infused, andduration of therapy. The 24-18 GA(0.7-1.3 mm) devices are suitablefor use with power injectors set to amaximum pressure of 300 psi (2068kPa) when connected to theNearPort™ IV Access.	Nexiva™ closed IV cathetersystems are intended to be insertedinto a patient's vascular system forshort term use to sample blood,monitor blood pressure, oradminister fluids. These cathetersmay be used for any patientpopulation with considerationgiven to adequacy of vascularanatomy, procedure beingperformed, fluids being infused,and duration of therapy. The 22-18GA (0.9-1.3 mm) devices aresuitable for use with powerinjectors set to a maximumpressure of 300 psi (2068 kPa)when access ports not suitable foruse with power injectors areremoved.	Modifications havebeen made to re-phrase and align withproduct usespecifications.The Indications forUse is beingnarrowed to limit useto the peripheralvenous system onlyto administer fluidsand/or medicationsand to sample blood.Narrowing theIndications for Usedoes not raise anynew or differentquestions of safety oreffectiveness.Additionally, powerinjection capabilityhas been expanded toinclude the 24 GAconfiguration, usingthe same test methodas the predicatedevice as supportedby performanceverification testing,which did not raiseany new or differentquestions of safetyand effectiveness.
Intended Use	Intravascular access	Intravascular access	Same
FundamentalScientificTechnology	Closed peripheral intravenouscatheter system designed with anintegrated extension tubingincorporating a Y (dual)-portinjection site. IncorporatesInstaflash™ technology to assistwith flashback visualization.Nexiva™ Closed IV CatheterSystem with NearPort™ IV Accessis compatible with the PIVOTM ProNeedle-free Blood Collection	Closed peripheral intravascularcatheter system designed with anintegrated extension setincorporating a single port or Y(dual)-port injection site.Incorporates Instaflash™technology to assist with flashbackvisualization	The subject deviceuses the samefundamentaltechnology comparedto the predicate device(K183399).The NearPort™ IVAccess component hasthe same fundamentalscientific technology
Attribute	SUBJECT (K231239)Nexiva™ Closed IV CatheterSystem with NearPort™ IVAccess	PREDICATE (K183399)BD Nexiva™ Closed IV CatheterSystem	Comparison &Discussion
	Device for needle-free blood draws.		however, the splitseptum design enablescompatibility with aneedle-free blooddraw device assupported by humanfactors validationtesting, which did notraise any new ordifferent questions ofsafety andeffectiveness.
	Primary Components Material Composition
ISO 10993-1BiocompatibilityContact Typeand Duration	Body Contact: Externallycommunicating deviceContact: Circulating bloodContact Duration: Limited (A)to Prolonged (B) (≤ 24 hrs to30 days)	Body Contact: Externallycommunicating deviceContact: Circulating bloodContact Duration: Limited (A) toProlonged (B) (≤ 24 hrs to 30days)	Same
Needle	Stainless Steel	Stainless Steel	Same
Catheter Tubing	Polyurethane with radiopaquebarium sulfate	Polyurethane with radiopaquebarium sulfate	Same
Grip	Polycarbonate + White Colorant	Polycarbonate + White Colorant	Same
Tip Shield	Polycarbonate + Gray Colorant	Polycarbonate + Gray Colorant	Same
CatheterAdapter	Copolyester	Copolyester	The materialformulation has beenmodified; however,the material resin typeremains the same.Testing in accordancewith ISO 10993-1requirements did notraise any new ordifferent questionsrelated to biologicalsafety
CatheterAdapter Wings	Thermoplastic Elastomer + GaugeSpecific ColorantGreen (18 GA)Pink (20 GA)Blue (22 GA)Yellow (24 GA)	Thermoplastic Elastomer + GaugeSpecific ColorantGreen (18 GA)Pink (20 GA)Blue (22 GA)Yellow (24 GA)	A modified Shore Adurometer is used inthe subject device butmaintains the samebase resins andcolorants, except anew green colorant
Attribute	SUBJECT (K231239)Nexiva™ Closed IV CatheterSystem with NearPort™ IVAccess	PREDICATE (K183399)BD Nexiva™ Closed IV CatheterSystem	Comparison &Discussion
			supplier has beenqualified. Testing inaccordance with ISO10993-1 requirementsdid not raise any newor different questionsrelated to biologicalsafety.
Extension Tubing	Thermoplastic Polyurethane	Thermoplastic Polyurethane	Same
Straight Luer Adapter	Copolyester	Copolyester	Same
Pinch Clamp	Acetal Copolymer	Acetal Copolymer	Same
MaxZero™	Polycarbonate / Silicone	Polycarbonate / Silicone	Same
NearPort™ IVAccess	Polycarbonate / Silicone	N/A + not part of predicate devicedesign	Polymer materialfamily is same as otherneedle-free connectorsoffered with predicatedevice.
CatheterDimensions	Catheter Diameters18 GA, 20 GA, 22 GA, 24 GACatheter Lengths0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN	Catheter Diameters18 GA, 20 GA, 22 GA, 24 GACatheter Lengths0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN,1.75 IN	A 24 GA x0.56 IN productconfiguration is not partof the subject devicesubmission; however,all other configurations(e.g., Gauge andLength) are within thebounds of the predicatedevice, which does notraise any new ordifferent questions ofsafety and effectiveness(i.e., performancetesting).
ProductConfigurations	• NearPort IV Access	• Single Port• Single Port with MaxZero• Dual Port• Dual Port with Q-Syte• Dual Port with Q-Syte and EndCap• Dual Port with MaxZero	NearPort IV Accesscomponent is a needle-free connector same asQ-Syte and MaxZero
SterilizationModality	Ethylene Oxide	Ethylene Oxide	Same
	bd.com
Attribute	SUBJECT (K231239)Nexiva™ Closed IV CatheterSystem with NearPort™ IVAccess	PREDICATE (K183399)BD Nexiva™ Closed IV CatheterSystem	Comparison &Discussion
Minimum SAL	$1 x 10^{-6}$	$1 x 10^{-6}$	Same
Energy Source	User operated	User operated	Same
Single Use Only	Yes	Yes	Same

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

Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA

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

Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA

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

Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA

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

Summary ofPerformanceTesting	A Risk Analysis in accordance with ISO 14971:2019 was conducted to assess theimpact of the proposed modifications to the predicate device.Performance tests completed on the subject devices were limited to those testsrequired to support a determination of substantial equivalence to the predicatedevice. A risk analysis was conducted to assess the impact of the proposedmodifications to the predicate device. When technological characteristics betweenthe subject and predicate devices were found to be identical, results of performancetesting conducted on the predicate devices were applied to the subject device. Theperformance tests listed below were conducted to ensure that the subject devicemeets predetermined design requirements:1) Compliance Testing Biocompatibility (ISO 10993-1) Body contact: Externally communicating device Contact: Circulating blood Contact duration: Limited (A) to Prolonged (B) (≤ 24 hrs to 30 days) Sterilization Residuals (ISO 10993-7) Packaging Testing (ASTM D4169) Sterilization Validation (ISO 11135-1) Performance Testing per ISO 10555-1 and ISO 10555-5 Peak Tensile Force (ISO 10555-1 §4.6) Liquid Leakage (ISO 10555-1 §4.7.1) Air Leakage (ISO 10555-1 §4.7.2) Gravity Flow Rate (ISO 10555-1 §4.9) Power Injection Flow Rate (ISO 10555-1 §4.10) Needle Safety Testing (ISO 23908) Luer Testing (ISO 594-1 and ISO 594-2) 2) BD Internal Studies
--------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Summary ofPerformanceTesting

A Risk Analysis in accordance with ISO 14971:2019 was conducted to assess theimpact of the proposed modifications to the predicate device.Performance tests completed on the subject devices were limited to those testsrequired to support a determination of substantial equivalence to the predicatedevice. A risk analysis was conducted to assess the impact of the proposedmodifications to the predicate device. When technological characteristics betweenthe subject and predicate devices were found to be identical, results of performancetesting conducted on the predicate devices were applied to the subject device. Theperformance tests listed below were conducted to ensure that the subject devicemeets predetermined design requirements:1) Compliance Testing Biocompatibility (ISO 10993-1) Body contact: Externally communicating device Contact: Circulating blood Contact duration: Limited (A) to Prolonged (B) (≤ 24 hrs to 30 days) Sterilization Residuals (ISO 10993-7) Packaging Testing (ASTM D4169) Sterilization Validation (ISO 11135-1) Performance Testing per ISO 10555-1 and ISO 10555-5 Peak Tensile Force (ISO 10555-1 §4.6) Liquid Leakage (ISO 10555-1 §4.7.1) Air Leakage (ISO 10555-1 §4.7.2) Gravity Flow Rate (ISO 10555-1 §4.9) Power Injection Flow Rate (ISO 10555-1 §4.10) Needle Safety Testing (ISO 23908) Luer Testing (ISO 594-1 and ISO 594-2) 2) BD Internal Studies

--------------------------------------

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Catheter tubing open flow pressure .
Catheter tubing rupture pressure .
System burst ●
Catheter adapter separation force ●
Extension tubing detachment force ●

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

Wing bending force ●
Needle cover removal force .
Needle cover retention .
. Flow control plug retention rate

	3) Evaluation of MR Compatibility per ASTM F2182-19 Standard Test Method forMeasurement of Radio Frequency Induced Heating On or Near PassiveImplants During Magnetic Resonance Imaging and Testing and LabelingMedical Devices for Safety in the Magnetic Resonance (MR) Environment,Guidance for Industry and Food and Drug Administration Staff, issued May2021
	4) Evaluation of Microbial Ingress per Intravascular Administration SetsPremarket Notification Submissions [510(k)] Guidance for Industry and FDAStaff, issued July 2008
	5) Usability testing per Applying Human Factors and Usability Engineering toMedical Devices Guidance for Industry and Food and Drug AdministrationStaff, issued February 2016
	Per design control requirements specified in 21 CFR 820.30, the subject devicesmet all predetermined acceptance criteria for the above-listed performance tests,demonstrating substantial equivalence to the predicate devices.
	Clinical studies are not required to demonstrate substantial equivalence to thepredicate device.
Summary ofSubstantialEquivalence	Based on the indications for use, technological characteristics, and results ofperformance testing, the subject device, Nexiva™ Closed IV Catheter System withNearPort™ IV Access has been demonstrated to be substantially equivalent to thepredicate BD Nexiva™ Closed IV Catheter System

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).