BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

Device Description

BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device

AI/ML Overview

This document is a 510(k) summary for the BD Nexiva Diffusics Closed IV Catheter System (K173354). It describes a modification to an existing device (predicate device K170283), specifically a change in the extension tubing polyurethane material formulation and manufacturer. The submission aims to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Attribute	Acceptance Criteria (Implicit from "met all predetermined acceptance criteria")	Reported Device Performance
Performance Testing	No Leak after Repeated Bending Cycles	No leaks after specified bending cycles.	Met predetermined acceptance criteria.
	Extension Set Pull Force	Withstand specified pull force without failure.	Met predetermined acceptance criteria.
	Extension Tube Yield / Rupture Pressure	Withstand specified pressure without yield or rupture.	Met predetermined acceptance criteria.
	Pinch Clamp Vacuum Occlusion	Achieve specified occlusion under vacuum conditions.	Met predetermined acceptance criteria.
	Pinch Clamp Engagement Force	Engage with specified force.	Met predetermined acceptance criteria.
Biocompatibility Testing (per ISO 10993-1:2009)	Cytotoxicity	Non-cytotoxic.	Met predetermined acceptance criteria.
	Sensitization	Non-sensitizing.	Met predetermined acceptance criteria.
	Intracutaneous Reactivity	Non-reactive intracutaneously.	Met predetermined acceptance criteria.
	Systemic Toxicity (Acute)	Non-systemically toxic in acute exposure.	Met predetermined acceptance criteria.
	Material-Mediated Pyrogenicity	Non-pyrogenic.	Met predetermined acceptance criteria.
	Subchronic Toxicity (subacute toxicity)	Non-toxic in subchronic exposure.	Met predetermined acceptance criteria.
	Haemocompatibility	Compatible with blood.	Met predetermined acceptance criteria.
Material/Physical Properties	Particulate Analysis (surface and fluid path)	Meet clinically relevant limits per USP <788>.	Met predetermined acceptance criteria.

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

The document does not explicitly state the numerical sample sizes for each test. It broadly mentions "Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate Tests devices." It also states, "When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device."

Sample size: Not explicitly stated. The tests are industrial-standard tests for medical device components.
Data provenance: Not explicitly stated, though it implicitly refers to "design verification" and "risk analysis" conducted by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc. The testing results are presented as having met internal, pre-determined criteria. Given the nature of a 510(k) submission for a material change, the testing would be prospective for the modified component.

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

This information is not applicable to this type of device and submission. The tests are physical, chemical, and biological performance tests for a medical device, not clinical studies requiring expert interpretation of outcomes. The "ground truth" is defined by the technical specifications and standards (e.g., ISO 10993-1, USP <788>) that the device must meet.

4. Adjudication Method for the Test Set

This information is not applicable. The nature of the tests (e.g., measuring pull force, pressure, or biological response) does not involve adjudication by human readers or experts in the sense of clinical image interpretation or diagnostics. The results are objective measurements compared against pre-defined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a Class II medical device (intravascular catheter) involving a material change. MRMC studies are typically associated with diagnostic imaging devices where human interpretation is a key component of the clinical workflow.

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

No, a standalone performance study was not done. This device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is derived from engineering specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility, USP <788> for particulate analysis), and internal design requirements developed by BD according to 21 CFR 820.30 Design Controls. These objective criteria define what constitutes acceptable performance for the device and its material components.

8. The Sample Size for the Training Set

This information is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this device.

Summary

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March 6, 2018

Becton Dickinson Infusion Therapy Systems, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K173354

Trade/Device Name: BD Nexiya Diffusics Closed IV Catheter Systems Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: October 23, 2017 Received: October 25, 2017

Dear Mark Job:

This letter corrects our substantially equivalent letter of December 15, 2017.

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 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.

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

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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.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173354

Device Name BD Nexiva™ Diffusics™ Closed IV Catheter System

Indications for Use (Describe)

BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's vascular system for short term use to sample blood pressure, or administer fluids. 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

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)

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K173354

510(k) Summary

21 CFR §807.92

BD Nexiva™ Diffusics™ Closed IV Catheter System

SubmitterInformation	Submitter Name:	Becton Dickinson Infusion Therapy Systems Inc.
	Submitter Address:	9450 South State StreetSandy, UT 84070
	Contact Person:	Henry BolandStaff Regulatory Affairs Specialisthenry.boland@bd.com(801) 565-2550
	Date of Preparation:	November 17, 2017
Subject Device	Trade Name:	BD Nexiva™ Diffusics™ Closed IV Catheter System
	Common Name:	Peripheral Intravascular or IV Catheter
	Regulation Number:	21 CFR §880.5200
	Regulation Name:	Intravascular Catheter
	Regulatory Class:	II
	Product Code:	FOZ
	Classification Panel:	General Hospital
PredicateDevice	Trade Name:	BD Nexiva™ Diffusics™ Closed IV Catheter System
	510(k) Reference:	K170283
	Common Name:	Peripheral Intravascular or IV Catheter
	Regulation Number:	21 CFR §880.5200
	Regulation Name:	Intravascular Catheter
	Regulatory Class:	II
	Product Code:	FOZ
	Classification Panel:	General Hospital
Reason forSubmission	The reason for this submission is to notify CDRH of a modification to the BDNexiva™ Diffusics™ Closed IV Catheter System. The modification is a change toextension tubing polyurethane material formulation and manufacturer.
DeviceDescription	BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascularcatheters. These devices have a radiopaque BD Vialon catheter with side holeslocated near the tip of the catheter which are designed to optimize power injectionprocedures. These devices also have a needle, needle shield, septum,stabilization platform, integrated extension tubing, clamp, Luer connector, and ventplug. The Luer connector displays gauge-specific maximum flow rate and themaximum power injector pressure limit setting. The needle and catheter areprotected by a needle cover. An end cap with protective cover is provided in theunit package.The closed system is designed to keep blood contained within the device

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Indications forUse(21 CFR§807.92(a)(5))	The subject device Indications for Use is the same as the predicate BD Nexiva™Diffusics™ Closed IV Catheter System (K170283).
	SUBJECT DEVICE	PREDICATE DEVICE(K170283)
	BD Nexiva Diffusics closed IV cathetersystems are intended to be inserted intoa patient's vascular system for shortterm use to sample blood, monitorblood pressure, or administer fluids.These devices may be used for anypatient population with considerationgiven to adequacy of vascular anatomy,procedure being performed, fluids beinginfused, and duration of therapy. Thesedevices are suitable for use with powerinjectors set to a maximum pressure of325 psi (2240 kPa) when access portsnot suitable for use with power injectorsare removed.	BD Nexiva Diffusics closed IV cathetersystems are intended to be inserted intoa patient's vascular system for shortterm use to sample blood, monitorblood pressure, or administer fluids.These devices may be used for anypatient population with considerationgiven to adequacy of vascular anatomy,procedure being performed, fluids beinginfused, and duration of therapy. Thesedevices are suitable for use with powerinjectors set to a maximum pressure of325 psi (2240 kPa) when access portsnot suitable for use with power injectorsare removed.
TechnologicalCharacteristics	Technological characteristics of the subject device are substantially equivalent tothe predicate device. The subject BD Nexiva™ Diffusics™ Closed IV CatheterSystem achieves its intended use based on the same technology and principles ofoperation as the predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. Thesubject device has been modified from the predicate device as listed below. Theresults of design verification demonstrate that these changes are substantiallyequivalent to the predicate device. All other aspects of the subject device areidentical to those of the predicate device.• Change to Extension Tubing polyurethane material formulation andmanufacturer
Attribute	SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter System	PREDICATEBD Nexiva™ Diffusics™ Closed IVCatheter System
	Catheter System	Catheter System (RT76265)
Design	A winged, power injectable, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with	A winged, power injectable, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with

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Attribute	SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter System		PREDICATEBD Nexiva™ Diffusics™ Closed IVCatheter System (K170283)
	flashback visualization.		flashback visualization.
	Component	SUBJECT DEVICE	PREDICATE DEVICE(K170283)
	Needle Cover	LDPE	LDPE
	Needle	Stainless Steel	Stainless Steel
	Needle Adhesive	Acrylated Urethane	Acrylated Urethane
	Needle Lubricant	Silicone	Silicone
Materials	Catheter Tubing	BD Vialon™ Polyurethanewith Barium Sulfate	BD Vialon™ Polyurethanewith Barium Sulfate
	Catheter Lubricant	Silicone	Silicone
	Catheter Tipping Lubricant	Silicone	Silicone
	Catheter Adapter Wings	TPE with gauge-specificcolorant	TPE with gauge-specificcolorant
	Catheter Adapter	Copolyester	Copolyester
	Wedge	Stainless steel	Stainless steel
	Septum Canister	Copolyester with greycolorant	Copolyester with greycolorant
	Septum	Polyisoprene	Polyisoprene
	V-Clip	Stainless steel with parylenecoating	Stainless steel with parylenecoating
	Retention Washer	Stainless steel	Stainless steel
	Tip Shield	Polycarbonate with greycolorant	Polycarbonate with greycolorant
	Grip/Needle Hub	Polycarbonate with whitecolorant	Polycarbonate with whitecolorant
	Pinch Clamp	Acetal with blue colorant	Acetal with blue colorant
	Extension Tubing	Polyurethane	Polyurethane
	Extension Tubing Adhesive	Acrylic	Acrylic
	Luer Adapter	Copolyester with gauge -specific colorantWhite print ink	Copolyester with gauge -specific colorantWhite print ink
	Luer Adapter Overmold	TPE with blue colorant	TPE with blue colorant
	End Cap	Polypropylene with whitecolorant	Polypropylene with whitecolorant
	End Cap Protective Cover	HDPE with blue colorant	HDPE with blue colorant
	Vent Plug	Polypropylene and acrylic-nylon membrane	Polypropylene and acrylic-nylon membrane

Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate Tests devices. A risk analysis was conducted to assess the impact of the proposed

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modifications to the subject devices. When technological characteristics between the subiect and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that specified design requirements were met:

No Leak after Repeated Bending Cycles ●
Extension Set Pull Force .
Extension Tube Yield / Rupture Pressure ●
Pinch Clamp Vacuum Occlusion
Pinch Clamp Engagement Force .

In addition, the following biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.

Cytotoxicity
Sensitization ●
Intracutaneous Reactivity ●
Systemic Toxicity (Acute) ●
Material-Mediated Pyrogenicity ●
Subchronic Toxicity (subacute toxicity) ●
Haemocompatibility ●

Finally, particulate analysis of the surface and fluid path was conducted, upon the guidance of USP <788>, as clinically relevant.

The subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.

Summary of Based on the indications for use, technological characteristics, and performance Substantial testing, the subject BD Nexiva™ Diffusics™ Closed IV Catheter System meets the Equivalence same pre-determined requirements as the predicate device, which BD developed as required by 21 CFR 820.30 Design Controls. The testing confirms that the subject device is substantially equivalent to the predicate BD Nexiva™ Diffusics™ 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).