BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

K250682 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Jun 3, 2025 · General Hospital

Device Facts

• Record ID: K250682
• Device Name: BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jun 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device 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. This device is 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 Story

Over-the-needle peripheral IV catheter system; includes needle, needle shield, septum, stabilization platform, extension tubing, clamp, Luer connector, and vent plug. Features BD Vialon™ polyurethane catheter with three side holes at the tip to optimize power injection by reducing contrast media exit velocity. BD Instaflash™ technology provides immediate blood visualization in the catheter; continuous return visible in extension tubing. Closed system design contains blood during insertion; septum wipes needle upon withdrawal to reduce exposure risk; passive needle protection reduces stick injury. Used in clinical settings by healthcare providers. Luer connector displays gauge-specific flow rates and pressure limits. Supports power injection up to 325 psi. Benefits include reduced blood exposure, improved insertion visualization, and compatibility with high-pressure contrast delivery.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included frequency response, kink resistance, blood fill time, ISO 80369-7 Luer connector testing, and ISO 11607-1/ASTM packaging validation (seal strength, leak detection). All tests met predetermined acceptance criteria.

Technological Characteristics

Peripheral IV catheter; BD Vialon™ polyurethane with barium sulfate. Components: stainless steel needle, polyisoprene septum, polycarbonate/copolyester adapters, TPE wings. Sterilization: Ethylene Oxide (SAL 1x10^-6). Connectivity: None. Dimensions: 18-24 GA; 0.75-1.75 inch lengths. Power injection rated to 325 psi. Complies with ISO 80369-7:2021 for small-bore connectors.

Indications for Use

Indicated for patients requiring peripheral vascular access for short-term blood sampling, blood pressure monitoring, or fluid administration. Suitable for any patient population based on vascular anatomy, procedure, fluid type, and therapy duration.

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™ Diffusics™ Closed IV Catheter System (K173354)
• BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K233529)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 3, 2025

Becton Dickinson Infusion Therapy Systems Inc.
Vantana Krishnakumar
Associate Staff Regulatory Affairs Specialist
9450 South State Street
Sandy, Utah 84070

Re: K250682

Trade/Device Name: BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: March 6, 2025
Received: March 6, 2025

Dear Vantana Krishnakumar:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250682 - Vantana Krishnakumar
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250682 - Vantana Krishnakumar
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250682 | |
| Device Name BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | |
| Indications for Use (Describe) BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with MaxZero™ Needle-free Connector | |
| BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device 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. This device is 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) | |
| 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 [e-mail] | |
| "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." | |

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

B

# K250682 – 510(k) Summary (21 CFR §807.92)

# BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

| Submitter Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
| --- | --- | --- |
| | Submitter Address: | 9450 South State Street, Sandy, Utah 84070 |
| | Contact Person: | Vantana Krishnakumar, Associate Staff Regulatory Affairs Specialist |
| | Email Address: | [e-mail] |
| | Phone Number: | 801-522-5000 |
| | Date of Preparation: | May 08, 2025 |
| Subject Devices | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR 880.5200 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR 880.5200 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |

Page 1 of 13

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

# bd.com

| Predicate Devices | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System |
| --- | --- | --- |
| | 510(k) Reference: | K173354 |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR 880.5200 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| | Note: K173354 serves as the Predicate device for the subject device BD Nexiva™ Diffusics™ Closed IV Catheter System | |
| | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector |
| | 510(k) Reference: | K233529 |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR 880.5200 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| | Note: K233529 serves as the Predicate device for the subject device BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | |

Page 2 of 13

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

# bd.com

| Device Description | BD Nexiva™ Diffusics™ Closed IV Catheter Systems (Nexiva Diffusics) and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Nexiva Diffusics with Max Zero) are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ Catheter Material with three 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. |
| --- | --- |
| A BD MaxZero™ device with protective cover is provided in the unit package for BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector kit. 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 needle stick injury. | |
| These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate 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). | |

Page 3 of 13

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

| Indications for Use
(21 CFR § 807.92(a)(5)) | BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with MaxZero™ Needle-free Connector

BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device 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. This device is 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. |
| --- | --- |
| Purpose of this submission | • Updating the indications for use for the Nexiva Diffusics with Max Zero to include blood pressure monitoring indication.
• Updated packaging for the subject devices Nexiva Diffusics and Nexiva Diffusics with Max Zero.
• Luer lock performance testing per ISO 80369-7:2021.
• Updated performance specifications related to blood pressure monitoring and blood sampling |
| Technological Characteristics | Technological characteristics of the subject devices are substantially equivalent to their predicate device. The subject BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector achieve their intended use based on the same technology and principles of operation as the predicate devices K173354 and K233529, respectively. |

Note: Highlighted blue text indicates differences from the predicate device.

| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV Catheter System | PREDICATE (K173354)
BD Nexiva™ Diffusics™ Closed IV Catheter System | Substantially Equivalent? |
| --- | --- | --- | --- |
| Classification | 21 CFR 880.5200 | 21 CFR 880.5200 | Yes
Same as predicate. |
| | Class II | Class II | |
| | FOZ - Intravascular Catheter | FOZ - Intravascular Catheter | |
| Indications for Use | BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral 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. This device is 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. | BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral 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. This device is 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. | |

Page 4 of 13

{8}

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

| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV Catheter System | PREDICATE (K173354)
BD Nexiva™ Diffusics™ Closed IV Catheter System | Substantially Equivalent? |
| --- | --- | --- | --- |
| | administer fluids. This device 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. This device is 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. | 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. | scope of the intended use of the device.

Additional minor wording changes with no change to the substance, meaning or scope. |
| Fundamental Scientific Technology | Closed peripheral intravascular catheter systems are designed with an integrated extension set incorporating a single port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization.

In addition, the catheter tip includes diffuser holes to reduce the velocity of contrast media exiting the catheter tip during CT scans. | Closed peripheral intravascular catheter systems are designed with an integrated extension set incorporating a single port injection site. Incorporates BD Instaflash technology to assist with flashback visualization.

In addition, the catheter tip includes diffuser holes to reduce the velocity of contrast media exiting the catheter tip during CT scans. | Yes
Added trademark symbol (™) to Instaflash, which has no impact to technological characteristics |
| Catheter Dimensions | Catheter Diameters
18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN | Catheter Diameters
18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN | Yes
Same as predicate |
| Product Configurations | Single Port | Single Port | Yes
Same as predicate |
| Sterilization Modality | Ethylene Oxide | Ethylene Oxide | Yes
Same as predicate. |
| Minimum SAL | 1 x 10^{-6} | 1 x 10^{-6} | Yes
Same as predicate. |

Page 5 of 13

{9}

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

| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | PREDICATE (K233529)
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | Substantially Equivalent? |
| --- | --- | --- | --- |
| Classification | 21 CFR 880.5200
Class II
FOZ - Intravascular Catheter | 21 CFR 880.5200
Class II
FOZ - Intravascular Catheter | Yes
Same as predicate. |
| Indications for Use | BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient’s **peripheral** vascular system for short term use to sample blood, **monitor blood pressure**, or **administer fluids**. **This device** 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. **This device** is 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. | 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 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. | Yes
Addition of ‘monitor blood pressure’ in the Indications for Use as the evidence is established since the last predicate submission. BD Nexiva Diffusics closed IV catheter system and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector have the same materials, intended uses and Indications of use. This addition to the Indications for Use to BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector does not raise any new or different questions of safety or effectiveness as demonstrated by kink resistance and frequency response performance testing.

The word “peripheral” has been added for clarification only with no change to the substance, meaning or scope of the intended use of the device.

Additional minor wording changes with no change to the substance, meaning or scope. |

Page 6 of 13

{10}

Becton Dickinson Infusion Therapy Systems Inc.

9450 South State Street

Sandy, Utah 84070 USA

bd.com

| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed
IV Catheter System with BD
MaxZero™ Needle-free
Connector | PREDICATE (K233529)
BD Nexiva™ Diffusics™ Closed
IV Catheter System with BD
MaxZero™ Needle-free
Connector | Substantially Equivalent? |
| --- | --- | --- | --- |
| Fundamental Scientific Technology | Closed peripheral intravascular catheter systems are designed with an integrated extension set incorporating a single port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization.
In addition, the catheter tip includes diffuser holes to reduce the velocity of contrast media exiting the catheter tip during CT scans. | Closed peripheral intravascular catheter systems are designed with an integrated extension set incorporating a single port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization.
In addition, the catheter tip includes diffuser holes to reduce the velocity of contrast media exiting the catheter tip during CT scans. | Yes
Same as predicate |
| Catheter Dimensions | Catheter Diameters
18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Catheter Diameters
18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Yes
Same as predicate |
| Product Configurations | Single Port with BD MaxZero™ Needle-free Connector | Single Port with BD MaxZero™ Needle-free Connector | Yes
Same as predicate |
| Sterilization Modality | Ethylene Oxide | Ethylene Oxide | Yes
Same as predicate. |
| Minimum SAL | 1 x 10-6 | 1 x 10-6 | Yes
Same as predicate. |

NOTE: Highlighted blue text indicates differences from the predicate device.

| Comparison of Subject / Predicate Sterile Packaging Materials | | | |
| --- | --- | --- | --- |
| Packaging Component | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System | PREDICATE
BD Nexiva™ Diffusics™
Closed IV Catheter System
(K173354) | Substantially Equivalent? |
| Top Web Material | PS 75 Medical paper | PS 75 Medical paper | Yes
Same as predicate |
| Bottom Web Material | PETG 16 mil Copolyester or
PETG [MED-G] 10 mil or 16
mil Copolyester | PETG 16 mil Copolyester or
PETG [MED-G] 16 mil
Copolyester | Yes
A change was made to the
bottom web material
formulation and bottom web
thickness. The results of
performance testing
demonstrate that the subject
device performs as intended. |

{11}

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

bd.com

| Comparison of Subject / Predicate Sterile Packaging Materials | | | |
| --- | --- | --- | --- |
| Packaging Component | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System | PREDICATE
BD Nexiva™ Diffusics™
Closed IV Catheter System
(K173354) | Substantially Equivalent? |
| | | | This change does not raise any new or different questions of safety or effectiveness. |
| Dispenser Box | Cardboard Clay Coated Newsback Linder Board or Solid Bleached Sulfate or
Coated Recycled Board / Coated Kraft Back | Cardboard Clay Coated Newsback Linder Board or Solid Bleached Sulfate | Yes
A change was made to the dispenser box material and thickness.
The results of performance testing demonstrate that the subject device performs as intended.
This change does not raise any new or different questions of safety or effectiveness. |
| Shipper Box | Corrugated (Liner/medium single wall board) | Corrugated (Liner/medium single wall board) | Yes
Same as predicate |
| Printed Top Web Colorant (Fixed / Variable) | Black + Gauge Specific Colorant:
Green
Pink
Blue
Yellow | Black + Gauge Specific Colorant:
Green
Pink
Blue
Yellow | Yes
Same as predicate |
| Comparison of Subject / Predicate Sterile Packaging Materials | | | |
| --- | --- | --- | --- |
| Packaging Component | SUBJECT
BD Nexiva™ Diffusics™ Closed
IV Catheter System with
MaxZero™ | PREDICATE
BD Nexiva™ Diffusics™ Closed
IV Catheter System with
MaxZero™ (K233529) | Substantially Equivalent? |
| Top Web Material | PS 75 Medical paper | PS 75 Medical paper | Yes
Same as predicate |

Page 8 of 13

{12}

Becton Dickinson Infusion Therapy Systems Inc.

9450 South State Street

Sandy, Utah 84070 USA

bd.com

| Comparison of Subject / Predicate Sterile Packaging Materials | | | |
| --- | --- | --- | --- |
| Packaging Component | SUBJECT
BD Nexiva™ Diffusics™ Closed
IV Catheter System with
MaxZero™ | PREDICATE
BD Nexiva™ Diffusics™ Closed
IV Catheter System with
MaxZero™ (K233529) | Substantially Equivalent? |
| Bottom Web Material | PETG 16 mil Copolyester or
PETG [MED-G] 10 mil or 16
mil Copolyester | PETG 16 mil Copolyester or
PETG [MED-G] 16 mil
Copolyester | Yes
A change was made to the
bottom web material
formulation and bottom web
thickness. The results of
performance testing
demonstrate that the subject
device performs as intended.
This change does not raise
any new or different
questions of safety or
effectiveness. |
| Dispenser Box | Cardboard Clay Coated
Newsback Linder Board or
Solid Bleached Sulfate
or
Coated Recycled Board /
Coated Kraft Back | Cardboard Clay Coated
Newsback Linder Board or Solid
Bleached Sulfate | Yes
A change was made to the
dispenser box material and
thickness.
The results of performance
testing demonstrate that the
subject device performs as
intended.
This change does not raise
any new or different
questions of safety or
effectiveness. |
| Shipper Box | Corrugated (Liner/medium
single wall board) | Corrugated (Liner/medium single
wall board) | Yes
Same as predicate |
| Printed Top Web
Colorant (Fixed /
Variable) | Black + Gauge Specific
Colorant:
Green
Pink
Blue
Yellow | Black + Gauge Specific
Colorant:
Green
Pink
Blue
Yellow | Yes
Same as predicate |

Page 9 of 13

{13}

Becton Dickinson Infusion Therapy Systems Inc.

9450 South State Street

Sandy, Utah 84070 USA

bd.com

| Comparison of Subject / Predicate Device Primary Device Component Materials | | | | |
| --- | --- | --- | --- | --- |
| Attribute | Component | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System | PREDICATE
BD Nexiva™ Diffusics™
Closed IV Catheter System
(K173354) | Substantially Equivalent? |
| Materials | Needle Cover | LDPE | LDPE | Yes |
| | Needle (Cannula) | Stainless Steel | Stainless Steel | Yes |
| | Needle Adhesive (Cannula Adhesive) | Acrylated Urethane | Acrylated Urethane | Yes |
| | Needle Lubricant (Cannula Lubricant) | Silicone | Silicone | Yes |
| | Catheter Tubing | BD Vialon™ Polyurethane with Barium Sulfate | BD Vialon™ Polyurethane with Barium Sulfate | Yes |
| | Catheter Lubricant | Silicone | Silicone | Yes |
| | Catheter Tipping Lubricant | Silicone | Silicone | Yes |
| | Catheter Adapter Wings | TPE with Gauge-Specific Colorant | TPE with Gauge-Specific Colorant | Yes |
| | Catheter Adapter | Copolyester | Copolyester | Yes |
| | Wedge | Stainless Steel | Stainless Steel | Yes |
| | Septum Canister | Copolyester with Grey Colorant | Copolyester with Grey Colorant | Yes |
| | Septum | Polyisoprene | Polyisoprene | Yes |
| | V-Clip | Stainless Steel with Parylene Coating | Stainless Steel with Parylene Coating | Yes |
| | Retention Washer | Stainless Steel | Stainless Steel | Yes |
| | Tip Shield | Polycarbonate with Grey Colorant | Polycarbonate with Grey Colorant | Yes |
| | Grip/Needle Hub | Polycarbonate with White Colorant | Polycarbonate with White Colorant | Yes |
| | Pinch Clamp | Acetal with Blue Colorant | Acetal with Blue Colorant | Yes |
| | Extension Tubing | Thermoplastic Polyurethane | Biomerics Polyurethane
NOTE: Biomerics is a supplier and not the type of polymer. This is corrected in the subject device submission with no change to material formulation | Yes |
| | Extension Tubing Adhesive | UV Cured Acrylic | Loctite
NOTE: Loctite is a supplier and not the type of adhesive. This is corrected in the subject device submission with no change to material formulation | Yes |
| | Luer Adapter | Copolyester with Gauge-Specific Colorant | Copolyester with Gauge-Specific Colorant | Yes |
| Luer Adapter Overmold | TPE with Blue Colorant and White Print Ink | TPE with Blue Colorant and White Print Ink | Yes | |

Page 10 of 13

{14}

Becton Dickinson Infusion Therapy Systems Inc.

9450 South State Street

Sandy, Utah 84070 USA

bd.com

| Comparison of Subject / Predicate Device Primary Device Component Materials | | | | |
| --- | --- | --- | --- | --- |
| Attribute | Component | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System | PREDICATE
BD Nexiva™ Diffusics™
Closed IV Catheter System
(K173354) | Substantially Equivalent? |
| | End Cap | Polypropylene with White Colorant | Polypropylene with White Colorant | Yes |
| | End Cap Protective Cover | HDPE with Blue Colorant | HDPE with Blue Colorant | Yes |
| | Vent Plug | Polypropylene and Acrylic-Nylon Membrane | Polypropylene and Acrylic- Nylon Membrane | Yes |
| Comparison of Subject / Predicate Device Primary Device Component Materials | | | | |
| --- | --- | --- | --- | --- |
| Attribute | Component | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System
with MaxZero™ Needle-free
Connector | PREDICATE
BD Nexiva™ Diffusics™
Closed IV Catheter System
with MaxZero™ Needle-free
Connector (K233529) | Substantially Equivalent? |
| Materials | Needle Cover | LDPE | LDPE | Yes |
| | Needle (Cannula) | Stainless Steel | Stainless Steel | Yes |
| | Needle Adhesive (Cannula Adhesive) | Acrylated Urethane | Acrylated Urethane | Yes |
| | Needle Lubricant (Cannula Lubricant) | Silicone | Silicone | Yes |
| | Catheter Tubing | BD Vialon™ Polyurethane
with Barium Sulfate | BD Vialon™ Polyurethane with
Barium Sulfate | Yes |
| | Catheter Lubricant | Silicone | Silicone | Yes |
| | Catheter Tipping Lubricant | Silicone | Silicone | Yes |
| | Catheter Adapter Wings | TPE with Gauge-Specific
Colorant | TPE with Gauge-Specific
Colorant | Yes |
| | Catheter Adapter | Copolyester | Copolyester | Yes |
| | Wedge | Stainless Steel | Stainless Steel | Yes |
| | Septum Canister | Copolyester with Grey Colorant | Copolyester with Grey Colorant | Yes |
| | Septum | Polyisoprene | Polyisoprene | Yes |
| | V-Clip | Stainless Steel with Parylene
Coating | Stainless Steel with Parylene
Coating | Yes |
| | Retention Washer | Stainless Steel | Stainless Steel | Yes |
| | Tip Shield | Polycarbonate with Grey
Colorant | Polycarbonate with Grey Colorant | Yes |
| | Grip/Needle Hub | Polycarbonate with White
Colorant | Polycarbonate with White Colorant | Yes |

Page 11 of 13

{15}

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

bd.com

| Comparison of Subject / Predicate Device Primary Device Component Materials | | | | |
| --- | --- | --- | --- | --- |
| Attribute | Component | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System
with MaxZero™ Needle-free
Connector | PREDICATE
BD Nexiva™ Diffusics™
Closed IV Catheter System
with MaxZero™ Needle-free
Connector (K233529) | Substantially
Equivalent? |
| | Pinch Clamp | Acetal with Blue Colorant | Acetal with Blue Colorant | Yes |
| | Extension Tubing | Thermoplastic Polyurethane | Biomerics Polyurethane
NOTE: Biomerics is a supplier and not the type of polymer. This is corrected in the subject device submission with no change to material formulation | Yes |
| | Extension Tubing Adhesive | UV Cured Acrylic | Loctite
NOTE: Loctite is a supplier and not the type of adhesive. This is corrected in the subject device submission with no change to material formulation | Yes |
| | Luer Adapter | Copolyester with Gauge-Specific
Colorant | Copolyester with Gauge-Specific
Colorant | Yes |
| | Luer Adapter Overmold | TPE with Blue Colorant and
White Print Ink | TPE with Blue Colorant and White
Print Ink | Yes |
| | End Cap | Polypropylene with White
Colorant | Polypropylene with White Colorant | Yes |
| | End Cap Protective
Cover | HDPE with Blue Colorant | HDPE with Blue Colorant | Yes |
| | Vent Plug | Polypropylene and Acrylic-Nylon Membrane | Polypropylene and Acrylic-Nylon
Membrane | Yes |

Page 12 of 13

{16}

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

Summary of Performance Tests

Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed modifications to predicate devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices/representative devices were applied to the subject devices. The performance tests listed below were conducted to ensure that the subject devices meet specified design requirements per BD internal requirements and standards as applicable:

BD Internal Requirements Testing:
- Frequency Response Testing
- Kink Resistance Testing
- Blood Fill Time Testing

Compliance with Standards Testing:
ISO 80369-7 Testing
- ISO 80369-7 Second edition 2021-05; Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

Packaging Testing
- ISO 11607-1 Second edition 2019-02 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems
- ASTM F2096-11 (Reapproved 2019) - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F88/F88M-15 - Standard Test Method for Seal Strength of Flexible Barrier Materials

Per the design control requirements specified in 21 CFR §820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.

Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Nexiva™ Diffusics™ Closed IV Catheter System has been demonstrated to be substantially equivalent to the predicate device, K173354 and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector has been demonstrated to be substantially equivalent to the predicate device, K233529.

Page 13 of 13