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

K233529 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Dec 1, 2023 · General Hospital

Device Facts

• Record ID: K233529
• Device Name: 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: Dec 1, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood or administer fluids. These devices may 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 Story

Over-the-needle peripheral IV catheter system; includes radiopaque BD Vialon™ polyurethane catheter with three side holes for power injection; features integrated extension tubing, clamp, Luer connector, vent plug, and BD MaxZero™ needle-free connector. Used in clinical settings by healthcare providers for vascular access. Device incorporates BD Instaflash™ technology for immediate blood visualization in catheter and extension tubing. Septum wipes blood from needle during withdrawal; needle tip passively protected upon removal to prevent needle stick injuries. Output is vascular access for fluid administration or blood sampling. Benefits include reduced blood exposure risk, improved flashback visualization, and power injection capability.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, including biocompatibility (ISO 10993-1), sterilization residuals (ISO 10993-7), packaging integrity (ISO 11607-1), and catheter performance (ISO 10555-1) such as gravity flow rate and burst pressure. Internal requirements for open flow pressure, power injection peak pressure, and catheter stability were also met.

Technological Characteristics

Over-the-needle catheter; materials: BD Vialon™ polyurethane (catheter), stainless steel (needle), copolyester (adapter), TPE (wings/overmold), polycarbonate (tip shield/hub), acetal (clamp), HDPE (end cap cover). Energy source: user-operated. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Dimensions: 18-24 GA; 0.75-1.75 inch lengths.

Indications for Use

Indicated for short-term vascular access for blood sampling or fluid administration in any patient population, considering vascular anatomy, procedure, fluid type, and therapy duration. Suitable for power injection up to 325 psi.

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)

Submission Summary (Full Text)

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December 1, 2023

Becton Dickinson Infusion Therapy Systems Inc. Sunny Patel Senior Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070

Re: K233529

Trade/Device Name: 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: November 1, 2023 Received: November 2, 2023

Dear Sunny Patel:

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.

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"

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(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 OS 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 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-reportingcombination-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.

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-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 ([e-mail]) or phone [phone] or 301-796-7100).

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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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## Indications for Use

510(k) Number (if known) K233529

Device Name

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

Indications for Use (Describe)

The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood or administer fluids. These devices may 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) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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bd.com

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# K233529- 510(k) Summary

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

| Submitter<br>Information | | | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Submitter Address: | 9450 South State Street, Sandy, Utah 84070 |
| | | | Contact Person: | Sunny Patel, Senior Regulatory Affairs Specialist |
| | | | Email Address: | [e-mail] |
| | | | Phone Number: | [phone] |
| Subject Device | | | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System<br>with BD MaxZero™ Needle-free Connector |
| | | | Common Name: | Peripheral Intravascular or IV Catheter |
| | | | 510(k) Reference: | K233529 |
| | | | 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 |
| Predicate Device | | | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System |
| | | | Common Name: | Peripheral Intravascular or IV Catheter |
| | | | 510(k) Reference: | K173354 |
| | | | 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 |
| Reason for<br>Submission | | | | The purpose of this submission is to introduce the BD Nexiva™ Diffusics™ Closed IV<br>Catheter System with BD MaxZero™ Needle-free Connector. |
| Device<br>Description | BD Nexiva™ Diffusics™ Closed IV Catheter Systems are over-the-needle, intravascular<br>(IV) catheters. These devices have a radiopaque BD Vialon™ catheter material with<br>three side holes located near the tip of the catheter which are designed to optimize power<br>injection procedures. These devices also have a needle, needle shield, septum,<br>stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug.<br>The Luer connector displays gauge specific maximum flow rate and the maximum<br>power injector pressure limit setting. The needle and catheter are protected by a needle<br>cover. An end cap with protective cover is provided in the unit package. A BD<br>MaxZero™ device with protective cover is provided in the unit package. | | | |

### Date: December 1, 2023

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bd.com

| Indications for Use<br>(21 CFR §<br>807.92(a)(5)) | The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into<br>a patient's vascular system for short term use to sample blood or administer fluids. These<br>devices may be used for any patient population with consideration given to adequacy of<br>vascular anatomy, procedure being performed, fluids being infused, and duration of<br>therapy. These devices are suitable for use with power injectors set to a maximum<br>pressure of 325 psi (2240 kPa) when access ports not suitable for use with power<br>injectors are removed. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|
| Technological<br>Characteristics | Technological characteristics of the subject BD Nexiva™ Diffusics™ Closed IV<br>Catheter System with BD MaxZero™ Needle-free Connector are substantially<br>equivalent to predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. The<br>subject device achieves its intended use based on the same technology and principles of<br>operation as the predicate device.<br><br>A comparison of the subject and predicate device technological characteristics is<br>provided in the table below. | | |
| | SUBJECT | PREDICATE (Κ173354) | |
| The closed system is designed to keep blood contained within the device throughout the<br>insertion process. The septum is designed to wipe visible blood from the needle surface<br>as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.<br>The needle tip is passively protected when the needle is removed, reducing the risk of<br>accidental needle stick injury.<br><br>These devices have BD Instaflash™ Needle Technology, allowing for immediate<br>visualization of blood along the catheter. Continuous blood return is seen in the<br>extension tubing. The vent plug prevents blood leakage from the extension tubing during<br>insertion. The stabilization platform and Luer connector are color coded to indicate<br>catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1<br>mm) = Pink, 18 GA (1.3 mm) = Green). | | | |

| Attribute | SUBJECT<br>BD Nexiva™ Diffusics™ Closed IV<br>Catheter System with BD<br>MaxZero™ Needle-free Connector | PREDICATE (K173354)<br>BD Nexiva™ Diffusics™ Closed IV<br>Catheter System | Comparison |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 880.5200<br>Class II<br>FOZ - Intravascular Catheter | 21 CFR 880.5200<br>Class II<br>FOZ - Intravascular Catheter | Same |
| Indications for<br>Use | The BD Nexiva™ Diffusics™ Closed<br>IV Catheter Systems are intended to<br>be inserted into a patient's vascular<br>system for short term use to sample<br>blood or administer fluids. These<br>devices may be used for any patient<br>population with consideration given<br>to adequacy of vascular anatomy,<br>procedure being performed, fluids<br>being infused, and duration of<br>therapy. These devices are suitable<br>for use with power injectors set to a<br>maximum pressure of 325 psi (2240<br>kPa) when access ports not suitable | The BD Nexiva™ Diffusics™ Closed<br>IV Catheter Systems are intended to<br>be inserted into a patient's vascular<br>system for short term use to sample<br>blood, monitor blood pressure, or<br>administer fluids. These devices may<br>be used for any patient population<br>with consideration given to adequacy<br>of vascular anatomy, procedure being<br>performed, fluids being infused, and duration of therapy. These devices are<br>suitable for use with power injectors<br>set to a maximum pressure of 325 psi (2240 kPa) when access ports not | Substantially Equivalent-<br>The subject and predicate<br>devices are both intended<br>to sample blood and<br>administer fluids.<br>The subject device<br>Indications for Use has<br>been narrowed to remove<br>"monitor blood pressure"<br>compared to the predicate<br>device.<br>Narrowing the<br>Indications for Use does<br>not raise any new or |
| Attribute | SUBJECT<br>BD Nexiva™ Diffusics™ Closed IV<br>Catheter System with BD<br>MaxZero™ Needle-free Connector | PREDICATE (K173354)<br>BD Nexiva™ Diffusics™ Closed IV<br>Catheter System | Comparison |
| | for use with power injectors are<br>removed. | suitable for use with power injectors<br>are removed. | different questions of<br>safety or effectiveness. |
| Intended Use | Intravascular access | Intravascular access | Same |
| Fundamental<br>Scientific<br>Technology | Closed peripheral intravascular<br>catheter system are designed with an<br>integrated extension set incorporating<br>a single port injection site.<br>Incorporates BD Instaflash™<br>technology to assist with flashback<br>visualization | Closed peripheral intravascular<br>catheter system are designed with an<br>integrated extension set incorporating<br>a single port injection site.<br>Incorporates BD Instaflash™<br>technology to assist with flashback<br>visualization | Same |
| | Primary Components Material Composition | | |
| ISO 10993-1<br>Biocompatibility<br>Contact Type and<br>Duration | Body Contact: Externally<br>communicating device<br>Contact: Circulating blood<br>Contact Duration: Limited (A)<br>to Prolonged (B) (≤ 24 hrs to<br>30 days) | Body Contact: Externally<br>communicating device<br>Contact: Circulating blood<br>Contact Duration: Limited (A)<br>to Prolonged (B) (≤ 24 hrs to<br>30 days) | Same |
| Needle (Cannula) | Stainless Steel | Stainless Steel | Same |
| Catheter Tubing | BD Vialon™ Polyurethane with<br>Barium Sulfate | BD Vialon™ Polyurethane with<br>Barium Sulfate | Same |
| Catheter Adapter | Copolyester | Copolyester | Same |
| Catheter Adapter<br>Wings | TPE with Gauge-Specific Colorant | TPE with Gauge-Specific Colorant | Same |
| Tip Shield | Polycarbonate with Grey Colorant | Polycarbonate with Grey Colorant | Same |
| Grip/Needle Hub | Polycarbonate with White Colorant | Polycarbonate with White Colorant | Same |
| Pinch Clamp | Acetal with Blue Colorant | Acetal with Blue Colorant | Same |
| Extension Tubing | Biomerics Polyurethane | Biomerics Polyurethane | Same |
| Luer Adapter | Copolyester with Gauge-Specific<br>Colorant | Copolyester with Gauge-Specific<br>Colorant | Same |
| Luer Adapter<br>Overmold | TPE with Blue Colorant and White<br>Print Ink | TPE with Blue Colorant and White<br>Print Ink | Same |
| End Cap | Polypropylene with White Colorant | Polypropylene with White Colorant | Same |
| End Cap<br>Protective Cover | HDPE with Blue Colorant | HDPE with Blue Colorant | Same |
| Vent Plug | Polypropylene and Acrylic-Nylon<br>Membrane | Polypropylene and Acrylic-Nylon<br>Membrane | Same |
| Catheter<br>Dimensions | Catheter Diameters<br>18 GA, 20 GA, 22 GA, 24 GA<br>Catheter Lengths<br>0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Catheter Diameters<br>18 GA, 20 GA, 22 GA, 24 GA<br>Catheter Lengths<br>0.75 IN, 1.00 IN, 1.25 IN | Different-<br>The subject and predicate<br>devices are substantially<br>equivalent. The longer<br>length (1.75 IN) subject<br>device configurations<br>were evaluated using the<br>equivalent test methods<br>as the predicate device. |
| Attribute | SUBJECT<br>BD Nexiva™ Diffusics™ Closed IV<br>Catheter System with BD<br>MaxZero™ Needle-free Connector | PREDICATE (K173354)<br>BD Nexiva™ Diffusics™ Closed IV<br>Catheter System | Comparison |
| | | | This modification did not<br>raise any new or different<br>questions of safety and<br>effectiveness. |
| Product<br>Configurations |…