BD Nexiva Diffusics Closed IV Catheter System

K170283 · Becton, Dickinson and Company · FOZ · Feb 28, 2017 · General Hospital

Device Facts

• Record ID: K170283
• Device Name: BD Nexiva Diffusics Closed IV Catheter System
• Applicant: Becton, Dickinson and Company
• Product Code: FOZ · General Hospital
• Decision Date: Feb 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

Over-the-needle peripheral IV catheter system; includes radiopaque BD Vialon catheter with side holes for optimized power injection; features integrated extension tubing, needle shield, septum, stabilization platform, and Luer connector. Closed system design contains blood during insertion; septum wipes needle upon withdrawal; passive needle tip protection reduces needlestick risk. BD Instaflash technology provides immediate blood visualization. Used in clinical settings by healthcare providers for vascular access. Output is venous access for fluid/medication delivery or monitoring. Benefits include reduced blood exposure, improved insertion visualization, and compatibility with high-pressure power injectors.

Clinical Evidence

Bench testing only. Performance testing included leak testing after repeated bending cycles and Luer adapter pull force testing. All predetermined acceptance criteria met.

Technological Characteristics

Materials: Stainless steel needle, polyurethane catheter/tubing, TPE wings, copolyester adapter/Luer, polycarbonate hub/shield, acetal clamp. Features: Side holes for flow, integrated extension set, passive needle protection, color-coded gauge sizes (18G-24G). Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for short-term vascular access in any patient population for blood sampling, blood pressure monitoring, or fluid administration, including 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 (K161777)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2017

Becton, Dickinson and Company c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313

Re: K170283

Trade/Device Name: BD NexivaTM Diffusics™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 13, 2017 Received: January 30, 2017

Dear Mr. Mark Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mark Job

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 devicerelated adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K170283

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, 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.

| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td><span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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# 510(k) Summary (21 CFR §807.92)

## BD Nexiva™ Diffusics™ Closed IV Catheter System

| Submitter<br>Information | Submitter Name:<br>Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.<br>9450 South State Street<br>Sandy, UT 84070 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:<br>Email Address:<br>Phone Number:<br>Fax Number<br>Date of Preparation: | Amy Honey<br>Regulatory Affairs Specialist<br>[e-mail]<br>[phone]<br>[phone]<br>January 13, 2017 |
| Subject Device | Trade Name:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System<br>Peripheral Intravascular or IV Catheter<br>21 CFR §880.5200<br>Intravascular Catheter<br>II<br>FOZ<br>General Hospital |
| Predicate<br>Device | Trade Name:<br>510(k) Reference:<br>Common Name:<br>Regulation Number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System<br>K161777<br>Peripheral Intravascular or IV Catheter<br>21 CFR §880.5200<br>Intravascular Catheter<br>II<br>FOZ<br>General Hospital |
| Device<br>Description | BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular<br>catheters. These devices have a radiopaque BD Vialon catheter with side holes<br>located near the tip of the catheter which are designed to optimize power injection<br>procedures. These devices also have a needle, needle shield, septum,<br>stabilization platform, integrated extension tubing, clamp, Luer connector, and vent<br>plug. The Luer connector displays gauge-specific maximum flow rate and the<br>maximum power injector pressure limit setting. The needle and catheter are<br>protected by a needle cover. An end cap with protective cover is provided in the<br>unit package.<br><br>The closed system is designed to keep blood contained within the device<br>throughout the insertion process. The septum is designed to wipe visible blood<br>from the needle surface as the needle is withdrawn from the catheter, further<br>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 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<br>during insertion. The stabilization platform and Luer connector are color coded to<br>indicate catheter gauge size (24 GA [0.7 mm]=Yellow, 22 GA [0.9 mm] =Blue, 20<br>GA [1.1 mm]=Pink, 18 GA [1.3 mm]=Green). | |
| Indications for<br>Use | BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a<br>patient's vascular system for short term use to sample blood, monitor blood<br>pressure, or administer fluids. These devices may be used for any patient<br>population with consideration given to adequacy of vascular anatomy, procedure<br>being performed, fluids being infused, and duration of therapy. These devices are<br>suitable for use with power injectors set to a maximum pressure of 325 psi (2240<br>kPa) when access ports not suitable for use with power injectors are removed. | |
| Technological<br>Characteristics | Technological characteristics of the subject and predicate devices are substantially<br>equivalent with respect to the basic design and materials, and the subject BD<br>Nexiva™ Diffusics™ Closed IV Catheter System achieves its intended use based<br>on the same technology and principles of operation as the predicate BD Nexiva™<br>Diffusics™ Closed IV Cather System. Design modifications have been made to the<br>subject device Luer adapter internal geometry to move the extension tubing / Luer<br>adapter bond location away from the extension tubing bend point. Performance<br>testing conducted to support the design modification are as follows: | |
| | No Leak after Repeated Bending Cycles | |

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- Luer Adapter Pull Force
All pre-determined acceptance criteria were met.

A comparison of the subject and predicate device technological characteristics is provided in the table below.

| Attribute | SUBJECT<br>BD Nexiva™ Diffusics™<br>Closed IV Catheter System | PREDICATE<br>BD Nexiva™ Diffusics™ Closed IV Catheter System<br>(K161777) |
|---------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Same as predicate | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter |
| Indications for<br>Use | Same as predicate | BD Nexiva Diffusics closed IV catheter systems are<br>intended to be inserted into a patient's vascular<br>system for short term use to sample blood, monitor<br>blood pressure, or administer fluids. These devices<br>may be used for any patient population with<br>consideration given to adequacy of vascular<br>anatomy, procedure being performed, fluids being<br>infused, and duration of therapy. These devices are<br>suitable for use with power injectors set to a<br>maximum pressure of 325 psi (2240 kPa) when<br>access ports not suitable for use with power injectors<br>are removed. |
| Fundamental<br>Scientific | Same as predicate | Closed peripheral intravascular catheter systems are<br>designed with an integrated extension set incorporating |

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| Attribute | SUBJECT<br>BD Nexiva™ Diffusics™<br>Closed IV Catheter System | PREDICATE<br>BD Nexiva™ Diffusics™ Closed IV Catheter System<br>(K161777) |
|--------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | | either a single port or Y (dual)-port injection site.<br>Incorporates BD Instaflash technology to assist with<br>flashback visualization.<br>In addition, the catheter tip includes diffuser holes to<br>reduce the velocity of contrast media exiting the catheter<br>tip during CT scans. |
| Primary Device<br>Materials | Same as predicate | Needle:<br>Stainless Steel<br>Catheter:<br>Polyurethane<br>Catheter Wings:<br>TPE<br>Catheter Adapter:<br>Copolyester<br>Needle Hub:<br>Polycarbonate<br>Tip Shield:<br>Polycarbonate<br>Extension Tubing:<br>Polyurethane<br>Luer Adapter:<br>Copolyester<br>Pinch Clamp:<br>Acetal |
| Physical /<br>Mechanical<br>Specifications | Same as predicate | Catheter Diameters<br>18G, 20G, 22G, 24G<br>Catheter Lengths<br>0.75", 1.00", 1.25" |
| Sterility | Same as predicate | Provided sterile (EO) |

| Summary of<br>Performance<br>Tests | Performance tests completed on the subject device were limited to those tests<br>required to support a determination of substantial equivalence to the predicate<br>device. A risk analysis was conducted to assess the impact of the proposed<br>modifications to the subject device, and the performance tests listed below were<br>identified to ensure that specified design requirements were met:<br>No Leak after Repeated Bending Cycles Luer Adapter Pull Force When technological characteristics between the subject and predicate device were<br>found to be identical, results of performance testing conducted on the predicate<br>device were applied to the subject device.<br>Per the design control requirements specified in 21 CFR 820.30, the subject<br>device met all predetermined acceptance criteria for the above-listed performance<br>tests, demonstrating substantial equivalence to the predicate device. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and results of<br>performance testing, the subject BD Nexiva™ Diffusics™ Closed IV Catheter<br>System has been demonstrated to be substantially equivalent to the predicate<br>device. |