BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM

K123734 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Jan 17, 2013 · General Hospital

Device Facts

• Record ID: K123734
• Device Name: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jan 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

Device Story

BD Nexiva Diffusics is a closed peripheral IV catheter system designed to minimize blood exposure and accidental needlestick injuries. System components include a radiopaque Vialon catheter, notched needle for flashback visualization, septum for blood containment, stabilization platform, extension tubing, clamp, vent plug, and Luer connector. Used by clinicians in clinical settings for vascular access. The device facilitates fluid administration, blood sampling, and pressure monitoring. It supports high-pressure power injection procedures. Clinicians operate the device to establish access; the closed design reduces contamination risk during insertion and needle removal. The stabilization platform secures the catheter, while the extension tubing allows for fluid delivery. Benefits include reduced clinician exposure to blood and enhanced safety via passive needle shielding.

Clinical Evidence

Bench testing only. Performance validated per ISO 10555-1 and ISO 10555-5 standards, including flow rate verification, Luer fitting integrity (ISO 594-1/2), and sterilization validation (ISO 11135-1). No clinical data presented.

Technological Characteristics

Peripheral IV catheter system; materials include radiopaque Vialon. Features passive needle-shielding, septum-based blood containment, and stabilization platform. Connectivity: Luer-lock compatible. Sterilization: Ethylene Oxide. Standards: ISO 594-1/2, ISO 10555-1/5, ISO 10993-1/7, ISO 11135-1, ISO 11607-1/2.

Indications for Use

Indicated for patients requiring vascular access for blood sampling, blood pressure monitoring, or fluid administration. Suitable for use with power injectors for contrast media delivery. No specific age or gender contraindications provided.

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 (K111366)

Submission Summary (Full Text)

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K12373ष

#### BD Medical

9450 Soulh State Street Sandy, Utah 84070 - 301
United Statea of America
Nel: 801 5685.2300
fex: 801.5685.2300
www.bd.com

BD

JAN 1 7 2013 .

Helping all people live healthy lives

## 510(k) Summary

### 21 CFR §807.92(c)

# 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: | Kimberly Geisler<br>Staff Regulatory Affairs Specialist<br>[e-mail]<br>[phone] (phone)<br>[phone] (fax) |
| | Date of Preparation: | December 4, 2012 |
| Subject Device | Trade Name:<br>Common Name:<br>Classification Name:<br>CFR Reference:<br>Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System<br>Peripheral Intravascular Catheter or IV Catheter<br>80 FOZ - Intravascular Catheter<br>21 CFR 880.5200 - Class II<br>General Hospital |
| Predicate Device | Trade Name:<br>Common Name:<br>Classification Name:<br>CFR Reference:<br>Classification Panel:<br>Premarket Notification: | BD Nexiva™ Diffusics™ Closed IV Catheter System<br>Peripheral Intravascular Catheter or IV Catheter<br>80 FOZ - Intravascular Catheter<br>21 CFR 880.5200 - Class II<br>General Hospital<br>K111366 |
| Device<br>Description | The BD Nexiva Diffusics device is designed to minimize blood exposure. It<br>includes a passive needle-shielding mechanism designed to reduce accidental<br>needlestick injury. The closed system is designed to keep blood contained<br>within the device throughout the insertion process, which may prevent potential<br>exposure for clinicians and patients. The system consists of a radiopaque<br>Vialon® material catheter, a notched needle to enhance flashback<br>visualization, a septum designed to remove visible blood from the needle<br>surface that seals after needle removal, a stabiliization platform, extension<br>tubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge catheter<br>systems are capable of withstanding high pressure injection procedures. The<br>stabilization platform and Luer adapter are color-coded. | |
| Indications for<br>Use | The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's<br>vascular system to sample blood, monitor blood pressure or administer fluids.<br>The BD Nexiva Diffusics catheters are suitable for use with power injectors<br>when a direct connection is made. | |
| Technological<br>Characteristics | Technological characteristics of the subject BD Nexiva™ Diffusics™ Closed<br>IV Catheter System are equivalent to that of the predicate BD Nexiva™<br>Diffusics™ Closed IV Catheter System with respect to device design and<br>function. Differences include modifications to the maximum flow rate<br>specifications. These differences do not raise any new questions regarding<br>safety or effectiveness. | |
| Summary of<br>Safety and<br>Performance<br>Tests | Pursuant to 21 CFR §820.30, Design Controls, design verification and<br>validation of the device modifications were performed according to the risk<br>analysis in compliance with ISO 14971:2009, Medical devices - Application of<br>risk management to medical devices. The following guidance documents and<br>FDA recognized consensus standards, in conjunction with in-house protocols,<br>were used to determine appropriate methods for evaluating the safety and<br>performance of the device.<br>Guidance on Premarket Notification [510(k)] Submission for Short-Term<br>and Long-Term Intravascular Catheters, March 16, 1995 ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for Syringes,<br>Needles and Certain other Medical Equipment Part 1: General<br>Requirements ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for Syringes,<br>Needles and Certain other Medical Equipment Part 2: Lock Fittings ISO 10555-1:1995 Amd2: 2004, Sterile, single use intravascular<br>catheters- Part 1: General Requirements ISO 10555-5:1996 (E) Corrigendum 1, Am 1, Sterile, single use<br>intravascular catheters- Part 5: Over-needle peripheral catheters ANSI/AAMI/ISO 10993-1:2009, Biological Evaluation of Medical Devices<br>Part 1: Evaluation and Testing FDA Blue Book Memorandum #G95-1, Use of International Standards<br>ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation<br>and Testing ANSI/AAMI/ISO 10993-7:2008, Biological Evaluation of Medical Devices<br>Part 7: Ethylene Oxide Sterilization Residuals ANSI/AAMI/ISO 11135-1:2007, International Standard Sterilization of<br>Health Care Products-Part 1: Requirements for development, validation,<br>and routine control of a sterilization process for medical devices Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry<br>and FDA, August 30, 2002 ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical<br>devices - Part 1: Requirements for materials, sterile barrier systems and<br>packaging systems ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medical<br>devices - Part 2: Validation requirements for forming, sealing and<br>assembly processes | |

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Becton Dickinson Infusion Therapy Systems Inc.

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Results of safety and performance testing demonstrated that the subject device met all predetermined acceptance criteria.

Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and safety and performance testing, the subject BD Nexiva™ Diffusics™ Closed IV Calheter System meets the predetemined requirements under 21 CFR 820.30, Design Controls, and demonstrates that the subject device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

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

March 26, 2013

Ms. Kimberly Geisler Staff Regulatory Affairs Specialist Becton, Dickinson and Company 9450 South State Street Sandy, UT 84070

Re: K123734

Trade/Device Name: BD Nexiva™ Diffusics™ Closed IV Catheter System Regulation Number: 21CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 4, 2013 Received: December 5, 2013

Dear Ms. Geisler:

This letter corrects our substantially equivalent letter of January 17, 2013.

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 (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.

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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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Janth 1 2013 03 Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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): | K123734 |
|---------------------------|-------------------------------------------------|
| Device Proprietary Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System |

Indications for Use:

The BD Noxiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to mo be Norte - binonice of administer fluids. The BD Nextra Diffusics catheters are suitable for use with power injectors when a direct connection is made. The maximum flow rate and maximum power injector pressure setting for each catheter size are listed in the table below:

| | Max Flow Rate<br>(ml/sec) | Max Injector Setting<br>(psi) |
|-----------------|---------------------------|-------------------------------|
| 24 GA x 0.75 IN | 3.0 | 325 |
| 22 GA x 1.00 IN | 6.5 | 325 |
| 20 GA x 1.00 IN | 10.0 | 325 |
| 20 GA x 1.25 IN | 10.0 | 325 |
| 18 GA x 1.25 IN | 15.0 | 325 |

Prescription Use V (Part 21 CFR 5801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 8801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Richard C. Chapman 2013.03.26 12:02:51 -04/00

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

432