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(ml/sec)	Max Injector Setting(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

Device Description

The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and Luer adapter are color-coded.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD Nexiva™ Diffusics™ Closed IV Catheter System, based on the provided text:

Important Note: The provided text is a 510(k) summary and FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some of the requested information (like specific sample sizes for training/test sets, data provenance for clinical studies, number/qualifications of experts for ground truth, and MRMC study details) is not present in this type of regulatory document. The responses below reflect what can be extracted from the given text.

Acceptance Criteria and Reported Device Performance

The core of the study described here is to demonstrate that the modified BD Nexiva™ Diffusics™ Closed IV Catheter System meets predetermined requirements, particularly in relation to its maximum flow rate specifications. The provided document doesn't list specific acceptance criteria as distinct quantitative metrics beyond the specified flow rates and pressure.

Acceptance Criteria / Performance Metric	Reported Device Performance
Mechanical Performance (Maximum Flow Rate for Power Injection):
24 GA x 0.75 IN Catheter: Max Flow Rate (ml/sec)	3.0 ml/sec
22 GA x 1.00 IN Catheter: Max Flow Rate (ml/sec)	6.5 ml/sec
20 GA x 1.00 IN Catheter: Max Flow Rate (ml/sec)	10.0 ml/sec
20 GA x 1.25 IN Catheter: Max Flow Rate (ml/sec)	10.0 ml/sec
18 GA x 1.25 IN Catheter: Max Flow Rate (ml/sec)	15.0 ml/sec
Mechanical Performance (Maximum Injector Pressure Setting):
All Catheter Sizes: Max Injector Setting (psi)	325 psi
General Safety and Performance:	Met all predetermined acceptance criteria
Compliance with 21 CFR 820.30 (Design Controls)	Compliant
Compliant with ISO 14971:2009 (Risk Management)	Compliant
Compliant with various ISO and ANSI/AAMI standards (listed in the text)	Compliant
No new questions regarding safety or effectiveness (vs. predicate device)	Demonstrated; substantially equivalent to predicate device

Study Information

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample sizes used for the "design verification and validation" testing.
- Data Provenance: Not specified. As a 510(k) submission, the data is typically generated internally by the manufacturer through laboratory and engineering tests, rather than a multi-center clinical trial with patient data. It is implied to be prospective testing carried out for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. The "testing" primarily involves engineering and performance verification against established standards and internal protocols, not interpretation by medical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No adjudication method is mentioned as the testing is performance-based and objective against specified metrics.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device clearance for an IV catheter, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related effectiveness are not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., ISO, ANSI/AAMI), and internal protocols. For example, the maximum flow rates are determined through physical testing in a laboratory setting, not through expert consensus or clinical outcomes data in the context of this 510(k) summary.
The sample size for the training set:
- Not applicable/Not specified. This is a traditional medical device, and the concept of a "training set" in the context of machine learning or AI is not relevant here. Device design and validation follow a different paradigm (design controls, risk analysis, verification/validation testing).
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary

{0}------------------------------------------------

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

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

SubmitterInformation	Submitter Name:Submitter Address:	Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070
	Contact Person:	Kimberly GeislerStaff Regulatory Affairs Specialistkimberly_geisler@bd.com(801) 565-2422 (phone)(801) 565-2749 (fax)
	Date of Preparation:	December 4, 2012
Subject Device	Trade Name:Common Name:Classification Name:CFR Reference:Classification Panel:	BD Nexiva™ Diffusics™ Closed IV Catheter SystemPeripheral Intravascular Catheter or IV Catheter80 FOZ - Intravascular Catheter21 CFR 880.5200 - Class IIGeneral Hospital
Predicate Device	Trade Name:Common Name:Classification Name:CFR Reference:Classification Panel:Premarket Notification:	BD Nexiva™ Diffusics™ Closed IV Catheter SystemPeripheral Intravascular Catheter or IV Catheter80 FOZ - Intravascular Catheter21 CFR 880.5200 - Class IIGeneral HospitalK111366
DeviceDescription	The BD Nexiva Diffusics device is designed to minimize blood exposure. Itincludes a passive needle-shielding mechanism designed to reduce accidentalneedlestick injury. The closed system is designed to keep blood containedwithin the device throughout the insertion process, which may prevent potentialexposure for clinicians and patients. The system consists of a radiopaqueVialon® material catheter, a notched needle to enhance flashbackvisualization, a septum designed to remove visible blood from the needlesurface that seals after needle removal, a stabiliization platform, extensiontubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge cathetersystems are capable of withstanding high pressure injection procedures. Thestabilization platform and Luer adapter are color-coded.
Indications forUse	The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient'svascular system to sample blood, monitor blood pressure or administer fluids.The BD Nexiva Diffusics catheters are suitable for use with power injectorswhen a direct connection is made.
TechnologicalCharacteristics	Technological characteristics of the subject BD Nexiva™ Diffusics™ ClosedIV Catheter System are equivalent to that of the predicate BD Nexiva™Diffusics™ Closed IV Catheter System with respect to device design andfunction. Differences include modifications to the maximum flow ratespecifications. These differences do not raise any new questions regardingsafety or effectiveness.
Summary ofSafety andPerformanceTests	Pursuant to 21 CFR §820.30, Design Controls, design verification andvalidation of the device modifications were performed according to the riskanalysis in compliance with ISO 14971:2009, Medical devices - Application ofrisk management to medical devices. The following guidance documents andFDA recognized consensus standards, in conjunction with in-house protocols,were used to determine appropriate methods for evaluating the safety andperformance of the device.Guidance on Premarket Notification [510(k)] Submission for Short-Termand Long-Term Intravascular Catheters, March 16, 1995 ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for Syringes,Needles and Certain other Medical Equipment Part 1: GeneralRequirements ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for Syringes,Needles and Certain other Medical Equipment Part 2: Lock Fittings ISO 10555-1:1995 Amd2: 2004, Sterile, single use intravascularcatheters- Part 1: General Requirements ISO 10555-5:1996 (E) Corrigendum 1, Am 1, Sterile, single useintravascular catheters- Part 5: Over-needle peripheral catheters ANSI/AAMI/ISO 10993-1:2009, Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing FDA Blue Book Memorandum #G95-1, Use of International StandardsISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluationand Testing ANSI/AAMI/ISO 10993-7:2008, Biological Evaluation of Medical DevicesPart 7: Ethylene Oxide Sterilization Residuals ANSI/AAMI/ISO 11135-1:2007, International Standard Sterilization ofHealth Care Products-Part 1: Requirements for development, validation,and routine control of a sterilization process for medical devices Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industryand FDA, August 30, 2002 ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials, sterile barrier systems andpackaging systems ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medicaldevices - Part 2: Validation requirements for forming, sealing andassembly processes

{1}------------------------------------------------

Becton Dickinson Infusion Therapy Systems Inc.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):	K123734
Device Proprietary Name:	BD Nexiva™ Diffusics™ Closed IV Catheter System

Indications for Use:

	Max Flow Rate(ml/sec)	Max Injector Setting(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)

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

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).