(61 days)
BD Nexiva 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 catheters 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. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 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, 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.
BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, vent plug and, with dual port configurations, a pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. For dual port configurations, a BD Q-Syte device or an end cap with protective cover is provided in the unit package. 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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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 needlestick 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. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter with 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. 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 needlestick 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 (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green).
The document describes the BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems and their substantial equivalence to predicate devices, based on performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Air Leakage | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Liquid Leakage | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Fluid Leakage at Venous Pressure | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Septum Assembly Failure / Separation at Max Pressure | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Cannula / Hub Bond Strength | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Strength of Union between Needle Hub and Needle Tube | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| Force to Remove Needle from Catheter System (Average System Drag) | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
| System Drag - Peak Offset Force | Pre-determined acceptance criteria (specific values not detailed in the provided text) | All pre-determined acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each performance test. It notes that "Performance testing performed to support the design modifications included" a list of tests. The data provenance is industrial, conducted by the manufacturer (Becton Dickinson Infusion Therapy Systems Inc.) for regulatory submission to the FDA. The tests are prospective in nature, assessing the physical and mechanical characteristics of the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This section is not applicable. The device is a physical medical device (intravascular catheter system), and its performance is evaluated based on objective physical and mechanical tests, not through human interpretation or expert ground truth establishment for a test set in the same way an AI algorithm for image analysis would be.
4. Adjudication method for the test set:
This section is not applicable for the reasons outlined in point 3. Performance is determined by meeting pre-determined objective criteria in physical tests.
5. 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:
This section is not applicable. The device is not an AI-assisted diagnostic tool or an algorithm that human readers would use. It is a medical device for vascular access.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable for the reasons outlined in point 5.
7. The type of ground truth used:
The "ground truth" for the performance tests are the objective engineering and regulatory standards and specifications for the physical and mechanical properties of intravascular catheter systems. These are not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML model, so there is no "training set" or ground truth establishment for it.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The graphic is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
Becton Dickinson Infusion Therapy Systems Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313
Re: K161777
Trade/Device Name: BD Nexiva™ and BD Nexiva™ Diffusics™ Closed IV Catheter Systems Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II, Product Code: FOZ Dated: August 12, 2016 Received: August 16, 2016
Dear Mr. 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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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 vou 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D Acting Division Director Science and Policy 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| 510(k) Number ( if known ) | |
| Device Name | BD Nexiva Closed IV Catheter System |
| Indications for Use (Describe) | BD Nexiva closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use tosample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population withconsideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration oftherapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300psi (2068 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
PRAStaff@fda.hhs.gov
"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."
FORM FDA 3881 (8/14) Page 1 of 1
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | |
|---|---|
| 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) | |
|---|---|
| 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
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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bd.com
Image /page/4/Picture/2 description: The image shows the BD logo. On the left is an orange circle with a white star-like shape inside. To the right of the circle are the letters "BD" in blue. The letters are large and bold.
510(k) Summary (21 CFR §807.92)
BD Nexiva™ and BD Nexiva™ Diffusics™ Closed IV Catheter Systems
| SubmitterInformation | Submitter Name:Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070 | DeviceDescription( BD Nexiva ) | BD Nexiva closed IV catheter systems are over-the-needle, intravascularcatheters. These devices have a radiopaque BD Vialon™ catheter, needle, needleshield, septum, stabilization platform, integrated extension tubing, clamp, Lueradapter, vent plug and, with dual port configurations, a pre-attached BD Q-SyteLuer Access Split Septum. The needle and catheter are protected by a needlecover. For dual port configurations, a BD Q-Syte device or an end cap withprotective cover is provided in the unit package. |
|---|---|---|---|---|
| Contact Person: | Kimberly GeislerStaff Regulatory Affairs Specialistkimberly.geisler@bd.com(801) 565-2422 (phone) | The closed system is designed to keep blood contained within the devicethroughout the insertion process. The septum is designed to wipe visible bloodfrom the needle surface as the needle is withdrawn from the catheter, furtherreducing the risk of blood exposure. The needle tip is passively protected whenthe needle is removed, reducing the risk of accidental needlestick injury. | ||
| Date of Preparation: | July 28, 2016 | These devices have BD Instaflash™ Needle Technology, allowing for immediatevisualization of blood along the catheter. Continuous blood return is seen in theextension tubing. The vent plug prevents blood leakage from the extension tubingduring insertion. Both the stabilization platform and Luer connector are color codedto indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue,20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). | ||
| Subject Device(BD Nexiva) | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Closed IV Catheter SystemPeripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital | DeviceDescription( BD NexivaDiffusics ) | BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascularcatheters. These devices have a radiopaque BD Vialon™ catheter with side holeslocated near the tip of the catheter which are designed to optimize power injectionprocedures. These devices also have a needle, needle shield, septum,stabilization platform, integrated extension tubing, clamp, Luer connector, and ventplug. The Luer connector displays gauge-specific maximum flow rate and themaximum power injector pressure limit setting. The needle and catheter areprotected by a needle cover. An end cap with protective cover is provided in theunit package. |
| PredicateDevice(BD Nexiva) | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Closed IV Catheter SystemK102520Peripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital | The closed system is designed to keep blood contained within the devicethroughout the insertion process. The septum is designed to wipe visible bloodfrom the needle surface as the needle is withdrawn from the catheter, furtherreducing the risk of blood exposure. The needle tip is passively protected whenthe needle is removed, reducing the risk of accidental needlestick injury. | |
| Subject Device(BD NexivaDiffusics) | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter SystemPeripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital | These devices have BD Instaflash™ Needle Technology, allowing for immediatevisualization of blood along the catheter. Continuous blood return is seen in theextension tubing. The vent plug prevents blood leakage from the extension tubingduring insertion. The stabilization platform and Luer connector are color coded toindicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA(1.1 mm)=Pink, 18GA (1.3 mm)=Green). | |
| PredicateDevice(BD NexivaDiffusics) | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter SystemK123734Peripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital |
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| Indications forUse(BD Nexiva) | Modifications were made to the Indications for Use for the purpose of aligning theIndications for Use across the BD Nexiva family of products and for clarification.Modifications include: 1) removal of the regulation reference as it is not relevant tothe healthcare practitioner; 2) removal of device features and performanceinformation which does not determine intended use; 3) removal of "less than 30days" since this statutory regulation language for 21 CFR §880.5200 regarding thedevice classification could be confusing to end users as the duration of use isdependent on a number of factors, including patient status, duration of treatment,and institutional protocol; 4) addition of "fluids being infused" and "duration oftherapy" as considerations for clinicians to evaluate prior to use of these cathetersfor a particular patient; and 5) minor wording changes. |
|---|---|
| --------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
None of these changes are critical to the intended use and do not raise new questions of safety and effectiveness of the devices when used as indicated.
| SUBJECT | PREDICATE (K102520) |
|---|---|
| BD Nexiva™ Closed IV Catheter System | BD Nexiva™ Closed IV Catheter System |
| Indications for Use | Indications for Use |
| BD Nexiva 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 catheters 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. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | As indicated in 21 CFR Part 880.5200, The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The 18-22 gauge Nexiva™ catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made. |
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| bd.com | |
|---|---|
| Indications forUse(BD NexivaDiffusics) | Modifications were made to the Indications for Use for the purpose of aligning theIndications for Use across the BD Nexiva family of products and for clarification.Modifications include: 1) addition of "short term use" in alignment with the deviceclassification; 2) addition of the intended patient population, which is consistentwith the predicate device, which does not indicate a specific patient populationand is intended for general use; 3) removal of the flow rate information as itpertains to device performance and does not determine intended use (Note: flowrate information is provided in the Instructions for Use); and 4) minor wordingchanges. None of these changes are critical to the intended use and do not raisenew questions of safety and effectiveness of the devices when used as indicated. | |||
|---|---|---|---|---|
| SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter SystemIndications for Use | PREDICATE (K123734)BD Nexiva™ Diffusics™ Closed IVCatheter SystemIndications for Use | |||
| BD Nexiva Diffusics closed IV cathetersystems are intended to be inserted into apatient's vascular system for short term useto sample blood, monitor blood pressure, oradminister fluids. These devices may beused for any patient population withconsideration given to adequacy of vascularanatomy, procedure being performed, fluidsbeing infused, and duration of therapy.These devices are suitable for use withpower injectors set to a maximum pressureof 325 psi (2240 kPa) when access ports notsuitable for use with power injectors areremoved. | The BD Nexiva™ Diffusics™ intravascularcatheter is inserted into a patient'svascular system to sample blood, monitorblood pressure or administer fluids. TheBD Nexiva Diffusics catheters are suitablefor use with power injectors when a directconnection is made. The maximum flowrate and maximum power injector pressuresetting for each catheter size are listed inthe 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 | ||
| TechnologicalCharacteristics | Technological characteristics of the subject and predicate devices are equivalent.The subject BD Nexiva™ and BD Nexiva™ Diffusics™ Closed IV CatheterSystems achieve their intended use based on the same technology and principlesof operation as the predicate BD Nexiva™ and BD Nexiva™ Diffusics™ Closed IVCather Systems, respectively. Design modifications were made to the subjectdevices to reduce the force required to withdraw the needle from the catheterassembly. Performance testing performed to support the design modificationsincluded:• Air Leakage• Liquid Leakage• Fluid Leakage at Venous Pressure• Septum Assembly Failure / Separation at Max Pressure• Cannula / Hub Bond Strength• Strength of Union between Needle Hub and Needle Tube• Force to Remove Needle from Catheter System (Average System Drag)• System Drag - Peak Offset ForceAll of the pre-determined acceptance criteria were met. |
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| Attribute | SUBJECTBD Nexiva™ Closed IV Catheter System | PREDICATE (K102520)BD Nexiva™ Closed IV Catheter System |
|---|---|---|
| Classification | Same as predicate | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter |
| FundamentalScientificTechnology | Same as predicate | Closed peripheral intravascular cathetersystem designed with an integrated extensionset incorporating either a single port or Y(dual)-port injection site. Incorporates BDInstaflash™ technology to assist withflashback visualization. |
| Components /Materials | Septum Canister:Copolyester + greycolorant* | Septum Canister:Copolyester + whitecolorant |
| All other subject component materials are the same as the predicate device | ||
| Physical /MechanicalSpecifications | Same as predicate | Catheter DiametersCatheter Lengths18G, 20G, 22G, 24G0.56", 0.75", 1.00",1.25", 1.75" |
*The subject BD Nexiva™ Closed IV Catheter System and subject BD Nexiva™ Diffusics™ Closed IV Catheter System septum canister materials are identical. As such, the Nexiva™ Closed IV Catheter System (K123734) serves as the reference device supporting this modification to the BD Nexiva™ Closed IV Catheter System non-patient contacting septum canister material.
| Attribute | SUBJECTBD Nexiva™ Diffusics™ Closed IVCatheter System | PREDICATE (K123734)BD Nexiva™ Diffusics™ Closed IV CatheterSystem |
|---|---|---|
| Classification | Same as predicate | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter |
| FundamentalScientificTechnology | Same as predicate | Closed peripheral intravascular cathetersystem designed with an integrated extensionset incorporating either a single port or Y(dual)-port injection site. Incorporates BDInstaflash™ technology to assist withflashback visualization.In addition, the catheter tip includes diffuserholes to reduce the velocity of contrast mediaexiting the catheter tip during CT scans. |
| Components /Materials | Septum Canister: Copolyester + greycolorant (modifiedresin to colorant ratiocompared to predicate)Septum: Polyisoprene (nolubricant) | Septum Canister: Copolyester + greycolorantSeptum: Polyisoprene + SiliconeLubricant |
| All other subject component materials are the same as the predicate device | ||
| Physical /MechanicalSpecifications | Same as predicate | Catheter Diameters Catheter Lengths18G, 20G, 22G, 24G 0.75", 1.00", 1.25" |
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| Summary ofPerformanceTests | The following performance testing was performed to demonstrate substantialequivalence of the subject BD NexivaTM and BD NexivaTM DiffusicsTM Closed IVCatheter Systems to the predicate BD NexivaTM Closed IV Catheter System(K102520) and BD NexivaTM DiffusicsTM Closed IV Catheter System (K123734),respectively, and applicable standards: |
|---|---|
| Air Leakage Liquid Leakage Fluid Leakage at Venous Pressure Septum Assembly Failure / Separation at Max Pressure Cannula / Hub Bond Strength Strength of Union between Needle Hub and Needle Tube Force to Remove Needle from Catheter System (Average System Drag) System Drag - Peak Offset Force All of the pre-determined acceptance criteria were met. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and performancetesting, the subject BD NexivaTM Closed IV Catheter System and BD NexivaTMDiffusicsTM Closed IV Catheter System are demonstrated to be substantiallyequivalent to the predicate BD NexivaTM Closed IV Catheter System (K102520)and BD NexivaTM DiffusicsTM Closed IV Catheter System (K123734), respectively. |
§ 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).