(103 days)
BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral 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 infused, and duration of therapy. The 22-18 GA (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 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 (single or dual port), vent plug, and pre-attached needleless connector (BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with protective cover is provided in the unit package (not available with all configurations).
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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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 (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
This document is a 510(k) summary for the BD Nexiva™ Closed IV Catheter System. It describes the device, its intended use, a comparison to predicate devices, and a summary of performance testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Per the design control requirements specified in 21 CFR §820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and states that the device met the criteria.
| Test Performed | Reported Device Performance |
|---|---|
| MaxZero Retention Rate (BD internal specification) | Met predetermined acceptance criteria |
| MaxZero Removal Torque (BD internal specification) | Met predetermined acceptance criteria |
| Flow Control Plug Retention Rate (BD internal specification) | Met predetermined acceptance criteria |
| Packaging Integrity (ASTM F2096) | Met predetermined acceptance criteria |
| Damage to Device (ISO 11607-1 §6.3.5) | Met predetermined acceptance criteria (testing conducted to ensure packaging system provides adequate protection to the product through the hazards of handling, distribution and storage) |
| Biocompatibility: Cytotoxicity | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Sensitization | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Intracutaneous Reactivity | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Systemic Toxicity (Acute) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Pyrogenicity (Material-Mediated Rabbit Pyrogen) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Pyrogenicity (LAL) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Subchronic Toxicity (subacute toxicity) | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Genotoxicity | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Implantation | Met predetermined acceptance criteria (leveraged from predicate devices) |
| Biocompatibility: Haemocompatibility | Met predetermined acceptance criteria (leveraged from predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual performance tests listed.
The provenance of the data is not explicitly stated as a country of origin or retrospective/prospective. The tests were likely conducted in-house by Becton Dickinson or by a contracted laboratory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This study does not involve clinical data or "ground truth" established by experts in a diagnostic sense. The tests performed are engineering and biocompatibility tests for a medical device. Therefore, this question is not applicable.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring adjudication of expert opinions or diagnostic findings.
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
Not applicable. This is a 510(k) submission for a physical medical device (IV catheter system), not an AI/Software as a Medical Device (SaMD).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a 510(k) submission for a physical medical device.
7. The Type of Ground Truth Used
Not applicable as this is a physical medical device and the performance tests are based on engineering and biocompatibility standards, not diagnostic "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The performance tests are for device validation.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2019
Becton Dickinson Infusion Therapy Systems Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K183399
Trade/Device Name: BD Nexiva™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: March 11, 2019 Received: March 12, 2019
Dear 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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for 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) K183399
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 peripheral 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 infused, and duration of therapy. The 22-18 GA (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.
| 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) |
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K183399
510(k) Summary (21 CFR §807.92)
BD Nexiva™ Closed IV Catheter System
| SubmitterInformation | Submitter Name:Submitter Address:Contact Person:Email Address:Phone Number:Fax NumberDate of Preparation: | Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070Kimberly GeislerRegulatory Affairs Managerkimberly.geisler@bd.com(801) 565-2422(801) 304-3963March 14, 2019 |
|---|---|---|
| Subject Device | 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 §880.5200Catheter, intravascular, therapeutic, short-term less than30 daysIIFOZ (Primary); FPA (Secondary)General Hospital |
| PredicateDevice 1 | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Closed IV Catheter System - Single Portwith MaxZero™ Needleless ConnectorK170336Peripheral Intravascular or IV Catheter21 CFR §880.5200Catheter, intravascular, therapeutic, short-term less than30 daysIIFOZ (primary); FPA (secondary)General Hospital |
| PredicateDevice 2 | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Nexiva™ Closed IV Catheter SystemK161777Peripheral Intravascular or IV Catheter21 CFR §880.5200Catheter, intravascular, therapeutic, short-term less than30 daysIIFOZGeneral Hospital |
| Reason forSubmission | The reason for this submission is the addition of BD Nexiva Closed IV CatheterSystem - Dual Port with MaxZero Needleless Connector configurations to theBD Nexiva Closed IV Catheter System product offerings. | |
| DeviceDescription | 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 (single or dual port), vent plug, and pre-attached needleless connector(BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheterare protected by a needle cover. A BD Q-Syte, MaxZero, or end cap withprotective cover is provided in the unit package (not available with allconfigurations). | |
| 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. | ||
| 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 (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue,20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green). | ||
| Indications forUse21 CFR§807.92(a)(5)) | The subject device Indications for Use is the same as the predicate devices, withtwo minor wording modifications: 1) addition of "peripheral" to clarify the location ofplacement within the patient's vascular system; and 2) modification of "Thesecatheters" to "These devices" for clarification and consistency. | |
| BD Nexiva closed IV catheter systems are intended to be inserted into a patient'speripheral vascular system for short term use to sample blood, monitor blood pressure, oradminister fluids. These devices may be used for any patient population with considerationgiven to adequacy of vascular anatomy, procedure being performed, fluids being infused,and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with powerinjectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitablefor use with power injectors are removed. | ||
| TechnologicalCharacteristics | Technological characteristics of the subject and predicate devices are substantiallyequivalent with respect to the device design and materials. The subject BD NexivaClosed IV Catheter System achieves its intended use based on the sametechnology and principles of operation as the predicate devices. | |
| Compared to the predicate devices, the subject device product offerings are beingexpanded to include the following BD Nexiva Closed IV Catheter System – DualPort with MaxZero Needleless Connector configurations: | ||
| 24 GA x 0.56 IN - Dual Port with MaxZero 24 GA x 0.75 IN - Dual Port with MaxZero 22 GA x 1.00 IN - Dual Port with MaxZero 22 GA x 1.75 IN – Dual Port with MaxZero 20 GA x 1.00 IN - Dual Port with MaxZero 20 GA x 1.25 IN - Dual Port with MaxZero 20 GA x 1.75 IN - Dual Port with MaxZero 18 GA x 1.25 IN - Dual Port with MaxZero |
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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
bd.com
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18 GA x 1.75 IN - Dual Port with MaxZero ●
Compared to the predicate devices, the subject BD Nexiva Closed IV Catheter System - Dual Port with MaxZero Needleless Connector configurations include a pre-attached MaxZero device on the Luer adapter and an additional MaxZero device in the unit package. Compared to the predicate devices, this represents a change to the connector on the Dual Port Y Luer adapter. No modifications are being made to the catheter sizes. Predicate and subject devices include the same catheter diameters (18 GA, 20 GA, 22 GA, 24GA) and catheter lengths (0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN).
| Attribute | SUBJECTBD Nexiva Closed IV CatheterSystem | PREDICATE 1(K170336)BD Nexiva Closed IV CatheterSystem (Single Port) withMaxZero NeedlelessConnector | PREDICATE 2(K161777)BD Nexiva Closed IV CatheterSystem |
|---|---|---|---|
| Indications forUse | BD Nexiva closed IV cathetersystems are intended to beinserted into a patient'speripheral vascular system forshort term use to sample blood,monitor blood pressure, oradminister fluids. These devicesmay be used for any patientpopulation with considerationgiven to adequacy of vascularanatomy, procedure beingperformed, fluids being infused,and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices aresuitable for use with powerinjectors set to a maximumpressure of 300 psi (2068 kPa)when access ports not suitablefor use with power injectors areremoved. | BD Nexiva Closed IV CatheterSystem - Single Port withMaxZero Needleless Connectordevices are intended to beinserted into a patient's vascularsystem for short term use tosample blood, monitor bloodpressure, or administer fluids.These catheters may be used forany patient population withconsideration given to adequacyof vascular anatomy, procedurebeing performed, fluids beinginfused, and duration of therapy.The 22-18 GA (0.9-1.3 mm)devices are suitable for use withpower injectors set to amaximum pressure of 300 psi(2068 kPa) when access portsnot suitable for use with powerinjectors are removed. | BD Nexiva closed IV cathetersystems are intended to beinserted into a patient's vascularsystem for short term use tosample blood, monitor bloodpressure, or administer fluids.These catheters may be used forany patient population withconsideration given to adequacyof vascular anatomy, procedurebeing performed, fluids beinginfused, and duration of therapy.The 22-18 GA (0.9-1.3 mm)devices are suitable for use withpower injectors set to amaximum pressure of 300 psi(2068 kPa) when access portsnot suitable for use with powerinjectors are removed. |
| Classification | 21 CFR §880.5200Class IIFOZ - Catheter, intravascular,therapeutic, short-term less than30 days (primary)FPA - IV Administration Set(secondary) | 21 CFR §880.5200Class IIFOZ - Catheter, intravascular,therapeutic, short-term less than30 days (primary)FPA - IV Administration Set(secondary) | 21 CFR §880.5200Class IIFOZ - Catheter, intravascular,therapeutic, short-term less than30 days (primary) |
| 510(k) Status | Subject of this premarketnotification | K170336 - Clearance dateMarch 10, 2017 | K161777 - Clearance dateAugust 29, 2016 |
| FundamentalScientificTechnology | Closed peripheral intravascularcatheter system designed withan integrated extension setincorporating a single port or Y(dual)-port injection site.Incorporates BD Instaflash™technology to assist withflashback visualization. | Closed peripheral intravascularcatheter system designed withan integrated extension setincorporating a single portinjection site. Incorporates BDInstaflash™ technology to assistwith flashback visualization. | Closed peripheral intravascularcatheter system designed with anintegrated extension setincorporating a single port or Y(dual)-port injection site.Incorporates BD Instaflash ™technology to assist withflashback visualization. |
| Primary Device Components / Materials | |||
| Needle | Stainless Steel | Stainless Steel | Stainless Steel |
| Catheter Tubing | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate |
| Catheter AdapterWings | TPE + Gauge-Specific Colorant | TPE + Gauge-Specific Colorant | TPE + Gauge-Specific Colorant |
| Catheter Adapter | Copolyester | Copolyester | Copolyester |
| Tip Shield | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant |
| Grip / NeedleHub | Polycarbonate + White Colorant | Polycarbonate + White Colorant | Polycarbonate + White Colorant |
| Pinch Clamp | Acetal | Acetal | Acetal |
| Extension Tubing | Polyurethane | Polyurethane | Polyurethane |
| Luer Adapter | Copolyester | Copolyester | Copolyester |
| Q-Syte | Polycarbonate / Silicone | N/A | Polycarbonate / Silicone |
| MaxZero | Polycarbonate / Silicone | Polycarbonate / Silicone | N/A |
| Catheter Diameters | Catheter Diameters | Catheter Diameters | |
| CatheterDimensions | 18 GA, 20 GA, 22 GA, 24GA | 18 GA, 20 GA, 22 GA, 24GA | 18 GA, 20 GA, 22 GA, 24GA |
| Catheter Lengths | Catheter Lengths | Catheter Lengths | |
| 0.56 IN, 0.75 IN, 1.00 IN, 1.25IN, 1.75 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25IN, 1.75 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN,1.75 IN | |
| • Single Port | • Single Port | • Single Port | |
| • Single Port with MaxZero | • Single Port with MaxZero | N/A | |
| ProductConfigurations | • Dual Port | N/A | • Dual Port |
| • Dual Port with Q-Syte | N/A | • Dual Port with Q-Syte | |
| • Dual Port with Q-Syte and EndCap | N/A | • Dual Port with Q-Syte and EndCap | |
| • Dual Port with MaxZero | N/A | N/A | |
| Sterility | Provided sterile (EO) | Provided sterile (EO) | Provided sterile (EO) |
A comparison of the subject and predicate device technological characteristics is provided in the table below, with differences highlighted in BOLD text.
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| Summary ofPerformanceTests | Performance tests completed on the subject device were limited to those testsrequired to support a determination of substantial equivalence to the predicatedevices. A risk analysis was conducted to assess the impact of the proposedmodifications to the predicate devices. When technological characteristicsbetween the subject and predicate devices were found to be identical, results ofperformance testing conducted on the predicate devices were applied to thesubject device. The performance tests listed below were conducted to ensure thatthe subject device meets specified design requirements: |
|---|---|
| MaxZero Retention Rate (BD internal specification) MaxZero Removal Torque (BD internal specification) Flow Control Plug Retention Rate (BD internal specification) Packaging Integrity (ASTM F2096) Damage to Device (ISO 11607-1 §6.3.5) (testing conducted to ensurepackaging system provides adequate protection to the product through thehazards of handling, distribution and storage) | |
| Biocompatibility testing, conducted in accordance to 1) ISO 10993-1:2009,Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and 2)Use of International Standard ISO 10993-1, "Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a risk management process" (issuedJune 16, 2016), was leveraged from the predicate devices, including: | |
| Cytotoxicity Sensitization Intracutaneous Reactivity Systemic Toxicity (Acute) Pyrogenicity (Material-Mediated Rabbit Pyrogen) Pyrogenicity (LAL) Subchronic Toxicity (subacute toxicity) Genotoxicity Implantation Haemocompatibility | |
| Per the design control requirements specified in 21 CFR §820.30, the subjectdevice met all predetermined acceptance criteria for the above-listed performancetests, demonstrating substantial equivalence to the predicate devices. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and results ofperformance testing, the subject BD Nexiva Closed IV Catheter System has beendemonstrated to be substantially equivalent to the predicate devices. |
§ 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).