(36 days)
BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient's vascular system for short term use to sample 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 22-18 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 System - Single Port with MaxZero Needleless Connector devices 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, and vent plug. The needle and catheter are protected by a needle cover. A MaxZero device 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 The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure.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 return 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).
The provided text describes specific performance tests for the BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector. However, it does not include the acceptance criteria or reported device performance for these tests in a detailed format that would allow for a direct creation of the requested table. It only states that the device "met all predetermined acceptance criteria."
Therefore, I cannot provide a table of acceptance criteria and reported device performance.
Furthermore, the document does not detail the following information regarding a hypothetical study proving the device meets acceptance criteria:
- Sample size used for the test set or the data provenance.
- Number of experts used to establish the ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- Whether a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific performance metrics and acceptance criteria for this particular device. It describes the types of tests performed (e.g., MaxZero Insertion Force, Cytotoxicity, Sensitization) and states that "the subject device met all predetermined acceptance criteria," but it doesn't quantify those criteria or the device's exact performance against them.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
Becton Dickinson Infusion Therapy Systems, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313
Re: K170336
Trade/Device Name: BD Nexiva™ Closed IV Catheter System-Single Port with MaxZero™ Needleless Connector Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: March 7, 2017 Received: March 8, 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Device Name
BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector
Indications for Use (Describe)
BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient's vascular system for short term use to sample 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 22-18 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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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
bd.com
Image /page/3/Picture/2 description: The image shows the logo for BD, a medical technology company. The logo consists of two parts: a circular orange symbol on the left and the letters "BD" in blue on the right. The orange symbol appears to be a stylized sun or starburst design. The letters "BD" are in a bold, sans-serif font.
K170336 510(k) Summary (21 CFR §807.92) BD Nexiva™ Closed IV Catheter System – Single Port with MaxZero™ Needleless Connector
| SubmitterInformation | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |
|---|---|---|---|
| Submitter Address: | 9450 South State StreetSandy, UT 84070 | ||
| Contact Person: | Kimberly GeislerRegulatory Affairs Manager | ||
| Email Address: | kimberly.geisler@bd.com | ||
| Phone Number: | (801) 565-2422 | ||
| Fax Number | (801) 304-3963 | ||
| Date of Preparation: | March 3, 2017 | ||
| Subject Device | Trade Name: | BD Nexiva™ Closed IV Catheter System – Single Portwith MaxZero™ Needleless Connector | |
| Common Name: | Peripheral Intravascular or IV Catheter | ||
| Regulation Number: | 21 CFR §880.5200 | ||
| Regulation Name: | Intravascular Catheter | ||
| Regulatory Class: | II | ||
| Product Code: | FOZ (primary); FPA (secondary) | ||
| Classification Panel: | General Hospital | ||
| PredicateDevice(BD Nexiva) | Trade Name: | BD Nexiva™ Closed IV Catheter System – Single Port | |
| 510(k) Reference: | K161777 | ||
| Common Name: | Peripheral Intravascular or IV Catheter | ||
| Regulation Number: | 21 CFR §880.5200 | ||
| Regulation Name: | Intravascular Catheter | ||
| Regulatory Class: | II | ||
| Product Code: | FOZ | ||
| Classification Panel: | General Hospital | ||
| PredicateDevice(MaxZero) | Trade Name: | MaxZero™ Needleless Connector (MZ1000) | |
| 510(k) Reference: | K132413 | ||
| Common Name: | Intravascular Administration Set or Needleless Connector | ||
| Regulation Number: | 21 CFR §880.5440 | ||
| Regulation Name: | Intravascular Administration Set | ||
| Regulatory Class: | II | ||
| Product Code: | FPA | ||
| Classification Panel: | General Hospital | ||
| Reason forSubmission | The reason for this submission is the addition of a MaxZero Needleless Connectorto the BD Nexiva Closed IV Catheter System - Single Port unit package. | ||
| DeviceDescription | BD Nexiva Closed IV Catheter System - Single Port with MaxZero NeedlelessConnector devices are over-the-needle, intravascular catheters. These deviceshave a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilizationplatform, integrated extension tubing, clamp, Luer adapter, and vent plug. Theneedle and catheter are protected by a needle cover. A MaxZero device withprotective cover is provided in the unit package. | ||
| 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 return along the catheter. Continuous blood return is seen inthe extension tubing. The vent plug prevents blood leakage from the extensiontubing during insertion. Both the stabilization platform and Luer connector are colorcoded to indicate catheter gauge size (24 GA (0.7 mm)=Yellow, 22 GA (0.9mm)=Blue, 20 GA (1.1 mm)=Pink, 18 GA (1.3 mm)=Green). | |||
| Indications forUse(21 CFR§807.92(a)(5)) | The subject device Indications for Use is the same as the predicate BD NexivaClosed IV Catheter System - Single Port device (K16177), with the exception ofthe device trade name. The subject device Indications for Use does not include thepredicate MaxZero Needleless Connector Indications for Use (K132413) since theMaxZero Needleless Connector is a component of the primary BD Nexiva ClosedIV Catheter System - Single Port device. The addition of the MaxZero NeedlelessConnector to the BD Nexiva Closed IV Catheter System unit package does notimpact the intended use of the MaxZero Needleless Connector compared to thepredicate device (K132413). As such, the differences between the subject andpredicate device Indications for Use do not change the intended use of thepredicate devices or raise different questions of safety and effectiveness. | ||
| SUBJECTBD Nexiva Closed IV Catheter System -Single Port with MaxZero NeedlelessConnectorIndications for Use | PREDICATE 1BD Nexiva Closed IV CatheterSystem - Single Port (K161777)Indications for Use | PREDICATE 2MaxZero NeedlelessConnector (K132413)Indications for Use | |
| Attribute | SUBJECTBD Nexiva Closed IV CatheterSystem - Single Port withMaxZero NeedlelessConnector | PREDICATE 1BD Nexiva Closed IV CatheterSystem - Single Port(K161777) | PREDICATE 2MaxZero NeedlelessConnector (K132413) |
| Owner | Becton Dickinson InfusionTherapy Systems Inc. | Becton Dickinson InfusionTherapy Systems Inc. | Becton, Dickinson andCompany (formerlyCareFusion) |
| Classification | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter(primary)FPA - IV Administration Set(secondary) | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | 21 CFR §880.5440Class IIFPA - IV Administration Set |
| 510(k) Status | Subject of this premarketnotification | K161777 - Clearance dateAugust 29, 2016 | K132413 - Clearance dateAugust 29, 2013 |
| FundamentalScientificTechnology | BD Nexiva Closed IV CatheterSystem - Single Port deviceSame as Predicate 1(BD Nexiva SP)MaxZero NeedlelessConnector deviceSame as Predicate 2(MaxZero) | Closed peripheral intravascularcatheter system designed withan integrated extension setincorporating a single portinjection site. Incorporates BDInstaflash™ technology to assistwith flashback visualization. | Closed, Luer activatedneedleless connectordesigned to prevent fluiddisplacement into thecatheter upon disconnectionof the male user (i.e., zeroreflux). During activation, amale Luer lock connectorcauses the valve to deflectand enables fluid to flowfreely around the valve andout the male Luer connector. |
| PrimaryDeviceComponents/ Materials | BD Nexiva Closed IV CatheterSystem - Single Port deviceSame as Predicate 1(BD Nexiva Closed IV CatheterSystem - Single Port)MaxZero NeedlelessConnector deviceSame as Predicate 2(MaxZero Needleless Connector) | Needle:Stainless SteelCatheter:PolyurethaneCatheter Wings:TPECatheter Adapter:CopolyesterNeedle Hub:PolycarbonateTip Shield:PolycarbonateExtension Tubing:PolyurethaneLuer Adapter:CopolyesterPinch Clamp:Acetal | Top:PolycarbonatePolycarbonateBase:SiliconeValve: |
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bd.com
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bd.com
Technological Technological characteristics of the subject and predicate devices are substantially Characteristics equivalent with respect to the device design and materials. The subject BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector achieves its intended use based on the same technology and principles of operation as the predicate BD Nexiva Closed IV Cather System - Single Port and MaxZero Needleless Connector, respectively.
The BD Nexiva Closed IV Catheter System - Single Port is being offered with a MaxZero Needleless Connector in the unit package as a convenience to the clinician. This configuration represents a change the MaxZero sterilization method from irradiation (e-beam) to ethylene oxide (EtO).
A comparison of the subject and predicate device technological characteristics is provided in the table below.
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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
bd.com
| Attribute | SUBJECTBD Nexiva Closed IV CatheterSystem - Single Port withMaxZero NeedlelessConnector | PREDICATE 1BD Nexiva Closed IV CatheterSystem - Single Port(K161777) | PREDICATE 2MaxZero NeedlelessConnector (K132413) |
|---|---|---|---|
| CatheterDimensions | Same as Predicate 1(BD Nexiva Closed IV CatheterSystem) | Catheter Diameters18 GA, 20 GA, 22 GA, 24GACatheter Lengths0.75 IN, 1.00 IN, 1.25 IN | N/A |
| Sterility | Provided sterile (EtO) | Provided sterile (EtO) | Provided sterile (irradiation) |
Summarv of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate Tests devices. A risk analysis was conducted to assess the impact of the proposed modifications to the subject devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were identified to ensure that specified design requirements were met:
- MaxZero Insertion Force ●
- . MaxZero Droplet Size
- MaxZero High Back Pressure ●
- MaxZero Droplet Separation ●
- MaxZero Flow Rate ●
- BD Nexiva Flow Control Plug Retention Rate ●
- . Packaging Integrity
- Damage to Device ●
In addition, the following biocompatibility testing was conducted on the MaxZero Needleless Connector as a result of the sterilization method change in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
- Cytotoxicity ●
- Sensitization .
- Intracutaneous Reactivity ●
- Systemic Toxicity (Acute)
- Haemocompatibility .
- Pyrogenicity (Material-Mediated Rabbit Pyrogen) .
- Pyrogenicity (LAL) .
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.
Summary of Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Nexiva Closed IV Catheter System (Single Substantial Equivalence Port) with MaxZero Needleless Connector has been demonstrated 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).