(36 days)
Not Found
No
The 510(k) summary describes a mechanical medical device (IV catheter system) and its performance testing, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used to access the vascular system for sampling blood, administering fluids, or measuring blood pressure, but it does not treat a disease or medical condition.
No
This device is an IV catheter system used for administering fluids or sampling blood pressure, not for diagnosing medical conditions. While it can sample blood, the primary purpose is not diagnostic interpretation of the sample.
No
The device description clearly outlines multiple physical components including a catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, and vent plug. Performance studies also focus on physical characteristics like insertion force, droplet size, flow rate, and packaging integrity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be inserted into a patient's vascular system for short-term use to sample blood pressure or administer fluids. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a catheter system designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve analyzing samples like blood, urine, or tissue outside the body.
Therefore, the BD Nexiva Closed IV Catheter System is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ, FPA
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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.
1
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,
Image /page/1/Picture/8 description: The image shows a signature of Tina Kiang. The signature is in black ink and is on a white background. There is a large looping design to the left of the name. There is also a small "-s" below the name.
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
2
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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3
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
| Submitter
| Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |
|---|---|---|---|
| Submitter Address: | 9450 South State Street | ||
| Sandy, UT 84070 | |||
| Contact Person: | Kimberly Geisler | ||
| Regulatory 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 Port | |
| with 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 | ||
| Predicate | |||
| Device | |||
| (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 | ||
| Predicate | |||
| Device | |||
| (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 for | |||
| Submission | The reason for this submission is the addition of a MaxZero Needleless Connector | ||
| to the BD Nexiva Closed IV Catheter System - Single Port unit package. | |||
| Device | |||
| Description | 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). | |||
| Indications for | |||
| Use | |||
| (21 CFR | |||
| §807.92(a)(5)) | The subject device Indications for Use is the same as the predicate BD Nexiva | ||
| Closed IV Catheter System - Single Port device (K16177), with the exception of | |||
| the device trade name. The subject device Indications for Use does not include the | |||
| predicate MaxZero Needleless Connector Indications for Use (K132413) since the | |||
| MaxZero Needleless Connector is a component of the primary BD Nexiva Closed | |||
| IV Catheter System - Single Port device. The addition of the MaxZero Needleless | |||
| Connector to the BD Nexiva Closed IV Catheter System unit package does not | |||
| impact the intended use of the MaxZero Needleless Connector compared to the | |||
| predicate device (K132413). As such, the differences between the subject and | |||
| predicate device Indications for Use do not change the intended use of the | |||
| predicate devices or raise different questions of safety and effectiveness. | |||
| SUBJECT | |||
| BD Nexiva Closed IV Catheter System - | |||
| Single Port with MaxZero Needleless | |||
| Connector | |||
| Indications for Use | PREDICATE 1 | ||
| BD Nexiva Closed IV Catheter | |||
| System - Single Port (K161777) | |||
| Indications for Use | PREDICATE 2 | ||
| MaxZero Needleless | |||
| Connector (K132413) | |||
| Indications for Use | |||
| Attribute | SUBJECT | ||
| BD Nexiva Closed IV Catheter | |||
| System - Single Port with | |||
| MaxZero Needleless | |||
| Connector | PREDICATE 1 | ||
| BD Nexiva Closed IV Catheter | |||
| System - Single Port | |||
| (K161777) | PREDICATE 2 | ||
| MaxZero Needleless | |||
| Connector (K132413) | |||
| Owner | Becton Dickinson Infusion | ||
| Therapy Systems Inc. | Becton Dickinson Infusion | ||
| Therapy Systems Inc. | Becton, Dickinson and | ||
| Company (formerly | |||
| CareFusion) | |||
| Classification | 21 CFR §880.5200 | ||
| Class II | |||
| FOZ - Intravascular Catheter | |||
| (primary) | |||
| FPA - IV Administration Set | |||
| (secondary) | 21 CFR §880.5200 | ||
| Class II | |||
| FOZ - Intravascular Catheter | 21 CFR §880.5440 | ||
| Class II | |||
| FPA - IV Administration Set | |||
| 510(k) Status | Subject of this premarket | ||
| notification | K161777 - Clearance date | ||
| August 29, 2016 | K132413 - Clearance date | ||
| August 29, 2013 | |||
| Fundamental | |||
| Scientific | |||
| Technology | BD Nexiva Closed IV Catheter | ||
| System - Single Port device | |||
| Same as Predicate 1 | |||
| (BD Nexiva SP) | |||
| MaxZero Needleless | |||
| Connector device | |||
| Same as Predicate 2 | |||
| (MaxZero) | Closed peripheral intravascular | ||
| catheter system designed with | |||
| an integrated extension set | |||
| incorporating a single port | |||
| injection site. Incorporates BD | |||
| Instaflash™ technology to assist | |||
| with flashback visualization. | Closed, Luer activated | ||
| needleless connector | |||
| designed to prevent fluid | |||
| displacement into the | |||
| catheter upon disconnection | |||
| of the male user (i.e., zero | |||
| reflux). During activation, a | |||
| male Luer lock connector | |||
| causes the valve to deflect | |||
| and enables fluid to flow | |||
| freely around the valve and | |||
| out the male Luer connector. | |||
| Primary | |||
| Device | |||
| Components | |||
| / Materials | BD Nexiva Closed IV Catheter | ||
| System - Single Port device | |||
| Same as Predicate 1 | |||
| (BD Nexiva Closed IV Catheter | |||
| System - Single Port) | |||
| MaxZero Needleless | |||
| Connector device | |||
| Same as Predicate 2 | |||
| (MaxZero Needleless Connector) | Needle: | ||
| Stainless Steel | |||
| Catheter: | |||
| Polyurethane | |||
| Catheter Wings: | |||
| TPE | |||
| Catheter Adapter: | |||
| Copolyester | |||
| Needle Hub: | |||
| Polycarbonate | |||
| Tip Shield: | |||
| Polycarbonate | |||
| Extension Tubing: | |||
| Polyurethane | |||
| Luer Adapter: | |||
| Copolyester | |||
| Pinch Clamp: | |||
| Acetal | Top: | ||
| Polycarbonate | |||
| Polycarbonate | |||
| Base: | |||
| Silicone | |||
| Valve: |
4
bd.com
5
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.
6
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
bd.com
| Attribute | SUBJECT
BD Nexiva Closed IV Catheter
System - Single Port with
MaxZero Needleless
Connector | PREDICATE 1
BD Nexiva Closed IV Catheter
System - Single Port
(K161777) | PREDICATE 2
MaxZero Needleless
Connector (K132413) |
|------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Catheter
Dimensions | Same as Predicate 1
(BD Nexiva Closed IV Catheter
System) | Catheter Diameters
18 GA, 20 GA, 22 GA, 24GA
Catheter Lengths
0.75 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.