(61 days)
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
Yes.
The device is intended to administer fluids, which can be part of a therapeutic regimen.
No.
The device is an IV catheter system intended for sampling blood, monitoring blood pressure, or administering fluids. While blood sampling and blood pressure monitoring can be part of a diagnostic process, the device itself does not perform any diagnostic analysis or provide a diagnosis.
No
The device description clearly outlines numerous physical components such as catheters, needles, tubing, and connectors, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into a patient's vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids. These are direct patient interventions, not tests performed in vitro (outside the body) on samples.
- Device Description: The description details a physical catheter system designed for insertion into a vein. It describes components like needles, tubing, and connectors used for accessing the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information based on testing in vitro.
Therefore, the BD Nexiva and BD Nexiva Diffusics closed IV catheter systems are medical devices used for accessing the vascular system, not for in vitro diagnostic testing.
N/A
Intended 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.
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.
Product codes
FOZ
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following performance testing was performed to demonstrate substantial equivalence of the subject BD NexivaTM and BD NexivaTM DiffusicsTM Closed IV Catheter 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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.
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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 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. |
| 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
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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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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
| Submitter
Information | Submitter Name:
Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, UT 84070 | Device
Description
( BD Nexiva ) | 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. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Kimberly Geisler
Staff Regulatory Affairs Specialist
kimberly.geisler@bd.com
(801) 565-2422 (phone) | | 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. |
| | Date of Preparation: | July 28, 2016 | | 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). |
| Subject Device
(BD Nexiva) | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Closed IV Catheter System
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital | Device
Description
( BD Nexiva
Diffusics ) | 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. |
| Predicate
Device
(BD Nexiva) | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Closed IV Catheter System
K102520
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital | | 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. |
| Subject Device
(BD Nexiva
Diffusics) | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital | | 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). |
| Predicate
Device
(BD Nexiva
Diffusics) | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System
K123734
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital | | |
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| Indications for
Use
(BD Nexiva) | Modifications were made to the Indications for Use for the purpose of aligning the
Indications 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 to
the healthcare practitioner; 2) removal of device features and performance
information which does not determine intended use; 3) removal of "less than 30
days" since this statutory regulation language for 21 CFR §880.5200 regarding the
device classification could be confusing to end users as the duration of use is
dependent on a number of factors, including patient status, duration of treatment,
and institutional protocol; 4) addition of "fluids being infused" and "duration of
therapy" as considerations for clinicians to evaluate prior to use of these catheters
for 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. |
7
| bd.com | |
|---|---|
| | Indications for
Use
(BD Nexiva
Diffusics) | Modifications were made to the Indications for Use for the purpose of aligning the
Indications for Use across the BD Nexiva family of products and for clarification.
Modifications include: 1) addition of "short term use" in alignment with the device
classification; 2) addition of the intended patient population, which is consistent
with the predicate device, which does not indicate a specific patient population
and is intended for general use; 3) removal of the flow rate information as it
pertains to device performance and does not determine intended use (Note: flow
rate information is provided in the Instructions for Use); and 4) 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
BD Nexiva™ Diffusics™ Closed IV
Catheter System
Indications for Use | PREDICATE (K123734)
BD Nexiva™ Diffusics™ Closed IV
Catheter System
Indications for Use | | |
| | 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. | The BD Nexiva™ Diffusics™ intravascular
catheter is inserted into a patient's
vascular system to sample blood, monitor
blood pressure or administer fluids. The
BD Nexiva Diffusics catheters are suitable
for use with power injectors when a direct
connection is made. The maximum flow
rate and maximum power injector pressure
setting for each catheter size are listed in
the table below: | | |
| | | Max Flow Rate
(mL/sec) | Max Injector Setting
(psi) | |
| | 24 GA x 0.75 IN | 3.0 | 325 | |
| | 22 GA x 1.00 IN | 6.5 | 325 | |
| | 20 GA x 1.00 IN | 10.0 | 325 | |
| | 20 GA x 1.25 IN | 10.0 | 325 | |
| | 18 GA x 1.25 IN | 15.0 | 325 | |
| | | | | |
| | Technological
Characteristics | Technological characteristics of the subject and predicate devices are equivalent.
The subject BD Nexiva™ and BD Nexiva™ Diffusics™ Closed IV Catheter
Systems achieve their intended use based on the same technology and principles
of operation as the predicate BD Nexiva™ and BD Nexiva™ Diffusics™ Closed IV
Cather Systems, respectively. Design modifications were made to the subject
devices to reduce the force required to withdraw the needle from the catheter
assembly. Performance testing performed to support the design modifications
included:
• 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. | | |
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| Attribute | SUBJECT
BD Nexiva™ Closed IV Catheter System | PREDICATE (K102520)
BD Nexiva™ Closed IV Catheter System |
|--------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Same as predicate | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter |
| Fundamental
Scientific
Technology | Same as predicate | Closed peripheral intravascular catheter
system designed with an integrated extension
set incorporating either a single port or Y
(dual)-port injection site. Incorporates BD
Instaflash™ technology to assist with
flashback visualization. |
| Components /
Materials | Septum Canister:
Copolyester + grey
colorant* | Septum Canister:
Copolyester + white
colorant |
| | All other subject component materials are the same as the predicate device | |
| Physical /
Mechanical
Specifications | Same as predicate | Catheter Diameters
Catheter Lengths
18G, 20G, 22G, 24G
0.56", 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 | SUBJECT
BD Nexiva™ Diffusics™ Closed IV
Catheter System | PREDICATE (K123734)
BD Nexiva™ Diffusics™ Closed IV Catheter
System |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Same as predicate | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter |
| Fundamental
Scientific
Technology | Same as predicate | Closed peripheral intravascular catheter
system designed with an integrated extension
set incorporating either a single port or Y
(dual)-port injection site. Incorporates BD
Instaflash™ technology to assist with
flashback visualization.
In addition, the catheter tip includes diffuser
holes to reduce the velocity of contrast media
exiting the catheter tip during CT scans. |
| Components /
Materials | Septum Canister: Copolyester + grey
colorant (modified
resin to colorant ratio
compared to predicate)
Septum: Polyisoprene (no
lubricant) | Septum Canister: Copolyester + grey
colorant
Septum: Polyisoprene + Silicone
Lubricant |
| All other subject component materials are the same as the predicate device | | |
| Physical /
Mechanical
Specifications | Same as predicate | Catheter Diameters Catheter Lengths
18G, 20G, 22G, 24G 0.75", 1.00", 1.25" |
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| Summary of
Performance
Tests | The following performance testing was performed to demonstrate substantial
equivalence of the subject BD NexivaTM and BD NexivaTM DiffusicsTM Closed IV
Catheter 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 of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and performance
testing, the subject BD NexivaTM Closed IV Catheter System and BD NexivaTM
DiffusicsTM Closed IV Catheter System are demonstrated to be substantially
equivalent to the predicate BD NexivaTM Closed IV Catheter System (K102520)
and BD NexivaTM DiffusicsTM Closed IV Catheter System (K123734), respectively. |