(147 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, safety features, and standard performance metrics of an IV catheter system. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes: The device is intended to administer fluids and/or medications, which fulfills a therapeutic purpose.
No
The device is an IV catheter system intended for administering fluids/medications and sampling blood, which are therapeutic and collection functions, not diagnostic.
No
The device description clearly outlines numerous physical components of an IV catheter system, including tubing, needles, shields, septums, and adapters. There is no mention of software as a component or the primary function of the 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 peripheral venous system to administer fluids/medications and sample blood. This is a direct interaction with the patient's body for therapeutic and diagnostic sample collection purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of an IV catheter system designed for insertion into a vein. It focuses on features related to insertion, blood containment, safety, and fluid/medication delivery.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples outside the body, or any other typical characteristics of an IVD.
- Performance Studies: The performance studies focus on the physical and functional aspects of the catheter system (tensile strength, leakage, flow rate, safety, biocompatibility, etc.), not on the analytical performance of testing biological samples.
In summary, the Nexiva™ Closed IV Catheter System is a medical device used for accessing the venous system for treatment and sample collection, not for performing diagnostic tests on those samples.
N/A
Intended Use / Indications for Use
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
Product codes (comma separated list FDA assigned to the subject device)
FOZ, FPA
Device Description
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle cover. A MaxZero™ needle-free connector with protective cover is provided in the 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 Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). These devices are available with wings. The catheter hub and wings are color coded to indicate the 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
peripheral venous 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)
A Risk Analysis in accordance with ISO 14971:2019 was conducted to assess the impact of the proposed modifications to the predicate device.
Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate device. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate device. 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 conducted to ensure that the subject device meets predetermined design requirements:
- Compliance Testing
- Biocompatibility (ISO 10993-1)
Body contact: Externally communicating device Contact: Circulating blood Contact duration: Limited (A) to Prolonged (B) (≤ 24 hrs to 30 days) - Sterilization Residuals (ISO 10993-7)
- Packaging Testing (ASTM D4169)
- Sterilization Validation (ISO 11135-1)
- Performance Testing per ISO 10555-1 and ISO 10555-5
- Peak Tensile Force (ISO 10555-1 §4.6)
- Liquid Leakage (ISO 10555-1 §4.7.1)
- Air Leakage (ISO 10555-1 §4.7.2)
- Gravity Flow Rate (ISO 10555-1 §4.9)
- Power Injection Flow Rate (ISO 10555-1 §4.10)
- Needle Safety Testing (ISO 23908)
- Luer Testing (ISO 594-1 and ISO 594-2)
- BD Internal Studies
- Catheter tubing open flow pressure.
- Catheter tubing rupture pressure.
- System burst
- Catheter adapter separation force
- Extension tubing detachment force
- Wing bending force
- Needle cover removal force.
- Needle cover retention.
- Flow control plug retention rate
- Evaluation of MR Compatibility per ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, Guidance for Industry and Food and Drug Administration Staff, issued May 2021
- Evaluation of Microbial Ingress per Intravascular Administration Sets Premarket Notification Submissions [510(k)] Guidance for Industry and FDA Staff, issued July 2008
- Usability testing per Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued February 2016
Per design control requirements specified in 21 CFR 820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices. Clinical studies are not required to demonstrate substantial equivalence to the predicate device.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 22, 2023
Becton Dickinson Infusion Therapy Systems Inc. Paul Holman Regulatory Affairs Manager 9450 South State Street Sandy, Utah 84070
Re: K231239
Trade/Device Name: Nexiva™ Closed IV Catheter System with NearPort™ IV Access Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: August 25, 2023 Received: August 25, 2023
Dear Paul Holman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231239
Device Name
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Indications for Use (Describe)
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
| 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
bd.com
Image /page/3/Picture/2 description: The image shows the BD logo. The logo consists of two parts: a stylized orange sun-like symbol on the left and the letters "BD" in blue on the right. The sun-like symbol is a circle with rays emanating from it, and the letters "BD" are in a bold, sans-serif font.
K231239 510(k) Summary (21 CFR §807.92) Nexiva™ Closed IV Catheter System with NearPort™ IV Access
| Submitter | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |
|---|---|---|---|
| Information | Submitter Address: | 9450 South State Street, Sandy, Utah 84070 | |
| Contact Person: | Paul Holman, Regulatory Affairs Manager | ||
| Email Address: | paul.holman@bd.com | ||
| Phone Number: | (801) 522-5000 | ||
| Date of Preparation: | September 22, 2023 | ||
| Subject Device | Trade Name: | Nexiva™ Closed IV Catheter System with NearPort™ IV Access | |
| Common Name: | Peripheral Intravascular or IV Catheter | ||
| 510(k) Reference: | K231239 | ||
| Regulation Number: | 21 CFR §880.5200 | ||
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | ||
| Regulatory Class: | II | ||
| Product Code: | FOZ, FPA | ||
| Classification Panel: | General Hospital | ||
| Predicate | Trade Name: | BD Nexiva™ Closed IV Catheter System | |
| Device | Common Name: | Peripheral Intravascular or IV Catheter | |
| 510(k) Reference: | K183399 | ||
| Regulation Number: | 21 CFR §880.5200 | ||
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | ||
| Regulatory Class: | II | ||
| Product Code: | FOZ, FPA | ||
| Classification Panel: | General Hospital | ||
| Reason for | The purpose of this submission is to notify the FDA of the introduction of the Nexiva™ | ||
| Submission | Closed IV Catheter System with NearPort™ IV Access, allowing for compatibility with a | ||
| needle-free blood draw device (e.g., PIVO™ Pro Needle-free Blood Collection Device). | |||
| Device | The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the- | ||
| needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter | |||
| tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp, | |||
| Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle | |||
| cover. A MaxZero™ needle-free connector with protective cover is provided in the | |||
| package. | |||
| bd.com | |||
| 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 Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. | |||
| Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. | |||
| In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). | |||
| These devices are available with wings. The catheter hub and wings are color coded to indicate the 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 Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access. | ||
| Technological | |||
| Characteristics | Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject device, Nexiva™ Closed IV Catheter System with NearPort™ IV Access, achieves its intended use based on the same technology and principles of operation as the predicate device. A comparison of the subject and predicate device technological characteristics is provided in the table below | ||
| SUBJECT (K231239) | PREDICATE (K183399) | Comparison & |
4
| Attribute | SUBJECT (K231239)
Nexiva™ Closed IV Catheter
System with NearPort™ IV
Access | PREDICATE (K183399)
BD Nexiva™ Closed IV Catheter
System | Comparison &
Discussion |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21 CFR 880.5200
Class II | 21 CFR 880.5200
Class II | |
| Classification | FOZ - Intravascular Catheter
FPA - Intravascular Administration
Set | FOZ - Intravascular Catheter
FPA - Intravascular Administration
Set | Same |
| Attribute | SUBJECT (K231239)
Nexiva™ Closed IV Catheter
System with NearPort™ IV
Access | PREDICATE (K183399)
BD Nexiva™ Closed IV Catheter
System | Comparison &
Discussion |
| Indications for
Use | The Nexiva™ Closed IV Catheter
System with NearPort™ IV Access is
intended to be inserted into a
patient's peripheral venous system
for short term use to administer
fluids and/or medications and to
sample blood. 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. The 24-18 GA
(0.7-1.3 mm) devices are suitable
for use with power injectors set to a
maximum pressure of 300 psi (2068
kPa) when connected to the
NearPort™ IV Access. | 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 22-18
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. | Modifications have
been made to re-
phrase and align with
product use
specifications.
The Indications for
Use is being
narrowed to limit use
to the peripheral
venous system only
to administer fluids
and/or medications
and to sample blood.
Narrowing the
Indications for Use
does not raise any
new or different
questions of safety or
effectiveness.
Additionally, power
injection capability
has been expanded to
include the 24 GA
configuration, using
the same test method
as the predicate
device as supported
by performance
verification testing,
which did not raise
any new or different
questions of safety
and effectiveness. |
| Intended Use | Intravascular access | Intravascular access | Same |
| Fundamental
Scientific
Technology | Closed peripheral intravenous
catheter system designed with an
integrated extension tubing
incorporating a Y (dual)-port
injection site. Incorporates
Instaflash™ technology to assist
with flashback visualization.
Nexiva™ Closed IV Catheter
System with NearPort™ IV Access
is compatible with the PIVOTM Pro
Needle-free Blood Collection | Closed peripheral intravascular
catheter system designed with an
integrated extension set
incorporating a single port or Y
(dual)-port injection site.
Incorporates Instaflash™
technology to assist with flashback
visualization | The subject device
uses the same
fundamental
technology compared
to the predicate device
(K183399).
The NearPort™ IV
Access component has
the same fundamental
scientific technology |
| Attribute | SUBJECT (K231239)
Nexiva™ Closed IV Catheter
System with NearPort™ IV
Access | PREDICATE (K183399)
BD Nexiva™ Closed IV Catheter
System | Comparison &
Discussion |
| | Device for needle-free blood draws. | | however, the split
septum design enables
compatibility with a
needle-free blood
draw device as
supported by human
factors validation
testing, which did not
raise any new or
different questions of
safety and
effectiveness. |
| | Primary Components Material Composition | | |
| ISO 10993-1
Biocompatibility
Contact Type
and Duration | Body Contact: Externally
communicating device
Contact: Circulating blood
Contact Duration: Limited (A)
to Prolonged (B) (≤ 24 hrs to
30 days) | Body Contact: Externally
communicating device
Contact: Circulating blood
Contact Duration: Limited (A) to
Prolonged (B) (≤ 24 hrs to 30
days) | Same |
| Needle | Stainless Steel | Stainless Steel | Same |
| Catheter Tubing | Polyurethane with radiopaque
barium sulfate | Polyurethane with radiopaque
barium sulfate | Same |
| Grip | Polycarbonate + White Colorant | Polycarbonate + White Colorant | Same |
| Tip Shield | Polycarbonate + Gray Colorant | Polycarbonate + Gray Colorant | Same |
| Catheter
Adapter | Copolyester | Copolyester | The material
formulation has been
modified; however,
the material resin type
remains the same.
Testing in accordance
with ISO 10993-1
requirements did not
raise any new or
different questions
related to biological
safety |
| Catheter
Adapter Wings | Thermoplastic Elastomer + Gauge
Specific Colorant
Green (18 GA)
Pink (20 GA)
Blue (22 GA)
Yellow (24 GA) | Thermoplastic Elastomer + Gauge
Specific Colorant
Green (18 GA)
Pink (20 GA)
Blue (22 GA)
Yellow (24 GA) | A modified Shore A
durometer is used in
the subject device but
maintains the same
base resins and
colorants, except a
new green colorant |
| Attribute | SUBJECT (K231239)
Nexiva™ Closed IV Catheter
System with NearPort™ IV
Access | PREDICATE (K183399)
BD Nexiva™ Closed IV Catheter
System | Comparison &
Discussion |
| | | | supplier has been
qualified. Testing in
accordance with ISO
10993-1 requirements
did not raise any new
or different questions
related to biological
safety. |
| Extension Tubing | Thermoplastic Polyurethane | Thermoplastic Polyurethane | Same |
| Straight Luer Adapter | Copolyester | Copolyester | Same |
| Pinch Clamp | Acetal Copolymer | Acetal Copolymer | Same |
| MaxZero™ | Polycarbonate / Silicone | Polycarbonate / Silicone | Same |
| NearPort™ IV
Access | Polycarbonate / Silicone | N/A + not part of predicate device
design | Polymer material
family is same as other
needle-free connectors
offered with predicate
device. |
| Catheter
Dimensions | Catheter Diameters
18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Catheter Diameters
18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN,
1.75 IN | A 24 GA x
0.56 IN product
configuration is not part
of the subject device
submission; however,
all other configurations
(e.g., Gauge and
Length) are within the
bounds of the predicate
device, which does not
raise any new or
different questions of
safety and effectiveness
(i.e., performance
testing). |
| Product
Configurations | • NearPort IV Access | • Single Port
• Single Port with MaxZero
• Dual Port
• Dual Port with Q-Syte
• Dual Port with Q-Syte and End
Cap
• Dual Port with MaxZero | NearPort IV Access
component is a needle-
free connector same as
Q-Syte and MaxZero |
| Sterilization
Modality | Ethylene Oxide | Ethylene Oxide | Same |
| | bd.com | | |
| Attribute | SUBJECT (K231239)
Nexiva™ Closed IV Catheter
System with NearPort™ IV
Access | PREDICATE (K183399)
BD Nexiva™ Closed IV Catheter
System | Comparison &
Discussion |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| Energy Source | User operated | User operated | Same |
| Single Use Only | Yes | Yes | Same |
5
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
6
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
7
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
8
| Summary of
Performance
Testing | A Risk Analysis in accordance with ISO 14971:2019 was conducted to assess the
impact of the proposed modifications to the predicate device.
Performance tests completed on the subject devices were limited to those tests
required to support a determination of substantial equivalence to the predicate
device. A risk analysis was conducted to assess the impact of the proposed
modifications to the predicate device. 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 conducted to ensure that the subject device
meets predetermined design requirements:
- Compliance Testing Biocompatibility (ISO 10993-1) Body contact: Externally communicating device Contact: Circulating blood Contact duration: Limited (A) to Prolonged (B) (≤ 24 hrs to 30 days) Sterilization Residuals (ISO 10993-7) Packaging Testing (ASTM D4169) Sterilization Validation (ISO 11135-1) Performance Testing per ISO 10555-1 and ISO 10555-5 Peak Tensile Force (ISO 10555-1 §4.6) Liquid Leakage (ISO 10555-1 §4.7.1) Air Leakage (ISO 10555-1 §4.7.2) Gravity Flow Rate (ISO 10555-1 §4.9) Power Injection Flow Rate (ISO 10555-1 §4.10) Needle Safety Testing (ISO 23908) Luer Testing (ISO 594-1 and ISO 594-2) 2) BD Internal Studies |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
- Catheter tubing open flow pressure .
- Catheter tubing rupture pressure .
- System burst ●
- Catheter adapter separation force ●
- Extension tubing detachment force ●
9
- Wing bending force ●
- Needle cover removal force .
- Needle cover retention .
- . Flow control plug retention rate
| | 3) Evaluation of MR Compatibility per ASTM F2182-19 Standard Test Method for
Measurement of Radio Frequency Induced Heating On or Near Passive
Implants During Magnetic Resonance Imaging and Testing and Labeling
Medical Devices for Safety in the Magnetic Resonance (MR) Environment,
Guidance for Industry and Food and Drug Administration Staff, issued May
2021 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 4) Evaluation of Microbial Ingress per Intravascular Administration Sets
Premarket Notification Submissions [510(k)] Guidance for Industry and FDA
Staff, issued July 2008 |
| | 5) Usability testing per Applying Human Factors and Usability Engineering to
Medical Devices Guidance for Industry and Food and Drug Administration
Staff, issued February 2016 |
| | Per design control requirements specified in 21 CFR 820.30, the subject devices
met all predetermined acceptance criteria for the above-listed performance tests,
demonstrating substantial equivalence to the predicate devices. |
| | Clinical studies are not required to demonstrate substantial equivalence to the
predicate device. |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and results of
performance testing, the subject device, Nexiva™ Closed IV Catheter System with
NearPort™ IV Access has been demonstrated to be substantially equivalent to the
predicate BD Nexiva™ Closed IV Catheter System |