(103 days)
Not Found
No
The document describes a physical medical device (IV catheter system) and its mechanical and material properties. There is no mention of software, algorithms, data processing, or any characteristics indicative of AI/ML technology.
Yes
The device is used to administer fluids, which is a therapeutic action, as it delivers substances for treatment.
No
The device is an IV catheter system intended for administering fluids, monitoring blood pressure, or sampling blood, and its description does not mention any diagnostic functions.
No
The device description clearly outlines numerous physical components (catheter, needle, shield, septum, tubing, connectors, etc.), indicating it is a hardware medical device.
Based on the provided information, 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 vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids. These are all procedures performed on the patient, not on a sample of the patient's body fluid or tissue outside the body for diagnostic purposes.
- Device Description: The description details a catheter system designed for direct insertion into a blood vessel. This aligns with its intended use for accessing the vascular system.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample or provide diagnostic information about a patient's condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Product codes (comma separated list FDA assigned to the subject device)
FOZ, FPA
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 (single or dual port), vent plug, and pre-attached needleless connector (BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with protective cover is provided in the unit package (not available with all configurations). The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash™ needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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 predicate 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 conducted to ensure that the subject device meets specified design requirements: MaxZero Retention Rate (BD internal specification), MaxZero Removal Torque (BD internal specification), Flow Control Plug Retention Rate (BD internal specification), Packaging Integrity (ASTM F2096), Damage to Device (ISO 11607-1 §6.3.5) (testing conducted to ensure packaging system provides adequate protection to the product through the hazards of handling, distribution and storage). Biocompatibility testing, conducted in accordance to 1) ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and 2) Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016), was leveraged from the predicate devices, including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute), Pyrogenicity (Material-Mediated Rabbit Pyrogen), Pyrogenicity (LAL), Subchronic Toxicity (subacute toxicity), Genotoxicity, Implantation, Haemocompatibility. Per the design control requirements specified in 21 CFR §820.30, the 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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March 20, 2019
Becton Dickinson Infusion Therapy Systems Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K183399
Trade/Device Name: BD Nexiva™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: March 11, 2019 Received: March 12, 2019
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183399
Device Name
BD Nexiva Closed IV Catheter System
Indications for Use (Describe)
BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K183399
510(k) Summary (21 CFR §807.92)
BD Nexiva™ Closed IV Catheter System
| Submitter
Information | Submitter Name:
Submitter Address:
Contact Person:
Email Address:
Phone Number:
Fax Number
Date of Preparation: | Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, UT 84070
Kimberly Geisler
Regulatory Affairs Manager
kimberly.geisler@bd.com
(801) 565-2422
(801) 304-3963
March 14, 2019 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | 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
Catheter, intravascular, therapeutic, short-term less than
30 days
II
FOZ (Primary); FPA (Secondary)
General Hospital |
| Predicate
Device 1 | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Closed IV Catheter System - Single Port
with MaxZero™ Needleless Connector
K170336
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Catheter, intravascular, therapeutic, short-term less than
30 days
II
FOZ (primary); FPA (secondary)
General Hospital |
| Predicate
Device 2 | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Closed IV Catheter System
K161777
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Catheter, intravascular, therapeutic, short-term less than
30 days
II
FOZ
General Hospital |
| Reason for
Submission | The reason for this submission is the addition of BD Nexiva Closed IV Catheter
System - Dual Port with MaxZero Needleless Connector configurations to the
BD Nexiva Closed IV Catheter System product offerings. | |
| 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 (single or dual port), vent plug, and pre-attached needleless connector
(BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter
are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with
protective cover is provided in the unit package (not available with all
configurations). | |
| | The closed system is designed to keep blood contained within the device
throughout the insertion process. The septum is designed to wipe visible blood
from the needle surface as the needle is withdrawn from the catheter, further
reducing the risk of blood exposure. The needle tip is passively protected when
the needle is removed, reducing the risk of accidental needlestick injury. | |
| | These devices have BD Instaflash needle technology, allowing for immediate
visualization of blood along the catheter. Continuous blood return is seen in the
extension tubing. The vent plug prevents blood leakage from the extension tubing
during insertion. Both the stabilization platform and Luer connector are color coded
to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue,
20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green). | |
| Indications for
Use
21 CFR
§807.92(a)(5)) | The subject device Indications for Use is the same as the predicate devices, with
two minor wording modifications: 1) addition of "peripheral" to clarify the location of
placement within the patient's vascular system; and 2) modification of "These
catheters" to "These devices" for clarification and consistency. | |
| | BD Nexiva closed IV catheter systems are intended to be inserted into a patient's
peripheral vascular system for short term use to sample blood, monitor blood pressure, or
administer fluids. These devices may be used for any patient population with consideration
given to adequacy of vascular anatomy, procedure being 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. | |
| Technological
Characteristics | Technological characteristics of the subject and predicate devices are substantially
equivalent with respect to the device design and materials. The subject BD Nexiva
Closed IV Catheter System achieves its intended use based on the same
technology and principles of operation as the predicate devices. | |
| | Compared to the predicate devices, the subject device product offerings are being
expanded to include the following BD Nexiva Closed IV Catheter System – Dual
Port with MaxZero Needleless Connector configurations: | |
| | 24 GA x 0.56 IN - Dual Port with MaxZero 24 GA x 0.75 IN - Dual Port with MaxZero 22 GA x 1.00 IN - Dual Port with MaxZero 22 GA x 1.75 IN – Dual Port with MaxZero 20 GA x 1.00 IN - Dual Port with MaxZero 20 GA x 1.25 IN - Dual Port with MaxZero 20 GA x 1.75 IN - Dual Port with MaxZero 18 GA x 1.25 IN - Dual Port with MaxZero | |
4
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 USA
bd.com
5
18 GA x 1.75 IN - Dual Port with MaxZero ●
Compared to the predicate devices, the subject BD Nexiva Closed IV Catheter System - Dual Port with MaxZero Needleless Connector configurations include a pre-attached MaxZero device on the Luer adapter and an additional MaxZero device in the unit package. Compared to the predicate devices, this represents a change to the connector on the Dual Port Y Luer adapter. No modifications are being made to the catheter sizes. Predicate and subject devices include the same catheter diameters (18 GA, 20 GA, 22 GA, 24GA) and catheter lengths (0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN).
| Attribute | SUBJECT
BD Nexiva Closed IV Catheter
System | PREDICATE 1
(K170336)
BD Nexiva Closed IV Catheter
System (Single Port) with
MaxZero Needleless
Connector | PREDICATE 2
(K161777)
BD Nexiva Closed IV Catheter
System |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | BD Nexiva closed IV catheter
systems are intended to be
inserted into a patient's
peripheral vascular system for
short term use to sample blood,
monitor blood pressure, or
administer fluids. These devices
may be used for any patient
population with consideration
given to adequacy of vascular
anatomy, procedure being
performed, fluids being infused,
and duration of therapy. The 22-
18 GA (0.9-1.3 mm) devices are
suitable for use with power
injectors set to a maximum
pressure of 300 psi (2068 kPa)
when access ports not suitable
for use with power injectors are
removed. | BD Nexiva Closed IV Catheter
System - Single Port with
MaxZero Needleless Connector
devices are 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. | 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 22-18 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. |
| Classification | 21 CFR §880.5200
Class II
FOZ - Catheter, intravascular,
therapeutic, short-term less than
30 days (primary)
FPA - IV Administration Set
(secondary) | 21 CFR §880.5200
Class II
FOZ - Catheter, intravascular,
therapeutic, short-term less than
30 days (primary)
FPA - IV Administration Set
(secondary) | 21 CFR §880.5200
Class II
FOZ - Catheter, intravascular,
therapeutic, short-term less than
30 days (primary) |
| 510(k) Status | Subject of this premarket
notification | K170336 - Clearance date
March 10, 2017 | K161777 - Clearance date
August 29, 2016 |
| Fundamental
Scientific
Technology | Closed peripheral intravascular
catheter system designed with
an integrated extension set
incorporating a single port or Y
(dual)-port injection site.
Incorporates BD Instaflash™
technology to assist with
flashback visualization. | 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 peripheral intravascular
catheter system designed with an
integrated extension set
incorporating a single port or Y
(dual)-port injection site.
Incorporates BD Instaflash ™
technology to assist with
flashback visualization. |
| | Primary Device Components / Materials | | |
| Needle | Stainless Steel | Stainless Steel | Stainless Steel |
| Catheter Tubing | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate |
| Catheter Adapter
Wings | TPE + Gauge-Specific Colorant | TPE + Gauge-Specific Colorant | TPE + Gauge-Specific Colorant |
| Catheter Adapter | Copolyester | Copolyester | Copolyester |
| Tip Shield | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant |
| Grip / Needle
Hub | Polycarbonate + White Colorant | Polycarbonate + White Colorant | Polycarbonate + White Colorant |
| Pinch Clamp | Acetal | Acetal | Acetal |
| Extension Tubing | Polyurethane | Polyurethane | Polyurethane |
| Luer Adapter | Copolyester | Copolyester | Copolyester |
| Q-Syte | Polycarbonate / Silicone | N/A | Polycarbonate / Silicone |
| MaxZero | Polycarbonate / Silicone | Polycarbonate / Silicone | N/A |
| | Catheter Diameters | Catheter Diameters | Catheter Diameters |
| Catheter
Dimensions | 18 GA, 20 GA, 22 GA, 24GA | 18 GA, 20 GA, 22 GA, 24GA | 18 GA, 20 GA, 22 GA, 24GA |
| | Catheter Lengths | Catheter Lengths | Catheter Lengths |
| | 0.56 IN, 0.75 IN, 1.00 IN, 1.25
IN, 1.75 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25
IN, 1.75 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN,
1.75 IN |
| | • Single Port | • Single Port | • Single Port |
| | • Single Port with MaxZero | • Single Port with MaxZero | N/A |
| Product
Configurations | • Dual Port | N/A | • Dual Port |
| | • Dual Port with Q-Syte | N/A | • Dual Port with Q-Syte |
| | • Dual Port with Q-Syte and End
Cap | N/A | • Dual Port with Q-Syte and End
Cap |
| | • Dual Port with MaxZero | N/A | N/A |
| Sterility | Provided sterile (EO) | Provided sterile (EO) | Provided sterile (EO) |
A comparison of the subject and predicate device technological characteristics is provided in the table below, with differences highlighted in BOLD text.
6
7
| Summary of
Performance
Tests | 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 predicate 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 conducted to ensure that
the subject device meets specified design requirements: |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MaxZero Retention Rate (BD internal specification) MaxZero Removal Torque (BD internal specification) Flow Control Plug Retention Rate (BD internal specification) Packaging Integrity (ASTM F2096) Damage to Device (ISO 11607-1 §6.3.5) (testing conducted to ensure
packaging system provides adequate protection to the product through the
hazards of handling, distribution and storage) |
| | Biocompatibility testing, conducted in accordance to 1) ISO 10993-1:2009,
Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and 2)
Use of International Standard ISO 10993-1, "Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management process" (issued
June 16, 2016), was leveraged from the predicate devices, including: |
| | Cytotoxicity Sensitization Intracutaneous Reactivity Systemic Toxicity (Acute) Pyrogenicity (Material-Mediated Rabbit Pyrogen) Pyrogenicity (LAL) Subchronic Toxicity (subacute toxicity) Genotoxicity Implantation Haemocompatibility |
| | Per the design control requirements specified in 21 CFR §820.30, the subject
device met all predetermined acceptance criteria for the above-listed performance
tests, demonstrating substantial equivalence to the predicate devices. |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and results of
performance testing, the subject BD Nexiva Closed IV Catheter System has been
demonstrated to be substantially equivalent to the predicate devices. |