(29 days)
Not Found
No
The 510(k) summary describes a physical medical device (IV catheter system) and its performance testing related to physical properties and compliance standards. There is no mention of software, algorithms, image processing, AI, DNN, or ML.
No.
The device is described as an IV catheter system for sampling blood or administering fluids, which are supportive functions for medical procedures and not in themselves therapeutic.
No
Explanation: The device is an IV catheter system intended for administering fluids or sampling blood, not for diagnosing medical conditions.
No
The device description clearly outlines numerous physical components (catheter, needle, shield, septum, etc.) and the performance studies focus on physical characteristics and compliance testing of these components. There is no mention of software as a component or its function.
Based on the provided information, the BD Nexiva™ Diffusics™ Closed IV Catheter System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to be inserted into a patient's vascular system to sample blood or administer fluids. This is a direct interaction with the patient's body for therapeutic or diagnostic sampling purposes, not for testing samples outside the body.
- Device Description: The description details a catheter system designed for insertion into the vascular system. There is no mention of components or functions related to analyzing biological samples in vitro.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening based on the analysis of samples
- Reagents, calibrators, or controls used for testing samples
- Any form of in vitro analysis or testing.
The device is clearly intended for in vivo use within the patient's vascular system.
N/A
Intended Use / Indications for Use
The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood 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 (comma separated list FDA assigned to the subject device)
FOZ
Device Description
BD Nexiva™ Diffusics™ Closed IV Catheter Systems are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ catheter material with three 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. A BD MaxZero™ device with protective cover is provided in the unit package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A Risk Analysis was conducted in accordance with ISO 14971, Medical Devices - Risk Management for Medical Devices was conducted to assess the impact of the proposed modifications to the predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. 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:
- Sterilization Residuals (ISO 10993-7)
- Biocompatibility (ISO 10993-1)
- Packaging Testing ISO 11607-1
- Aseptic Presentation Test (ISO 11607-1, Section 7)
- Simulated Shipping Conditioning (ISO 11607-1, Section 8)
- Bubble Leak Detection (Package Integrity) (ISO 11607-1, Section 8)
- Package Peel Force Pouch Seal Strength (ISO 11607-1, Section 5.1.8 and 5.1.9c)
- Packaging Materials Microbial Barrier (ISO 11607-1, Annex C)
- Ink Permanency/Text Legibility (ISO 11607-1, Section 5.4)
- Seal Width (ISO 11607-1, Section 5.1.6d; 5.1.8c and 5.1.9d)
- Packaging must protect the product from damages (Damage to Device) ISO 11607-1)
- Testing in accordance with ISO 10555-1
- Gravity Flow Rate (ISO 10555-1. Section 4.9)
- Catheter Burst Pressure (ISO 10555-1, Section 4.10)
- Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) (ASTM F2096-11)
- Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15)
- Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169-16)
- BD Internal Requirements
- Open flow pressure
- Power injection peak pressure
- Catheter stability
Key Results: Per 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 device. 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2023
Becton Dickinson Infusion Therapy Systems Inc. Sunny Patel Senior Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070
Re: K233529
Trade/Device Name: BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: November 1, 2023 Received: November 2, 2023
Dear Sunny Patel:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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
3
Indications for Use
510(k) Number (if known) K233529
Device Name
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
Indications for Use (Describe)
The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood or administer fluids. These devices may 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) |
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4
bd.com
Image /page/4/Picture/2 description: The image shows the BD logo. The logo consists of two parts: a stylized sun-like symbol in orange and the letters "BD" in blue. The sun-like symbol is on the left, and the letters "BD" are on the right.
K233529- 510(k) Summary
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
| Submitter
| Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | ||
|---|---|---|---|---|
| Submitter Address: | 9450 South State Street, Sandy, Utah 84070 | |||
| Contact Person: | Sunny Patel, Senior Regulatory Affairs Specialist | |||
| Email Address: | sunny.patel@bd.com | |||
| Phone Number: | (817) 609-9594 | |||
| Subject Device | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System | ||
| with BD MaxZero™ Needle-free Connector | ||||
| Common Name: | Peripheral Intravascular or IV Catheter | |||
| 510(k) Reference: | K233529 | |||
| Regulation Number: | 21 CFR §880.5200 | |||
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | |||
| Regulatory Class: | II | |||
| Product Code: | FOZ | |||
| Classification Panel: | General Hospital | |||
| Predicate Device | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System | ||
| Common Name: | Peripheral Intravascular or IV Catheter | |||
| 510(k) Reference: | K173354 | |||
| Regulation Number: | 21 CFR §880.5200 | |||
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | |||
| Regulatory Class: | II | |||
| Product Code: | FOZ | |||
| Classification Panel: | General Hospital | |||
| Reason for | ||||
| Submission | The purpose of this submission is to introduce the BD Nexiva™ Diffusics™ Closed IV | |||
| Catheter System with BD MaxZero™ Needle-free Connector. | ||||
| Device | ||||
| Description | BD Nexiva™ Diffusics™ Closed IV Catheter Systems are over-the-needle, intravascular | |||
| (IV) catheters. These devices have a radiopaque BD Vialon™ catheter material with | ||||
| three 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. A BD | ||||
| MaxZero™ device with protective cover is provided in the unit package. |
Date: December 1, 2023
5
bd.com
| Indications for Use
(21 CFR §
807.92(a)(5)) | The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into
a patient's vascular system for short term use to sample blood 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. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|
| Technological
Characteristics | Technological characteristics of the subject BD Nexiva™ Diffusics™ Closed IV
Catheter System with BD MaxZero™ Needle-free Connector are substantially
equivalent to predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. The
subject device 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 | PREDICATE (Κ173354) | |
| 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 needle stick 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 (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1
mm) = Pink, 18 GA (1.3 mm) = Green). | | | |
| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV
Catheter System with BD
MaxZero™ Needle-free Connector | PREDICATE (K173354)
BD Nexiva™ Diffusics™ Closed IV
Catheter System | Comparison |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 880.5200
Class II
FOZ - Intravascular Catheter | 21 CFR 880.5200
Class II
FOZ - Intravascular Catheter | Same |
| Indications for
Use | The 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 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 | The 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 | Substantially Equivalent-
The subject and predicate
devices are both intended
to sample blood and
administer fluids.
The subject device
Indications for Use has
been narrowed to remove
"monitor blood pressure"
compared to the predicate
device.
Narrowing the
Indications for Use does
not raise any new or |
| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV
Catheter System with BD
MaxZero™ Needle-free Connector | PREDICATE (K173354)
BD Nexiva™ Diffusics™ Closed IV
Catheter System | Comparison |
| | for use with power injectors are
removed. | suitable for use with power injectors
are removed. | different questions of
safety or effectiveness. |
| Intended Use | Intravascular access | Intravascular access | Same |
| Fundamental
Scientific
Technology | Closed peripheral intravascular
catheter system are 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 are designed with an
integrated extension set incorporating
a single port injection site.
Incorporates BD Instaflash™
technology to assist with flashback
visualization | Same |
| | 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 (Cannula) | Stainless Steel | Stainless Steel | Same |
| Catheter Tubing | BD Vialon™ Polyurethane with
Barium Sulfate | BD Vialon™ Polyurethane with
Barium Sulfate | Same |
| Catheter Adapter | Copolyester | Copolyester | Same |
| Catheter Adapter
Wings | TPE with Gauge-Specific Colorant | TPE with Gauge-Specific Colorant | Same |
| Tip Shield | Polycarbonate with Grey Colorant | Polycarbonate with Grey Colorant | Same |
| Grip/Needle Hub | Polycarbonate with White Colorant | Polycarbonate with White Colorant | Same |
| Pinch Clamp | Acetal with Blue Colorant | Acetal with Blue Colorant | Same |
| Extension Tubing | Biomerics Polyurethane | Biomerics Polyurethane | Same |
| Luer Adapter | Copolyester with Gauge-Specific
Colorant | Copolyester with Gauge-Specific
Colorant | Same |
| Luer Adapter
Overmold | TPE with Blue Colorant and White
Print Ink | TPE with Blue Colorant and White
Print Ink | Same |
| End Cap | Polypropylene with White Colorant | Polypropylene with White Colorant | Same |
| End Cap
Protective Cover | HDPE with Blue Colorant | HDPE with Blue Colorant | Same |
| Vent Plug | Polypropylene and Acrylic-Nylon
Membrane | Polypropylene and Acrylic-Nylon
Membrane | Same |
| 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
0.75 IN, 1.00 IN, 1.25 IN | Different-
The subject and predicate
devices are substantially
equivalent. The longer
length (1.75 IN) subject
device configurations
were evaluated using the
equivalent test methods
as the predicate device. |
| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV
Catheter System with BD
MaxZero™ Needle-free Connector | PREDICATE (K173354)
BD Nexiva™ Diffusics™ Closed IV
Catheter System | Comparison |
| | | | This modification did not
raise any new or different
questions of safety and
effectiveness. |
| Product
Configurations | Single Port with BD MaxZero™ Needle-free Connector | Single Port | Different-
The subject and predicate
devices are offered in the
same single port
configuration. The BD
MaxZero™ Needle-free
Connector is included as
a kit component in the
subject device unit
package. The addition of
the BD MaxZero™
Needle-free Connector as
a kit component does not
alter the intended use of
the subject device
compared to the predicate
device. |
| Sterilization
Modality | Ethylene Oxide | Ethylene Oxide | Same |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| Energy Source | User operated | User operated | Same |
| Disposable or
Reusable | Disposable | Disposable | Same |
| Single Use Only | Yes | Yes | Same |
6
7
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA
bd.com
8
bd.com
A Risk Analysis was conducted in accordance with ISO 14971, Medical Devices - Risk Summary of Management for Medical Devices was conducted to assess the impact of the proposed Performance modifications to the predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. Tests 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: 1) Compliance Testing: . Sterilization Residuals (ISO 10993-7) ● Biocompatibility (ISO 10993-1) Packaging Testing ISO 11607-1 . Aseptic Presentation Test (ISO 11607-1, Section 7) -Simulated Shipping Conditioning (ISO 11607-1, Section 8) -Bubble Leak Detection (Package Integrity) (ISO 11607-1, Section 8) -Package Peel Force Pouch Seal Strength (ISO 11607-1, Section 5.1.8 and 5.1.9c) -Packaging Materials Microbial Barrier (ISO 11607-1, Annex C) --Ink Permanency/Text Legibility (ISO 11607-1, Section 5.4) Seal Width (ISO 11607-1, Section 5.1.6d; 5.1.8c and 5.1.9d) -Packaging must protect the product from damages (Damage to Device) ISO 11607-1) ● Testing in accordance with ISO 10555-1 Gravity Flow Rate (ISO 10555-1. Section 4.9) -Catheter Burst Pressure (ISO 10555-1, Section 4.10) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble ● Test) (ASTMF 2096-11) . Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-15) Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169-16) ● 2) BD Internal Requirements ● Open flow pressure ● Power injection peak pressure Catheter stability ● Per 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 device. Clinical studies are not required to demonstrate substantial equivalence to the predicate device. Summary of Based on the indications for use, technological characteristics, and results of performance testing, Substantial the subject BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-Equivalence free Connector has been demonstrated to be substantially equivalent to the predicate BD NexivaTM Diffusics™ Closed IV Catheter System (K173354).