(51 days)
Not Found
No
The summary 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 terms related to AI/ML.
No.
The device is used to administer fluids or sample blood, not to provide therapy.
No
The device is intended for administering fluids, sampling blood, or monitoring blood pressure, which are functions related to treatment or monitoring rather than diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug, indicating it is a hardware 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 vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids. These are direct interactions with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical catheter system designed for insertion into a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, or analytical instruments used on samples like blood, urine, or tissue.
Therefore, the BD Nexiva™ Diffusics™ Closed IV Catheter System is a medical device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's vascular system for short term use to sample blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter with side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed modifications to the subject devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that specified design requirements were met:
- No Leak after Repeated Bending Cycles ●
- Extension Set Pull Force .
- Extension Tube Yield / Rupture Pressure ●
- Pinch Clamp Vacuum Occlusion
- Pinch Clamp Engagement Force .
In addition, the following biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
- Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity ●
- Systemic Toxicity (Acute) ●
- Material-Mediated Pyrogenicity ●
- Subchronic Toxicity (subacute toxicity) ●
- Haemocompatibility ●
Finally, particulate analysis of the surface and fluid path was conducted, upon the guidance of USP , as clinically relevant.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6, 2018
Becton Dickinson Infusion Therapy Systems, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K173354
Trade/Device Name: BD Nexiya Diffusics Closed IV Catheter Systems Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: October 23, 2017 Received: October 25, 2017
Dear Mark Job:
This letter corrects our substantially equivalent letter of December 15, 2017.
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 to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Tina Kiang
-s
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) K173354
Device Name BD Nexiva™ Diffusics™ Closed IV Catheter System
Indications for Use (Describe)
BD Nexiva™ Diffusics™ Closed IV Catheter Systems are intended to be inserted into a patient's vascular system for short term use to sample blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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K173354
510(k) Summary
21 CFR §807.92
BD Nexiva™ Diffusics™ Closed IV Catheter System
| Submitter
| Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | ||
|---|---|---|---|---|
| Submitter Address: | 9450 South State Street | |||
| Sandy, UT 84070 | ||||
| Contact Person: | Henry Boland | |||
| Staff Regulatory Affairs Specialist | ||||
| henry.boland@bd.com | ||||
| (801) 565-2550 | ||||
| Date of Preparation: | November 17, 2017 | |||
| Subject Device | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System | ||
| Common Name: | Peripheral Intravascular or IV Catheter | |||
| Regulation Number: | 21 CFR §880.5200 | |||
| Regulation Name: | Intravascular Catheter | |||
| Regulatory Class: | II | |||
| Product Code: | FOZ | |||
| Classification Panel: | General Hospital | |||
| Predicate | ||||
| Device | Trade Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System | ||
| 510(k) Reference: | K170283 | |||
| Common Name: | Peripheral Intravascular or IV Catheter | |||
| Regulation Number: | 21 CFR §880.5200 | |||
| Regulation Name: | Intravascular Catheter | |||
| Regulatory Class: | II | |||
| Product Code: | FOZ | |||
| Classification Panel: | General Hospital | |||
| Reason for | ||||
| Submission | The reason for this submission is to notify CDRH of a modification to the BD | |||
| Nexiva™ Diffusics™ Closed IV Catheter System. The modification is a change to | ||||
| extension tubing polyurethane material formulation and manufacturer. | ||||
| Device | ||||
| Description | BD Nexiva Diffusics closed IV catheter systems are over-the-needle, intravascular | |||
| catheters. These devices have a radiopaque BD Vialon catheter with side holes | ||||
| located near the tip of the catheter which are designed to optimize power injection | ||||
| procedures. These devices also have a needle, needle shield, septum, | ||||
| stabilization platform, integrated extension tubing, clamp, Luer connector, and vent | ||||
| plug. The Luer connector displays gauge-specific maximum flow rate and the | ||||
| maximum power injector pressure limit setting. The needle and catheter are | ||||
| protected by a needle cover. An end cap with protective cover is provided in the | ||||
| unit package. | ||||
| The closed system is designed to keep blood contained within the device |
4
| Indications for
Use
(21 CFR
§807.92(a)(5)) | The subject device Indications for Use is the same as the predicate BD Nexiva™
Diffusics™ Closed IV Catheter System (K170283). | |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | PREDICATE DEVICE
(K170283) |
| | BD Nexiva Diffusics closed IV catheter
systems are intended to be inserted into
a patient's vascular system for short
term use to sample blood, monitor
blood pressure, or administer fluids.
These devices may be used for any
patient population with consideration
given to adequacy of vascular anatomy,
procedure being performed, fluids being
infused, and duration of therapy. These
devices are suitable for use with power
injectors set to a maximum pressure of
325 psi (2240 kPa) when access ports
not suitable for use with power injectors
are removed. | BD Nexiva Diffusics closed IV catheter
systems are intended to be inserted into
a patient's vascular system for short
term use to sample blood, monitor
blood pressure, or administer fluids.
These devices may be used for any
patient population with consideration
given to adequacy of vascular anatomy,
procedure being performed, fluids being
infused, and duration of therapy. These
devices are suitable for use with power
injectors set to a maximum pressure of
325 psi (2240 kPa) when access ports
not suitable for use with power injectors
are removed. |
| Technological
Characteristics | Technological characteristics of the subject device are substantially equivalent to
the predicate device. The subject BD Nexiva™ Diffusics™ Closed IV Catheter
System achieves its intended use based on the same technology and principles of
operation as the predicate BD Nexiva™ Diffusics™ Closed IV Catheter System. The
subject device has been modified from the predicate device as listed below. The
results of design verification demonstrate that these changes are substantially
equivalent to the predicate device. All other aspects of the subject device are
identical to those of the predicate device.
• Change to Extension Tubing polyurethane material formulation and
manufacturer | |
| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV
Catheter System | PREDICATE
BD Nexiva™ Diffusics™ Closed IV
Catheter System |
| | Catheter System | Catheter System (RT76265) |
| Design | A winged, power injectable, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with | A winged, power injectable, polyurethane IV catheter with an integrated extension set incorporating either a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with |
5
| Attribute | SUBJECT
BD Nexiva™ Diffusics™ Closed IV
Catheter System | | PREDICATE
BD Nexiva™ Diffusics™ Closed IV
Catheter System (K170283) | |
|-----------|---------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------|--|
| | flashback visualization. | | flashback visualization. | |
| | Component | SUBJECT DEVICE | PREDICATE DEVICE
(K170283) | |
| | Needle Cover | LDPE | LDPE | |
| | Needle | Stainless Steel | Stainless Steel | |
| | Needle Adhesive | Acrylated Urethane | Acrylated Urethane | |
| | Needle Lubricant | Silicone | Silicone | |
| Materials | Catheter Tubing | BD Vialon™ Polyurethane
with Barium Sulfate | BD Vialon™ Polyurethane
with Barium Sulfate | |
| | Catheter Lubricant | Silicone | Silicone | |
| | Catheter Tipping Lubricant | Silicone | Silicone | |
| | Catheter Adapter Wings | TPE with gauge-specific
colorant | TPE with gauge-specific
colorant | |
| | Catheter Adapter | Copolyester | Copolyester | |
| | Wedge | Stainless steel | Stainless steel | |
| | Septum Canister | Copolyester with grey
colorant | Copolyester with grey
colorant | |
| | Septum | Polyisoprene | Polyisoprene | |
| | V-Clip | Stainless steel with parylene
coating | Stainless steel with parylene
coating | |
| | Retention Washer | Stainless steel | Stainless steel | |
| | Tip Shield | Polycarbonate with grey
colorant | Polycarbonate with grey
colorant | |
| | Grip/Needle Hub | Polycarbonate with white
colorant | Polycarbonate with white
colorant | |
| | Pinch Clamp | Acetal with blue colorant | Acetal with blue colorant | |
| | Extension Tubing | Polyurethane | Polyurethane | |
| | Extension Tubing Adhesive | Acrylic | Acrylic | |
| | Luer Adapter | Copolyester with gauge -
specific colorant
White print ink | Copolyester with gauge -
specific colorant
White print ink | |
| | Luer Adapter Overmold | TPE with blue colorant | TPE with blue colorant | |
| | End Cap | Polypropylene with white
colorant | Polypropylene with white
colorant | |
| | End Cap Protective Cover | HDPE with blue colorant | HDPE with blue colorant | |
| | Vent Plug | Polypropylene and acrylic-
nylon membrane | Polypropylene and acrylic-
nylon membrane | |
Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate Tests devices. A risk analysis was conducted to assess the impact of the proposed
6
modifications to the subject devices. When technological characteristics between the subiect 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 specified design requirements were met:
- No Leak after Repeated Bending Cycles ●
- Extension Set Pull Force .
- Extension Tube Yield / Rupture Pressure ●
- Pinch Clamp Vacuum Occlusion
- Pinch Clamp Engagement Force .
In addition, the following biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
- Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity ●
- Systemic Toxicity (Acute) ●
- Material-Mediated Pyrogenicity ●
- Subchronic Toxicity (subacute toxicity) ●
- Haemocompatibility ●
Finally, particulate analysis of the surface and fluid path was conducted, upon the guidance of USP , as clinically relevant.
The subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.
Summary of Based on the indications for use, technological characteristics, and performance Substantial testing, the subject BD Nexiva™ Diffusics™ Closed IV Catheter System meets the Equivalence same pre-determined requirements as the predicate device, which BD developed as required by 21 CFR 820.30 Design Controls. The testing confirms that the subject device is substantially equivalent to the predicate BD Nexiva™ Diffusics™ Closed IV Catheter System.