(29 days)
Not Found
No
The summary describes a mechanical medical device (IV catheter system) and its physical features and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is used to sample blood, monitor blood pressure, or administer fluids, which are diagnostic and supportive functions, not directly therapeutic.
No
The description of the device's intended use indicates it is for administering fluids, monitoring blood pressure, or sampling blood, which are therapeutic or monitoring functions, not diagnostic ones. While blood sampling can be used for diagnostic purposes, the device itself is a tool for obtaining the sample, not for performing the diagnosis.
No
The device description clearly outlines physical components such as catheters, needles, tubing, and connectors, indicating it is a hardware medical device. There is no mention of software as a component or the primary function.
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 catheter system designed for insertion into a blood vessel. It describes components like a needle, catheter, extension tubing, and connectors, all consistent with a device used for accessing the vascular system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any analysis or testing of a specimen outside the body. It is used to obtain the specimen (blood sampling) or deliver substances (administer fluids) or monitor within the body.
Therefore, the BD Nexiva Diffusics closed IV catheter system is a medical device used for accessing the vascular system, 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, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Product codes (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 throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate catheter gauge size (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
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 device. A risk analysis was conducted to assess the impact of the proposed modifications to the subject device, and the performance tests listed below were identified to ensure that specified design requirements were met:
No Leak after Repeated Bending Cycles Luer Adapter Pull Force When technological characteristics between the subject and predicate device were found to be identical, results of performance testing conducted on the predicate device were applied to the subject device. 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 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Becton, Dickinson and Company c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313
Re: K170283
Trade/Device Name: BD NexivaTM Diffusics™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 13, 2017 Received: January 30, 2017
Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Mark Job
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 devicerelated adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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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) K170283
Device Name BD Nexiva Diffusics Closed IV Catheter System
Indications for Use (Describe)
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ 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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510(k) Summary (21 CFR §807.92)
BD Nexiva™ Diffusics™ Closed IV Catheter System
| Submitter
Information | Submitter Name:
Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, UT 84070 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
Email Address:
Phone Number:
Fax Number
Date of Preparation: | Amy Honey
Regulatory Affairs Specialist
amy.honey@bd.com
(801) 304-3908
(801) 304-3963
January 13, 2017 |
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital |
| Predicate
Device | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System
K161777
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital |
| 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
throughout the insertion process. The septum is designed to wipe visible blood
from the needle surface as the needle is withdrawn from the catheter, further
reducing the risk of blood exposure. The needle tip is passively protected when | |
| | the needle is removed, reducing the risk of accidental needlestick injury. | |
| | These devices have BD Instaflash needle technology, allowing for immediate
visualization of blood along the catheter. Continuous blood return is seen in the
extension tubing. The vent plug prevents blood leakage from the extension tubing
during insertion. The stabilization platform and Luer connector are color coded to
indicate catheter gauge size (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 | 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 and predicate devices are substantially
equivalent with respect to the basic design and materials, and 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 Cather System. Design modifications have been made to the
subject device Luer adapter internal geometry to move the extension tubing / Luer
adapter bond location away from the extension tubing bend point. Performance
testing conducted to support the design modification are as follows: | |
| | No Leak after Repeated Bending Cycles | |
4
- Luer Adapter Pull Force
All pre-determined acceptance criteria were met.
A comparison of the subject and predicate device technological characteristics is provided in the table below.
| Attribute | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System | PREDICATE
BD Nexiva™ Diffusics™ Closed IV Catheter System
(K161777) |
|---------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Same as predicate | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter |
| Indications for
Use | Same as predicate | 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. |
| Fundamental
Scientific | Same as predicate | Closed peripheral intravascular catheter systems are
designed with an integrated extension set incorporating |
5
| Attribute | SUBJECT
BD Nexiva™ Diffusics™
Closed IV Catheter System | PREDICATE
BD Nexiva™ Diffusics™ Closed IV Catheter System
(K161777) |
|--------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | | either a single port or Y (dual)-port injection site.
Incorporates BD Instaflash technology to assist with
flashback visualization.
In addition, the catheter tip includes diffuser holes to
reduce the velocity of contrast media exiting the catheter
tip during CT scans. |
| Primary Device
Materials | Same as predicate | Needle:
Stainless Steel
Catheter:
Polyurethane
Catheter Wings:
TPE
Catheter Adapter:
Copolyester
Needle Hub:
Polycarbonate
Tip Shield:
Polycarbonate
Extension Tubing:
Polyurethane
Luer Adapter:
Copolyester
Pinch Clamp:
Acetal |
| Physical /
Mechanical
Specifications | Same as predicate | Catheter Diameters
18G, 20G, 22G, 24G
Catheter Lengths
0.75", 1.00", 1.25" |
| Sterility | Same as predicate | Provided sterile (EO) |
| 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
device. A risk analysis was conducted to assess the impact of the proposed
modifications to the subject device, and the performance tests listed below were
identified to ensure that specified design requirements were met:
No Leak after Repeated Bending Cycles Luer Adapter Pull Force When technological characteristics between the subject and predicate device were
found to be identical, results of performance testing conducted on the predicate
device were applied to the subject device.
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 device. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and results of
performance testing, the subject BD Nexiva™ Diffusics™ Closed IV Catheter
System has been demonstrated to be substantially equivalent to the predicate
device. |