(43 days)
Not Found
No
The provided text describes a standard intravascular catheter with features focused on safety and fluid administration. There is no mention of AI or ML technology in the intended use, device description, or performance studies summary.
No
The device is used to administer fluids, not to treat a condition.
No.
The device is used to administer fluids, not to diagnose a condition.
No
The device description clearly details physical components such as a catheter, needle, septum, stabilization platform, extension tubing, clamp, vent plug, and Luer connector, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "inserted into a patient's vascular system to administer fluids." This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a catheter system designed for insertion into the body and fluid administration. It does not describe any components or processes related to analyzing samples of bodily fluids or tissues outside of the body for diagnostic purposes.
- Lack of Diagnostic Information: The document focuses on the physical characteristics of the catheter, its ability to withstand pressure, and safety features related to insertion and blood containment. There is no mention of measuring analytes, detecting biomarkers, or providing any diagnostic information.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is a tool for delivering substances directly into the body.
N/A
Intended Use / Indications for Use
The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Product codes
FOZ
Device Description
The BD Nexiva Diffusics device is designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of a radiopaque Vialon® material catheter, a notched needle to enhance flashback visualization, a septum designed to remove visible blood from the needle surface that seals after needle removal, a stabiliization platform, extension tubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge catheter systems are capable of withstanding high pressure injection procedures. The stabilization platform and Luer adapter are color-coded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
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)
Results of safety and performance testing demonstrated that the subject device met all predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K12373ष
BD Medical
9450 Soulh State Street Sandy, Utah 84070 - 301
United Statea of America
Nel: 801 5685.2300
fex: 801.5685.2300
www.bd.com
BD
JAN 1 7 2013 .
Helping all people live healthy lives
510(k) Summary
21 CFR §807.92(c)
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: | Kimberly Geisler
Staff Regulatory Affairs Specialist
kimberly_geisler@bd.com
(801) 565-2422 (phone)
(801) 565-2749 (fax) |
| | Date of Preparation: | December 4, 2012 |
| Subject Device | Trade Name:
Common Name:
Classification Name:
CFR Reference:
Classification Panel: | BD Nexiva™ Diffusics™ Closed IV Catheter System
Peripheral Intravascular Catheter or IV Catheter
80 FOZ - Intravascular Catheter
21 CFR 880.5200 - Class II
General Hospital |
| Predicate Device | Trade Name:
Common Name:
Classification Name:
CFR Reference:
Classification Panel:
Premarket Notification: | BD Nexiva™ Diffusics™ Closed IV Catheter System
Peripheral Intravascular Catheter or IV Catheter
80 FOZ - Intravascular Catheter
21 CFR 880.5200 - Class II
General Hospital
K111366 |
| Device
Description | The BD Nexiva Diffusics device is designed to minimize blood exposure. It
includes a passive needle-shielding mechanism designed to reduce accidental
needlestick injury. The closed system is designed to keep blood contained
within the device throughout the insertion process, which may prevent potential
exposure for clinicians and patients. The system consists of a radiopaque
Vialon® material catheter, a notched needle to enhance flashback
visualization, a septum designed to remove visible blood from the needle
surface that seals after needle removal, a stabiliization platform, extension
tubing, a clamp, a vent plug and a Luer connector. The 18-24 gauge catheter
systems are capable of withstanding high pressure injection procedures. The
stabilization platform and Luer adapter are color-coded. | |
| Indications for
Use | The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patient's
vascular system to sample blood, monitor blood pressure or administer fluids.
The BD Nexiva Diffusics catheters are suitable for use with power injectors
when a direct connection is made. | |
| Technological
Characteristics | Technological characteristics of the subject BD Nexiva™ Diffusics™ Closed
IV Catheter System are equivalent to that of the predicate BD Nexiva™
Diffusics™ Closed IV Catheter System with respect to device design and
function. Differences include modifications to the maximum flow rate
specifications. These differences do not raise any new questions regarding
safety or effectiveness. | |
| Summary of
Safety and
Performance
Tests | Pursuant to 21 CFR §820.30, Design Controls, design verification and
validation of the device modifications were performed according to the risk
analysis in compliance with ISO 14971:2009, Medical devices - Application of
risk management to medical devices. The following guidance documents and
FDA recognized consensus standards, in conjunction with in-house protocols,
were used to determine appropriate methods for evaluating the safety and
performance of the device.
Guidance on Premarket Notification [510(k)] Submission for Short-Term
and Long-Term Intravascular Catheters, March 16, 1995 ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for Syringes,
Needles and Certain other Medical Equipment Part 1: General
Requirements ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for Syringes,
Needles and Certain other Medical Equipment Part 2: Lock Fittings ISO 10555-1:1995 Amd2: 2004, Sterile, single use intravascular
catheters- Part 1: General Requirements ISO 10555-5:1996 (E) Corrigendum 1, Am 1, Sterile, single use
intravascular catheters- Part 5: Over-needle peripheral catheters ANSI/AAMI/ISO 10993-1:2009, Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing FDA Blue Book Memorandum #G95-1, Use of International Standards
ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation
and Testing ANSI/AAMI/ISO 10993-7:2008, Biological Evaluation of Medical Devices
Part 7: Ethylene Oxide Sterilization Residuals ANSI/AAMI/ISO 11135-1:2007, International Standard Sterilization of
Health Care Products-Part 1: Requirements for development, validation,
and routine control of a sterilization process for medical devices Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry
and FDA, August 30, 2002 ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical
devices - Part 1: Requirements for materials, sterile barrier systems and
packaging systems ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medical
devices - Part 2: Validation requirements for forming, sealing and
assembly processes | |
1
Becton Dickinson Infusion Therapy Systems Inc.
.
.
.
2
23
Results of safety and performance testing demonstrated that the subject device met all predetermined acceptance criteria.
Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, and safety and performance testing, the subject BD Nexiva™ Diffusics™ Closed IV Calheter System meets the predetemined requirements under 21 CFR 820.30, Design Controls, and demonstrates that the subject device is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2013
Ms. Kimberly Geisler Staff Regulatory Affairs Specialist Becton, Dickinson and Company 9450 South State Street Sandy, UT 84070
Re: K123734
Trade/Device Name: BD Nexiva™ Diffusics™ Closed IV Catheter System Regulation Number: 21CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 4, 2013 Received: December 5, 2013
Dear Ms. Geisler:
This letter corrects our substantially equivalent letter of January 17, 2013.
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 (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.
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.
4
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Anthony D. Janth 1 2013 03 Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number (if known): | K123734 |
|---|---|
| Device Proprietary Name: | BD Nexiva™ Diffusics™ Closed IV Catheter System |
Indications for Use:
The BD Noxiva™ Diffusics™ intravascular catheter is inserted into a patient's vascular system to mo be Norte - binonice of administer fluids. The BD Nextra Diffusics catheters are suitable for use with power injectors when a direct connection is made. The maximum flow rate and maximum power injector pressure setting for each catheter size are listed in the table below:
| | Max Flow Rate
(ml/sec) | Max Injector Setting
(psi) |
|-----------------|---------------------------|-------------------------------|
| 24 GA x 0.75 IN | 3.0 | 325 |
| 22 GA x 1.00 IN | 6.5 | 325 |
| 20 GA x 1.00 IN | 10.0 | 325 |
| 20 GA x 1.25 IN | 10.0 | 325 |
| 18 GA x 1.25 IN | 15.0 | 325 |
Prescription Use V (Part 21 CFR 5801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 8801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard C. Chapman 2013.03.26 12:02:51 -04/00
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _
432