(137 days)
Not Found
No
The summary describes a mechanical intravascular catheter system with features for safety and ease of use. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No.
This device is an intravascular catheter used for sampling blood, monitoring blood pressure, or administering fluids, which are diagnostic and supportive functions, not direct therapeutic treatments.
No
The device is an intravascular catheter used for sampling blood, monitoring blood pressure, or administering fluids. While these actions might be part of diagnostic processes, the catheter itself does not analyze or interpret data to diagnose a condition.
No
The device description clearly outlines multiple physical components made of various materials (catheter, needle, septum, platform, tubing, clamp, plug, connector). It also describes bench testing involving physical properties and performance, not just software validation.
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 to sample blood, monitor blood pressure, or administer fluids. These are direct interactions with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical device designed for insertion into the body, including a catheter, needle, tubing, and connectors. It focuses on features related to insertion, safety (needle shielding), and fluid handling within 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 diagnosis, monitoring, or screening. This device does not perform any analysis or testing of specimens in vitro. It is used to obtain the specimen or deliver substances to the body.
Therefore, the BD Nexiva™ Diffusics™ intravascular catheter is a medical device used for direct patient care within the vascular system, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
80 FOZ, 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. See Table 1 for a list of BD Nexiva Diffusios available aatheter sizes.
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
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)
Studies were designed and performed to demonstrate that the BD Nexiva Diffusics device met-predetermined product specifications. Bench-testing was performed to ensure the safety and effectiveness of the device, to verify conformity to the standards listed in this application, and to demonstrate substantial equivalence to the predicate. No new issues of safety and effectiveness were raised with the testing performed so therefore the BD Nexiva Diffusics (subject) is substantially equivalent to the predicate devices. Performance testing included in-vitro testing in accordance with ISO 10555-1 and ISO 10555-5 and included flow rate testing, catheter strength and performance, clamp performance, labeling durability, extension tube and septum integrity and biocompatiblity evaluation in accordance with ISO 10993-1.
No clinical test results were included in this submission.
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).
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SEP 3 0 2011
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Section 5 510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS FOR BD NEXIVA™ DIFFUSICS™ CLOSED IV CATHETER SYSTEM
1. SUBMITTER INFORMATION:
Submitter:
Becton Dickinson Infusion Therapy Systems Inc 9450 South State Street Sandy, UT 84070
Contact Person:
Telephone: FAX:
Rachel LeBlanc Staff Regulatory Affairs Specialist (801) 565-2649 (801) 565-2749
Date Summary was prepared: September 20, 2011
2. DEVICE INFORMATION:
Trade Name:
BD Nexiva™ Diffusics™ Closed IV Catheter System Common Name: Peripheral Intravascular Catheter or IV Catheter Classification: 80 FOZ - Intravascular Catheter CFR Reference: 21 CFR 880.5200 - Class II Classification Panel: General Hospital
3. PREDICATE DEVICE INFORMATION:
Substantial equivalence is being claimed to the following legally marketed devices.
| Trade Name: | BD Nexiva™ Closed IV Catheter System |
|---|---|
| Common Name: | Peripheral Intravascular Catheter or IV Catheter |
| Classification: | 80 FOZ - Intravascular Catheter |
| CFR Reference: | 21 CFR 880.5200 - Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | Special 510(k) K102520, Traditional 510(k) K032843 |
| Trade Name: | BD Angiocath IV Catheter with Sideholes |
| Common Name: | Peripheral Intravascular Catheter or IV Catheter |
| Trade Name: | BD Angiocath IV Catheter with Sideholes |
|---|---|
| Common Name: | Peripheral Intravascular Catheter or IV Catheter |
| Classification: | 80FOZ - Intravascular Catheter |
| CFR Reference: | 880.5200 |
| Classification Panel: | General Hospital |
| Premarket Notifications: | K950301 (was a preamendment device before clearance under this 510(k) for a revised |
| sterilization standard) |
4. DESCRIPTION OF DEVICE:
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 (20)
1
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. See Table 1 for a list of BD Nexiva Diffusios available aatheter sizes.
Table 1. List of BD Nexiva™ Diffusics™ Available Catheter Sizes
| Gauge Size | Color Code
per ISO-10555-5 | Length in inches |
|------------|-------------------------------|------------------|
| 24 GA | Yellow | .75" |
| 22 GA | Blue | 1.0" |
| 20 GA | Pink | 1.0" |
| 20 GA | Pink | 1.25" |
| 18 GA | Green | 1.25" |
5. 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.
6. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE
Technological Characteristics
in the management of the many of the comments of the country of
Technological similarities between the subject BD Nexiva Diffusics Closed IV Catheter System and the predicate devices remain substantially equivalent. There are no new questions raised regarding safety or efficacy of the subject BD Nexiva Diffusics Closed IV Catheters.
| Table 2. Comparison between BD Nexiva™ Diffusics™ and predicates | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ------------------------------------------------------------------ | -- | -- |
| Factor/Component | BD Nexiva
Diffusics | BD Nexiva
(K102520) | BD Angiocath
with Sideholes
(K950301) |
|--------------------------------------------|------------------------|------------------------|---------------------------------------------|
| Same intended use | Yes | Yes | Yes |
| Same Vialon catheter
material | Yes | Yes | No (Teflon) |
| Radiopaque catheter | Yes | Yes | Yes |
| Flashback visualization | Yes | Yes | No |
| Needle-shielding feature | Yes | Yes | No |
| Closed IV catheter system | Yes | Yes | No |
| Ethylene oxide sterilization | Yes | Yes | Yes |
| Single use, sterile device | Yes | Yes | Yes |
| Multiple gauge sizes and
needle lengths | Yes | Yes | Yes |
2
The BD Nexiva Diffusics (subject) has the same intended use and similar technological characteristics as the predicates.
7. Bench Testing:
Studies were designed and performed to demonstrate that the BD Nexiva Diffusics device met-predetermined product specifications. Bench-testing was performed to ensure the safety and effectiveness of the device, to verify conformity to the standards listed in this application, and to demonstrate substantial equivalence to the predicate. No new issues of safety and effectiveness were raised with the testing performed so therefore the BD Nexiva Diffusics (subject) is substantially equivalent to the predicate devices. Performance testing included in-vitro testing in accordance with ISO 10555-1 and ISO 10555-5 and included flow rate testing, catheter strength and performance, clamp performance, labeling durability, extension tube and septum integrity and biocompatiblity evaluation in accordance with ISO 10993-1.
8. Clinical Tests Submitted:
No clinical test results were included in this submission.
9. Conclusions
Performance testing was conducted in accordance with consensus standards and design control requirements. Nonclinical test results and technological characteristics of like gauge size catheters were shown to be equivalent between the subject device and the predicate device. The differences among the devices do not raise any issues of safety or effectiveness. The subject BD Nexiva Diffusics device met the minimum requirements and are substantially equivalent in design, materials, sterilization, principles of operations and indications for use to the predicates.
Based on the above summary and the enclosed sections of this premarket notification regarding substantial equivalence to the predicate device, Becton Dickinson Infusion Therapy Systems Inc. concludes that the BD Nexiva Diffusics device is substantially equivalent to the predicates and does not raise any new questions regarding safety and efficicacy.
The term "substantial equivalence" as used in this 510(tk) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21CFR 807, subpart E under which a device can be marketed without premarket approval or reclasslication. A determination of substantial equivalency udner this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No stalements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts,
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with three distinct, curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Rachel LeBlanc Staff Regulatory Affairs Specialist Becton Dickinson and Company (BD) 9450 South State Street Sandy, Utah 84070
SEP 3 0 2011
Re: K111366
Trade/Device Name: BD Nexiva" Diffusics™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 21, 2011 Received: September 22, 2011
Dear Ms. LeBlanc:
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.
4
Page 2 - Ms. LeBlanc
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/CentersQffices/CDRH/CDRHOffices /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 h11p://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 Sinall 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/Resourcesfor You/Industry/default.html
Sincerely yours.
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K111364
BD Nexiva™ Diffusics™
BD Nexiva™ Diffus PreMarket Notification- Traditional 510(k) Section 4 Indications for Use
Indications for Use
510(k) Number (if known)
Device Proprietary Name: BD Nexiva™ Diffusics™ Closed IV Catheter System
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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
__ 9/30/11
(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page _ of _
510(k) Number:
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