(126 days)
Not Found
No
The summary describes a mechanical medical device (intravascular catheter) and its physical features for safety and performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material biocompatibility and manufacturing quality metrics (DPPM, Cpk).
No.
The device is used for basic medical procedures like sampling blood, monitoring blood pressure, or administering fluids, which are supportive functions and not inherently therapeutic. Its primary features relate to safety and convenience (e.g., needle-shielding, blood containment) rather than direct treatment of a disease or condition.
No
The device is an IV catheter used for administering fluids, monitoring blood pressure, and sampling blood, not for diagnosing a medical condition.
No
The device description clearly outlines physical components made of materials like Vialon™ polyurethane, integrated extension tubing, a Y adapter, a clamp, a luer access port, and a passive needleshielding mechanism. This indicates a hardware-based medical device, not a software-only one.
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, not tests performed in vitro (outside the body) on samples.
- Device Description: The description focuses on the physical components and how they function within the patient's vascular system (catheter, tubing, ports, needle-shielding). It describes a "closed system" for containing blood during insertion, not for analyzing blood samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory testing. The performance metrics (DPPM, Cpk) relate to manufacturing quality and physical performance, not diagnostic accuracy.
In summary, the BD Nexiva™ Closed IV Catheter System is a medical device used for accessing the vascular system for therapeutic and monitoring purposes, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-22 gauge Nexiva™ catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
Product codes
FOZ
Device Description
The BD Nexiva™ Closed IV Catheter System consists of an over-the needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needleshielding mechanism.
The design of the Nexiva™ IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the NexivaTM device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection of a BD Q-Syte™ luer access port.
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)
Nonclinical Tests:
Product Performance Characteristics/Verification Testing and Acceptance Criteria:
- Premature Decouple Force: DPPM
§ 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
Becton Dickinson Infusion Therapy Systems, Inc. 9450 South State Street Sandy UT 84070 tel: 801-565-2662 fax: 801-565-2749 iustice alder@hd.com
K102520/S2
Helping all people
live healthy lives
SPECIAL PREMARKET NOTIFICATION [510(K)] Summary- BD NexivaTM Closed IV Catheter System
Submitter:
Becton Dickinson Infusion Therapy Systems, Inc.
Address:
9450 South State Street Sandy, UT 84070
Contact Person:
Trade Names:
Common Name:
Classification Name:
Justice Alder Specialist, Regulatory Affairs
Telephone Number: Fax Number:
801-565-2749
801-565-2662
August 30, 2010
Date Summary Prepared:
BD Nexiva™ Closed IV Catheter System
Intravascular Catheter
Intravascular Catheter (FOZ) 880.5200
Unmodified/Predicate Device: (K032843) BD NexivaTM Closed IV Catheter System
Description of the device:
The BD Nexiva™ Closed IV Catheter System consists of an over-the needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needleshielding mechanism.
The design of the Nexiva™ IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the NexivaTM device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection of a BD Q-Syte™ luer access port.
1
Intended Use of the BD Nexiva™ Closed IV Catheter System device: [21 CFR Part 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES; General Hospital and Personal Use Therapeutic Devices Sec. 880.5200]
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-22 gauge Nexiva™ catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
Technological Characteristics Comparison:
The BD NexivaTM Closed IV Catheter products have the same technological characteristics with no changes in intended use. The subject device has similar design features and materials as the predicate device. The table below shows the design features and material comparisons between the predicate and subject device.
| Subject Device | Predicate Device | |
|---|---|---|
| 1. Catheter adapter, | ||
| tip shield | Catheter Adapter - | |
| Decreased adapter pocket | ||
| width to 0.075" for tighter | ||
| control of adapter retention | ||
| lock mechanism | ||
| Tip Shield -Decrease V-clip | ||
| pocket opening to 0.077" for | ||
| tighter control of V-clip | ||
| movement when engaged | ||
| with adapter | ||
| Tip Shield -Scaling of Internal | ||
| ID through holes to cannula | ||
| gauge to improve control of | ||
| cannula to tip shield | ||
| movement | Catheter Adapter -Adapter | |
| pocket width set at 0.088" | ||
| Tip Shield -V-clip pocket | ||
| width set at 0.084" | ||
| Tip Shield -Internal ID holes | ||
| were generalized to | ||
| accommodate all cannula | ||
| gauge sizes | ||
| 2. Catheter material. | Catheter material -Vialon | Catheter material - Vialon |
| Catheter adapter | X40, Radio opaque material | |
| Catheter Adapter-24Ga ID | ||
| set to 0.0406" decreased by | ||
| 0.0004" | X50, Radio opaque material | |
| Catheter Adapter -24Ga ID | ||
| 0.0410" | ||
| 3. Catheter adapter, | ||
| needle cover | Catheter Adapter -needle | |
| cover modified to remove | ||
| bumps, have a straight | ||
| interference fit and a solid | ||
| stop feature | ||
| Needle Cover -Length set to | ||
| 2.26" (0.040" shortened) | Catheter Adapter -needle | |
| cover interface had 2 bump | ||
| interference features and a | ||
| tapered nose | ||
| Needle Cover -Length was | ||
| 2.30" | ||
| 4. Extension tubing | Ext. Tubing -increased | |
| diameters for 18,20 Ga | ||
| product | Ext. Tubing -all gauges | |
| microbore tubing | ||
| 5. Clamp | Clamp -pinch clamp | Clamp -slide clamp |
| 6. Catheter adapter, Luer | ||
| adapter | Catheter Adapter -tubing | |
| junction increased ID for | ||
| macrobore tubing, | ||
| optimized for adhesive | ||
| addition) | ||
| Luer Adapter -tubing | ||
| junction increased ID for | ||
| macrobore tubing, | ||
| optimized for adhesive | ||
| addition) | Catheter Adapter - | |
| designed for microbore | ||
| tubing and solvent bond | ||
| joint | ||
| Luer Adapter -tubing | ||
| junction defined with a | ||
| swedge design | ||
| 7. Leur adapter | Luer Adapter -PCTG "Y" | |
| adapter | ||
| 8. Catheter adapter | Catheter Adapter -smaller | |
| adapter wing structure | ||
| (confined within overmolded | ||
| soft wing) | Catheter Adapter -large | |
| adapter wing structure | ||
| (confined within overmolded | ||
| soft wing) | ||
| 9. Tip shield | Tip Shield -improved | |
| ergonomic gripping side wall | ||
| design to prevent user | ||
| applying force to catheter | ||
| adapter directly | Tip Shield -Straight side wall | |
| design | ||
| 10. Packaging | Package -Rigid design | Package -Blister package of |
| constrained unit package | ||
| (dispenser, shipper scaled to | ||
| new unit package) | assembly | |
| 11. Straight luer adapter | Straight Luer Adapter - | |
| added new configuration | Straight Luer Adapter -did | |
| not exist | ||
| 12. Vent plug | Vent Plug -placed in straight | |
| adapter for air venting | Vent Plug -placed on "Y" | |
| adapter for air venting | ||
| 13. Q-Syte, Q-Syte Dust | ||
| Cover, and End Cap | Q-Syte, Q-Syte Dust Cover | |
| and End Cap -removed for | ||
| straight configuration | Q-Syte, Q-Syte Dust Cover | |
| and End Cap -placed on "Y" | ||
| configuration | ||
| 14. Cannula | Cannula -bump indented into | |
| cannula for tip shield retention | Cannula -ferrule bound to | |
| cannula for tip shield retention | ||
| 15. Retaining feature | Retaining Feature -washer | |
| retains cannula "bump" to | ||
| prevent tip shield removal | Retaining Feature -retention | |
| plate retains cannula ferrule to | ||
| prevent tip shield removal | ||
| 16. V-Clip | V-Clip -flag for cannula tip | |
| barrier | V-Clip -no cannula tip barrier | |
| (barrier provided by retention | ||
| plate) | ||
| 17. Cannula, Catheter | Cannula -ID, OD gauge size | |
| increase as ferrule removed | ||
| Catheter -tip resized to | ||
| cannula gauge increase | Cannula -smaller gauge size | |
| to accommodate cannula | ||
| ferrule | ||
| Catheter -tip confirms to | ||
| cannula gauge size | ||
| 18. Wedge | Wedge -Improved reduced ID | |
| wedge design as ferrule was | ||
| removed from cannula | Wedge -larger ID wedge to | |
| accommodate cannula ferrule | ||
| 19. Tip shield | Tip Shield -internal ID holes | |
| scaled to smaller cannula size | Tip Shield -internal ID | |
| increased for larger cannula | ||
| size | ||
| 20. Grip | Grip -internal ID increased for | |
| larger cannula size | Grip -internal ID holes scaled | |
| to smaller cannula size |
2
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.
3
4
Nonclinical Tests Support Substantial Equivalence:
The BD Nexiva™ Closed IV Catheter System is composed of material that have been tested in accordance with ANSI/AAMI/ISO 10993-1 2003 (E) standards. The design verification activities, acceptance criterion, and results have been summarized below which demonstrates safety and efficacy of the device.
.
| Associated
Modification | Product Performance Characteristics/Verification Testing | Acceptance Criteria for
Product Verification |
|----------------------------|-----------------------------------------------------------|-------------------------------------------------|
| 1 | Premature Decouple Force | DPPM