Nexiva™ Closed IV Catheter System with NearPort™ IV Access
Device Facts
| Record ID | K231239 |
|---|---|
| Device Name | Nexiva™ Closed IV Catheter System with NearPort™ IV Access |
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Sep 22, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
Device Story
Over-the-needle peripheral IV catheter system; includes radiopaque Vialon™ tubing, needle, needle shield, septum, stabilization platform, extension tubing, clamp, Luer adapter, vent plug, and MaxZero™ needle-free connector. Designed as a closed system to contain blood during insertion; septum wipes needle upon withdrawal to reduce exposure risk; passive needle tip protection prevents needlestick injuries. Features Instaflash™ technology for immediate blood return visualization. NearPort™ IV Access allows compatibility with needle-free blood collection devices (e.g., PIVO™ Pro) and supports power injection. Used in clinical settings by healthcare providers for fluid/medication administration and blood sampling. Output is venous access; enables therapeutic delivery and diagnostic sampling. Benefits include reduced blood exposure, improved safety, and expanded compatibility with blood collection and power injection systems.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated through bench testing (ISO 10555-1/5, ISO 23908, ISO 594-1/2), biocompatibility (ISO 10993-1/7), packaging (ASTM D4169), sterilization validation (ISO 11135-1), MR compatibility (ASTM F2182-19), microbial ingress evaluation, and human factors usability testing.
Technological Characteristics
Closed peripheral IV catheter system. Materials: Polyurethane (tubing), Stainless Steel (needle), Polycarbonate (grip/shield/connector), Copolyester (adapter), Thermoplastic Elastomer (wings), Acetal Copolymer (clamp), Silicone (septum). Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Energy: User-operated. Power injection: Up to 300 psi (24-18 GA).
Indications for Use
Indicated for peripheral venous access in any patient population for short-term administration of fluids/medications and blood sampling. 24-18 GA devices are compatible with power injectors up to 300 psi when using the NearPort™ IV Access.
Regulatory Classification
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.
Predicate Devices
- BD Nexiva™ Closed IV Catheter System (K183399)
Submission Summary (Full Text)
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September 22, 2023
Becton Dickinson Infusion Therapy Systems Inc. Paul Holman Regulatory Affairs Manager 9450 South State Street Sandy, Utah 84070
Re: K231239
Trade/Device Name: Nexiva™ Closed IV Catheter System with NearPort™ IV Access Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: August 25, 2023 Received: August 25, 2023
Dear Paul Holman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K231239
#### Device Name
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
### Indications for Use (Describe)
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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bd.com
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# K231239 510(k) Summary (21 CFR §807.92) Nexiva™ Closed IV Catheter System with NearPort™ IV Access
| Submitter | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------|
| Information | Submitter Address: | 9450 South State Street, Sandy, Utah 84070 | |
| | Contact Person: | Paul Holman, Regulatory Affairs Manager | |
| | Email Address: | paul.holman@bd.com | |
| | Phone Number: | (801) 522-5000 | |
| | Date of Preparation: | September 22, 2023 | |
| Subject Device | Trade Name: | Nexiva™ Closed IV Catheter System with NearPort™ IV Access | |
| | Common Name: | Peripheral Intravascular or IV Catheter | |
| | 510(k) Reference: | K231239 | |
| | Regulation Number: | 21 CFR §880.5200 | |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | |
| | Regulatory Class: | II | |
| | Product Code: | FOZ, FPA | |
| | Classification Panel: | General Hospital | |
| Predicate | Trade Name: | BD Nexiva™ Closed IV Catheter System | |
| Device | Common Name: | Peripheral Intravascular or IV Catheter | |
| | 510(k) Reference: | K183399 | |
| | Regulation Number: | 21 CFR §880.5200 | |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 days | |
| | Regulatory Class: | II | |
| | Product Code: | FOZ, FPA | |
| | Classification Panel: | General Hospital | |
| Reason for | | The purpose of this submission is to notify the FDA of the introduction of the Nexiva™ | |
| Submission | Closed IV Catheter System with NearPort™ IV Access, allowing for compatibility with a<br>needle-free blood draw device (e.g., PIVO™ Pro Needle-free Blood Collection Device). | | |
| Device | The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-<br>needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter<br>tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp,<br>Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle<br>cover. A MaxZero™ needle-free connector with protective cover is provided in the<br>package. | | |
| bd.com | | | |
| 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 Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. | | | |
| Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. | | | |
| In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). | | | |
| These devices are available with wings. The catheter hub and wings are color coded to indicate the 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<br>(21 CFR § 807.92(a)(5)) | The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. 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. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access. | | |
| Technological<br>Characteristics | Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject device, Nexiva™ Closed IV Catheter System with NearPort™ IV Access, achieves its intended use based on the same technology and principles of operation as the predicate device. A comparison of the subject and predicate device technological characteristics is provided in the table below | | |
| | SUBJECT (K231239) | PREDICATE (K183399) | Comparison & |
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| Attribute | SUBJECT (K231239)<br>Nexiva™ Closed IV Catheter<br>System with NearPort™ IV<br>Access | PREDICATE (K183399)<br>BD Nexiva™ Closed IV Catheter<br>System | Comparison &<br>Discussion |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21 CFR 880.5200<br>Class II | 21 CFR 880.5200<br>Class II | |
| Classification | FOZ - Intravascular Catheter<br>FPA - Intravascular Administration<br>Set | FOZ - Intravascular Catheter<br>FPA - Intravascular Administration<br>Set | Same |
| Attribute | SUBJECT (K231239)<br>Nexiva™ Closed IV Catheter<br>System with NearPort™ IV<br>Access | PREDICATE (K183399)<br>BD Nexiva™ Closed IV Catheter<br>System | Comparison &<br>Discussion |
| Indications for<br>Use | The Nexiva™ Closed IV Catheter<br>System with NearPort™ IV Access is<br>intended to be inserted into a<br>patient's peripheral venous system<br>for short term use to administer<br>fluids and/or medications and to<br>sample blood. These devices may be<br>used for any patient population with<br>consideration given to adequacy of<br>vascular anatomy, procedure being<br>performed, fluids being infused, and<br>duration of therapy. The 24-18 GA<br>(0.7-1.3 mm) devices are suitable<br>for use with power injectors set to a<br>maximum pressure of 300 psi (2068<br>kPa) when connected to the<br>NearPort™ IV Access. | Nexiva™ closed IV catheter<br>systems are intended to be inserted<br>into a patient's vascular system for<br>short term use to sample blood,<br>monitor blood pressure, or<br>administer fluids. These catheters<br>may be used for any patient<br>population with consideration<br>given to adequacy of vascular<br>anatomy, procedure being<br>performed, fluids being infused,<br>and duration of therapy. The 22-18<br>GA (0.9-1.3 mm) devices are<br>suitable for use with power<br>injectors set to a maximum<br>pressure of 300 psi (2068 kPa)<br>when access ports not suitable for<br>use with power injectors are<br>removed. | Modifications have<br>been made to re-<br>phrase and align with<br>product use<br>specifications.<br>The Indications for<br>Use is being<br>narrowed to limit use<br>to the peripheral<br>venous system only<br>to administer fluids<br>and/or medications<br>and to sample blood.<br>Narrowing the<br>Indications for Use<br>does not raise any<br>new or different<br>questions of safety or<br>effectiveness.<br>Additionally, power<br>injection capability<br>has been expanded to<br>include the 24 GA<br>configuration, using<br>the same test method<br>as the predicate<br>device as supported<br>by performance<br>verification testing,<br>which did not raise<br>any new or different<br>questions of safety<br>and effectiveness. |
| Intended Use | Intravascular access | Intravascular access | Same |
| Fundamental<br>Scientific<br>Technology | Closed peripheral intravenous<br>catheter system designed with an<br>integrated extension tubing<br>incorporating a Y (dual)-port<br>injection site. Incorporates<br>Instaflash™ technology to assist<br>with flashback visualization.<br>Nexiva™ Closed IV Catheter<br>System with NearPort™ IV Access<br>is compatible with the PIVOTM Pro<br>Needle-free Blood Collection | Closed peripheral intravascular<br>catheter system designed with an<br>integrated extension set<br>incorporating a single port or Y<br>(dual)-port injection site.<br>Incorporates Instaflash™<br>technology to assist with flashback<br>visualization | The subject device<br>uses the same<br>fundamental<br>technology compared<br>to the predicate device<br>(K183399).<br>The NearPort™ IV<br>Access component has<br>the same fundamental<br>scientific technology |
| Attribute | SUBJECT (K231239)<br>Nexiva™ Closed IV Catheter<br>System with NearPort™ IV<br>Access | PREDICATE (K183399)<br>BD Nexiva™ Closed IV Catheter<br>System | Comparison &<br>Discussion |
| | Device for needle-free blood draws. | | however, the split<br>septum design enables<br>compatibility with a<br>needle-free blood<br>draw device as<br>supported by human<br>factors validation<br>testing, which did not<br>raise any new or<br>different questions of<br>safety and<br>effectiveness. |
| | Primary Components Material Composition | | |
| ISO 10993-1<br>Biocompatibility<br>Contact Type<br>and Duration | Body Contact: Externally<br>communicating device<br>Contact: Circulating blood<br>Contact Duration: Limited (A)<br>to Prolonged (B) (≤ 24 hrs to<br>30 days) | Body Contact: Externally<br>communicating device<br>Contact: Circulating blood<br>Contact Duration: Limited (A) to<br>Prolonged (B) (≤ 24 hrs to 30<br>days) | Same |
| Needle | Stainless Steel | Stainless Steel | Same |
| Catheter Tubing | Polyurethane with radiopaque<br>barium sulfate | Polyurethane with radiopaque<br>barium sulfate | Same |
| Grip | Polycarbonate + White Colorant | Polycarbonate + White Colorant | Same |
| Tip Shield | Polycarbonate + Gray Colorant | Polycarbonate + Gray Colorant | Same |
| Catheter<br>Adapter | Copolyester | Copolyester | The material<br>formulation has been<br>modified; however,<br>the material resin type<br>remains the same.<br>Testing in accordance<br>with ISO 10993-1<br>requirements did not<br>raise any new or<br>different questions<br>related to biological<br>safety |
| Catheter<br>Adapter Wings | Thermoplastic Elastomer + Gauge<br>Specific Colorant<br>Green (18 GA)<br>Pink (20 GA)<br>Blue (22 GA)<br>Yellow (24 GA)…
