CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

K242429 · Becton Dickinson Inc. (Bd) · SEF · Apr 9, 2025 · General Hospital

Device Facts

• Record ID: K242429
• Device Name: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
• Applicant: Becton Dickinson Inc. (Bd)
• Product Code: SEF · General Hospital
• Decision Date: Apr 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters.

Device Story

CentroVena CVC is a power-injectable, radiopaque polyurethane catheter for short-term central venous access. The CentroVena One Insertion System integrates an introducer needle with a passive safety mechanism, syringe, guidewire, and self-dilating catheter into a preassembled unit to facilitate placement. Used in clinical settings by healthcare professionals, the system utilizes the Seldinger technique. The device provides a conduit for fluid administration, blood withdrawal, and pressure monitoring. The integrated insertion system includes a drape clip to organize the sterile field and prevent guidewire embolism. The catheter features a tapered tip and reformulated polyurethane for improved insertion characteristics. Healthcare providers use the device to establish venous access; the output is the established catheter line, which enables therapeutic delivery and diagnostic monitoring, benefiting patients by providing reliable, short-term central venous access.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (ISO 10993), mechanical integrity (ISO 10555-1/3, ISO 11070), radiopacity (ASTM F640), hemolysis (ASTM F756), MR safety, and sharps injury prevention (ISO 23908).

Technological Characteristics

Materials: Polyurethane (catheter, hubs, extension legs), Acetal (clamp), Nitinol/Stainless Steel (guidewire), Polycarbonate (hubs/tabs), HDPE (dilator). Design: Tapered tip, multi-lumen (dual/triple), radiopaque. Connectivity: None. Energy: None. Sterilization: Sterile. Standards: ISO 10555-1/3, ISO 10993-1, ISO 80369-7, ASTM F640, ASTM F756, ISO 11070, ISO 23908.

Indications for Use

Indicated for patients requiring short-term (< 30 days) central venous access for IV therapy, blood sampling, pressure monitoring, or power injection of contrast media.

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 Acute Central Line (K190855)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

April 9, 2025

Becton Dickinson Inc. (BD)
Connor Dahl
Staff Regulatory Affairs Specialist
605 North 5600 West
Salt Lake City, Utah 84116

Re: K242429
Trade/Device Name: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: SEF
Dated: March 6, 2025
Received: March 7, 2025

Dear Connor Dahl:

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 (the 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 available 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.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242429 - Connor Dahl
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K242429 - Connor Dahl
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K242429

Device Name
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

Indications for Use (Describe)
CentroVena Central Venous Catheter (CVC)

Acute central venous catheters are indicated to provide short term access (&lt; 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

CentroVena One Insertion System

The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters.

Acute central venous catheters are indicated to provide short term access (&lt; 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services [phone]

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7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services [phone]

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K242429 – 510k Summary – The CentroVena Central Venous Catheter (CVC)

with the CentroVena One Insertion System

21 CFR 807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part(I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based on is presented in the following table.

| General Provisions | Submitter Name: | Becton Dickinson Inc.(BD) |
| --- | --- | --- |
| | Submitter Address: | 605 North 5600 West Salt Lake City, UT 84116 |
| | Contact Person: | Connor Dahl -Staff Regulatory Affairs Specialist |
| | Telephone Number: | 801.522.5000 |
| | Fax Number: | 801.522.5425 |
| | Date of Preparation: | 04/09/2025 |
| Subject Device | Trade Name(s): | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System |
| | Common Name: | Central venous catheter with manual insertion system |
| | Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days |
| | Class: | 2 |
| | Regulation Number: | 21 CFR 880.5200 |
| | Product Code: | SEF |
| | Classification Panel | General Hospital |

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| Predicate Device | Predicate Trade Name: Classification Name: Class: Product Code: Regulation Number: Premarket Notification #: Manufacturer: Classification Panel: | BD Acute Central Line Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days 2 FOZ 21 CFR 880.5200 K190855 Bard Access Systems, Inc General Hospital |
| --- | --- | --- |
| Device Description | CentroVena Central Venous Catheters are power-injectable, constructed of medical grade polyurethane and designed for insertion into the central venous system. The central venous catheters are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with other applicable insertion kit accessories. The CentroVena One Insertion System integrates the essential components for placing central venous catheters. It combines an introducer needle with a passive needle tip safety mechanism, syringe, guidewire, and self-dilating catheter into one unit. The device is preassembled and also has an integrated drape clip permanently attached to the guidewire designed to keep the system organized in the sterile field and prevent guidewire embolism. | |
| Intended Use | BD Acute Central Lines are intended for short-term access to the central venous system for intravenous therapy and blood sampling. | |
| Indications for Use | CentroVena Central Venous Catheter (CVC) Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting | |

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# CentroVena One Insertion System

The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters.

Acute central venous catheters are indicated to provide short term access (&lt; 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

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Technological characteristics of the subject, the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System, are substantially equivalent with respect to basic design, function and fundamental scientific technology to those of the cited predicate device.

Key differences in the subject device when compared to the predicate device are as follows:

- Design: Catheter Tip Shape and Geometry changed from the predicate
- Materials: Polyurethane Formulation changed to achieve tapered tip geometry
- Labeling: Contraindications previously included with the predicate device, were changed to precautions in the subject device
- Packaging: CentroVena One Insertion System Kits were introduced and will be packaged in sterile, single-use sealed trays with an additional sealed header bag that was previously not included with the predicate.

The following table provides a comparison between the subject and predicate devices.

| Attribute | Subject Device
CentroVena Central Venous Catheter (CVC)
with the CentroVena One Insertion System | Predicate Device
BD Acute Central Line | Equivalency |
| --- | --- | --- | --- |
| Owner | Becton Dickinson Inc. (BD) | Becton Dickinson Inc. (BD) | Equivalent |
| Indications for Use | CentroVena Central Venous Catheter (CVC)
Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow | Acute central venous catheters are indicated to provide short-term access (< 30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. | Equivalent
The Indications for use of the subject catheter are equivalent. The inclusion of the insertion device, which serves to facilitate placement of the parent catheter, does not change the overall intended use of the parent device and does not raise new or different questions of safety or effectiveness compared to the predicate, BD Acute Central Line Basic Kit. |
| Catheter Size | Catheter Length | Lumen | Power Injection Flow Rate | Maximum Power Injector Pressure Setting |
| 7F Triple Lumen | 16 cm and 20 cm | Distal | 10 mL/s | 325 psi |
| Medial/Proximal | 9 mL/s |
| Distal | 9 mL/s |
| 30 cm | Medial/Proximal | 7 mL/s | |

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| | Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

CentroVena One Insertion System

The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters.

Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.

7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting | | |
| --- | --- | --- | --- |

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| | 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting | | |
| --- | --- | --- | --- |
| **Commercial Name** | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | BD Acute Central Line | |
| **Catheter Configurations** | 7 Fr Triple Lumen x 16 cm
7 Fr Triple Lumen x 20 cm
7 Fr Triple Lumen x 30 cm
7 Fr, Dual Lumen x 16 cm
7 Fr, Dual Lumen x 20 cm | 7 Fr Triple Lumen x 16 cm
7 Fr Triple Lumen x 20 cm
7 Fr Triple Lumen x 30 cm | Equivalent
While a dual lumen configuration was not included in the predicate, an additional dual lumen configuration does not raise new or different questions of safety or effectiveness. The dual lumen was evaluated using the same methods as the triple lumen and function in equivalent ways. Testing was performed and submitted on both configurations when the triple lumen was not the worst-case scenario. Results from testing did not raise any new concerns of safety and effectiveness. |

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| | | | |
| --- | --- | --- | --- |
| Principle of Operation | Same | Conduit for fluids in and out of the central venous system | Equivalent |
| Duration of Use | Same | Short term (<30 days) | Equivalent |
| Insertion Site | Same | Jugular, subclavian or femoral veins | Equivalent |
| Means of Insertion | • Percutaneous insertion using Seldinger Technique (Basic)
• Percutaneous insertion using the CentroVena One Insertion System | • Percutaneous insertion using Seldinger Technique.(Basic)
• The Centrovena One Insertion System was not included with predicate | Equivalent
The insertion device was not a means of insertion in the predicate device. However, the insertion device is comprised of components used in the predicate device traditional (Basic) Seldinger kits. This combination of kit components was evaluated using human factors and risk management approaches to show that there are no additional or increased risks in placing the subject CentroVena CVC with the insertion device compared to a traditional placement. Therefore, the addition of an insertion tool does not raise any new questions of safety or effectiveness. |
| Catheter Tip | Tapered Tip | Blunt Tip | Equivalent
The polyurethane was reformulated to achieve the tapered tip geometry The modified tip geometry was evaluated with functional performance testing and did not raise any new questions of safety or effectiveness. |

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| Catheter Tip Placement Location | Same | Central venous system, with lower 1/3 of superior vena cava (SVC) preferred | Equivalent |
| --- | --- | --- | --- |
| Skives on Catheter Shaft | Skives are moved back on the catheter shaft due to tapered tip. | Skives are towards the front of the catheter | Equivalent
Movement of the skives distally from the tip of the catheter was due to a change in tip geometry and was evaluated by functional and performance testing and does not raise any new questions of safety or effectiveness. |

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| Subject Device Materials | Catheter Materials | Catheter Materials | Equivalent |
| --- | --- | --- | --- |
| | Female Luer Hubs:
Polyurethane | Female Luer Hubs:
Polyurethane | |
| | Thumb Clamp:
Acetal | Thumb Clamp:
Acetal | |
| | Extension Legs:
Polyurethane | Extension Legs:
Polyurethane | |
| | Catheter Junction:
Polyurethane | Catheter Junction:
Polyurethane | |
| | Catheter Shaft Tubing:
Polyurethane | Catheter Shaft Tubing:
Polyurethane | |
| | Soft Tip (Tapered):
Reformulated Polyurethane | Soft Tip (Blunt):
Polyurethane | |
| | Kit Component Materials (Basic)
Same | Kit Component Materials (Basic)
Syringe, Luer Slip, 5mL
Polypropylene | |
| | | Guidewire with Hoop, 60 cm
Nitinol and Stainless Steel | |
| | | Guidewire with Hoop, 70 cm
Nitinol and Stainless Steel
Needle, Introducer, 18 Ga
Stainless Steel and K-Resin | |
| | | Dilator, 8F x 10cm
HDPE
Mini Scalpel, 11 Blade ABS
and Stainless Steel | |
| | Dead End Caps Polypropylene
Suture Wing
Silicone | | |
| | Fastener Suture Wing
Polycarbonate | | |

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| | CentroVena One Insertion System Materials
Syringe: Polypropylene
Guidewire with J-Tip:
Nitinol/Stainless Steel
White Hub: Polycarbonate
Gray Release Tabs:
Polycarbonate
Introducer Needle & Integrated Sheath:
Stainless Steel/Polyurethane | There was no insertion system device
included in Predicate | The components of the
CentroVena One Insertion
System were not included in the
predicate as there was no
insertion systems device
included in the predicate.

The intended use of the syringe
will remain the same as the
predicate as the device will still
be used to inject fluids into, or
withdraw fluids from, the body
as per the definition described
by FDA regulation 880.5860. |
| --- | --- | --- | --- |

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| Power Injection Maximum Flow Rate | Triple Lumen: 16 and 20 cm lengths:
- Distal (17 Ga.) – 10 mL/sec
- Medial (18 Ga.) – 9 mL/sec
- Proximal (18 Ga.) – 9 mL/sec30 cm length:
- Distal (17 Ga.) – 9 mL/sec
- Medial (18 Ga.) – 7 mL/sec
- Proximal (18 Ga.) – 7 mL/secDual Lumen: 16 and 20 cm lengths:
- Distal (15 Ga.) – 10 mL/sec
- Proximal (17 Ga.) – 10 mL/sec | Triple Lumen: 16 and 20 cm lengths:
- Distal (17 Ga.) – 10 mL/sec
- Medial (18 Ga.) – 9 mL/sec
- Proximal (18 Ga.) – 9 mL/sec30 cm length:
- Distal (17 Ga.) – 9 mL/sec
- Medial (18 Ga.) – 7 mL/sec
- Proximal (18 Ga.) – 7 mL/sec | Equivalent
While a dual lumen configuration was not included in the predicate, an additional dual lumen configuration does not raise new or different questions of safety or effectiveness. The dual lumen was evaluated using the same methods as the triple lumen and function in equivalent ways. Testing was performed and submitted on both configurations when the triple lumen was not the worst-case scenario. Results from testing did not raise any new concerns of safety and effectiveness. |
| --- | --- | --- | --- |
| Kit Packaging | CentroVena Basic (Seldinger) Kits
- Thermoformed HIPS tray sealed with a Tyvek lidCentroVena One Insertion System Kits
- Thermoformed HIPS tray within a sealed header bag sealed with a Tyvek lid | Basic (Seldinger) Kits
- Thermoformed HIPS tray sealed with a Tyvek lidInsertion System Kits
- Not Applicable to Predicate Device | Equivalent
Additional header bag for insertion kits have no impact on substantial equivalence as the kit configuration was not utilized in the predicate device. |
| Sterility | Same | Provided Sterile | Equivalent |

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The technological differences listed above were evaluated using industry consensus standards, and as defined in the risk assessment. The modifications to subject device when compared to the cited predicate device have been evaluated and demonstrated through functional performance testing to have no new or different concerns regarding safety and effectiveness.

The following performance tests were conducted in determining substantial equivalence of the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System to the predicate BD Acute Central Line:

| Testing Relating to the CentroVena Central Venous Catheter (CVC) | |
| --- | --- |
| Reference Standard: ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process | |
| Biocompatibility Testing | Tests to confirm that the catheter is free from biological hazard.
Testing Performed includes:
• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogenicity
• Subchronic Systemic Toxicity
• Genotoxicity
• Hemocompatibility
• Implantation |
| Reference Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements | |
| Test(s) | • Clamp Engagement
• Leak Test
• Dimensional Test
• Implantable Length
• Extension Leg Length
• Burst Test
• Hydraulic Catheter Burst Test
• Power Injection Conditioning
• Gravity Flow
• Luer to Extension Leg Tensile Test
• Extension Leg to Catheter Junction Tensile
• Catheter Junction to Shaft Tensile
• Shaft Tensile Test |
| Reference Standard: ASTM F640-2020 – Standard Test Methods for Radiopacity of Plastics for Medical Use | |
| Test(s) | • Radiopacity |
| Reference Standard: ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials | |
| Test(s) | • Mechanical Hemolysis |
| Reference Standard: ISO 10555-3:2013 – Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters | |

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| | Test(s) | • Tip Tensile
• Catheter Printing |
| --- | --- | --- |
| | Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, 1995 | |
| | Test(s) | • Catheter Collapse Test
• Shaft Tensile and Elongation Test
• Suture Wing Integrity Test
• Priming Volume
• OD Swell
• Tip Stability Test
• Guidewire Drag Test |
| | Reference Standards: ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications – Part 1: General Requirements and ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications | |
| | Test(s) | • Dimensions
• ISO Luer Functional Performance |
| | Reference Standard: FDA Guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, 2023 | |
| | Test(s) | • MR Testing |
| | Reference Standard: USP <788>:2012 Small Volume Injections – Particulate Matter in Injections | |
| | Test(s) | • Particulate Testing |
| | | |
| | Testing Relating to the CentroVena One Insertion System | |
| | Reference Standard: ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. | |
| | Biocompatibility Testing | Tests to confirm that the system is free from biological hazard.
Testing Performed includes:
• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogenicity
• Genotoxicity
• Hemocompatibility |
| Reference Standard: FDA Guidance Document, 2019, Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling | | |

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| | Test(s) | - Guidewire Dimensions
- Guidewire Corrosion Resistance
- Guidewire Particulate
- Guidewire Tensile
- Guidewire Kink Resistance
- Guidewire Torque Strength
- Guidewire Tip Flexibility
- Simulated Use Conditioning |
| --- | --- | --- |
| | Reference Standard: ISO 11070:2014 Sterile Single-Use Intravascular Introducers, Dilators and Guidewires | |
| | Test(s) | - Effective Needle Length
- Guidewire and Sheath Radiopacity
- Corrosion Resistance
- Guidewire Surface Defects
- Sheath Surface
- Lubricant
- Needle / Hub Separation Force
- Sheath Separation Force
- Guidewire Uncoiling
- Guidewire Shear Force, Fracture
- Guidewire Shear Force, Flexure
- Guidewire Peak Tensile Force
- Guidewire Size Designation
- Needle Size Designation |
| | Reference Standard: ASTM F640-20 Radiopacity | |
| | Test(s) | - Radiopacity |
| | Reference Standard: ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials | |
| | Test(s) | - Mechanical Hemolysis |
| | Reference Standard: FDA Guidance, 2005, Sharps Injury Prevention | |
| | Test(s) | - Needle Point Exposure Limit
- Needle Safety and Reliability
- Needle Use
- Needle Reliability
- Needle Tip Access |
| | Reference Standard: ISO 10555-1:2013 Intravascular Catheters – Sterile and Single-Use Catheters General Requirements | |
| | Test(s) | - Sheath Tip
- Sheath Surface |
| | Reference Standard: ISO 10555-5:2008 Intravascular Catheters – Sterile and Single-Use Catheters Over-Needle Peripheral Catheters | |
| | Test(s) | - Needle / Sheath Outer Diameter
- Lie Distance |
| | Reference Standard: ISO 23908:2011 Sharps Injury Protection – Requirements and Test Methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. | |

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| | Test(s) | • Needle Point Exposure Limit
• Needle Safety and Reliability
• Needle Use
• Needle Tip Access |
| --- | --- | --- |
| | Reference Standard: ISO 7864:2016 Sterile Hypodermic Needles for Single Use – Requirements and Test Methods | |
| | Test(s) | • Needle Cleanliness
• Needle Hub Socket Cleanliness
• Needle Point |
| | Reference Standard: ISO 80369-1:2018 and -7:2021 Small-bore Connectors for Liquids and Gases in Healthcare Applications Part 1: General Requirements, Part 7: Connectors for Intravascular or Hypodermic Applications | |
| | Test(s) | • Dimensions
• ISO Luer Functional Performance |
| | Reference Standard: ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices – Requirements and Test Methods | |
| | Test(s) | • Needle Cleanliness
• Needle Surface
• Needle Stiffness
• Needle Breakage |
| | Reference Standard: USP <788>:2012 Small Volume Injections – Particulate Matter in Injections | |
| | Test(s) | • Particulate |
| Technological Comparison to Predicate Device | Technological characteristics of the subject CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System are substantially equivalent with regard to the intended use and basic design and function of the predicate device, BD Acute Central Line (K190855). The tip geometry, materials, labeling and packaging modifications and the addition of an insertion system device differ from the predicate device. The inclusion of the CentroVena One Insertion System has no impact on the substantial equivalence as it is comprised of several of the same components used in the predicate device kits. Therefore, these differences do not alter the intended use of the subject device, and do not raise any new or different questions regarding safety or effectiveness when compared to the predicate device. | |
| Summary of Substantial Equivalence | Based on the risk management activities and testing, the subject device, CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System, has been demonstrated to be substantially equivalent to the cited predicate device. | |

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