BD Centro Vena Acute Central Line (7 French Dual Lumen)

K200266 · Bard Access Systems, Inc. (Bard Has Joined Bd) · FOZ · Apr 7, 2020 · General Hospital

Device Facts

• Record ID: K200266
• Device Name: BD Centro Vena Acute Central Line (7 French Dual Lumen)
• Applicant: Bard Access Systems, Inc. (Bard Has Joined Bd)
• Product Code: FOZ · General Hospital
• Decision Date: Apr 7, 2020
• Decision: SESE
• Submission Type: Special
• 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 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.

Device Story

BD CentroVena™ Acute Central Line is a percutaneous, radiopaque, polyurethane central venous catheter; provides short-term (<30 days) access to central venous system. Used for IV fluid/drug/blood product administration, blood withdrawal, CVP monitoring, and power injection of contrast media. Operated by clinicians in clinical settings. Device features soft tip; dual-lumen configuration. During power injection, contrast media is delivered via external power injector; catheter maintains structural integrity under specified flow rates and pressures. Benefits include reliable venous access for critical care therapies and diagnostic imaging. Healthcare providers use output (e.g., contrast delivery, fluid infusion) to manage patient therapy and diagnostic workflows.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via biocompatibility (ISO 10993-1), particulate matter (USP <788>), and mechanical testing (ISO 10555-1/3, ISO 80369-7, ASTM F640-12). Tests included clamp engagement, leak, burst, power injection conditioning, gravity flow, tensile strength, radiopacity, collapse, suture wing integrity, OD swell, tip stability, and guidewire drag.

Technological Characteristics

Polyurethane catheter; 7 French dual-lumen; radiopaque; soft tip. Luer connectors compliant with ISO 80369-7. Percutaneous insertion. Sterile, single-use. Power injection rated: 10 mL/sec at 325 psi. No software or electronic components.

Indications for Use

Indicated for patients requiring short-term (<30 days) central venous access for IV therapy, blood product/drug/parenteral nutrition administration, blood withdrawal, CVP monitoring, and 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 (7 French Triple Lumen) (K190855)

Reference Devices

• PowerPICC Provena (K162443)

Submission Summary (Full Text)

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April 7, 2020

Bard Access Systems, Inc. (Bard has joined BD) Breanna Casados Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K200266

Trade/Device Name: BD CentroVena™ Acute Central Line (7 French Dual Lumen) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: March 6, 2020 Received: March 9, 2020

Dear Breanna Casados:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D. 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) K200266

Device Name

BD CentroVenaTM Acute Central Line (7 French Dual Lumen)

Indications for Use (Describe)

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.

| Catheter Length | Lumen(s) | Power Injection<br>Flow Rate | Maximum Power<br>Injector Pressure<br>Setting |
|-----------------|----------|------------------------------|-----------------------------------------------|
| 16 cm and 20 cm | Distal | 10 mL/sec | 325 psi |
| | Proximal | 10 mL/sec | |

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) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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# 510(k) Summary for BD CentroVena™ Acute Central Line

### 21 CFR 807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part(1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is presented in the following table:

| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|-----------------------|-----------------------|--------------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Breanna Casados<br>Regulatory Affairs Specialist |
| | Telephone Number: | 801.522.5243 |
| | Fax Number: | 801.522.5425 |
| | Date of Preparation: | 4/6/2020 |
| Subject Device | Trade Name(s): | BD CentroVena™ Acute Central Line (7 French Dual Lumen) |
| | Common Name: | Acute Central Line |
| | Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days |
| | Class: | 2 |
| | Regulation Number: | 21 CFR 880.5200 |
| | Product Code: | FOZ |
| | Classification Panel | General Hospital |
| Predicate<br>Device | Predicate Trade Name: | BD Acute Central Line (7 French Triple Lumen) |
| | Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days |
| | Class: | 2 |
| | Product Code: | FOZ |
| | Regulation Number: | 21 CFR 880.5200 |

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| | Premarket Notification #: | K190855 | | | | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------|-----------------------------------------------|--|--|--|
| | Manufacturer: | Bard Access Systems, Inc. (wholly owned subsidiary of BD) | | | | | |
| | Classification Panel | General Hospital | | | | | |
| | Reference Trade Name: | PowerPICC Provena | | | | | |
| Reference<br>Device | Classification Name: | Percutaneous, Implanted, Long-term Intravascular Catheter | | | | | |
| | Class: | II | | | | | |
| | Product Code: | LJS | | | | | |
| | Regulation Number: | 21 CFR 880.5970 | | | | | |
| | Premarket Notification #: | K162443 | | | | | |
| | Manufacturer: | Bard Access Systems, Inc. | | | | | |
| | A family of power injectable central venous catheters constructed of medical grade polyurethane and is designed for<br>insertion into the central venous system. BD power injectable acute central lines are radiopaque and have a soft tip that is<br>more pliable than the catheter body. Each catheter is provided in a sterile package with applicable insertion kit accessories.<br>The maximum pressure injector settings and maximum power injection flow rate are specified in the table below: | | | | | | |
| Device<br>Description | Catheter Length | Lumen(s) | Power Injection<br>Flow Rate | Maximum Power<br>Injector Pressure<br>Setting | | | |
| | 16 cm and 20 cm | Distal | 10 mL/sec | 325 psi | | | |
| | | Proximal | 10 mL/sec | | | | |
| Intended Use | BD Acute Central Lines are intended for short-term access to the central venous system for intravenous therapy and blood<br>sampling. | | | | | | |

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| Acute central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They<br>are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood<br>withdrawal, central venous pressure monitoring, and power injection of contrast media. | | | | monitoring, and power injection of contrast media. | | | | | | monitoring, and power injection of contrast media. | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------|----------------------------------------------------|-----------------|--------------------|---------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------|-----------------|-----------------------------|---------------------------|-----------------------------------------|
| Indications for<br>Use | Catheter Length | Lumen(s) | Power Injection<br>Flow Rate | Maximum Power<br>Injector Pressure<br>Setting | | | Catheter Length | Lumen(s) | Power Injection Flow Rate | Maximum Power Injector Pressure Setting | | Catheter Length | Lumen(s) | Power Injection Flow Rate | Maximum Power Injector Pressure Setting |
| | 16 cm and 20 cm | Distal | 10 mL/sec | 325 psi | | | 16 cm and 20 cm | Distal<br>Proximal | 10 mL/sec<br>10 mL/sec | 325 psi | | 16 cm and 20 cm | Distal<br>Medial / Proximal | 10 mL/sec<br>9 mL/sec | 325 psi |
| | | Proximal | 10 mL/sec | | | | | | | | | 30 cm | Distal<br>Medial / Proximal | 9 mL/sec<br>7 mL/sec | |
| Technological characteristics of the subject BD CentroVena™ Acute Central Line are substantially equivalent with respect<br>to basic design, function and fundamental scientific technology to those of the cited predicate device. | | | | | Commercial Name | BD CentroVena™ Acute Central Line | | | | | BD Acute Central Line | | | | |
| Key differences in the subject device when compared to the predicate device are as follows: | | | | | Catheter Dimensions | 7 Fr Dual Lumen x 16 cm<br>7 Fr Dual Lumen x 20 cm | | | | | 7 Fr Triple Lumen x 16 cm<br>7 Fr Triple Lumen x 20 cm<br>7 Fr Triple Lumen x 30 cm | | | | |
| • The subject device has 2 lumens and the predicate device has 3 lumens | | | | | Luer Hub Dimensions | Compliant to ISO 80369-7 | | | | | Compliant to ISO 594-1 and 594-2 | | | | |
| • The lumen geometry | | | | | Lumen Shape | Two "D" shaped lumens: one 15 Ga and one 17 Ga | | | | | Three wedge-shaped lumens: two 18 Ga and one 17 Ga | | | | |
| • The strain relief at the joint between the extension legs and the luer hubs | | | | | Duration of Use | Same | | | | | Short term (<30 days) | | | | |
| Technological<br>Characteristics | Attribute | Subject Device – BD CentroVena™ Acute<br>Central Line<br>(7 French Dual Lumen) | Predicate Device - BD Acute Central Line<br>(7 French Triple Lumen) | | Means of insertion | Same | | | | | Percutaneous | | | | |
| | Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. | | Insertion Site | Same | | | | | Jugular, subclavian, or femoral | | | | |
| | Classification | Same | FOZ – 21 CFR 880.5200<br>Short-term Intravascular Catheter | | Primary Device Materials | Catheter Base Materials | | | | | Catheter Base Materials | | | | |
| | 510(k) Status | Subject of this Premarket Notification | K190855 – Concurrence date Nov. 1, 2019 | | Materials | Shaft Tubing:<br>Same | | | | | Shaft Tubing:<br>Polyurethane | | | | |
| | Indications for<br>Use | Acute central venous catheters are indicated to<br>provide short-term access (< 30 days) to the<br>central venous system. They are designed for<br>administering I.V. fluids, blood products, drugs<br>and parenteral nutrition solutions, as well as<br>blood withdrawal, central venous pressure | Acute central venous catheters are indicated to<br>provide short-term access (< 30 days) to the<br>central venous system. They are designed for<br>administering I.V. fluids, blood products, drugs<br>and parenteral nutrition solutions, as well as<br>blood withdrawal, central venous pressure | | | | | | | | | | | | |

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| K200266 S001 | | | |
|--------------|--|--|--|
| | | | |

| | Luer Connector:<br>Same<br>Extension Legs:<br>Same<br>Junction:<br>Same<br>Strain Relief:<br>Polyurethane | Luer Connector:<br>Polyurethane<br>Extension Legs:<br>Polyurethane<br>Junction:<br>Polyurethane<br>Strain Relief:<br>N/A |
|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of<br>Lumens | Two (2) | Three (3) |
| Power Injection<br>Maximum Flow<br>Rate | 16 and 20 cm length:<br>• Distal (15 Ga.) – 10 mL/sec<br>• Proximal (17 Ga.) – 10 mL/sec | 16 and 20 cm length:<br>• Distal (16 Ga.) – 10 mL/sec<br>• Medial (18 Ga.) – 9 mL/sec<br>• Proximal (18 Ga.) – 9 mL/sec<br>30 cm length:<br>• Distal (16 Ga.) – 9 mL/sec<br>• Medial (18 Ga.) – 7 mL/sec<br>• Proximal (18 Ga.) – 7 mL/sec |
| Sterility | Same | Provided Sterile |
| Safety &<br>Performance<br>Tests | The Power Injection Maximum Flow Rates as indicated in the IFU statement differ in that the Proximal flow rate of the<br>subject device is 10 mL/sec, whereas the flow rate of the Proximal of the predicate device is 9 mL/sec. The technological<br>differences listed above were evaluated using industry consensus standards, and as defined in the Risk Assessment. A<br>risk analysis was performed for the modifications done to the subject device, in accordance to ISO 14971, Medical Devices<br>- Applications of Risk Management to Medical Devices. BAS has identified and evaluated the risks associated with the<br>changes; these risks were adequately mitigated through verification and validation testing. Therefore, these differences in<br>technological characteristics between the subject and predicate devices do not raise new or different questions of safety or<br>effectiveness.<br><br>The following performance tests were conducted or adopted from the predicate device to establish the performance of the<br>BD CentroVena™ Acute Central Line, and in determining substantial equivalence to the predicate BD Acute Central Line<br>(7F Triple Lumen). All testing passed the predetermined acceptance criteria. | |
| | Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and<br>testing within a risk management process | |
| Biocompatibility Testing | Biocompatibility tests were leveraged from the predicate BD Acute Central Line and<br>reference device (K162443) to confirm that the catheter is free from biological<br>hazard. | |
| Reference Standard: USP<788>Particulate Matter in Injections | | |
| Particulate Matter<br>Testing | Particulate Matter Testing conducted on the predicate BD Acute Central Line was<br>adopted by the subject device. | |
| Reference Standard: ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General<br>requirements | | |
| Clamp Engagement | Test to confirm that the catheter assembly will not leak when the clamp is engaged. | |
| Leak Test | Test to confirm that the catheter assembly will not leak when the distal end of the<br>catheter is occluded. | |
| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD and lumen area for<br>dual lumen catheters to ensure compliance with dimensional specification. | |
| Implantable Length | Test to measure useful length for catheters to ensure compliance with dimensional<br>specification. | |
| Extension Leg Length | Test to measure and confirm extension leg length compliance with dimensional<br>specification. | |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure<br>present in the catheter at maximum flow conditions when the distal end is occluded. | |
| Hydraulic Catheter<br>Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure<br>present in the catheter at maximum flow conditions when the distal end is occluded. | |
| Power Injection<br>Conditioning | Test to confirm the catheter does not leak or burst as a result of power injections at<br>maximum indicated flow rate. | |
| Gravity Flow | Test to measure the gravity flow performance of a full-length catheter. | |
| Luer to Extension Leg<br>Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimum<br>peak tensile force. | |

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| K200266 S001 | |
|--------------|--|
|--------------|--|

| Extension Leg to<br>Trifurcation Tensile Test | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trifurcation to Shaft<br>Tensile Test | |
| Shaft Tensile Test | |
| | Reference Standard: ASTM F640-12 - Standard Test Methods for Determining Radiopacity<br>for Medical Use |
| Radiopacity | Test to demonstrate catheter radio-detectability. |
| | Reference Standard: ISO 10555-3:2013 - Intravascular catheters - Sterile and single-use catheters - Part 3:<br>Central venous catheters |
| Tip Tensile | Test to demonstrate the peak tensile force of each test piece exceeds the minimum<br>peak tensile force. |
| | Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term<br>and Long-Term Intravascular Catheters, 1995 |
| Catheter Collapse Test | Test to measure the flow rate of aspiration and demonstrate that the catheter will not<br>collapse under a vacuum. |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at break. |
| Suture Wing Integrity<br>Test | Test to measure the maximum force a catheter junction suture wing can withstand<br>prior to break. |
| OD Swell | Test to confirm that the catheter does not swell beyond twice the size of the labeled<br>OD during power injection. |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientation during power<br>injection (tip pointing in direction of venous flow) at the maximum indicated flow rate. |
| Guidewire Drag Test | Test to ensure that the guidewire used to place the catheter can be removed without<br>difficulty. |
| | Reference Standard: ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare<br>applications - Part 7: Connectors for intravascular or hypodermic applications |

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| | Luer Testing | Testing to ensure that luer connectors meet requirements for Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrew Torque, and Resistance to Overriding. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…