(64 days)
No
The summary describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as an acute central venous catheter for short-term access to the central venous system, designed for administering fluids, blood products, drugs, and for blood withdrawal, not for treating a disease or condition.
No
The device description and intended use indicate it is an acute central venous catheter for administering fluids, blood products, drugs, parenteral nutrition, blood withdrawal, central venous pressure monitoring, and power injection of contrast media. These are therapeutic or monitoring functions, not diagnostic.
No
The device description clearly states it is a family of power injectable central venous catheters constructed of medical grade polyurethane, which are physical hardware devices. The performance studies also focus on physical properties and performance of the catheter hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for accessing the central venous system for administering fluids, blood products, drugs, parenteral nutrition, blood withdrawal, pressure monitoring, and contrast media injection. These are all procedures performed in vivo (within the body).
- Device Description: The device is a catheter designed for insertion into the central venous system. This is an invasive procedure performed in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. The performance studies focus on the physical and mechanical properties of the catheter and its ability to function correctly within the body.
Therefore, this device is a medical device used for therapeutic and diagnostic procedures performed in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Acute central venous catheters are indicated to provide short-term access (Particulate Matter in Injections
Particulate Matter Testing: Particulate Matter Testing conducted on the predicate BD Acute Central Line was adopted by the subject device.
Reference Standard: ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General 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 catheter is occluded.
Dimensional Test: Test to measure OD and ID for single lumen catheters and OD and lumen area for dual lumen catheters to ensure compliance with dimensional specification.
Implantable Length: Test to measure useful length for catheters to ensure compliance with dimensional specification.
Extension Leg Length: Test to measure and confirm extension leg length compliance with dimensional specification.
Burst Test: Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded.
Hydraulic Catheter Burst Test: Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded.
Power Injection Conditioning: Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate.
Gravity Flow: Test to measure the gravity flow performance of a full-length catheter.
Luer to Extension Leg Tensile Test: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
Extension Leg to Trifurcation Tensile Test: Not Found
Trifurcation to Shaft Tensile Test: Not Found
Shaft Tensile Test: Not Found
Reference Standard: ASTM F640-12 - Standard Test Methods for Determining Radiopacity 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: Central venous catheters
Tip Tensile: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, 1995
Catheter Collapse Test: Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum.
Shaft Tensile Test: Test to evaluate the maximum catheter strain and modulus at break.
Suture Wing Integrity Test: Test to measure the maximum force a catheter junction suture wing can withstand prior to break.
OD Swell: Test to confirm that the catheter does not swell beyond twice the size of the labeled OD during power injection.
Tip Stability Test: Test to confirm that the catheter tip remains in the same orientation during power 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 difficulty.
Reference Standard: ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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.
Dimensions: Dimensional testing to characterize luer dimensions.
Leak Testing: Sub-atmospheric Leak Testing and Luer Positive Pressure Leak
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
3
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
| Provisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Breanna Casados | |
| 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 | ||
| 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 |
4
| Premarket Notification #: | K190855 | ||||||
|---|---|---|---|---|---|---|---|
| Manufacturer: | Bard Access Systems, Inc. (wholly owned subsidiary of BD) | ||||||
| Classification Panel | General Hospital | ||||||
| Reference Trade Name: | PowerPICC Provena | ||||||
| Reference | |||||||
| 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 | |||||||
| insertion into the central venous system. BD power injectable acute central lines are radiopaque and have a soft tip that is | |||||||
| more pliable than the catheter body. Each catheter is provided in a sterile package with applicable insertion kit accessories. | |||||||
| The maximum pressure injector settings and maximum power injection flow rate are specified in the table below: | |||||||
| Device | |||||||
| Description | Catheter Length | Lumen(s) | Power Injection | ||||
| Flow Rate | Maximum Power | ||||||
| Injector Pressure | |||||||
| 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 | ||||||
| sampling. |
5
| Acute central venous catheters are indicated to provide short-term access (Particulate Matter in Injections | | |
| Particulate Matter
Testing | Particulate Matter Testing conducted on the predicate BD Acute Central Line was
adopted by the subject device. | |
| Reference Standard: ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General
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
catheter is occluded. | |
| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD and lumen area for
dual lumen catheters to ensure compliance with dimensional specification. | |
| Implantable Length | Test to measure useful length for catheters to ensure compliance with dimensional
specification. | |
| Extension Leg Length | Test to measure and confirm extension leg length compliance with dimensional
specification. | |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure
present in the catheter at maximum flow conditions when the distal end is occluded. | |
| Hydraulic Catheter
Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure
present in the catheter at maximum flow conditions when the distal end is occluded. | |
| Power Injection
Conditioning | Test to confirm the catheter does not leak or burst as a result of power injections at
maximum indicated flow rate. | |
| Gravity Flow | Test to measure the gravity flow performance of a full-length catheter. | |
| Luer to Extension Leg
Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimum
peak tensile force. | |
8
9
| K200266 S001 | |
|---|---|
| -------------- | -- |
| Extension Leg to
| Trifurcation Tensile Test | |
|---|---|
| Trifurcation to Shaft | |
| Tensile Test | |
| Shaft Tensile Test | |
| Reference Standard: ASTM F640-12 - Standard Test Methods for Determining Radiopacity | |
| 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: | |
| Central venous catheters | |
| Tip Tensile | Test to demonstrate the peak tensile force of each test piece exceeds the minimum |
| peak tensile force. | |
| Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term | |
| and Long-Term Intravascular Catheters, 1995 | |
| Catheter Collapse Test | Test to measure the flow rate of aspiration and demonstrate that the catheter will not |
| collapse under a vacuum. | |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at break. |
| Suture Wing Integrity | |
| Test | Test to measure the maximum force a catheter junction suture wing can withstand |
| prior to break. | |
| OD Swell | Test to confirm that the catheter does not swell beyond twice the size of the labeled |
| OD during power injection. | |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientation during power |
| 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 |
| difficulty. | |
| Reference Standard: ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare | |
| applications - Part 7: Connectors for intravascular or hypodermic applications |
10
| 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. | |
|---|---|---|
| Dimensions | Dimensional testing to characterize luer dimensions. | |
| Leak Testing | Sub-atmospheric Leak Testing and Luer Positive Pressure Leak | |
| Technological | ||
| Comparison to | ||
| Predicate | ||
| Device | Technological characteristics of the subject BD CentroVenaTM Acute Central Line are substantially equivalent with regard to the design and function of the predicate device, BD Acute Central Line (K190855). The subject device differs from the predicate in dimensional specifications including lumen geometry and number of lumens. However, 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 BD CentroVenaTM Acute Central Line (7F Dual Lumen) is substantially equivalent to the cited predicate device. |