(237 days)
Not Found
No
The device is a physical medical device (central venous catheter and insertion system) and the provided documentation focuses on its physical properties, materials, and performance testing, with no mention of AI, machine learning, or software components that would contain an AI model.
Yes.
The device facilitates the administration of IV fluids, blood products, drugs, and parenteral nutrition solutions, which are all therapeutic interventions designed to treat or manage medical conditions. It also enables blood withdrawal and central venous pressure monitoring, which are diagnostic, but given the primary stated uses, the device's overall purpose is strongly therapeutic.
Yes
The device's intended use specifies "central venous pressure monitoring," which is a diagnostic function used to assess a patient's cardiovascular status.
No
The device is a physical medical device (central venous catheter and insertion system) and contains no mention of software components or functionality. Performance studies involve physical and mechanical testing, not software validation.
No
This device is a central venous catheter used for administering fluids, blood products, and medication, as well as blood withdrawal and pressure monitoring. It is an invasive device used directly on the patient's body, not for in vitro examination of specimens.
N/A
Intended Use / Indications for Use
CentroVena Central Venous Catheter (CVC)
Acute central venous catheters are indicated to provide short term access (:2012)
Testing Relating to the CentroVena One Insertion System
- 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
- Tests (Reference Standard: FDA Guidance Document, 2019, Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling) - Guidewire Dimensions, Guidewire Corrosion Resistance, Guidewire Particulate, Guidewire Tensile, Guidewire Kink Resistance, Guidewire Torque Strength, Guidewire Tip Flexibility, Simulated Use Conditioning
- Tests (Reference Standard: ISO 11070:2014) - 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
- Radiopacity (Reference Standard: ASTM F640-20)
- Mechanical Hemolysis (Reference Standard: ASTM F756-17)
- Tests (Reference Standard: FDA Guidance, 2005, Sharps Injury Prevention) - Needle Point Exposure Limit, Needle Safety and Reliability, Needle Use, Needle Reliability, Needle Tip Access
- Tests (Reference Standard: ISO 10555-1:2013) - Sheath Tip, Sheath Surface
- Tests (Reference Standard: ISO 10555-5:2008) - Needle / Sheath Outer Diameter, Lie Distance
- Tests (Reference Standard: ISO 23908:2011) - Needle Point Exposure Limit, Needle Safety and Reliability, Needle Use, Needle Tip Access
- Tests (Reference Standard: ISO 7864:2016) - Needle Cleanliness, Needle Hub Socket Cleanliness, Needle Point
- Tests (Reference Standard: ISO 80369-1:2018 and -7:2021) - Dimensions, ISO Luer Functional Performance
- Tests (Reference Standard: ISO 9626:2016) - Needle Cleanliness, Needle Surface, Needle Stiffness, Needle Breakage
- Particulate (Reference Standard: USP :2012)
Key Results: The technological differences between the subject device and the predicate device were evaluated using industry consensus standards and risk assessment. The modifications to the subject device (tip geometry, materials, labeling, packaging, and the addition of an insertion system) were evaluated and demonstrated through functional performance testing to have no new or different concerns regarding safety and effectiveness.
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.
Not Found
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).
FDA 510(k) Clearance Letter - CentroVena Central Venous Catheter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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.
Page 2
K242429 - Connor Dahl Page 2
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-
Page 3
K242429 - Connor Dahl Page 3
assistance/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,
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 2
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 (: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
Page 19
Page 14 of 15
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.
Page 20
Page 15 of 15
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 :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. |