(64 days)
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.
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:
| 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 |
This document is an FDA 510(k) Premarket Notification for a medical device: the BD CentroVena™ Acute Central Line (7 French Dual Lumen). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy of a novel AI/software device. Therefore, the questions related to AI/software performance (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance, effect size of human improvement with AI) are not applicable to this type of submission.
Instead, this submission focuses on demonstrating the physical and functional equivalence of a new iteration of an intravascular catheter to existing ones. The "acceptance criteria" here refer to standard performance and safety tests for such medical devices, rather than statistical thresholds for AI model performance.
Here's an analysis of the provided text in the context of the requested information, highlighting what is (and isn't) present:
Context of the Document: This submission seeks 510(k) clearance for a new version of an acute central line catheter. It compares the "subject device" (BD CentroVena™ Acute Central Line) to a "predicate device" (BD Acute Central Line) to argue that it is substantially equivalent, meaning it performs as safely and effectively as existing devices. This is achieved through detailed comparisons of specifications, materials, and comprehensive performance testing.
1. A table of acceptance criteria and the reported device performance:
The document mentions that "All testing passed the predetermined acceptance criteria." However, it does not provide a specific table detailing the numerical acceptance criteria alongside the quantitative results for each test. Instead, it lists the types of performance tests conducted and implicitly states that the outcomes met the necessary standards for substantial equivalence.
Here's a summary of the mentioned tests and their purpose, which serves as a proxy for the acceptance criteria and implied "reported performance" (since they all passed):
| Acceptance Criteria (Measured by Test Purpose) | Reported Device Performance (Implied by "All testing passed") |
|---|---|
| Biocompatibility: Catheter is free from biological hazard. | Confirmed (leveraged from predicate and reference device) |
| Particulate Matter: Compliance with USP <788>. | Tested and confirmed (leveraged from predicate device) |
| Clamp Engagement: Catheter assembly will not leak when clamp is engaged. | Passed |
| Leak Test: Catheter assembly will not leak when distal end is occluded. | Passed |
| Dimensional Test: OD, ID, and lumen area compliance with specifications. | Passed |
| Implantable Length: Useful length compliance with specifications. | Passed |
| Extension Leg Length: Compliance with dimensional specifications. | Passed |
| Burst Test (Catheter & Hydraulic): Catheter burst pressure exceeds peak pressure at max flow. | Passed |
| Power Injection Conditioning: Catheter does not leak or burst as a result of power injections at max flow rate. | Passed |
| Gravity Flow: Performance of a full-length catheter. | Passed |
| Tensile Tests (Luer to Leg, Leg to Trifurcation, Trifurcation to Shaft, Shaft, Tip): Peak tensile force exceeds minimum. | Passed |
| Radiopacity: Catheter radio-detectability. | Passed |
| Catheter Collapse Test: Flow rate of aspiration and no collapse under vacuum. | Passed |
| Suture Wing Integrity Test: Max force catheter junction suture wing can withstand prior to break. | Passed |
| OD Swell: Does not swell beyond twice the labeled OD during power injection. | Passed |
| Tip Stability Test: Tip remains in same orientation during power injection at max flow rate. | Passed |
| Guidewire Drag Test: Guidewire can be removed without difficulty. | Passed |
| Luer Testing (Stress Cracking, Separation from Axial Load/Unscrew Torque, Overriding, Dimensions, Leak): Compliance with ISO 80369-7. | All Luer tests passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify numerical sample sizes for the performance tests conducted. It generally refers to "All testing," "each test piece," implying that appropriate sample sizes were used per industry standards, but the exact numbers are not disclosed.
- Data Provenance: The tests were conducted internally by the manufacturer (Bard Access Systems, Inc. / BD) to demonstrate compliance with standards and equivalence. These are laboratory/bench tests performed on the physical device, not clinical data from patients. The data is prospective in the sense that the tests were specifically performed for this submission. The "country of origin of the data" would be where the tests were performed, presumably within the manufacturer's facilities, likely in the US (Salt Lake City, Utah is the submitter address).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. This is a physical device submission, not an AI/software submission. "Ground truth" in the AI sense (e.g., expert labels on medical images) does not apply here. The "ground truth" for the device's performance is established by the specified engineering and material standards (e.g., ISO, ASTM, USP) and the results of laboratory tests.
4. Adjudication method for the test set:
This question is not applicable. There is no "adjudication" in the sense of reconciling disagreements between multiple human readers or comparing AI outputs to human interpretations. Device performance is determined through objective, quantifiable physical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This question is not applicable, as this is a physical medical device and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable, as this is a physical medical device and does not involve an algorithm.
7. The type of ground truth used:
The "ground truth" here is defined by:
- Engineering Standards and Specifications: e.g., ISO 10993-1, USP <788>, ISO 10555-1, ASTM F640-12, ISO 10555-3, ISO 80369-7, and FDA guidance documents.
- Device Design Parameters: The specified dimensional requirements, material properties, and functional performance (e.g., flow rates, pressure resistance).
- Objective Test Measurements: Quantifiable laboratory measurements from performance tests.
8. The sample size for the training set:
This question is not applicable. There is no "training set" in the context of a physical medical device submission.
9. How the ground truth for the training set was established:
This question is not applicable. There is no "training set" or "ground truth" established for it in this context. The "ground truth" for proving substantial equivalence relies on adherence to established engineering standards and validated test methodologies.
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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
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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 (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
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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 InjectionFlow Rate | Maximum PowerInjector PressureSetting |
|---|---|---|---|
| 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:
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| Contact Person: | Breanna CasadosRegulatory 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 | |
| PredicateDevice | 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 | ||||||
| ReferenceDevice | 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 forinsertion into the central venous system. BD power injectable acute central lines are radiopaque and have a soft tip that ismore 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: | |||||||
| DeviceDescription | Catheter Length | Lumen(s) | Power InjectionFlow Rate | Maximum PowerInjector PressureSetting | |||
| 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 bloodsampling. |
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| Acute central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. Theyare designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as bloodwithdrawal, 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 forUse | Catheter Length | Lumen(s) | Power InjectionFlow Rate | Maximum PowerInjector PressureSetting | 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 | DistalProximal | 10 mL/sec10 mL/sec | 325 psi | 16 cm and 20 cm | DistalMedial / Proximal | 10 mL/sec9 mL/sec | 325 psi | ||||
| Proximal | 10 mL/sec | 30 cm | DistalMedial / Proximal | 9 mL/sec7 mL/sec | |||||||||||
| Technological characteristics of the subject BD CentroVena™ Acute Central Line are substantially equivalent with respectto 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 cm7 Fr Dual Lumen x 20 cm | 7 Fr Triple Lumen x 16 cm7 Fr Triple Lumen x 20 cm7 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) | ||||||||||||
| TechnologicalCharacteristics | Attribute | Subject Device – BD CentroVena™ AcuteCentral Line(7 French Dual Lumen) | Predicate Device - BD Acute Central Line(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 880.5200Short-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:Same | Shaft Tubing:Polyurethane | ||||||||||
| Indications forUse | Acute central venous catheters are indicated toprovide short-term access (< 30 days) to thecentral venous system. They are designed foradministering I.V. fluids, blood products, drugsand parenteral nutrition solutions, as well asblood withdrawal, central venous pressure | Acute central venous catheters are indicated toprovide short-term access (< 30 days) to thecentral venous system. They are designed foradministering I.V. fluids, blood products, drugsand parenteral nutrition solutions, as well asblood withdrawal, central venous pressure |
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| K200266 S001 | |||
|---|---|---|---|
| Luer Connector:SameExtension Legs:SameJunction:SameStrain Relief:Polyurethane | Luer Connector:PolyurethaneExtension Legs:PolyurethaneJunction:PolyurethaneStrain Relief:N/A | |
|---|---|---|
| Number ofLumens | Two (2) | Three (3) |
| Power InjectionMaximum FlowRate | 16 and 20 cm length:• Distal (15 Ga.) – 10 mL/sec• Proximal (17 Ga.) – 10 mL/sec | 16 and 20 cm length:• Distal (16 Ga.) – 10 mL/sec• Medial (18 Ga.) – 9 mL/sec• Proximal (18 Ga.) – 9 mL/sec30 cm length:• Distal (16 Ga.) – 9 mL/sec• Medial (18 Ga.) – 7 mL/sec• Proximal (18 Ga.) – 7 mL/sec |
| Sterility | Same | Provided Sterile |
| Safety &PerformanceTests | The Power Injection Maximum Flow Rates as indicated in the IFU statement differ in that the Proximal flow rate of thesubject device is 10 mL/sec, whereas the flow rate of the Proximal of the predicate device is 9 mL/sec. The technologicaldifferences listed above were evaluated using industry consensus standards, and as defined in the Risk Assessment. Arisk analysis was performed for the modifications done to the subject device, in accordance to ISO 14971, Medical Devices- Applications of Risk Management to Medical Devices. BAS has identified and evaluated the risks associated with thechanges; these risks were adequately mitigated through verification and validation testing. Therefore, these differences intechnological characteristics between the subject and predicate devices do not raise new or different questions of safety oreffectiveness.The following performance tests were conducted or adopted from the predicate device to establish the performance of theBD CentroVena™ Acute Central Line, and in determining substantial equivalence to the predicate BD Acute Central Line(7F Triple Lumen). All testing passed the predetermined acceptance criteria. | |
| Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation andtesting within a risk management process | ||
| Biocompatibility Testing | Biocompatibility tests were leveraged from the predicate BD Acute Central Line andreference device (K162443) to confirm that the catheter is free from biologicalhazard. | |
| Reference Standard: USP<788>Particulate Matter in Injections | ||
| Particulate MatterTesting | Particulate Matter Testing conducted on the predicate BD Acute Central Line wasadopted by the subject device. | |
| Reference Standard: ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: Generalrequirements | ||
| 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 thecatheter is occluded. | |
| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD and lumen area fordual lumen catheters to ensure compliance with dimensional specification. | |
| Implantable Length | Test to measure useful length for catheters to ensure compliance with dimensionalspecification. | |
| Extension Leg Length | Test to measure and confirm extension leg length compliance with dimensionalspecification. | |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressurepresent in the catheter at maximum flow conditions when the distal end is occluded. | |
| Hydraulic CatheterBurst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressurepresent in the catheter at maximum flow conditions when the distal end is occluded. | |
| Power InjectionConditioning | Test to confirm the catheter does not leak or burst as a result of power injections atmaximum indicated flow rate. | |
| Gravity Flow | Test to measure the gravity flow performance of a full-length catheter. | |
| Luer to Extension LegTensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimumpeak tensile force. |
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| K200266 S001 | |
|---|---|
| -------------- | -- |
| Extension Leg toTrifurcation Tensile Test | |
|---|---|
| Trifurcation to ShaftTensile Test | |
| Shaft Tensile Test | |
| Reference Standard: ASTM F640-12 - Standard Test Methods for Determining Radiopacityfor 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 minimumpeak tensile force. |
| Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Termand Long-Term Intravascular Catheters, 1995 | |
| Catheter Collapse Test | Test to measure the flow rate of aspiration and demonstrate that the catheter will notcollapse under a vacuum. |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at break. |
| Suture Wing IntegrityTest | Test to measure the maximum force a catheter junction suture wing can withstandprior to break. |
| OD Swell | Test to confirm that the catheter does not swell beyond twice the size of the labeledOD during power injection. |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientation during powerinjection (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 withoutdifficulty. |
| Reference Standard: ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcareapplications - 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. | |
|---|---|---|
| Dimensions | Dimensional testing to characterize luer dimensions. | |
| Leak Testing | Sub-atmospheric Leak Testing and Luer Positive Pressure Leak | |
| TechnologicalComparison toPredicateDevice | 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 ofSubstantialEquivalence | 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. |
§ 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).