(213 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 provided text describes the BD Acute Central Line, a medical device, and its substantial equivalence to a predicate device, the Arrow Central Venous Catheter (K071538). The document outlines various performance tests conducted to establish this equivalence, along with the criteria used.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table listing "acceptance criteria" alongside "reported device performance" with specific numerical results for each test. Instead, it states that "All testing passed the predetermined acceptance criteria." The acceptance criteria are implicitly defined by the standards and the purpose of each test.
Here’s a summary of the tests performed and their implied acceptance criteria:
| Test Name | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing (ISO 10993-1:2009) | Catheter free from biological hazard; materials acceptable for intended purpose (based on Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subchronic Systemic Toxicity, Genotoxicity, Hemocompatibility, Implantation) | Passed |
| Clamp Engagement | Catheter assembly will not leak when clamp is engaged. | Passed |
| Leak Test | Catheter assembly will not leak when the distal end of the catheter is occluded. | Passed |
| Dimensional Test | OD and ID/lumen area comply with dimensional specifications. | Passed |
| Implantable Length | Useful length complies with dimensional specifications. | Passed |
| Extension Leg Length | Extension leg length complies with dimensional specifications. | Passed |
| Burst Test | Catheter burst pressure exceeds peak pressure in catheter at maximum flow conditions when distal end is occluded. | Passed |
| Hydraulic Catheter Burst Test | Catheter burst pressure exceeds peak pressure in catheter at maximum flow conditions when distal end is occluded. | Passed |
| Power Injection Conditioning | Catheter does not leak or burst as a result of power injections at maximum indicated flow rate. | Passed |
| Gravity Flow | Meets specified gravity flow performance for a full-length catheter. | Passed |
| Luer to Extension Leg Tensile Test | Peak tensile force exceeds minimum peak tensile force. | Passed |
| Extension Leg to Trifurcation Tensile Test | Peak tensile force exceeds minimum peak tensile force. | Passed |
| Trifurcation to Shaft Tensile Test | Peak tensile force exceeds minimum peak tensile force. | Passed |
| Shaft Tensile Test | Maximum catheter strain and modulus at break meet specified criteria. | Passed |
| Radiopacity (ASTM F640-12) | Catheter is radio-detectable. | Passed |
| Tip Tensile (ISO 10555-3:2013) | Peak tensile force exceeds minimum peak tensile force. | Passed |
| Catheter Collapse Test | Demonstrates aspiration flow rate and that catheter will not collapse under vacuum. | Passed |
| Suture Wing Integrity Test | Maximum force catheter junction suture wing can withstand prior to break meets specified criteria. | Passed |
| Priming Volume | Volume required to prime full-length catheter meets specified criteria. | Passed |
| OD Swell | Catheter does not swell beyond twice the size of the labeled OD during power injection. | Passed |
| Tip Stability Test | Catheter tip remains in same orientation during power injection (tip pointing in direction of venous flow) at maximum indicated flow rate. | Passed |
| Guidewire Drag Test | Guidewire can be removed without difficulty. | Passed |
| Luer Testing (ISO 594: Part 1 & 2) | Luer connectors meet requirements for Leak, Leak Decay, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Gauging. | Passed |
| Particulate Testing (USP <788>) | Particulate matter on catheter post-manufacture does not exceed prescribed particle sizes. | Passed |
| MR Safety | Device is safe for use in an MR environment. | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each of the performance tests. It mentions that testing was conducted "by or for BAS per guidance documents and standards in conjunction with in-house protocols." The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The device is a physical medical device (central venous catheter), not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy. The "ground truth" for this device's performance is established through physical and material property testing against engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a physical medical device. Performance is determined by objective measurements against established standards, not by agreement among adjudicators.
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 is not applicable. The BD Acute Central Line is a physical medical device and not an AI or diagnostic imaging device for which MRMC comparative effectiveness studies with human readers would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the BD Acute Central Line's performance is based on established industry consensus standards and in-house protocols for performance testing of medical devices, specifically intravascular catheters. This includes physical, chemical, and biological testing as outlined in standards like ISO 10993-1, ISO 10555, ASTM F640-12, USP <788>, and FDA guidance documents. The acceptance criteria for these tests serve as the "ground truth" against which the device's performance is measured.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a physical medical device.
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November 1, 2019
Bard Access Systems, Inc. (Bard has joined BD) % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K190855
Trade/Device Name: BD Acute Central Line Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: October 3, 2019 Received: October 7, 2019
Dear Dave Yungvirt:
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
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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 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 (QS) 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,
Geeta Pamidimukkala Acting 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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Indications for Use
510(k) Number (if known) K190855
Device Name BD Acute Central Line
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.
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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K190855 510(k) Summary for BD Acute Central Line
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) | ||
|---|---|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |||
| Contact Person: | Sean LoringRegulatory Affairs Specialist | |||
| Telephone Number: | 801.522.5634 | |||
| Fax Number: | 801.522.5425 | |||
| Date of Preparation: | 10/31/2019 | |||
| SubjectDevice | Trade Name(s): | BD Acute Central Line | ||
| 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: | Arrow Central Venous Catheter | ||
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days | |||
| Class: | 2 | |||
| Product Code: | FOZ | |||
| Regulation Number: | 21 CFR 880.5200 | |||
| Premarket Notification #: | K071538 | |||
| Manufacturer: | Arrow | |||
| Classification Panel | General Hospital | |||
| DeviceDescription | A family of power injectable central venous catheters constructed of medical grade polyurethane and isdesigned for insertion into the central venous system. BD power injectable acute central lines areradiopaque, and have a soft tip that is more pliable than the catheter body. Each catheter is provided in asterile package with applicable insertion kit accessories. The maximum pressure injector settings andmaximum power injection flow rate are specified in the table below: | |||
| Catheter Length | Lumen(s) | Power InjectionFlow Rate | Maximum PowerInjector PressureSetting | |
| 16 cm and 20 cm | DistalMedial / Proximal | 10 mL/sec9 mL/sec | 325 psi |
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| Catheter Length | Lumen(s) | Power InjectionFlow Rate | Maximum PowerInjector PressureSetting | ||
|---|---|---|---|---|---|
| 16 cm and 20 cm | DistalMedial / Proximal | 10 mL/sec9 mL/sec | 325 psi | ||
| 30 cm | DistalMedial/ Proximal | 9 mL/sec7 mL/sec | |||
| TechnologicalCharacteristics | Attribute | Subject Device – BD Acute Central Line | Predicate Device – Arrow Central Venous Catheter | Discussion of Characteristicsbetweensubject and predicate | |
| Owner | Bard Access Systems, Inc. | Arrow | |||
| Classification | Same | FOZ – 21 CFR 880.5200 | Classification ofsubject device isthe same as thepredicate | ||
| 510(k) Status | Subject of this Premarket Notification | K071538 – Concurrencedate August 30, 2007 | |||
| Indicationsfor Use | Acute central venous catheters areindicated to provide short-term access(< 30 days) to the central venoussystem. They are designed foradministering I.V. fluids, bloodproducts, drugs and parenteralnutrition solutions, as well as bloodwithdrawal, central venous pressuremonitoring, and power injection ofcontrast media. | The Arrow CVC isintended to provide short-term (<30 days) centralvenous access fortreatment of diseases orconditions requiringcentral venous access,including, but not limitedto the following:• Lack of usableperipheral IV sites• Central venouspressuremonitoring• Total parenteralnutrition (TPN)• Infusions of fluids,medications, orchemotherapy• Frequent bloodsampling orreceiving bloodtransfusions/bloodproducts | Indications foruse between thesubject andpredicatedevices aresubstantiallyequivalent. | ||
| CommercialName | BD Acute Central Line | Arrow Central VenousCatheter |
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| CatheterDimensions | 7 Fr Triple Lumen x 16 cm7 Fr Triple Lumen x 20 cm7 Fr Triple Lumen x 30 cm | 7 Fr Triple Lumen x 16 cm7 Fr Triple Lumen x 20 cm | Additionalcatheter lengthof 30 cm doesnot raise new ordifferentquestions ofsafety oreffectivenessand a riskassessment didnot identify anynew orsignificantlymodified risks. |
|---|---|---|---|
| Duration ofUse | Same | Short term (<30 days) | Both the subjectand predicatedevices areindicated for usefor less than 30days. |
| Means ofinsertion | Same | Percutaneous | Means ofinsertion isidenticalbetween thesubject andpredicatedevices. |
| Insertion Site | Same | Jugular, subclavian, orfemoral veins | Insertion sites forthe subject andpredicatedevices areidentical. |
| PrimaryDeviceMaterials | Catheter Base MaterialsShaft Tubing:PolyurethaneLuer Connector:PolyurethaneExtension Legs:PolyurethaneJunction:Polyurethane | Catheter Base MaterialsShaft Tubing:PolyurethaneLuer Connector:PolyurethaneExtension Legs:PolyurethaneJunction:Polyurethane | Catheter basematerials for thepredicate deviceare proprietary. |
| CatheterProximalConfiguration | Same | Side-hole skive | Lumenconfigurationsare substantiallyequivalentbetween thesubject andpredicatedevices. |
| CatheterMedialConfiguration | Same | Side-hole skive | Lumenconfigurationsare substantiallyequivalentbetween thesubject and |
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| predicatedevices. | ||||||
|---|---|---|---|---|---|---|
| CatheterDistalConfiguration | Same | Formed tip | Tipconfigurations ofthe subject andthe predicatedevice aresubstantiallyequivalent. | |||
| Number ofLumens | Same | Triple Lumen | Same aspredicate device. | |||
| PowerInjectionMaximumFlow Rate | 16 and 20 cm length:• 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 | 16 and 20 cm length:• Distal (16 Ga.) – 10 mL/sec• Medial (18 Ga.) – 5 mL/sec• Proximal (18 Ga.) - 5 mL/sec | Differences inpower injectionmaximum flowrates do notraise additionalquestions ofsafety oreffectiveness. | |||
| Sterility | Same (10-6)Ethylene OxideAAMI 11135:2014 | Provided Sterile | The subject andpredicatedevices are bothprovided sterile. | |||
| The technological differences listed above were evaluated using industry consensus standards, and asdefined in the Risk Assessment. Therefore, these differences in technological characteristics between thesubject and predicate devices do not raise new or different questions of safety or effectiveness. | ||||||
| The following performance tests were conducted by or for BAS per guidance documents and standards inconjunction with in-house protocols to establish the performance of the BD Acute Central Line, and indetermining substantial equivalence to the predicate Arrow Central Venous Catheter. All testing passedthe predetermined acceptance criteria. | ||||||
| Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation andtesting within a risk management process | ||||||
| Tests to confirm that the catheter is free from biological hazard per testing. A health-based risk assessment per ISO 10993-1 was performed for determining theacceptability of the material for the intended purpose. | ||||||
| Safety &PerformanceTests | Biocompatibility Testing | 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: 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. |
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| 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 CatheterBurst 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 InjectionConditioning | 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 LegTensile Test | |
| Extension Leg toTrifurcation Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. |
| Trifurcation to ShaftTensile Test | |
| Shaft Tensile Test | |
| Reference Standard: ASTM F640-12 – Standard Test Methods for Radiopacity of Plasticsfor 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 Guidance: 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 not collapse 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 withstand prior to break. |
| Priming Volume | Test to measure the volume required to prime a full-length catheter. |
| 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. |
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| Reference Standards: ISO 594: Conical Fittings for a 6% (Luer) Taper for Syringes, Needles, and CertainOther Medical Equipment - Part 1: General Requirements and Part 2: Lock Fittings | |
|---|---|
| Luer Testing | Testing to ensure that luer connectors meet requirements for:• Leak• Leak Decay• Stress Cracking• Resistance to Separation from Axial Load• Resistance to Separation from Unscrewing• Resistance to Overriding• Gauging |
| Reference Standard: USP<788>: Sizing and Counting Particulate Matter | |
| Particulate Testing | Testing to ensure that particulate matter on the catheter post-manufacture is notexceeded for prescribed particle sizes. |
| Reference Standard: FDA Guidance on Establishing Safety and Compatibility of Passive Implants in theMagnetic Resonance (MR) Environment, 2014 | |
| MR Safety | Testing to demonstrate that the subject device is safe for use in an MR environment. |
| Diagram | Image: Diagram of Catheter with labels: Female Luer Hubs, Thumb Clamp, Trifurcation/Suture Wing, Soft Tip, Catheter Shaft Tubing, Extension Legs |
| TechnologicalComparisonto PredicateDevice | Technological characteristics of the subject BD Acute Central Line are substantially equivalent with regardto the basic design and function of the predicate device, Arrow Central Venous Catheter (K071538). Thepriming volumes, differ from the predicate device. However, these differences do not alter the intended useof the subject device, and do not raise any new or different questions regarding safety or effectivenesswhen compared to the predicate device. |
| Summary ofSubstantialEquivalence | Based on the risk management activities and testing, the subject BD Acute Central Line has beendemonstrated to be substantially equivalent to the cited predicate device. |
Based on the indications for use, technological characteristics, and results of performance testing, the Conclusion: subject BD Acute Central Line has been demonstrated to be substantially equivalent to the predicate devices.
§ 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).