(30 days)
BD Cathena Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The catheters are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices are available with or without multi-access BD Multiguard technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (1.7 mm)=Grey). These devices are not made with natural rubber latex.
This document describes a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter, demonstrating its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or comparative effectiveness against human readers, as it is a physical medical device. The acceptance criteria and "study" described refer to various design verification tests and compliance with recognized standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests and standards compliance that serve as the acceptance criteria. The reported device performance is that it met all predetermined acceptance criteria.
| Acceptance Criteria (Performance Tests) | Reported Device Performance |
|---|---|
| Package maintains integrity | Met all predetermined acceptance criteria |
| Needle cover does not fall off | Met all predetermined acceptance criteria |
| Force to remove needle cover | Met all predetermined acceptance criteria |
| Incremental force to decouple shielded needle from catheter adapter during safety activation | Met all predetermined acceptance criteria |
| System penetration force | Met all predetermined acceptance criteria |
| Needle to needle hub pull force | Met all predetermined acceptance criteria |
| Time to visualize flashback in flash chamber | Met all predetermined acceptance criteria |
| Catheter average drag force | Met all predetermined acceptance criteria |
| Force to break adhesion between catheter unit and needle (initial adhesion) | Met all predetermined acceptance criteria |
| Force to remove needle from catheter unit (average system drag) | Met all predetermined acceptance criteria |
| Force to prematurely decouple tip-shield from adapter | Met all predetermined acceptance criteria |
| Needle is not re-exposed upon application of compressive force | Met all predetermined acceptance criteria |
| Tensile force to defeat safety system | Met all predetermined acceptance criteria |
| No air leakage from device in a connected state at low pressure less than 30 psi | Met all predetermined acceptance criteria |
| Device burst pressure | Met all predetermined acceptance criteria |
| Catheter separation force | Met all predetermined acceptance criteria |
| Blood escape time | Met all predetermined acceptance criteria |
| Force to connect Luer to catheter adapter | Met all predetermined acceptance criteria |
| Time to visualize flashback in catheter adapter | Met all predetermined acceptance criteria |
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| Gauging (ISO 594-1) | Met all predetermined acceptance criteria |
| Liquid leakage (ISO 594-1,-2, ISO 10555-1) | Met all predetermined acceptance criteria |
| Air leakage (ISO 594-1,-2) | Met all predetermined acceptance criteria |
| Separation force (ISO 594-1.-2) | Met all predetermined acceptance criteria |
| Stress cracking (ISO 594-2) | Met all predetermined acceptance criteria |
| Unscrewing torque (ISO 594-2) | Met all predetermined acceptance criteria |
| Ease of assembly (ISO 594-2) | Met all predetermined acceptance criteria |
| Resistance to overriding (ISO 594-2) | Met all predetermined acceptance criteria |
| Radio detectability (ISO 10555-1) | Met all predetermined acceptance criteria |
| Surface (ISO 10555-1. -5) | Met all predetermined acceptance criteria |
| Corrosion resistance (ISO 10555-1) | Met all predetermined acceptance criteria |
| Peak tensile force (ISO 10555-1) | Met all predetermined acceptance criteria |
| Flow rate (ISO 10555-1) | Met all predetermined acceptance criteria |
| Power injection (ISO 10555-1) | Met all predetermined acceptance criteria |
| Distal tip (ISO 105551-1) | Met all predetermined acceptance criteria |
| Needle point (ISO 10555-5) | Met all predetermined acceptance criteria |
| Strength of union between needle hub and needle tube (ISO 10555-5) | Met all predetermined acceptance criteria |
| Vent fitting (ISO 10555-1) | Met all predetermined acceptance criteria |
| Activation of the sharps injury protection feature (ISO 23908) | Met all predetermined acceptance criteria |
| Security of safe mode protection (ISO 23908) | Met all predetermined acceptance criteria |
| Biocompatibility (ISO 10993-1:2009) | Met all predetermined acceptance criteria |
| Simulated clinical use testing (FDA Guidance, IEC 62366-1:2015) | Met all predetermined acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each of the performance or standards tests. It generically states "Performance tests completed on the subject device were those tests required to support a determination of substantial equivalence to the predicate devices. Design verification tests were performed based on the risk analysis." It also does not specify the origin of any data (e.g., country of origin, retrospective/prospective), as these are laboratory and simulated use tests rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not a study involving human interpretation of medical images or data requiring expert ground truth in that sense. The "ground truth" for these tests would be derived from physical measurements and adherence to engineering specifications and international standards.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective physical or material property measurements, and standards compliance. There is no mention of adjudication among multiple evaluators.
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
Not applicable. This is a physical medical device (intravenous catheter and safety mechanism), not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the tests mentioned are:
- Engineering Specifications: The design specifications for the device, including dimensions, forces, pressures, and other physical properties.
- International Standards: Adherence to recognized international standards such as ISO 594, ISO 10555, ISO 23908, and ISO 10993 for various aspects like gauging, leakage, mechanical strength, sharps injury protection, and biocompatibility.
- Risk Analysis Outcomes: The design verification tests were performed based on a risk analysis, meaning acceptance criteria were likely set to mitigate identified risks.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of physical medical device design verification described here. The development of the device involves engineering design, prototyping, and iterative testing, not machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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July 30, 2018
Becton, Dickinson and Company % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172506
Trade/Device Name: BD Cathena™ Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: July 19, 2017 Received: August 18, 2017
Dear Mark Job:
This letter corrects our substantially equivalent letter of September 17th, 2017
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.
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the name "Geeta K. Pamidimukkala -S" in a simple, sans-serif font. The text is arranged in two lines, with "Geeta K." on the first line and "Pamidimukkala -S" on the second line. The text is black against a white background.
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure:
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Indications for Use
510(k) Number (if known)
Device Name BD Cathena Safety IV Catheter
Indications for Use (Describe)
BD Cathena Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The catheters are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
| 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 (21 CFR §807.92)
BD Cathena™ Safety IV Catheter
| SubmitterInformation | Submitter Name:Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070 |
|---|---|---|
| Contact Person:Email Address:Phone Number:Fax NumberDate of Preparation: | Henry BolandStaff Regulatory Affairs Specialisthenry.boland@bd.com(801) 565-2550(801) 304-3963September 14, 2017 | |
| Subject Device | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Cathena™ Safety IV CatheterPeripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital |
| PredicateDevice(BD InsyteAutoguard BC) | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | BD Insyte™ Autoguard™ BCK110443Peripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital |
| PredicateDevice(Introcan Safety3) | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | Introcan Safety® 3 Closed IV CatheterK111236Peripheral Intravascular or IV Catheter21 CFR §880.5200Intravascular CatheterIIFOZGeneral Hospital |
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| Reason forSubmission | The purpose of this Traditional 510(k) premarket notification is to notify CDRH ofthe introduction of the BD Cathena™ Safety IV Catheter device that has beendemonstrated to be substantially equivalent to the predicate devices listed above. |
|---|---|
| DeviceDescription | BD Cathena™ Safety IV Catheters are over-the-needle, intravascular catheters.These devices include a radiopaque BD Vialon™ catheter, needle, grip, passivesafety needle shield, and flash chamber with removable vent plug. The needle andcatheter are protected by a needle cover. These devices have BD Instaflash™Needle Technology, allowing for immediate visualization of blood along thecatheter. The flash chamber provides confirmation that the device has entered thevessel. The needle tip is passively protected when the needle is removed, reducingthe risk of accidental needlestick injury. |
| These devices are available with or without multi-access BD Multiguard technology,which is designed to stop the flow of blood from the catheter hub until a Luerconnection is made. Once a connection is made, fluids or blood can flow throughthe catheter hub in either direction. | |
| These devices are available with or without wings. The catheter hub and wings arecolor coded to indicate the catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (1.7 mm)=Grey).These devices are not made with natural rubber latex. |
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| Indications for Use(21 CFR §807.92(a)(5)) | SUBJECTBD Cathena™ Safety IVCatheter | PREDICATE(K110443)BD Insyte™ Autoguard™BC | PREDICATE(K111236)Introcan Safety® 3 ClosedIV Catheter |
|---|---|---|---|
| BD Cathena Safety IVCatheters are intended tobe inserted into a patient'speripheral vascular systemfor short term use to sampleblood, monitor bloodpressure, or administerfluids. These catheters maybe used for any patientpopulation withconsideration given toadequacy of vascularanatomy, procedure beingperformed, fluids beinginfused, and duration oftherapy. The catheters aresuitable for use with powerinjectors set to a maximumpressure of 325 psi (2240kPa). | The BD Insyte AutoguardBC catheter is inserted intoa patient's vascular systemto sample blood, monitorblood pressure, oradminister fluids. | Introcan Safety 3 ClosedIntravascular Catheter isinserted into a patient'svascular system for shortterm use (less than 30days) to sample blood,monitor blood pressure oradminister fluids and bloodintravascularly.The 18-22 gauge cathetermay be used with powerinjectors at a maximumpressure of 300 psi with aluer lock connection only. | |
| The subject and predicate devices have the same intended use. Both the subjectand predicate devices are peripheral intravascular catheters intended to be insertedinto the vascular system for short term use to sample blood, monitor bloodpressure, or administer fluids intravenously. Patient population information wasadded to the subject device indication for use to clarify the patient population forwhich these devices can be used. The power injection pressure was also increasedto 325psi to align with current power injector capabilities. The differences betweenthe subject and predicate devices' indications for use do not change the intendeduse and do not raise different questions of safety and effectiveness. | |||
| TechnologicalCharacteristics | Technological characteristics of the subject and predicate devices are substantiallyequivalent with respect to the device design and materials. The subjectBD Cathena™ Safety IV Catheter achieves its intended use based on the sametechnology and principles of operation as the predicate BD Insyte™ Autoguard™BC and Introcan Safety® 3 Closed IV Catheter, respectively. | ||
| A comparison of the subject and predicate device technological characteristics isprovided in the table below. | |||
| Attribute | SUBJECTBD Cathena™ Safety IVCatheter | PREDICATE(K110443)BD Insyte™ Autoguard™ BC | PREDICATE(K111236)Introcan Safety® 3 Closed IVCatheter |
| 21 CFR 8880-5200 | 21 CFR 8880.5200 | 21 CFR 8880.5200 | |
| Technology | passive needlestick safetymechanism and a multi-useblood control septum.Incorporates BD Instaflash™technology to assist withflashback visualization. | active needlestick safetymechanism and a one-timeuse blood control septum.Incorporates BD Instaflash™technology to assist withflashback visualization. | passive needlestick safetymechanism and a multi-useblood control septum.Incorporates catheterflashback technology to assistwith flashback visualization. |
| Safety ShieldPolystyrene | BarrelPolypropylene orPolycarbonate | ||
| Primary | Grip / Needle HubPolypropylene | Needle HubPolycarbonate | |
| DeviceComponents/ Materials | NeedleStainless Steel | NeedleStainless Steel | Unknown |
| Catheter AdapterPolypropylene | Catheter AdapterPolypropylene | ||
| Catheter TubingPolyurethane with radiopaquebarium sulfate | Catheter TubingPolyurethane with radiopaquebarium sulfate | ||
| Catheter Diameters | Catheter Diameters | Catheter Diameters | |
| Catheter | 16 G, 18 G, 20 G, 22 G, 24 GCatheter Lengths | 16G, 18 G, 20 G, 22 G, 24 GCatheter Lengths | 18 G, 20 G, 22 G, 24 GCatheter Lengths |
| Dimensions | 0.75 IN, 1.00 IN, 1.25 IN, 1.75IN, 2.00 IN | 0.75 IN, 1.00 IN, 1.16 IN, 1.77IN, 1.88 IN | 0.75 IN, 1.00 IN, 1.25 IN, 1.75IN |
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Summary of Performance tests completed on the subject device were those tests required to Performance support a determination of substantial equivalence to the predicate devices. Tests Design verification tests were performed based on the risk analysis. Results of these tests demonstrate that the BD Cathena™ Safety IV Catheter is substantially equivalent to the predicate devices. Design verification testing included the following:
- Package maintains integrity ●
- Needle cover does not fall off
- Force to remove needle cover
- Incremental force to decouple shielded needle from catheter adapter ● during safety activation
- System penetration force
- Needle to needle hub pull force
- Time to visualize flashback in flash chamber ●
- Catheter average drag force ●
- Force to break adhesion between catheter unit and needle (initial ● adhesion)
- Force to remove needle from catheter unit (average system drag)
- Force to prematurely decouple tip-shield from adapter ●
- Needle is not re-exposed upon application of compressive force .
- . Tensile force to defeat safety system
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- No air leakage from device in a connected state at low pressure less than ● 30 psi
- Device burst pressure ●
- Catheter separation force
- Blood escape time ●
- . Force to connect Luer to catheter adapter
- Time to visualize flashback in catheter adapter
Standards Compliance
- Gauging (ISO 594-1) ●
- Liquid leakage (ISO 594-1,-2, ISO 10555-1) ●
- Air leakage (ISO 594-1,-2) .
- Separation force (ISO 594-1.-2) ●
- Stress cracking (ISO 594-2)
- Unscrewing torque (ISO 594-2)
- Ease of assembly (ISO 594-2) ●
- Resistance to overriding (ISO 594-2) ●
- Radio detectability (ISO 10555-1)
- Surface (ISO 10555-1. -5) ●
- . Corrosion resistance (ISO 10555-1)
- Peak tensile force (ISO 10555-1) ●
- Flow rate (ISO 10555-1)
- Power injection (ISO 10555-1) ●
- Distal tip (ISO 105551-1) ●
- Needle point (ISO 10555-5)
- Strength of union between needle hub and needle tube (ISO 10555-5)
- Vent fitting (ISO 10555-1) ●
- Activation of the sharps injury protection feature (ISO 23908)
- Security of safe mode protection (ISO 23908) ●
In addition, biocompatibility testing was conducted on the BD Cathena™ Safety IV Catheters in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. Testing included cytotoxicity, sensitization, intracutaneous reactivity, acute svstemic toxicity, subchronic toxicity (subacute toxicity), genotoxicity, implantation, and haemocompatibility. Additionally, material-mediated pyrogenicity was also performed.
Simulated clinical use testing was performed on the device, per FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015 Medical devices - Part 1:Application of usability engineering to medical devices.
Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.
Summary of Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Cathena™ Safety IV Catheters have been Substantial Equivalence 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).