(135 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 devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices 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 (IV) 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 (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.
The provided text does not describe an AI/ML-driven device or study. Instead, it is a 510(k) premarket notification for a medical device (BD Cathena™ Safety IV Catheter), which is an intravascular catheter. The submission outlines the device, its intended use, comparison to predicate devices, and performance tests conducted to demonstrate substantial equivalence, but it does not involve any AI/ML components or studies that would require the specific criteria requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies).
Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance from the provided text in the context of an AI/ML study. The performance tests mentioned (e.g., time to visualize flashback, force to break adhesion, burst pressure, flow rate, power injection) are specific to the mechanical and functional properties of an IV catheter, not AI/ML model performance.
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January 24, 2020
Becton Dickinson Infusion Therapy Systems, Inc. Henry Boland Staff Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070
Re: K192493
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: December 19, 2019 Received: December 20, 2019
Dear Henry Boland:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 mediation-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 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) K192493
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 devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices 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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bd.com
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510(k) Summary (21 CFR §807.92)
BD Cathena™ Safety IV Catheter
| Submitter | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|---|
| Information | Submitter Address: | 9450 South State StreetSandy, UT 84070 |
| Contact Person: | Henry BolandStaff Regulatory Affairs Specialist | |
| Email Address: | henry.boland@bd.com | |
| Phone Number: | (801) 565-2550 | |
| Date of Preparation: | January 23, 2020 | |
| Subject Device | Trade Name: | BD Cathena™ Safety IV Catheter |
| 510(k) Reference: | K192493 | |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Regulation Number: | 21 CFR §880.5200 | |
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than30 days | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| Predicate | Trade Name: | BD Cathena™ Safety IV Catheter |
| Device | 510(k) Reference: | K172506, cleared 17 September 2017 |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Regulation Number: | 21 CFR §880.5200 | |
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than30 days | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| Reference | Trade Name: | BD Insyte™ Autoguard™ BC Safety IV Catheter |
| Device | 510(k) Reference: | K110443, cleared 19 July 2011 |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| Regulation Number: | 21 CFR §880.5200 | |
| Regulation Name: | Catheter, intravascular, therapeutic, short-term less than30 days | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| Reason for Submission | The reason for this submission is the introduction of a performance specification(due to a change in material supplier and grade of silicone lubricant),modification of catheter tubing dimensions, and modifications to productlabeling. | |
| Device Description | BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV)catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip,passive safety needle shield, and flash chamber with removable vent plug. Theneedle and catheter are protected by a needle cover. These devices have BDInstaflash™ Needle Technology, allowing for immediate visualization of bloodalong the catheter. The flash chamber provides confirmation that the device hasentered the vessel. The needle tip is passively protected when the needle isremoved, reducing the risk of accidental needlestick injury.These devices are available with or without multi-access BD Multiguardtechnology, which is designed to stop the flow of blood from the catheter hubuntil a Luer connection is made. Once a connection is made, fluids or blood canflow through the catheter hub in either direction.These devices are available with or without wings. The catheter hub and wingsare color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA(1.7 mm) = Grey). These devices are not made with natural rubber latex. | |
| Indications for Use(21 CFR §807.92(a)(5)) | The subject device Indications for Use is identical to the predicate BD Cathena™Safety IV Catheter, with the exception that 'catheters' was changed to 'devices'in some cases.BD Cathena™ Safety IV Catheters are intended to be inserted into a patient'speripheral vascular system for short term use to sample blood, monitor bloodpressure, or administer fluids. These devices may be used for any patientpopulation with consideration given to adequacy of vascular anatomy, procedurebeing performed, fluids being infused, and duration of therapy. These devices aresuitable for use with power injectors set to a maximum pressure of 325 psi (2240kPa) |
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bd.com
Technological characteristics of the subject device are substantially equivalent to the subject Technological Characteristics BD Cathena™ Safety IV Catheter achieves its intended use based on the same technology and principles of operation as the predicate device.
The changes to the device include the introduction of a performance specification (due to a change in material supplier and grade of the needle lubricant from a 2-part silicone material), modification of catheter tubing dimensions for the 18, 20, 22, and 24G catheters, and modifications to product labeling. There were no changes to the product performance specifications as a result of the catheter tubing dimension changes. Biocompatibility evaluation was performed for the change in silicone, performance testing was performed to support the modifications in the catheter tubing.
A comparison of the subject and predicate device technological characteristics is provided in the table below.
| Attribute | SUBJECTBD Cathena™ Safety IV Catheter | PREDICATE (K172506)BD Cathena™ Safety IV Catheter | Comparison |
|---|---|---|---|
| Classification | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | Identical |
| Indication forUse | BD Cathena™ Safety IV Catheters areintended to be inserted into a patient'speripheral vascular system for short term useto sample blood, monitor blood pressure, oradminister fluids. These devices may be usedfor any patient population with considerationgiven to adequacy of vascular anatomy,procedure being performed, fluids beinginfused, and duration of therapy. Thesedevices are suitable for use with powerinjectors set to a maximum pressure of 325 psi(2240 kPa). | BD Cathena™ Safety IV Catheters are intendedto be inserted into a patient's peripheralvascular system for short term use to sampleblood, monitor blood pressure, or administerfluids. These catheters may be used for anypatient population with consideration givento adequacy of vascular anatomy, procedurebeing performed, fluids being infused, andduration of therapy. The catheters aresuitable for use with power injectors set to amaximum pressure of 325 psi (2240 kPa). | Identical, with the exception that 'catheters'was changed to 'devices' in some cases. |
| Attribute | SUBJECTBD Cathena™ Safety IV Catheter | PREDICATE (K172506)BD Cathena™ Safety IV Catheter | Comparison |
| FundamentalScientificTechnology | Peripheral intravascular catheter designedwith a passive needlestick safety mechanismand a multi-use blood control septum.Incorporates BD Instaflash™ technology toassist with flashback visualization. | Peripheral intravascular catheter designedwith a passive needlestick safety mechanismand a multi-use blood control septum.Incorporates BD Instaflash™ technology toassist with flashback visualization. | Identical |
| PrimaryDeviceComponents /Materials | Safety ShieldAcrylonitrile Butadiene Styrene | Safety ShieldPolystyrene | Change in safety shield and silicone lubricantmaterials |
| Grip / Needle HubPolypropylene | Grip / Needle HubPolypropylene | ||
| NeedleStainless Steel | NeedleStainless Steel | ||
| Needle Lubricant1-part Silicone | Needle Lubricant2-part Silicone | ||
| Catheter AdapterPolypropyleneCatheter TubingPolyurethane with radiopaque barium sulfate | Catheter AdapterPolypropyleneCatheter TubingPolyurethane with radiopaque barium sulfate | ||
| CatheterDimensions | Catheter Diameters16 G, 18 G, 20 G, 22 G, 24 GCatheter Lengths0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN, 2.00 IN | Catheter Diameters16 G, 18 G, 20 G, 22 G, 24 GCatheter Lengths0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN, 2.00 IN | Change in catheter tubing dimensions for the18 G, 20 G, 22 G, and 24 G catheters |
| Shelf-Life | 3 years | 1 year | Change in shelf life from 1 year to 3 years. |
| Attribute | SUBJECTBD Cathena™ Safety IV Catheter | PREDICATE (K172506)BD Cathena™ Safety IV Catheter | Comparison |
| SterilizationMethod | EO (SAL 10^-6) | EO (SAL 10^-6) | Identical |
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bd.com
Performance tests completed on the subject device were limited to those tests Summary of Performance required to support a determination of substantial equivalence to the predicate Tests device. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets pre-determined design requirements:
BD Internal Specification
- . Time to visualize flashback in flash chamber
- Force to break adhesion between catheter unit and needle (initial adhesion) ●
- Force to remove needle from catheter unit (average system drag) .
- Device burst pressure
- Catheter separation force
- Time to visualize flashback in catheter adapter ●
- Procedural leak time
Standards Compliance
- . Flow rate (ISO 10555-1 Intravascular catheters - Sterile and single-use catheters -Part 1: General requirements)
- . Power injection (ISO 10555-1 Intravascular catheters — Sterile and single-use catheters -Part 1: General requirements)
The subject device complies with sterilization requirements of ISO 11135:2014. Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
The subject device complies with particulate testing - USP <788> Particulate Matter in Injections.
A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and 2) FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016), was conducted. Biocompatibility data was leveraged from the reference device in addition to performing additional endpoints when required.
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| 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 device. | |
| Summary of | Based on the indications for use, technological characteristics, and results of |
| Substantial | performance testing, the subject BD Cathena™ Safety IV Catheters has been |
| Equivalence | demonstrated to be substantially equivalent to the 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).