Who is the manufacturer of BD Cathena (TM) Safety IV Catheter?

Becton Dickinson Infusion Therapy Systems, Inc. filed the 510(k) submission for BD Cathena (TM) Safety IV Catheter (K192493).

What is the FDA product code for BD Cathena (TM) Safety IV Catheter?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BD Cathena (TM) Safety IV Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BD Cathena (TM) Safety IV Catheter?

BD Cathena™ Safety IV Catheter (K172506).

Who can help prepare an FDA 510(k) submission like BD Cathena (TM) Safety IV Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD Cathena (TM) Safety IV Catheter

K192493 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Jan 24, 2020 · General Hospital

Device Facts

Record ID	K192493
Device Name	BD Cathena (TM) Safety IV Catheter
Applicant	Becton Dickinson Infusion Therapy Systems, Inc.
Product Code	FOZ · General Hospital
Decision Date	Jan 24, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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).

Device Story

Over-the-needle peripheral IV catheter; includes radiopaque polyurethane catheter, needle, grip, passive safety needle shield, and flash chamber with vent plug. Features BD Instaflash™ technology for immediate blood visualization in catheter; optional multi-access BD Multiguard™ technology stops blood flow from hub until Luer connection. Used in clinical settings by healthcare providers for vascular access. Needle tip passively protected upon removal to prevent needlestick injuries. Hubs color-coded by gauge. Benefits include reduced needlestick risk, improved visualization of vessel entry, and controlled blood flow.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included flashback visualization time, adhesion/drag forces, burst pressure, catheter separation force, leak time, flow rate, and power injection testing per ISO 10555-1. Biocompatibility evaluated per ISO 10993-1:2018. Particulate testing performed per USP <788>.

Technological Characteristics

Peripheral IV catheter. Materials: Polyurethane (catheter), Stainless Steel (needle), Polypropylene (grip/hub/adapter), Acrylonitrile Butadiene Styrene (safety shield). Lubricant: 1-part silicone. Sterilization: Ethylene Oxide (SAL 10^-6). Dimensions: 16G-24G, 0.75-2.00 inch lengths. Passive safety mechanism. Complies with ISO 10555-1, ISO 11135:2014, and USP <788>.

Indications for Use

Indicated for insertion into peripheral vascular system for short-term blood sampling, blood pressure monitoring, or fluid administration. Suitable for any patient population based on vascular anatomy, procedure, fluid type, and therapy duration. Compatible with power injectors up to 325 psi.

Regulatory Classification

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.

Predicate Devices

BD Cathena™ Safety IV Catheter (K172506)

Reference Devices

BD Insyte™ Autoguard™ BC Safety IV Catheter (K110443)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ bd.com Image /page/3/Picture/2 description: The image shows the BD logo. The logo consists of an orange circle with white rays emanating from the center, resembling a sun. To the right of the circle are the letters "BD" in a bold, blue font. The letters are large and easily readable. # 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 Street Sandy, UT 84070 | | | Contact Person: | Henry Boland Staff 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 than 30 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 than 30 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 than 30 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 product labeling. | | | 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. 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. | | | 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'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) | | {4}------------------------------------------------ {5}------------------------------------------------ #### 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 | SUBJECT BD Cathena™ Safety IV Catheter | PREDICATE (K172506) BD Cathena™ Safety IV Catheter | Comparison | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Classification | 21 CFR §880.5200 Class II FOZ - Intravascular Catheter | 21 CFR §880.5200 Class II FOZ - Intravascular Catheter | Identical | | Indication for Use | 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 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 population 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). | Identical, with the exception that 'catheters' was changed to 'devices' in some cases. | | Attribute | SUBJECT BD Cathena™ Safety IV Catheter | PREDICATE (K172506) BD Cathena™ Safety IV Catheter | Comparison | | Fundamental Scientific Technology | Peripheral intravascular catheter designed with a passive needlestick safety mechanism and a multi-use blood control septum. Incorporates BD Instaflash™ technology to assist with flashback visualization. | Peripheral intravascular catheter designed with a passive needlestick safety mechanism and a multi-use blood control septum. Incorporates BD Instaflash™ technology to assist with flashback visualization. | Identical | | Primary Device Components / Materials | Safety Shield Acrylonitrile Butadiene Styrene | Safety Shield Polystyrene | Change in safety shield and silicone lubricant materials | | | Grip / Needle Hub Polypropylene | Grip / Needle Hub Polypropylene | | | | Needle Stainless Steel | Needle Stainless Steel | | | | Needle Lubricant 1-part Silicone | Needle Lubricant 2-part Silicone | | | | Catheter Adapter Polypropylene Catheter Tubing Polyurethane with radiopaque barium sulfate | Catheter Adapter Polypropylene Catheter Tubing Polyurethane with radiopaque barium sulfate | | | Catheter Dimensions | Catheter Diameters 16 G, 18 G, 20 G, 22 G, 24 G Catheter Lengths 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN, 2.00 IN | Catheter Diameters 16 G, 18 G, 20 G, 22 G, 24 G Catheter Lengths 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN, 2.00 IN | Change in catheter tubing dimensions for the 18 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 | SUBJECT BD Cathena™ Safety IV Catheter | PREDICATE (K172506) BD Cathena™ Safety IV Catheter | Comparison | | Sterilization Method | EO (SAL 10^-6) | EO (SAL 10^-6) | Identical | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 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. {9}------------------------------------------------ | | 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. |

BD Cathena (TM) Safety IV Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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BD Cathena (TM) Safety IV Catheter

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Indications for Use

Device Story

Clinical Evidence

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Indications for Use

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Reference Devices

Submission Summary (Full Text)

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