BD Cathena Safety IV Catheter

K201717 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Sep 22, 2020 · General Hospital

Device Facts

• Record ID: K201717
• Device Name: BD Cathena Safety IV Catheter
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 22, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended 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

BD Cathena™ Safety IV Catheter is an over-the-needle peripheral intravascular catheter. It features a radiopaque polyurethane catheter, stainless steel needle, and passive safety needle shield to prevent needlestick injuries. Includes BD Instaflash™ technology for immediate blood visualization in the flash chamber to confirm vessel entry. Optional BD Multiguard™ technology acts as a blood control septum to stop flow from the hub until a Luer connection is established. Used by clinicians in clinical settings for short-term vascular access. The device is inserted into the patient's peripheral vein; once the needle is removed, the safety shield engages. The clinician monitors blood flow via the flash chamber and connects the hub to infusion or monitoring equipment. The device facilitates fluid administration, blood sampling, and pressure monitoring, benefiting patients by providing reliable, safe vascular access with reduced risk of blood exposure and needlestick injury.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included force to break adhesion, system drag, catheter separation force, blood escape time, procedural leak time, and testing per ISO 10555-1:2014. Biocompatibility, sterilization, and additional mechanical testing (ISO 10555-5, ISO 23908) were leveraged from the predicate device.

Technological Characteristics

Over-the-needle peripheral IV catheter. Materials: Polyurethane (tubing), Stainless Steel (needle), Polypropylene (hub/grip), Acrylonitrile Butadiene Styrene (safety shield). Features: Passive safety needle shield, BD Instaflash™ visualization, optional BD Multiguard™ blood control septum. Dimensions: 16-24 GA. Sterilization: Ethylene Oxide (SAL 10^-6). Power injector compatible up to 325 psi.

Indications for Use

Indicated for any patient population requiring peripheral vascular access for short-term blood sampling, blood pressure monitoring, or fluid administration. Suitable for use 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 (K192493)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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".

September 22, 2020

Becton Dickinson Infusion Therapy Systems Inc. Paul Holman Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070

Re: K201717

Trade/Device Name: BD Cathena TM Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 25, 2020 Received: August 27, 2020

Dear Paul Holman:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Payal Patel 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

## 510(k) Number (if known)

K201717

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)**

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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bd.com

# K201717 510(k) Summary (21 CFR §807.92) BD Cathena™ Safety IV Catheter

| Submitter<br>Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | Submitter Address: | 9450 South State Street<br>Sandy, Utah 84070 |
| | Contact Person: | Paul Holman<br>Regulatory Affairs Specialist |
| | Email Address: | [e-mail] |
| | Phone Number: | [phone] |
| | Date of Preparation: | July 20, 2020 |
| Subject Device | Trade Name: | BD Cathena™ Safety IV Catheter |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | 510(k) Reference: | K201717 |
| | Regulation Number: | 21 CFR §880.5200 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than<br>30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| Predicate<br>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<br>30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| Reason for<br>Submission | The purpose of this submission is to notify the FDA of the following changes:<br>• Introduction of BD Cathena™ Safety IV Catheter 16 GA configurations<br>with BD Multiguard™ Technology;<br>• Modification of the initial adhesion specification for all BD Cathena™<br>Safety IV Catheter 16 GA configurations; | |

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| bd.com |
|--------|
| |

| | Use of universal blood control adapter in all BD Cathena™ Safety IV<br>Catheter 16 GA catheter configurations; and Updates to the BD Cathena™ Safety IV Catheter Instructions for Use to<br>improve clarity, reflect current clinical practice, and include flow rates for<br>the new 16 GA configurations. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV)<br>catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip,<br>passive safety needle shield, and flash chamber with removable vent plug. The<br>needle and catheter are protected by a needle cover. These devices have BD<br>Instaflash™ Needle Technology, allowing for immediate visualization of blood<br>along the catheter. The flash chamber provides confirmation that the device has<br>entered the vessel. The needle tip is passively protected when the needle is<br>removed, reducing the risk of accidental needlestick injury.<br><br>These devices are available with or without multi-access BD Multiguard™<br>Technology, which is designed to stop the flow of blood from the catheter hub<br>until a Luer connection is made. Once a connection is made, fluids or blood can<br>flow through the catheter hub in either direction.<br><br>These devices are available with or without wings. The catheter hub and wings are<br>color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA<br>(0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7<br>mm) = Grey). These devices are not made with natural rubber latex. |
| Indications for<br>Use<br>(21 CFR §<br>807.92(a)(5)) | The subject device Indications for Use is identical to the predicate BD Cathena™<br>Safety IV Catheter.<br><br>BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's<br>peripheral vascular system for short term use to sample blood, monitor blood<br>pressure, or administer fluids. These devices may be used for any patient<br>population with consideration given to adequacy of vascular anatomy, procedure<br>being performed, fluids being infused, and duration of therapy. These devices are<br>suitable for use with power injectors set to a maximum pressure of 325 psi (2240<br>kPa). |
| Technological<br>Characteristics | Technological characteristics of the subject device are substantially equivalent to<br>the predicate device. The subject BD Cathena™ Safety IV Catheter achieves its<br>intended use based on the same technology and principles of operation as the<br>predicate device.<br><br>A comparison of the subject and predicate device technological characteristics is<br>provided in the table below. |

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## bd.com

| Attribute | SUBJECT<br>BD Cathena™ Safety IV Catheter | PREDICATE (K192493)<br>BD Cathena™ Safety IV Catheter | Comparison |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | Identical |
| Indications<br>for Use | BD Cathena™ Safety IV Catheters<br>are intended to be inserted into a<br>patient's peripheral vascular system<br>for short term use to sample blood,<br>monitor blood pressure, or<br>administer fluids. These devices<br>may be used for any patient<br>population with consideration given<br>to adequacy of vascular anatomy,<br>procedure being performed, fluids<br>being infused, and duration of<br>therapy. These devices are suitable<br>for use with power injectors set to a<br>maximum pressure of 325 psi (2240<br>kPa). | BD Cathena™ Safety IV Catheters<br>are intended to be inserted into a<br>patient's peripheral vascular system<br>for short term use to sample blood,<br>monitor blood pressure, or<br>administer fluids. These devices<br>may be used for any patient<br>population with consideration given<br>to adequacy of vascular anatomy,<br>procedure being performed, fluids<br>being infused, and duration of<br>therapy. These devices are suitable<br>for use with power injectors set to a<br>maximum pressure of 325 psi (2240<br>kPa). | Identical |
| Fundamental<br>Scientific<br>Technology | Peripheral intravascular catheter<br>designed with a passive needlestick<br>safety mechanism and a multi-use<br>blood control septum. Incorporates<br>BD Instaflash™ technology to<br>assist with flashback visualization. | Peripheral intravascular catheter<br>designed with a passive needlestick<br>safety mechanism and a multi-use<br>blood control septum. Incorporates<br>BD Instaflash™ technology to assist<br>with flashback visualization. | Identical |
| Primary<br>Device<br>Components /<br>Materials | Safety Shield<br>Acrylonitrile Butadiene Styrene | Safety Shield<br>Acrylonitrile Butadiene Styrene | Identical |
| | Grip / Needle Hub<br>Polypropylene | Grip / Needle Hub<br>Polypropylene | Identical |
| | Needle<br>Stainless Steel | Needle<br>Stainless Steel | Identical |
| | Catheter Adapter<br>Polypropylene | Catheter Adapter<br>Polypropylene | Identical |
| | Catheter Tubing<br>Polyurethane with radiopaque<br>barium sulfate | Catheter Tubing<br>Polyurethane with radiopaque<br>barium sulfate | Identical |
| Catheter<br>Dimensions | Catheter Diameters<br>16 GA, 18 GA, 20 GA, 22 GA, 24<br>GA<br>Catheter Lengths | Catheter Diameters<br>16 GA, 18 GA, 20 GA, 22 GA, 24<br>GA<br>Catheter Lengths | Identical |
| Attribute | SUBJECT<br>BD Cathena™ Safety IV Catheter | PREDICATE (K192493)<br>BD Cathena™ Safety IV Catheter | Comparison |
| | 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN,<br>2.00 IN | 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN,<br>2.00 IN | |
| Shelf Life | 3 years | 3 years | Identical |
| Sterilization<br>Method | EO (SAL 10-6) | EO (SAL 10-6) | Identical |

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## bd.com

A Risk Analysis in accordance with ISO 14971:2007 was conducted to assess the Summary of Performance impact of the proposed modifications to the predicate device.

Tests

Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate device 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 Studies
- Force to break adhesion between catheter unit and needle (initial o adhesion)
- Force to remove needle from catheter unit (average system drag) o
- Catheter separation force o
- Blood escape time O
- Procedural leak time O
- Testing per ISO 10555-1:2014 ●

The following data testing was leveraged from the predicate device:

- . Testing per ISO 10555-5:2013 and ISO 23908:2011
- EO residuals per ISO 10993-7:2008 ●
- . Sterilization validation per ISO 11135:2014

A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, and 2) FDA guidance Use of harmonized 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. Based

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## bd.com

| Summary of<br>Substantial<br>Equivalence | on the assessment, biocompatibility data was leveraged from the predicate<br>devices.<br><br>Per design control requirements specified in 21 CFR 820.30, the subject devices<br>met all predetermined acceptance criteria for the above-listed performance tests,<br>demonstrating substantial equivalence to the predicate devices.<br><br>Based on the indications for use, technological characteristics, and results of<br>performance testing, the subject BD Cathena™ Safety IV Catheter is substantially<br>equivalent to the predicate device. |
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