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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to specifically answer questions about acceptance criteria and comprehensive study details like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for AI/human performance studies.

The document focuses on demonstrating substantial equivalence to a predicate device (K192443) for minor modifications, primarily the introduction of 16 GA configurations and updates to specifications and instructions for use. It primarily relies on leveraging data from the predicate device and internal BD studies for specific performance tests.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "Per design control requirements specified in 21 CFR 820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."

However, the specific "predetermined acceptance criteria" and the "reported device performance" are not explicitly listed in a table format in the provided text. The tests performed are:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Force to break adhesion between catheter unit and needle (initial adhesion) meets specifications	Met predetermined design requirements
Force to remove needle from catheter unit (average system drag) meets specifications	Met predetermined design requirements
Catheter separation force meets specifications	Met predetermined design requirements
Blood escape time meets specifications	Met predetermined design requirements
Procedural leak time meets specifications	Met predetermined design requirements
Testing per ISO 10555-1:2014 meets specifications	Met predetermined design requirements
Testing per ISO 10555-5:2013 and ISO 23908:2011 meets specifications (leveraged from predicate)	Met predetermined design requirements
EO residuals per ISO 10993-7:2008 meets specifications (leveraged from predicate)	Met predetermined design requirements
Sterilization validation per ISO 11135:2014 meets specifications (leveraged from predicate)	Met predetermined design requirements
Biocompatibility in accordance with ISO 10993-1:2018 and FDA guidance meets specifications (leveraged from predicate)	Met predetermined design requirements

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "BD Internal Studies" for some tests, but details about sample size or data provenance (retrospective/prospective, country of origin) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is a physical medical device (intravascular catheter), not an AI-powered diagnostic or decision support system that typically requires expert-established ground truth for its performance evaluation (e.g., in reading medical images). The testing involves physical properties and performance characteristics of the catheter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As mentioned above, this type of testing is not relevant for the evaluation of a physical medical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This device is a physical invasive medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests conducted, the "ground truth" would be defined by engineering specifications, industry standards (e.g., ISO), and known physical properties of materials. For example, the "ground truth" for "force to break adhesion" would be a specific measurable force value derived from engineering design and safety requirements. Biocompatibility relies on well-established testing protocols and standards.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical product, not an AI system that requires a "training set" in the machine learning sense. The term "training set" is not relevant here.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As stated above, the concept of a "training set" and its "ground truth" is not relevant to the evaluation of this physical medical device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

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."

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bd.com

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

SubmitterInformation	Submitter Name:	Becton Dickinson Infusion Therapy Systems Inc.
	Submitter Address:	9450 South State StreetSandy, Utah 84070
	Contact Person:	Paul HolmanRegulatory Affairs Specialist
	Email Address:	paul.holman@bd.com
	Phone Number:	(801) 834-3607
	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 than30 days
	Regulatory Class:	II
	Product Code:	FOZ
	Classification Panel:	General Hospital
PredicateDevice	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
Reason forSubmission	The purpose of this submission is to notify the FDA of the following changes:• Introduction of BD Cathena™ Safety IV Catheter 16 GA configurationswith BD Multiguard™ Technology;• Modification of the initial adhesion specification for all BD Cathena™Safety IV Catheter 16 GA configurations;

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bd.com

	Use of universal blood control adapter in all BD Cathena™ Safety IVCatheter 16 GA catheter configurations; and Updates to the BD Cathena™ Safety IV Catheter Instructions for Use toimprove clarity, reflect current clinical practice, and include flow rates forthe new 16 GA configurations.
DeviceDescription	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 Multiguard™Technology, 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 wings arecolor 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 (1.7mm) = Grey). These devices are not made with natural rubber latex.
Indications forUse(21 CFR §807.92(a)(5))	The subject device Indications for Use is identical to the predicate BD Cathena™Safety IV Catheter.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).
TechnologicalCharacteristics	Technological characteristics of the subject device are substantially equivalent tothe predicate device. The subject BD Cathena™ Safety IV Catheter achieves itsintended use based on the same technology and principles of operation as thepredicate device.A comparison of the subject and predicate device technological characteristics isprovided in the table below.

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Attribute	SUBJECTBD Cathena™ Safety IV Catheter	PREDICATE (K192493)BD Cathena™ Safety IV Catheter	Comparison
Classification	21 CFR §880.5200Class IIFOZ - Intravascular Catheter	21 CFR §880.5200Class IIFOZ - Intravascular Catheter	Identical
Indicationsfor Use	BD Cathena™ Safety IV Cathetersare intended to be inserted into apatient's peripheral vascular systemfor short term use to sample blood,monitor blood pressure, oradminister fluids. These devicesmay be used for any patientpopulation with consideration givento adequacy of vascular anatomy,procedure being performed, fluidsbeing infused, and duration oftherapy. These devices are suitablefor use with power injectors set to amaximum pressure of 325 psi (2240kPa).	BD Cathena™ Safety IV Cathetersare intended to be inserted into apatient's peripheral vascular systemfor short term use to sample blood,monitor blood pressure, oradminister fluids. These devicesmay be used for any patientpopulation with consideration givento adequacy of vascular anatomy,procedure being performed, fluidsbeing infused, and duration oftherapy. These devices are suitablefor use with power injectors set to amaximum pressure of 325 psi (2240kPa).	Identical
FundamentalScientificTechnology	Peripheral intravascular catheterdesigned with a passive needlesticksafety mechanism and a multi-useblood control septum. IncorporatesBD Instaflash™ technology toassist with flashback visualization.	Peripheral intravascular catheterdesigned with a passive needlesticksafety mechanism and a multi-useblood control septum. IncorporatesBD Instaflash™ technology to assistwith flashback visualization.	Identical
PrimaryDeviceComponents /Materials	Safety ShieldAcrylonitrile Butadiene Styrene	Safety ShieldAcrylonitrile Butadiene Styrene	Identical
	Grip / Needle HubPolypropylene	Grip / Needle HubPolypropylene	Identical
	NeedleStainless Steel	NeedleStainless Steel	Identical
	Catheter AdapterPolypropylene	Catheter AdapterPolypropylene	Identical
	Catheter TubingPolyurethane with radiopaquebarium sulfate	Catheter TubingPolyurethane with radiopaquebarium sulfate	Identical
CatheterDimensions	Catheter Diameters16 GA, 18 GA, 20 GA, 22 GA, 24GACatheter Lengths	Catheter Diameters16 GA, 18 GA, 20 GA, 22 GA, 24GACatheter Lengths	Identical
Attribute	SUBJECTBD Cathena™ Safety IV Catheter	PREDICATE (K192493)BD Cathena™ Safety IV Catheter	Comparison
	0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN,2.00 IN	0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN,2.00 IN
Shelf Life	3 years	3 years	Identical
SterilizationMethod	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 ofSubstantialEquivalence	on the assessment, biocompatibility data was leveraged from the predicatedevices.Per design control requirements specified in 21 CFR 820.30, the subject devicesmet all predetermined acceptance criteria for the above-listed performance tests,demonstrating substantial equivalence to the predicate devices.Based on the indications for use, technological characteristics, and results ofperformance testing, the subject BD Cathena™ Safety IV Catheter is substantiallyequivalent to the predicate device.
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Summary ofSubstantialEquivalence

on the assessment, biocompatibility data was leveraged from the predicatedevices.Per design control requirements specified in 21 CFR 820.30, the subject devicesmet all predetermined acceptance criteria for the above-listed performance tests,demonstrating substantial equivalence to the predicate devices.Based on the indications for use, technological characteristics, and results ofperformance testing, the subject BD Cathena™ Safety IV Catheter is substantiallyequivalent to the predicate device.

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Regulation Number and Section

§ 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).