BD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

Device Description

BD Insyte™ Autoguard™ Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The 24-20 GA (0.7-1.1 mm) 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.

BD Insyte™ Autoguard™ Shielded IV Catheter incorporates BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate 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, 14 GA (2.1 mm) = Orange).

BD Insyte™ Autoguard™ Shielded IV Catheter facilitates the introduction of guidewires and other vascular access devices. The following labeled gauge sizes correspond to the following inside diameter (ID): 24 GA (0.40 mm ID), 22 GA (0.55 mm ID), 20 GA (0.7 mm ID), 18 GA (0.8 mm ID), 16 GA (1.2 mm ID), and 14 GA (1.6 mm ID).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.

The 24-18 GA (0.7-1.1 mm) 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.

BD Insyte™ Autoguard™ BC Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ BC Shielded IV Catheter is 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).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is 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).

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

AI/ML Overview

This document is a 510(k) clearance letter for three IV catheter devices, indicating that they are substantially equivalent to a previously cleared predicate device (K201075). It describes the changes made (new performance specifications and revised IFU) and provides a summary of performance tests conducted.

However, it does not contain the detailed acceptance criteria and reported device performance information that you specifically asked for in a table, nor does it describe a study that "proves the device meets the acceptance criteria" in the format of a clinical trial or algorithm validation study. The document primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on bench testing and comparisons of technological characteristics, rather than extensive clinical studies or AI algorithm performance validation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it is not present. Similarly, information regarding sample sizes for test/training sets, data provenance, expert ground truth adjudication for AI, MRMC studies, standalone algorithm performance, or training set ground truth establishment is not applicable or not provided within this 510(k) clearance document, as it pertains to a physical medical device (IV catheter) and not an AI/ML-driven device.

The study described to demonstrate substantial equivalence consists of bench testing to verify new performance specifications and ensuring compliance with relevant ISO and ASTM standards.

Here's an overview of the information that is available in relation to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in this document. The document states that "the subject device met all predetermined acceptance criteria for the above-listed performance tests," but it does not specify what those acceptance criteria were (e.g., specific thresholds or ranges for frequency response, kink resistance, or blood fill time). It also does not present the numerical results ("reported device performance") of these tests.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The document describes bench testing of physical devices, not an AI/ML system or a clinical study with a "test set" of patients or data in the context of AI validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. This information is relevant for AI/ML device validation and is not present for this physical medical device.

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

Not applicable / Not provided. This information is relevant for AI/ML device validation and is not present for this 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:

No. This is not an AI/ML device, so an MRMC study is not relevant.

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

No. This is not an AI/ML device.

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

Not applicable / Not provided. For the performance tests listed (Frequency Response, Kink Resistance, Blood Fill Time, Catheter Separation Force), the "ground truth" would be the direct measurements obtained from the physical properties of the devices themselves, compared against pre-defined engineering specifications.

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/ML device.

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

Not applicable / Not provided. This is not an AI/ML device.

Summary of Performance Tests and Compliance (as described in the document):

The document states that a risk analysis was conducted to assess the impact of modifications. When technological characteristics were identical to the predicate, results from the predicate were applied. For other aspects, the following tests were conducted:

BD Internal Requirements:

Frequency Response Testing: To support blood pressure monitoring indications.
Kink Resistance Testing: To support blood pressure monitoring indications.
Blood Fill Time Testing: To support blood sampling indications.
Catheter Separation Force: (No specific indication mentioned, but likely related to structural integrity during withdrawal)

Compliance with Standards Testing:

Luer Testing: According to ISO 80369-7 (Small-bore connectors for liquids and gases in healthcare applications).
Packaging Testing: According to ISO 11607-1, ASTM F2096-11 (for gross leaks), and ASTM F88/F88M-15 (for seal strength).
Biocompatibility: According to ISO 10993-1 (general biological evaluation) and ISO 10993-5 (for in vitro cytotoxicity).

Conclusion: The document explicitly states: "Per the 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." This indicates that the tests were performed and the results aligned with the internal and regulatory specifications, affirming the device's substantial equivalence.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 27, 2025

Becton Dickinson Infusion Therapy Systems Inc.
Laura Castelnoble
Staff Regulatory Affairs Specialist
9450 South State Street
Sandy, Utah 84070

Re: K251654
Trade/Device Name: BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: May 29, 2025
Received: May 30, 2025

Dear Laura Castelnoble:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251654 - Laura Castelnoble Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K251654 - Laura Castelnoble Page 3

Sincerely,

PORSCHE P. BENNETT -S

Porsche Bennett
For David Wolloscheck, Ph.D.
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

Page 4

FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251654

Device Name:
BD Insyte™ Autoguard™ Shielded IV Catheter
BD Insyte™ Autoguard™ BC Shielded IV Catheter
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

Indications for Use (Describe)

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)

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."

Page 5

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

510(k) Summary (21 CFR §807.92)

BD Insyte™ Autoguard™ Shielded IV Catheter
BD Insyte™ Autoguard™ BC Shielded IV Catheter
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

Submitter Information

Field	Information
Submitter Name:	Becton Dickinson Infusion Therapy Systems Inc.
Submitter Address:	9450 South State Street, Sandy, Utah 84070
Contact Person:	Laura Castelnoble, Staff Regulatory Affairs Specialist
Email Address:	Laura.Castelnoble@bd.com
Phone Number:	801-522-5000
Date of Preparation:	May 29, 2025

Subject Device

Field	Information
Trade Name:	BD Insyte™ Autoguard™ Shielded IV CatheterBD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
Common Name:	Peripheral Intravascular or IV Catheter/ Catheter Introducer
Regulation Number:	21 CFR 880.520021 CFR 870.1340 (secondary for BD Insyte™ Autoguard™ Shielded IV Catheter only)
Regulation Name:	Catheter, intravascular, therapeutic, short-term less than 30 days/ Catheter Introducer
Regulatory Class:	II
Product Code:	FOZ (Primary); DYB (Secondary)
Classification Panel:	General Hospital

Predicate Device

Field	Information
Trade Name:	BD Insyte™ Autoguard™ Shielded IV CatheterBD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
510(k) Reference:	K201075
Common Name:	Peripheral Intravascular or IV Catheter/Catheter Introducer
Regulation Number:	21 CFR 880.520021 CFR 870.1340 (secondary for BD Insyte™ Autoguard™ Shielded IV Catheter only)
Regulation Name:	Catheter, intravascular, therapeutic, short-term less than 30 days / Catheter Introducer
Regulatory Class:	II
Product Code:	FOZ (Primary); DYB (Secondary)
Classification Panel:	General Hospital

Page 6

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Reason for Submission

The purpose of this submission is to notify the FDA of the following:

Creation of new performance specifications for Blood Fill Time (Blood Sampling), Frequency Response (Blood Pressure Monitoring), Catheter Kink Resistance (Blood Pressure Monitoring) to support the current indications for use
Revised IFU to clarify potential complications, warnings, precautions and instructions related to the blood pressure monitoring and arterial use, ensure compliance with EUMDR and other minor clerical changes.

Device Description

BD Insyte™ Autoguard™ Shielded IV Catheter

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter

BD Insyte™ Autoguard™ BC Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

Page 7

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.

The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

Page 8

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Indications for Use (21 CFR § 807.92(a)(5))

BD Insyte™ Autoguard™ Shielded IV Catheter

BD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Shielded IV Catheter

BD Insyte™ Autoguard™ BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).

Technological Characteristics

Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject device Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter, and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter achieve their intended use based on the same technology and principles of operation as the predicate device.

A comparison of the subject and predicate device technological characteristics is provided in the table below.

Note: Highlighted blue text indicates differences from the predicate device

Page 9

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Attribute	SUBJECTBD Insyte™ Autoguard™, Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro Shielded IV Catheter	PREDICATE (K201075)BD Insyte™ Autoguard™, Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro Shielded IV Catheter	Substantially Equivalent?
Classification	21 CFR 880.520021 CFR 870.1340 (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY)Class IIFOZ - Intravascular CatheterDYB – Catheter Introducer (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY)	21 CFR 880.520021 CFR 870.1340 (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY)Class IIFOZ - Intravascular CatheterDYB – Catheter Introducer (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY)	Same as the predicate.
Indications for Use – Single Port Configurations	BD Insyte™ Autoguard™ Shielded IV CatheterBD Insyte™ Autoguard™ Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).BD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient	BD Insyte™ Autoguard™ Shielded IV CatheterBD Insyte Autoguard shielded 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 also be used to facilitate the placement of guidewires and other vascular access devices without pre-attached hubs. 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. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).BD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte Autoguard BC shielded 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	YesSame as predicate with minor wording changes as indicated with no change to the substance, meaning or scope.

Page 10

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Attribute	SUBJECTBD Insyte™ Autoguard™, Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro Shielded IV Catheter	PREDICATE (K201075)BD Insyte™ Autoguard™, Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro Shielded IV Catheter	Substantially Equivalent?
	population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa)BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device 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 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).	consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBD Insyte Autoguard BC Pro shielded 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. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
Fundamental Scientific Technology	BD Insyte™ Autoguard™ Shielded IV CatheterPeripheral intravascular catheter designed with an active needlestick safety mechanism. Incorporates BD Instaflash™ technology to assist with flashback visualization. Facilitates placement of guidewires and other vascular access devices.BD Insyte™ Autoguard™ BC / BD Insyte™ Autoguard™ BC ProPeripheral intravascular catheter designed with an active needlestick safety mechanism and a one-time use blood control septum (offered with or without	BD Insyte™ Autoguard™ Shielded IV CatheterPeripheral intravascular catheter designed with an active needlestick safety mechanism. Incorporates BD Instaflash™ technology to assist with flashback visualization. Facilitates placement of guidewires and other vascular access devices.BD Insyte™ Autoguard™ BC / BD Insyte™ Autoguard™ BC ProPeripheral intravascular catheter designed with an active needlestick safety mechanism and a one-time use blood control septum (offered with or without this technology). Incorporates BD	YesSame as predicate

Page 11

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Attribute	SUBJECTBD Insyte™ Autoguard™, Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro Shielded IV Catheter	PREDICATE (K201075)BD Insyte™ Autoguard™, Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro Shielded IV Catheter	Substantially Equivalent?
Fundamental Scientific Technology	this technology). Incorporates BD Instaflash™ technology to assist with flashback visualization.	Instaflash™ technology to assist with flashback visualization.	YesSame as predicate
Catheter Dimensions	BD Insyte™ Autoguard™Catheter Diameters - 14GA, 16 GA, 18 GA, 20 GA, 22GA, 24 GACatheter Lengths - 0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN, 1.75IN, 1.77IN, 1.88INBD Insyte™ Autoguard™ BCCatheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GACatheter Lengths – 0.75IN, 1.00IN, 1.16IN, 1.77IN, 1.88INBD Insyte™ Autoguard™ BC ProCatheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GACatheter Lengths – 0.75IN, 1.00IN, 1.16 IN, 1.25IN, 1.77IN, 1.88IN	BD Insyte™ Autoguard™Catheter Diameters - 14GA, 16 GA, 18 GA, 20 GA, 22GA, 24 GACatheter Lengths - 0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN, 1.75IN, 1.77IN, 1.88INBD Insyte™ Autoguard™ BCCatheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GACatheter Lengths – 0.75IN, 1.00IN, 1.16IN, 1.77IN, 1.88INBD Insyte™ Autoguard™ BC ProCatheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GACatheter Lengths – 0.75IN, 1.00IN, 1.16 IN, 1.25IN, 1.77IN, 1.88IN	YesSame as predicate
Product Configurations	• 14 – 24GA (Insyte Autoguard ONLY)• 14 – 24GA Winged (Insyte Autoguard ONLY)• 16 – 24GA• 16 – 24GA Winged	• 14 – 24GA (Insyte Autoguard ONLY)• 14 – 24GA Winged (Insyte Autoguard ONLY)• 16 – 24GA• 16 – 24GA Winged	YesSame as predicate

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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Attribute	SUBJECT	PREDICATE	Substantially Equivalent?
Sterilization Modality	• Ethylene Oxide	• Ethylene Oxide	YesSame as predicate

Device Materials

Component	SUBJECT	PREDICATE	Substantially Equivalent?
Needle Cover	Polypropylene	Polypropylene	Same as predicate
Needle	Stainless Steel	Stainless Steel	Same as predicate
Catheter Tubing	Polyurethane with barium sulfate	Polyurethane with barium sulfate	Same as predicate
Catheter Adapter	Polypropylene + Colorant24GA (Yellow)22GA (Blue)20GA (Pink)18GA (Green)16GA (Gray)14GA (Orange) – Insyte Autoguard ONLY	Polypropylene + Colorant24GA (Yellow)22GA (Blue)20GA (Pink)18GA (Green)16GA (Gray)14GA (Orange) – Insyte Autoguard ONLY	Same as predicate.A new catheter adapter green colorant sub-supplier was qualified.Previous Supplier: Green Pigment - Lionel Green 6Y-501, CAS #14302-13-7Current Supplier: Green Pigment – Vynamon, VYG6YFWC, CAS #14302-13-7No change to colorant formulation and use concentration in the adapter. The modified green pigment maintains the same CAS#14302-13-7, and % concentration. There are no other changes to resin raw materials, processing or technology.
Catheter Wedge	Stainless Steel	Stainless Steel	Same as predicate
Safety Activation Button	Polycarbonate +White Colorant	Polycarbonate +White Colorant	Same as predicate
Grip	Polycarbonate	Polycarbonate	Same as predicate
Needle Hub	Polycarbonate	Polycarbonate	Same as predicate
Barrel	Polypropylene	Polypropylene	Same as predicate
Lubricants	Silicone	Silicone	Same as predicate
Porous Flow Plug (Vent Plug)	Porous Polyethylene with Carboxymethyl Cellulose (CMC)	Porous Polyethylene with Carboxymethyl Cellulose (CMC)	Same as predicate
Spring	Stainless Steel	Stainless Steel	Same as predicate

Page 13

Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Component	SUBJECT	PREDICATE	Substantially Equivalent?
Septum (Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro ONLY)	Silicone	Silicone	Same as predicate
Septum Actuator (Insyte™ Autoguard™ BC and Insyte™ Autoguard™ BC Pro ONLY)	Polypropylene	Polypropylene	Same as predicate
Comparison of Subject / Predicate Device Primary Device Component Materials	Top Web: Medical Grade Paper with heat seal coatingBottom Web: Nylon / Polyethylene substrate polymer layers	Top Web: Medical Grade Paper with heat seal coatingBottom Web: Nylon / Polyethylene substrate polymer layers	Both subject and predicate materials consist of packaging paper material which includes heat-sealing coating designed for medical applications. The difference in thickness does not impact sterile barrier or device performance.The results of performance testing demonstrate that the subject device performs as intended

Summary of Performance 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. A risk analysis was conducted to assess the impact of the proposed modifications 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 devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets specified design requirements:

BD Internal Requirements:

Frequency Response Testing,
Kink Resistance Testing,
Blood Fill Time Testing,
Catheter Separation Force,

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Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com

Compliance with Standards Testing:

Luer Testing

ISO 80369-7 Second edition 2021-05; Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

Packaging Testing

ISO 11607-1 Second edition 2019-02 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems

ASTM F2096-11 (Reapproved 2019) - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F88/F88M-15 - Standard Test Method for Seal Strength of Flexible Barrier Materials

Biocompatibility

ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

ISO 109933-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

Per the 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 Substantial Equivalence

Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter, and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter have been demonstrated to be substantially equivalent to the legally marketed predicate devices, K201075.

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).