(28 days)
No.
The document describes basic medical devices (IV catheters) that are purely mechanical in their function, lacking any mention of computational or intelligent features that would suggest the presence of an AI model.
No.
Explanation: The device is intended for purposes such as sampling blood, monitoring blood pressure, or administering fluids, which are diagnostic or supportive rather than directly therapeutic interventions. While administering fluids can support therapy, the device itself does not provide a therapeutic action.
No.
The device is an IV catheter used for sampling blood, monitoring blood pressure, or administering fluids, but it does not perform diagnostic functions itself. While it can "sample blood" and "monitor blood pressure," these are data collection functions, not diagnostic interpretation or analysis.
No
The device description clearly outlines hardware components such as a catheter, needle, grip, flash chamber, and barrel. It also mentions physical features like a spring mechanism for needle retraction and refers to physical testing related to kinks, blood flow, and packaging integrity. There is no mention of software in the intended use, device description, or performance studies.
No.
The device is an IV catheter used for short-term insertion into the peripheral vascular system to sample blood, monitor blood pressure, or administer fluids. It is not intended for the in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
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).
Product codes
FOZ, DYB
Device Description
BD Insyte™ Autoguard™ Shielded IV Catheter
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
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
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 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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's peripheral vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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,
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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"
Page 2
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)
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).
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:
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"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 Catheter |
| BD Insyte™ Autoguard™ BC Shielded IV Catheter | |
| BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | |
| Common Name: | Peripheral Intravascular or IV Catheter/ Catheter Introducer |
| Regulation Number: | 21 CFR 880.5200 |
| 21 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 Catheter |
| BD Insyte™ Autoguard™ BC Shielded IV Catheter | |
| BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | |
| 510(k) Reference: | K201075 |
| Common Name: | Peripheral Intravascular or IV Catheter/Catheter Introducer |
| Regulation Number: | 21 CFR 880.5200 |
| 21 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
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
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 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
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 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 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).
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 | SUBJECT
BD 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 880.5200
21 CFR 870.1340 (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY)
Class II
FOZ - Intravascular Catheter
DYB – Catheter Introducer (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY) | 21 CFR 880.5200
21 CFR 870.1340 (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY)
Class II
FOZ - Intravascular Catheter
DYB – Catheter Introducer (BD Insyte™ Autoguard™ Shielded IV Catheter ONLY) | Same as the predicate. |
| Indications for Use – Single Port Configurations | 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 | BD Insyte™ Autoguard™ Shielded IV Catheter
BD 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 Catheter
BD 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 | Yes
Same 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 | SUBJECT
BD 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 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). | 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 Catheter
BD 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 Catheter
Peripheral 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 Pro
Peripheral 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 Catheter
Peripheral 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 Pro
Peripheral 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 | Yes
Same as predicate |
Page 11
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| Attribute | SUBJECT
BD 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. | Yes
Same as predicate |
| Catheter Dimensions | BD Insyte™ Autoguard™
Catheter Diameters - 14GA, 16 GA, 18 GA, 20 GA, 22GA, 24 GA
Catheter Lengths - 0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN, 1.75IN, 1.77IN, 1.88IN
BD Insyte™ Autoguard™ BC
Catheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GA
Catheter Lengths – 0.75IN, 1.00IN, 1.16IN, 1.77IN, 1.88IN
BD Insyte™ Autoguard™ BC Pro
Catheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GA
Catheter 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 GA
Catheter Lengths - 0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN, 1.75IN, 1.77IN, 1.88IN
BD Insyte™ Autoguard™ BC
Catheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GA
Catheter Lengths – 0.75IN, 1.00IN, 1.16IN, 1.77IN, 1.88IN
BD Insyte™ Autoguard™ BC Pro
Catheter Diameters - 16 GA, 18 GA, 20 GA, 22GA, 24 GA
Catheter Lengths – 0.75IN, 1.00IN, 1.16 IN, 1.25IN, 1.77IN, 1.88IN | Yes
Same 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 | Yes
Same as predicate |
Page 12
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 | Yes |
| Same 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 + Colorant | ||
| 24GA (Yellow) | |||
| 22GA (Blue) | |||
| 20GA (Pink) | |||
| 18GA (Green) | |||
| 16GA (Gray) | |||
| 14GA (Orange) – Insyte Autoguard ONLY | Polypropylene + Colorant | ||
| 24GA (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 #14302-13-7
Current Supplier: Green Pigment – Vynamon, VYG6YFWC, CAS #14302-13-7
No 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 coating |
Bottom Web: Nylon / Polyethylene substrate polymer layers | Top Web: Medical Grade Paper with heat seal coating
Bottom 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,
Page 14
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.