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

K201075 · Becton, Dickinson and Company · FOZ · Dec 18, 2020 · General Hospital

Device Facts

• Record ID: K201075
• Device Name: BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
• Applicant: Becton, Dickinson and Company
• Product Code: FOZ · General Hospital
• Decision Date: Dec 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

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

Device Story

Over-the-needle peripheral IV catheters; include radiopaque polyurethane catheter, needle, flash chamber, and spring-loaded push-button shielding mechanism. BC/BC Pro models include blood control septum to limit blood exposure during Luer connection. Instaflash™ technology provides visual confirmation of vessel entry. Used by clinicians for vascular access; facilitates guidewire placement. Needle retracts into barrel upon button activation to prevent needlestick injuries. Power injection compatible (22-18 GA).

Clinical Evidence

Bench testing only. Evaluated per ISO 10555-1, ISO 10555-5, ISO 594-1/2, ISO 23908, and ISO 11070. Biocompatibility testing conducted per ISO 10993-1, -3, -4, -5, -6, -7, -10, -11, and -12. Sterilization and packaging validated per ISO 11135, ISO 11607-1/2, and USP <788> for particulate matter.

Technological Characteristics

Single lumen peripheral IV catheter; materials: Polypropylene (cover, adapter, barrel), Polycarbonate (grip, hub, button), Stainless Steel (needle, wedge, spring), Polyurethane (tubing), Silicone (lubricant, septum), Porous Polyethylene (plug). Active push-button needle shielding; blood control septum (BC/BC Pro). Sterilized via Ethylene Oxide.

Indications for Use

Indicated for patients requiring peripheral vascular access for short-term blood sampling, blood pressure monitoring, or fluid administration. Suitable for any patient population based on vascular anatomy, procedure, and therapy duration. 22-18 GA models compatible with power injectors up to 300 psi.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• BD Insyte™ Autoguard™ Shielded IV Catheter (K952861)
• BD Insyte™ Autoguard™ BC Shielded IV Catheter (K110443)
• Introcan® Safety™ IV Catheter (K021094)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

December 18, 2020

Kimberly Geisler Sr. Manager, Regulatory Affairs 9450 South State Street Sandy, Utah 84070

Re: K201075

Trade/Device Name: BD Insyte™ Autoguard ™Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter, 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, DYB Dated: November 17, 2020 Received: November 19, 2020

Dear Kimberly Geisler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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

Sincerely,

CAPT Alan M. Stevens Acting 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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# Indications for Use

510(k) Number (if known) K201075

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

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 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).

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 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).

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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bd.com

Image /page/3/Picture/2 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular symbol on the left and the letters "BD" on the right. The circular symbol is orange and features a stylized image of a sun or star. The letters "BD" are in blue and have a rounded, sans-serif font.

#### Submitter Name: Becton Dickinson Infusion Therapy Systems Inc. Submitter Information Submitter Address: 9450 South State Street Sandy, Utah 84070 Contact Person: Paul Holman Regulatory Affairs Specialist Email Address: [e-mail] Phone Number: [phone] Date of Preparation: December 17, 2020 BD Insyte™ Autoguard™ Shielded IV Catheter Subject Device Trade Name: BD Insyte™ Autoguard™ BC Shielded IV Catheter BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter 510(k) Reference: K201075 Peripheral Intravascular or IV Catheter Common Name: Regulation Number: 21 CFR §880.5200 (primary) 21 CFR §870.1340 (secondary for BD Insyte™ Autoguard™ Shielded IV Catheters only) Regulation Name: Catheter, intravascular, therapeutic, short-term less than 30 days Regulatory Class: II FOZ (primary) Product Code: DYB (secondary for BD Insyte™ Autoguard™ Shielded IV Catheter only) Classification Panel: General Hospital BD Insyte™ Autoguard™ Shielded IV Catheter Predicate Trade Name: Device 510(k) Reference: K952861 Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21 CFR §880.5200 Regulation Name: Catheter, intravascular, therapeutic, short-term less than 30 days Regulatory Class: II Product Code: FOZ Classification Panel: General Hospital

# 510(k) Summary: K201075

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

| Predicate<br>Device | Trade Name: | BD Insyte™ Autoguard™ BC Shielded IV Catheter |
|-----------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Reference: | K110443 |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR §880.5200 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than<br>30 days |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| Predicate<br>Device | Trade Name: | Introcan® Safety™ IV Catheter |
| | 510(k) Reference: | K021094 |
| | Common Name: | Peripheral Intravascular or IV Catheter/<br>Catheter Introducer |
| | Regulation Number: | 21 CFR §880.5200 and §870.1340 |
| | Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30<br>days Catheter Introducer |
| | Regulatory Class: | II |
| | Product Code: | FOZ/DYB |
| | Classification Panel: | Cardiovascular |
| Device<br>Description | | BD Insyte™ Autoguard™ Shielded IV Catheter |
| | | BD Insyte™ Autoguard™ shielded IV catheters are over-the-needle, intravascular (IV)<br>catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip with<br>button, flash chamber with vent plug, and barrel. The needle and catheter are protected<br>by a needle cover. |
| | | The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ needle technology, allowing<br>for immediate visualization of blood along the catheter. The flash chamber provides<br>confirmation that the device has entered the vessel. These devices incorporate BD<br>Autoguard™ push-button shielding technology which is activated when the button is<br>depressed. A spring mechanism retracts the needle and flash chamber into the barrel,<br>fully encasing the needle and reducing the risk of accidental needlestick injury. |
| | | These devices are available with or without wings. The catheter hub and wings are<br>color coded to indicate outside catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA<br>(0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm)<br>= Grey, 14 GA (2.1 mm) = Orange). |
| | | These devices facilitate the introduction of guidewires and other vascular access<br>devices. The following labeled gauge sizes correspond to the listed inside diameter: 24<br>GA (0.40 mm), 22 GA (0.55 mm), 20 GA (0.7 mm), 18 GA (0.8 mm), 16 GA (1.2 mm),<br>and 14 GA (1.6 mm). |
| | | The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a<br>maximum pressure of 300 psi (2068 kPa) |

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#### bd.com

# BD Insyte™ Autoguard™ BC Shielded IV Catheter

BD Insyte™ Autoguard™ BC shielded IV catheters are over-the-needle, intravascular (IV) catheters with blood control technology. These devices include a radiopaque BD Vialon™ catheter, needle, grip with button, flash chamber with vent plug, and 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 blood control technology limits blood exposure to the device user.

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.

These devices 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.

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) = Grev).

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 over-the-needle, intravascular (IV) catheters with blood control technology. These devices include a radiopaque BD Vialon™ catheter, needle, grip with button, flash chamber with vent plug, and 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 blood control technology limits blood exposure to the device user.

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.

These devices incorporate BD Autoguard™ push-button shielding technology which is activated when the button is depressed. A spring mechanism retracts the needle and

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| flash chamber into the barrel, fully encasing the needle and reducing the risk of<br>accidental needlestick injury. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| These devices are available with or without wings. The catheter hub and wings are<br>color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9<br>mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) =<br>Grey).<br>The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a<br>maximum pressure of 300 psi (2068 kPa). | |
| Indications for<br>Use<br>(21 CFR §<br>807.92(a)(5)) | BD Insyte™ Autoguard™ Shielded IV Catheter<br><br>BD Insyte™ Autoguard™ shielded IV catheters are intended to be inserted into a<br>patient's peripheral vascular system for short term use to sample blood, monitor blood<br>pressure, or administer fluids. These devices may also be used to facilitate the<br>placement of guidewires and other vascular access devices without pre-attached hubs.<br>These devices may be used for any patient population with consideration given to<br>adequacy of vascular anatomy, procedure being performed, fluids being infused, and<br>duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power<br>injectors set to a maximum pressure of 300 psi (2068 kPa). |
| | BD Insyte™ Autoguard™ BC Shielded IV Catheter<br><br>BD Insyte™ Autoguard™ BC shielded IV catheters are intended to be inserted into a<br>patient's peripheral vascular system for short term use to sample blood, monitor blood<br>pressure, or administer fluids. These devices may be used for any patient population<br>with consideration given to adequacy of vascular anatomy, procedure being performed,<br>fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are<br>suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). |
| | BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter<br><br>BD Insyte™ Autoguard™ BC Pro shielded IV catheters are intended to be inserted into<br>a patient's peripheral vascular system for short term use to sample blood, monitor<br>blood pressure, or administer fluids. These devices may be used for any patient<br>population with consideration given to adequacy of vascular anatomy, procedure being<br>performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm)<br>devices are suitable for use with power injectors set to a maximum pressure of 300 psi<br>(2068 kPa). |
| Technological<br>Characteristics | Technological characteristics of the subject devices are substantially equivalent to the<br>predicate devices. The subject BD Insyte™ Autoguard™ Shielded IV Catheter, BD<br>Insyte™ Autoguard™ BC Shielded IV Catheter, and BD Insyte™ Autoguard™ BC Pro<br>Shielded IV Catheter achieve their intended use based on the same technology and<br>principles of operation as the predicate devices. |

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#### bd.com

Comparisons of the subject and predicate devices technological characteristics are provided in the tables below.

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#### bd.com

# Subject / Predicate Device Comparison of Intended Use, Materials and Technological Characteristics Subject Device: BD Insyte™ Autoguard™ Shielded IV Catheter

| Attribute | SUBJECT<br>BD Insyte™ Autoguard™ Shielded IV<br>Catheter | PREDICATE<br>BD Insyte™ Autoguard™ Shielded IV<br>Catheter<br>(K952861) | PREDICATE<br>BBraun Introcan® Safety™ IV<br>Catheter<br>(K021094) | Substantial Equivalence |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR §880.5200<br>21 CFR §870.1340<br>Class II<br>FOZ - Intravascular Catheter (primary)<br>DYB - Catheter Introducer (secondary) | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | 21 CFR §880.5200<br>21 CFR §870.1340<br>Class II<br>FOZ – Intravascular Catheter<br>DYB – Catheter Introducer | Same |
| Indications for<br>Use | BD Insyte™ Autoguard™ shielded IV<br>catheters are intended to be inserted into<br>a patient's peripheral vascular system for<br>short term use to sample blood, monitor<br>blood pressure, or administer fluids.<br>These devices may also be used to<br>facilitate the placement of guidewires and<br>other vascular access devices without<br>pre-attached hubs. These devices may be<br>used for any patient population with<br>consideration given to adequacy of<br>vascular anatomy, procedure being<br>performed, fluids being infused, and<br>duration of therapy. The 22-18 GA (0.9-<br>1.3 mm) devices are suitable for use with<br>power injectors set to a maximum<br>pressure of 300 psi (2068 kPa). | An intravascular catheter is intended to<br>be inserted into the patient's vascular<br>system for short term use to sample<br>blood, monitor blood pressure, or<br>administer fluids intravenously. | The BBraun Introcan® Safety IV<br>Catheter is a passive anti-needle<br>stick device to provide venous or<br>arterial access for the infusion of<br>fluids, drugs, and/or blood<br>components, or to facilitate the<br>placement of Vascular Access<br>devices such as guidewires,<br>indwelling central venous<br>catheters, peripherally inserted<br>central catheters, and midline<br>catheters into the vascular system. | Substantially Equivalent<br>The subject device Indication for Use has<br>been modified compared to the BD Insyte™<br>Autoguard™ Shielded IV Catheter<br>predicate to clarify vascular insertion<br>location, patient population, and power<br>injection capabilities. These revisions serve<br>to clarify product use and do not change the<br>intended use of the product or introduce<br>new features or functionality for vascular<br>access; therefore, there are no new<br>questions of safety or effectiveness.<br>The subject device Indication for Use<br>includes the facilitation of guidewire and<br>other vascular access device placement<br>which does not alter the overall intended<br>use of the product with respect to the<br>BBraun predicate device. |
| Attribute | SUBJECT<br>BD Insyte ™ Autoguard™ Shielded IV<br>Catheter | PREDICATE<br>BD Insyte ™ Autoguard™ Shielded IV<br>Catheter<br>(K952861) | PREDICATE<br>BBraun Introcan® Safety™ IV<br>Catheter<br>(K021094) | Substantial Equivalence |
| Fundamental<br>Scientific<br>Technology | Single lumen with tapered tip peripheral<br>intravascular catheter designed with an<br>active needlestick safety mechanism.<br>Incorporates BD Instaflash™ technology<br>to assist with flashback visualization.<br>Facilitates placement of guidewires and<br>other vascular access devices. | Single lumen with tapered tip peripheral<br>intravascular catheter designed with an<br>active needlestick safety mechanism.<br>Incorporates BD Instaflash™ technology<br>to assist with flashback visualization. | Single lumen with tapered tip<br>peripheral intravascular catheter<br>designed with a passive needlestick<br>safety* mechanism. Facilitates<br>placement of guidewires and other<br>vascular access devices. | Substantially Equivalent<br>The subject and predicate BD Insyte™<br>Autoguard™ Safety IV Catheter active<br>needlestick safety mechanisms are identical.<br>*Passive and active needle safety<br>mechanisms are well accepted technology<br>for needlestick injury prevention in the<br>clinical setting. |
| Primary Device<br>Components /<br>Materials | Needle Cover: Polypropylene<br>Barrel: Polypropylene<br>Grip: Polycarbonate<br>Needle Hub: Polycarbonate<br>Safety Activation Button: Polycarbonate<br>Catheter Adapter: Polypropylene<br>Catheter Wedge: Stainless Steel<br>Needle: Stainless Steel<br>Catheter Tubing: Polyurethane with<br>radiopaque barium sulfate<br>Lubricants: Silicone<br>Spring: Stainless Steel<br>Porous Flow Plug: Porous Polyethylene<br>with Carboxymethyl Cellulose (CMC) | Needle Cover: Polypropylene<br>Barrel: Polycarbonate<br>Grip: Polycarbonate<br>Needle Hub: Polycarbonate<br>Safety Activation Button: Polycarbonate<br>Catheter Adapter: Polypropylene<br>Catheter Wedge: Stainless Steel<br>Needle: Stainless Steel<br>Catheter Tubing: Polyurethane with<br>radiopaque barium sulfate<br>Lubricants: Silicone<br>Spring: Stainless Steel<br>Porous Flow Plug: Porous Polyethylene<br>with Carboxymethyl Cellulose (CMC) | Needle Cover: Polypropylene<br>Catheter Tubing: Radiopaque<br>Polyurethane (PUR) or Teflon<br>(FEP)<br>Catheter Adapter: Polypropylene<br>Needle: Chrome-Nickel steel<br>Needle Hub: ABS<br>Catheter Wedge: Stainless Steel<br>Safety Clip: Stainless steel<br>Lubricants: Silicone | Substantially Equivalent<br>The subject and predicate BD Insyte™<br>Autoguard™ Shielded IV Catheter<br>materials are the same except the barrel<br>material. The change in barrel material<br>(non-patient contacting) does not alter or<br>raise new questions of safety and efficacy.<br>Subject device material differences<br>compared to the predicate BBraun<br>Introcan® Safety™ IV Catheter (K021094)<br>are non-significant relative to the catheter<br>introducer indication. Materials contacting<br>and interfacing with the guidewire or other<br>vascular access device include catheter<br>tubing, catheter adapter and catheter wedge.<br>These materials are substantially equivalent<br>to the predicate BBraun Introcan® Safety™<br>IV Catheter. |
| Attribute | SUBJECT<br>BD Insyte™ Autoguard™ Shielded IV<br>Catheter | PREDICATE<br>BD Insyte™ Autoguard™ Shielded IV<br>Catheter<br>(K952861) | PREDICATE<br>BBraun Introcan® Safety™ IV<br>Catheter<br>(K021094) | Substantial Equivalence |
| Catheter<br>Dimensions | Catheter Diameters<br>14 GA, 16 GA, 18 GA, 20 GA, 22 GA,<br>24 GA<br>Catheter Lengths<br>0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN,<br>1.75 IN, 1.77 IN, 1.88 IN<br>Catheter ID<br>0.0190 IN - 0.0705 IN | Catheter Diameters<br>14 GA, 16 GA, 18 GA, 20 GA, 22 GA,<br>24 GA<br>Catheter Lengths<br>0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN,<br>1.75 IN, 1.77 IN, 1.88 IN<br>Catheter ID<br>0.0190 IN - 0.0705 IN | Catheter Diameters<br>14 GA, 16 GA, 18 GA, 20 GA,<br>22 GA, 24 GA<br>Catheter Lengths<br>0.55 IN, 0.75 IN, 1.00 IN, 1.25 IN,<br>1.75 IN, 2.00 IN, 2.50 IN<br>Catheter ID<br>0.018 IN - 0.064 IN | Substantially Equivalent<br>The subject device and predicate BD<br>Insyte™ Autoguard™ Shielded IV Catheter<br>dimensions are identical. The subject and<br>predicate devices are available in<br>winged/non-winged configurations with<br>similar gauges, lengths, and sizes.<br>Catheter ID dimensions allow passage of<br>vascular access devices, including a<br>standard appropriately sized guidewire or<br>catheter through the lumen of the<br>subject/predicate devices. |
| Performance | Power Injection<br>The 22-18 GA (0.9-1.3 mm) devices are<br>suitable for use with power injectors set<br>to a maximum pressure of 300 psi (2068<br>kPa)<br>Flashback Chamber / Technology<br>Yes<br>Safety Design<br>Yes<br>Radiopaque<br>Yes<br>Must allow passage of appropriate size<br>guide wire or catheter<br>Yes | Power Injection<br>The 22-18 GA (0.9-1.3 mm) devices are<br>suitable for use with power injectors set<br>to a maximum pressure of 300 psi (2068<br>kPa)<br>Flashback Chamber / Technology<br>Yes<br>Safety Design<br>Yes<br>Radiopaque<br>Yes | Power Injection<br>The 22-18 GA power injection<br>max pressure 300 psi (2068 kPa)<br>Flashback Chamber / Technology<br>Yes<br>Safety Design<br>Yes<br>Radiopaque<br>Yes<br>Must allow passage of appropriate<br>size guide wire or catheter<br>Yes | Same |
| Attribute | SUBJECT<br>BD Insyte™ Autoguard™ Shielded IV<br>Catheter | PREDICATE<br>BD Insyte™ Autoguard™ Shielded IV<br>Catheter<br>(K952861) | PREDICATE<br>BBraun Introcan® Safety™ IV<br>Catheter<br>(K021094) | Substantial Equivalence |
| Standards<br>Compliance | ISO 594-1<br>ISO 594-2<br>ISO 10555-1<br>ISO 10555-5<br>ISO 23908<br>ISO 11070 | ISO 594-1<br>ISO 594-2<br>ISO 10555-1<br>ISO 10555-5<br>ISO 23908 | Unknown | Substantially Equivalent<br>The subject device was evaluated to current<br>FDA recognized and industry consensus<br>standards applicable to the device<br>classification and FDA product codes. |
| Attribute | SUBJECT<br>BD Insyte™ Autoguard™ BC Shielded IV Catheter<br>BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATE<br>BD Insyte™ Autoguard™ BC Shielded IV<br>Catheter<br>(K110443) | Substantial Equivalence | |
| Classification | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | Same | |
| Indications for Use | BD Insyte™ Autoguard™ BC Shielded IV Catheter:<br>BD Insyte™ Autoguard™ BC shielded IV catheters are<br>intended to be inserted into a patient's peripheral vascular<br>system for short term use to sample blood, monitor blood<br>pressure, or administer fluids. These devices may be used for<br>any patient population with consideration given to adequacy of<br>vascular anatomy, procedure being performed, fluids being<br>infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm)<br>devices are suitable for use with power injectors set to a<br>maximum pressure of 300 psi (2068 kPa).<br>BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter:<br>BD Insyte™ Autoguard™ BC Pro shielded IV catheters are<br>intended to be inserted into a patient's peripheral vascular<br>system for short term use to sample blood, monitor blood<br>pressure, or administer fluids. These devices may be used for<br>any patient population with consideration given to adequacy of<br>vascular anatomy, procedure being performed, fluids being<br>infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm)<br>devices are suitable for use with power injectors set to a<br>maximum pressure of 300 psi (2068 kPa). | The BD Insyte™ Autoguard™ BC catheter is<br>inserted into a patient's vascular system to sample<br>blood, monitor blood pressure, or administer<br>fluids. | Substantially Equivalent<br>The subject device Indication for Use has been<br>modified to clarify vascular insertion location,<br>duration of use, patient population, power<br>injection capabilities and to align with current<br>industry standards and FDA expectations<br>These revisions serve to clarify product use and<br>do not change the intended use of the product or<br>introduce new features or functionality;<br>therefore, there are no new questions of safety<br>or effectiveness when considering a claim of<br>substantial equivalence. | |
| Attribute | SUBJECT<br>BD Insyte™ Autoguard™ BC Shielded IV Catheter<br>BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter…