(240 days)
NotFound
No
The device description and performance studies focus on mechanical and material properties, not computational analysis or algorithms. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No.
The device is used to insert into a patient's peripheral vascular system to sample blood, monitor blood pressure, or administer fluids, which are diagnostic or supportive functions rather than direct therapeutic treatment.
No
Explanation: The device is an IV catheter intended for purposes such as administering fluids, monitoring blood pressure, or sampling blood. While blood sampling for lab analysis can lead to a diagnosis, the catheter itself is a tool for accessing the vascular system and not for performing a diagnostic test or analyzing data to provide a diagnosis.
No
The device description clearly outlines physical components such as a catheter, needle, grip, flash chamber, barrel, and needle cover, indicating it is a hardware medical device.
Based on the provided text, the BD Insyte™ Autoguard™ Shielded IV Catheters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the devices are for insertion into a patient's peripheral vascular system for purposes like sampling blood, monitoring blood pressure, administering fluids, and facilitating the placement of other vascular access devices. These are all procedures performed in vivo (within the living body).
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The BD Insyte™ Autoguard™ catheters are used to obtain the sample (blood) or administer substances, not to perform the diagnostic test on the sample itself.
- Device Description: The description details the physical components and function of the catheter for insertion into a blood vessel. It does not describe any components or processes related to analyzing biological samples.
Therefore, the primary function and intended use of these devices are for accessing the vascular system for therapeutic or sampling purposes, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for 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).
Product codes
FOZ, DYB
Device Description
BD Insyte™ Autoguard™ Shielded IV Catheter:
BD Insyte™ Autoguard™ shielded IV catheters are over-the-needle, intravascular (IV) catheters. 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 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 outside 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).
These devices facilitate the introduction of guidewires and other vascular access devices. The following labeled gauge sizes correspond to the listed inside diameter: 24 GA (0.40 mm), 22 GA (0.55 mm), 20 GA (0.7 mm), 18 GA (0.8 mm), 16 GA (1.2 mm), 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 maximum pressure of 300 psi (2068 kPa).
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 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) = 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
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)
A risk analysis per ISO 14971:2007 “Medical Devices-Application of risk management to medical devices” was conducted to assess the impact of the proposed modifications to the predicate devices.
Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. There are no leveraged tests from the predicate devices.
The following standards were applied:
ISO 10555-1: 2013 + A1:2017 Sterile, single-use intravascular catheters - Part 1: General requirements
ISO 10555-5 :2013 Intravascular catheters - Sterile and single-use catheters Part 5: Over-needle peripheral catheters
ISO 594-1:1986 Conical Fitting with a 6% (Luer) Taper for Syringes, Needless and certain other medical equipment – Part 1: General Requirements
ISO 594-2:1998 Conical Fittings with a 6% (Luer) Taper for syringes, needless and certain other medical equipment - Part 2: Lock Fittings
ISO 23908:2011 Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 11070:2014 "Sterile single-use intravascular introducer, dilators and guidewires
A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and 2) FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016), was conducted. The following testing was undertaken to support the biocompatibility of the subject devices:
ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Particulate Matter per USP
Sterilization and Packaging validation included:
ISO 11135-1:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11607-1:2006+AI:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Key Results: 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.
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).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) |
☐ 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: paul.holman@bd.com Phone Number: (801) 565-2838 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
4
bd.com |
---|
| Predicate
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 | |
30 days | ||
Regulatory Class: | II | |
Product Code: | FOZ | |
Classification Panel: | General Hospital | |
Predicate | ||
Device | Trade Name: | Introcan® Safety™ IV Catheter |
510(k) Reference: | K021094 | |
Common Name: | Peripheral Intravascular or IV Catheter/ | |
Catheter Introducer | ||
Regulation Number: | 21 CFR §880.5200 and §870.1340 | |
Regulation Name: | Catheter, intravascular, therapeutic, short-term less than 30 | |
days Catheter Introducer | ||
Regulatory Class: | II | |
Product Code: | FOZ/DYB | |
Classification Panel: | Cardiovascular | |
Device | ||
Description | BD Insyte™ Autoguard™ Shielded IV Catheter | |
BD Insyte™ Autoguard™ shielded IV catheters are over-the-needle, intravascular (IV) | ||
catheters. 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 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 outside 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). | ||
These devices facilitate the introduction of guidewires and other vascular access | ||
devices. The following labeled gauge sizes correspond to the listed inside diameter: 24 | ||
GA (0.40 mm), 22 GA (0.55 mm), 20 GA (0.7 mm), 18 GA (0.8 mm), 16 GA (1.2 mm), | ||
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 | ||
maximum pressure of 300 psi (2068 kPa) |
5
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
6
| 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) = | |
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). | |
Indications for | |
Use | |
(21 CFR § | |
807.92(a)(5)) | 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 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). |
| Technological
Characteristics | Technological characteristics of the subject devices are substantially equivalent to the
predicate devices. The subject BD 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 devices. |
7
bd.com
Comparisons of the subject and predicate devices technological characteristics are provided in the tables below.
8
bd.com
Subject / Predicate Device Comparison of Intended Use, Materials and Technological Characteristics Subject Device: BD Insyte™ Autoguard™ Shielded IV Catheter
| Attribute | SUBJECT
BD Insyte™ Autoguard™ Shielded IV
Catheter | PREDICATE
BD Insyte™ Autoguard™ Shielded IV
Catheter
(K952861) | PREDICATE
BBraun Introcan® Safety™ IV
Catheter
(K021094) | Substantial Equivalence |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR §880.5200
21 CFR §870.1340
Class II
FOZ - Intravascular Catheter (primary)
DYB - Catheter Introducer (secondary) | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter | 21 CFR §880.5200
21 CFR §870.1340
Class II
FOZ – Intravascular Catheter
DYB – Catheter Introducer | Same |
| Indications for
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 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). | An intravascular catheter is intended to
be inserted into the patient's vascular
system for short term use to sample
blood, monitor blood pressure, or
administer fluids intravenously. | The BBraun Introcan® Safety IV
Catheter is a passive anti-needle
stick device to provide venous or
arterial access for the infusion of
fluids, drugs, and/or blood
components, or to facilitate the
placement of Vascular Access
devices such as guidewires,
indwelling central venous
catheters, peripherally inserted
central catheters, and midline
catheters into the vascular system. | Substantially Equivalent
The subject device Indication for Use has
been modified compared to the BD Insyte™
Autoguard™ Shielded IV Catheter
predicate to clarify vascular insertion
location, patient population, and power
injection capabilities. These revisions serve
to clarify product use and do not change the
intended use of the product or introduce
new features or functionality for vascular
access; therefore, there are no new
questions of safety or effectiveness.
The subject device Indication for Use
includes the facilitation of guidewire and
other vascular access device placement
which does not alter the overall intended
use of the product with respect to the
BBraun predicate device. |
| Attribute | SUBJECT
BD Insyte ™ Autoguard™ Shielded IV
Catheter | PREDICATE
BD Insyte ™ Autoguard™ Shielded IV
Catheter
(K952861) | PREDICATE
BBraun Introcan® Safety™ IV
Catheter
(K021094) | Substantial Equivalence |
| Fundamental
Scientific
Technology | Single lumen with tapered tip 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. | Single lumen with tapered tip peripheral
intravascular catheter designed with an
active needlestick safety mechanism.
Incorporates BD Instaflash™ technology
to assist with flashback visualization. | Single lumen with tapered tip
peripheral intravascular catheter
designed with a passive needlestick
safety* mechanism. Facilitates
placement of guidewires and other
vascular access devices. | Substantially Equivalent
The subject and predicate BD Insyte™
Autoguard™ Safety IV Catheter active
needlestick safety mechanisms are identical.
*Passive and active needle safety
mechanisms are well accepted technology
for needlestick injury prevention in the
clinical setting. |
| Primary Device
Components /
Materials | Needle Cover: Polypropylene
Barrel: Polypropylene
Grip: Polycarbonate
Needle Hub: Polycarbonate
Safety Activation Button: Polycarbonate
Catheter Adapter: Polypropylene
Catheter Wedge: Stainless Steel
Needle: Stainless Steel
Catheter Tubing: Polyurethane with
radiopaque barium sulfate
Lubricants: Silicone
Spring: Stainless Steel
Porous Flow Plug: Porous Polyethylene
with Carboxymethyl Cellulose (CMC) | Needle Cover: Polypropylene
Barrel: Polycarbonate
Grip: Polycarbonate
Needle Hub: Polycarbonate
Safety Activation Button: Polycarbonate
Catheter Adapter: Polypropylene
Catheter Wedge: Stainless Steel
Needle: Stainless Steel
Catheter Tubing: Polyurethane with
radiopaque barium sulfate
Lubricants: Silicone
Spring: Stainless Steel
Porous Flow Plug: Porous Polyethylene
with Carboxymethyl Cellulose (CMC) | Needle Cover: Polypropylene
Catheter Tubing: Radiopaque
Polyurethane (PUR) or Teflon
(FEP)
Catheter Adapter: Polypropylene
Needle: Chrome-Nickel steel
Needle Hub: ABS
Catheter Wedge: Stainless Steel
Safety Clip: Stainless steel
Lubricants: Silicone | Substantially Equivalent
The subject and predicate BD Insyte™
Autoguard™ Shielded IV Catheter
materials are the same except the barrel
material. The change in barrel material
(non-patient contacting) does not alter or
raise new questions of safety and efficacy.
Subject device material differences
compared to the predicate BBraun
Introcan® Safety™ IV Catheter (K021094)
are non-significant relative to the catheter
introducer indication. Materials contacting
and interfacing with the guidewire or other
vascular access device include catheter
tubing, catheter adapter and catheter wedge.
These materials are substantially equivalent
to the predicate BBraun Introcan® Safety™
IV Catheter. |
| Attribute | SUBJECT
BD Insyte™ Autoguard™ Shielded IV
Catheter | PREDICATE
BD Insyte™ Autoguard™ Shielded IV
Catheter
(K952861) | PREDICATE
BBraun Introcan® Safety™ IV
Catheter
(K021094) | Substantial Equivalence |
| Catheter
Dimensions | Catheter Diameters
14 GA, 16 GA, 18 GA, 20 GA, 22 GA,
24 GA
Catheter Lengths
0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN,
1.75 IN, 1.77 IN, 1.88 IN
Catheter ID
0.0190 IN - 0.0705 IN | Catheter Diameters
14 GA, 16 GA, 18 GA, 20 GA, 22 GA,
24 GA
Catheter Lengths
0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN,
1.75 IN, 1.77 IN, 1.88 IN
Catheter ID
0.0190 IN - 0.0705 IN | Catheter Diameters
14 GA, 16 GA, 18 GA, 20 GA,
22 GA, 24 GA
Catheter Lengths
0.55 IN, 0.75 IN, 1.00 IN, 1.25 IN,
1.75 IN, 2.00 IN, 2.50 IN
Catheter ID
0.018 IN - 0.064 IN | Substantially Equivalent
The subject device and predicate BD
Insyte™ Autoguard™ Shielded IV Catheter
dimensions are identical. The subject and
predicate devices are available in
winged/non-winged configurations with
similar gauges, lengths, and sizes.
Catheter ID dimensions allow passage of
vascular access devices, including a
standard appropriately sized guidewire or
catheter through the lumen of the
subject/predicate devices. |
| Performance | Power Injection
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)
Flashback Chamber / Technology
Yes
Safety Design
Yes
Radiopaque
Yes
Must allow passage of appropriate size
guide wire or catheter
Yes | Power Injection
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)
Flashback Chamber / Technology
Yes
Safety Design
Yes
Radiopaque
Yes | Power Injection
The 22-18 GA power injection
max pressure 300 psi (2068 kPa)
Flashback Chamber / Technology
Yes
Safety Design
Yes
Radiopaque
Yes
Must allow passage of appropriate
size guide wire or catheter
Yes | Same |
| Attribute | SUBJECT
BD Insyte™ Autoguard™ Shielded IV
Catheter | PREDICATE
BD Insyte™ Autoguard™ Shielded IV
Catheter
(K952861) | PREDICATE
BBraun Introcan® Safety™ IV
Catheter
(K021094) | Substantial Equivalence |
| Standards
Compliance | ISO 594-1
ISO 594-2
ISO 10555-1
ISO 10555-5
ISO 23908
ISO 11070 | ISO 594-1
ISO 594-2
ISO 10555-1
ISO 10555-5
ISO 23908 | Unknown | Substantially Equivalent
The subject device was evaluated to current
FDA recognized and industry consensus
standards applicable to the device
classification and FDA product codes. |
| Attribute | SUBJECT
BD Insyte™ Autoguard™ BC Shielded IV Catheter
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATE
BD Insyte™ Autoguard™ BC Shielded IV
Catheter
(K110443) | Substantial Equivalence | |
| Classification | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter | Same | |
| Indications for Use | 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 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). | The BD Insyte™ Autoguard™ BC catheter is
inserted into a patient's vascular system to sample
blood, monitor blood pressure, or administer
fluids. | Substantially Equivalent
The subject device Indication for Use has been
modified to clarify vascular insertion location,
duration of use, patient population, power
injection capabilities and to align with current
industry standards and FDA expectations
These revisions serve to clarify product use and
do not change the intended use of the product or
introduce new features or functionality;
therefore, there are no new questions of safety
or effectiveness when considering a claim of
substantial equivalence. | |
| Attribute | SUBJECT
BD Insyte™ Autoguard™ BC Shielded IV Catheter
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATE
BD Insyte™ Autoguard™ BC Shielded IV
Catheter
(K110443) | Substantial Equivalence | |
| Fundamental
Scientific
Technology | Peripheral intravascular catheter designed with an active
needlestick safety mechanism and a one-time use blood
control septum. Incorporates BD Instaflash™ technology to
assist with flashback visualization. | Peripheral intravascular catheter designed with an
active needlestick safety mechanism and a one-
time use blood control septum. Incorporates BD
Instaflash™ technology to assist with flashback
visualization. | Substantially Equivalent
There are no significant design differences
between the subject devices and BD Insyte™
Autoguard™ BC Shielded IV Catheter
predicate. | |
| Primary Device
Components /
Materials | Needle Cover: Polypropylene
Barrel: Polypropylene
Grip: Polycarbonate
Needle Hub: Polycarbonate
Safety Activation Button: Polycarbonate
Catheter Adapter: Polypropylene
Catheter Wedge: Stainless Steel
Needle: Stainless Steel
Catheter Tubing: Polyurethane with radiopaque barium
sulfate
Lubricants: Silicone
Spring: Stainless Steel
Porous Flow Plug: Porous Polyethylene with
Carboxymethyl Cellulose (CMC)
Septum: Silicone
Septum Actuator: Polypropylene | Needle Cover: Polypropylene
Barrel: Polycarbonate
Grip: Polycarbonate
Needle Hub: Polycarbonate
Safety Activation Button: Polycarbonate
Catheter Adapter: Polypropylene
Catheter Wedge: Stainless Steel
Needle: Stainless Steel
Catheter Tubing: Polyurethane with radiopaque
barium sulfate
Lubricants: Silicone
Spring: Stainless Steel
Porous Flow Plug: Porous Polyethylene with
Carboxymethyl Cellulose (CMC)
Septum: Silicone
Septum Actuator: Polypropylene | Substantially Equivalent
The subject and predicate device materials are
the same except for the barrel change from
polycarbonate to polypropylene (non-patient
contacting). The change in barrel material does
not alter or raise new questions of safety and
efficacy; therefore, it is substantially equivalent. | |
| Catheter
Dimensions | Catheter Diameters
16 GA, 18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.16 IN, 1.25IN ( BD Insyte™ Autoguard™
BC Pro Shielded IV Catheter ONLY) 1.77 IN, 1.88 IN | Catheter Diameters
16 GA, 18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths
0.75 IN, 1.00 IN, 1.16 IN, 1.77 IN, 1.88 IN | Substantially Equivalent
New 1.25 IN configuration was introduced for
BD Insyte™ Autoguard™ BC Pro Shielded IV
Catheter ONLY.
This 1.25 IN length falls within the range of the
existing predicate, the new length does not raise
any new or different questions of safety or | |
| Attribute | SUBJECT
BD Insyte™ Autoguard™ BC Shielded IV Catheter
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATE
BD Insyte™ Autoguard™ BC Shielded IV
Catheter
(K110443) | Substantial Equivalence | |
| | | | effectiveness as demonstrated through design
verification testing; therefore, it is substantially
equivalent. | |
| Performance | Power Injection
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)
Flashback Chamber / Technology
Yes
Blood Control Mechanism
Yes
Needle Safety Design
Yes
Radiopaque
Yes | Power Injection
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)
Flashback Chamber / Technology
Yes
Blood Control Mechanism
Yes
Needle Safety Design
Yes
Radiopaque
Yes | Same | |
| Standards
Compliance | ISO 594-1
ISO 594-2
ISO 10555-1
ISO 10555-5
ISO 23908 | ISO 594-1
ISO 594-2
ISO 10555-1
ISO 10555-5
ISO 23908 | Same | |
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Subject / Predicate Device Comparison of Intended Use, Materials and Technological Characteristics
Subject Device: BD Insyte™ Autoguard™ BC Shielded IV Catheter
Subject Device: BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
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| Summary of
Performance
Tests | A risk analysis per ISO 14971:2007 “Medical Devices-Application of risk management
to medical devices” was conducted to assess the impact of the proposed modifications
to the predicate devices.
Performance tests completed on the subject devices were limited to those tests required
to support a determination of substantial equivalence to the predicate devices. There are
no leveraged tests from the predicate devices.
ISO 10555-1: 2013 + A1:2017 Sterile, single-use intravascular catheters - Part 1:
General requirements ISO 10555-5 :2013 Intravascular catheters - Sterile and single-use catheters Part 5:
Over-needle peripheral catheters ISO 594-1:1986 Conical Fitting with a 6% (Luer) Taper for Syringes, Needless and
certain other medical equipment – Part 1: General Requirements ISO 594-2:1998 Conical Fittings with a 6% (Luer) Taper for syringes, needless
and certain other medical equipment - Part 2: Lock Fittings ISO 23908:2011 Sharps injury protection — Requirements and test methods —
Sharps protection features for single-use hypodermic needles, introducers for
catheters and needles used for blood sampling ISO 11070:2014 "Sterile single-use intravascular introducer, dilators and
guidewires A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and 2) FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016), was conducted. The following testing was undertaken to support the biocompatibility of the subject devices: ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of
tests for interactions with blood ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local
effects after implantation ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | • ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials
• Particulate Matter per USP |
| | Sterilization and Packaging validation |
| | • ISO 11135-1:2014 Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine control of a sterilization
process for medical devices
• ISO 11607-1:2006+AI:2014 Packaging for terminally sterilized medical devices -
Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2:
Validation requirements for forming, sealing and assembly processes
• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene
oxide sterilization residuals |
| 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. |
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