(240 days)
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).
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 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 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).
This is a 510(k) summary for three IV catheter devices, which are physical medical devices, not AI/ML-driven software devices. Therefore, the questions related to AI/ML specific acceptance criteria, study types, ground truth, sample sizes for training/test sets, expert qualifications, and adjudication methods are not applicable.
The document describes the acceptance criteria and supporting studies for these traditional medical devices primarily through a comparison to predicate devices and adherence to established international standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparative table of technological characteristics, rather than a direct table of acceptance criteria and performance against those criteria in a quantitative sense. However, it implicitly states that the subject devices meet the performance of equivalent predicate devices and relevant standards.
Here's a summary derived from the "Performance" rows in the comparison tables:
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Power Injection Capability (22-18 GA devices): Suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). | For all subject devices: 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). (Stated as "Same" in Substantial Equivalence column compared to predicates) |
| Flashback Chamber / Technology: Presence and functionality of flashback chamber. | For all subject devices: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates) They incorporate BD Instaflash™ technology to assist with flashback visualization. |
| Safety Design (Needlestick Safety Mechanism): Device incorporates a safety mechanism to reduce the risk of accidental needlestick injury. | For all subject devices: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). They 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. For BD Insyte™ Autoguard™ Shielded IV Catheter, it's noted: "The subject and predicate BD Insyte™ Autoguard™ Safety IV Catheter active needlestick safety mechanisms are identical." |
| Radiopaque: Catheter is radiopaque. | For all subject devices: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). Catheter tubing is polyurethane with radiopaque barium sulfate. |
| Guidewire Passage (for BD Insyte™ Autoguard™ Shielded IV Catheter): Must allow passage of appropriate size guide wire or catheter. | For BD Insyte™ Autoguard™ Shielded IV Catheter: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). "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." |
| Blood Control Mechanism (for BC and BC Pro Shielded IV Catheters): Presence and functionality of a blood control septum to stop blood flow until Luer connection. | For BD Insyte™ Autoguard™ BC Shielded IV Catheter & BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter: Yes. (Stated as "Same" in Substantial Equivalence column compared to predicates). 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. |
| Material Biocompatibility: Compliance with ISO 10993 series for biological evaluation. | Bio-compatibility evaluation conducted in accordance with ISO 10993-1, 3, 4, 5, 6, 10, 11, 12, and FDA guidance. Conclusion: Evaluation results support the biocompatibility of the subject devices. |
| Sterilization & Packaging: Compliance with relevant ISO standards for sterilization and packaging validation. | Validation conducted in accordance with ISO 11135-1 (Ethylene oxide sterilization), ISO 11607-1, 11607-2 (Packaging), and ISO 10993-7 (Ethylene oxide sterilization residuals). Conclusion: The devices meet these standards. |
| General Requirements for Intravascular Catheters: Compliance with ISO 10555-1 and ISO 10555-5. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
| Conical Fittings (Luer): Compliance with ISO 594-1 and ISO 594-2. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
| Sharps Injury Protection: Compliance with ISO 23908. | Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. Conclusion: Compliance demonstrated. |
| Intravascular Introducer, Dilators, and Guidewires (for BD Insyte™ Autoguard™ Shielded IV Catheter): Compliance with ISO 11070 for facilitation of guidewires and other vascular access 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. Conclusion: Compliance demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices." It does not specify sample sizes for these tests, nor does it explicitly mention data provenance (e.g., country of origin). Since these are physical devices, the testing would typically involve laboratory bench testing, animal testing (if applicable, not specified here), and potentially human clinical trials (not described in this summary, implying equivalence was sufficient).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is not an AI/ML device where expert ground truth is established for a dataset. The "ground truth" for these physical devices is determined by adherence to established engineering, materials, and biological safety standards (e.g., ISO standards) and performance specifications.
4. Adjudication Method for the Test Set:
Not applicable. No expert adjudication process is described for evaluating the performance of these physical devices against a dataset. Device performance is assessed via objective measurements against predefined standards and specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for diagnostic imaging AI/ML devices where human readers interpret medical images. This document pertains to physical intravascular catheters.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the device's performance relies on:
- Compliance with International Standards: ISO 10555, ISO 594, ISO 23908, ISO 11070 for performance, and ISO 10993 and ISO 11135/11607 for biocompatibility, sterilization, and packaging.
- Engineering Specifications: Meeting pre-defined physical and functional requirements for parameters like pressure limits, dimensions, and material properties.
- Substantial Equivalence to Predicate Devices: Demonstrating that the new devices are as safe and effective as previously cleared devices.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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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 (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
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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) |
|---|
| ☑ 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
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| bd.com |
|---|
| PredicateDevice | 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 than30 days | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| PredicateDevice | 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 30days Catheter Introducer | |
| Regulatory Class: | II | |
| Product Code: | FOZ/DYB | |
| Classification Panel: | Cardiovascular | |
| DeviceDescription | 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 withbutton, flash chamber with vent plug, and barrel. The needle and catheter are protectedby a needle cover. | ||
| The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ needle technology, allowingfor immediate visualization of blood along the catheter. The flash chamber providesconfirmation that the device has entered the vessel. These devices incorporate BDAutoguard™ push-button shielding technology which is activated when the button isdepressed. 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 arecolor 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 accessdevices. The following labeled gauge sizes correspond to the listed inside diameter: 24GA (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 amaximum 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 ofaccidental needlestick injury. | |
|---|---|
| These devices are available with or without wings. The catheter hub and wings arecolor coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9mm) = 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 amaximum pressure of 300 psi (2068 kPa). | |
| Indications forUse(21 CFR §807.92(a)(5)) | BD Insyte™ Autoguard™ Shielded IV CatheterBD Insyte™ Autoguard™ shielded IV catheters are intended to be inserted into apatient's peripheral vascular system for short term use to sample blood, monitor bloodpressure, or administer fluids. These devices may also be used to facilitate theplacement of guidewires and other vascular access devices without pre-attached hubs.These devices may be used for any patient population with consideration given toadequacy of vascular anatomy, procedure being performed, fluids being infused, andduration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with powerinjectors set to a maximum pressure of 300 psi (2068 kPa). |
| BD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC shielded IV catheters are intended to be inserted into apatient's peripheral vascular system for short term use to sample blood, monitor bloodpressure, or administer fluids. These devices may be used for any patient populationwith 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 aresuitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). | |
| BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro shielded IV catheters are intended to be inserted intoa patient's peripheral vascular system for short term use to sample blood, monitorblood pressure, or administer fluids. These devices may be used for any patientpopulation with consideration given to adequacy of vascular anatomy, procedure beingperformed, 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). | |
| TechnologicalCharacteristics | Technological characteristics of the subject devices are substantially equivalent to thepredicate devices. The subject BD Insyte™ Autoguard™ Shielded IV Catheter, BDInsyte™ Autoguard™ BC Shielded IV Catheter, and BD Insyte™ Autoguard™ BC ProShielded IV Catheter achieve their intended use based on the same technology andprinciples 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 | SUBJECTBD Insyte™ Autoguard™ Shielded IVCatheter | PREDICATEBD Insyte™ Autoguard™ Shielded IVCatheter(K952861) | PREDICATEBBraun Introcan® Safety™ IVCatheter(K021094) | Substantial Equivalence |
|---|---|---|---|---|
| Classification | 21 CFR §880.520021 CFR §870.1340Class IIFOZ - Intravascular Catheter (primary)DYB - Catheter Introducer (secondary) | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | 21 CFR §880.520021 CFR §870.1340Class IIFOZ – Intravascular CatheterDYB – Catheter Introducer | Same |
| Indications forUse | BD Insyte™ Autoguard™ shielded IVcatheters are intended to be inserted intoa patient's peripheral vascular system forshort term use to sample blood, monitorblood pressure, or administer fluids.These devices may also be used tofacilitate the placement of guidewires andother vascular access devices withoutpre-attached hubs. These devices may beused for any patient population withconsideration given to adequacy ofvascular anatomy, procedure beingperformed, fluids being infused, andduration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use withpower injectors set to a maximumpressure of 300 psi (2068 kPa). | An intravascular catheter is intended tobe inserted into the patient's vascularsystem for short term use to sampleblood, monitor blood pressure, oradminister fluids intravenously. | The BBraun Introcan® Safety IVCatheter is a passive anti-needlestick device to provide venous orarterial access for the infusion offluids, drugs, and/or bloodcomponents, or to facilitate theplacement of Vascular Accessdevices such as guidewires,indwelling central venouscatheters, peripherally insertedcentral catheters, and midlinecatheters into the vascular system. | Substantially EquivalentThe subject device Indication for Use hasbeen modified compared to the BD Insyte™Autoguard™ Shielded IV Catheterpredicate to clarify vascular insertionlocation, patient population, and powerinjection capabilities. These revisions serveto clarify product use and do not change theintended use of the product or introducenew features or functionality for vascularaccess; therefore, there are no newquestions of safety or effectiveness.The subject device Indication for Useincludes the facilitation of guidewire andother vascular access device placementwhich does not alter the overall intendeduse of the product with respect to theBBraun predicate device. |
| Attribute | SUBJECTBD Insyte ™ Autoguard™ Shielded IVCatheter | PREDICATEBD Insyte ™ Autoguard™ Shielded IVCatheter(K952861) | PREDICATEBBraun Introcan® Safety™ IVCatheter(K021094) | Substantial Equivalence |
| FundamentalScientificTechnology | Single lumen with tapered tip peripheralintravascular catheter designed with anactive needlestick safety mechanism.Incorporates BD Instaflash™ technologyto assist with flashback visualization.Facilitates placement of guidewires andother vascular access devices. | Single lumen with tapered tip peripheralintravascular catheter designed with anactive needlestick safety mechanism.Incorporates BD Instaflash™ technologyto assist with flashback visualization. | Single lumen with tapered tipperipheral intravascular catheterdesigned with a passive needlesticksafety* mechanism. Facilitatesplacement of guidewires and othervascular access devices. | Substantially EquivalentThe subject and predicate BD Insyte™Autoguard™ Safety IV Catheter activeneedlestick safety mechanisms are identical.*Passive and active needle safetymechanisms are well accepted technologyfor needlestick injury prevention in theclinical setting. |
| Primary DeviceComponents /Materials | Needle Cover: PolypropyleneBarrel: PolypropyleneGrip: PolycarbonateNeedle Hub: PolycarbonateSafety Activation Button: PolycarbonateCatheter Adapter: PolypropyleneCatheter Wedge: Stainless SteelNeedle: Stainless SteelCatheter Tubing: Polyurethane withradiopaque barium sulfateLubricants: SiliconeSpring: Stainless SteelPorous Flow Plug: Porous Polyethylenewith Carboxymethyl Cellulose (CMC) | Needle Cover: PolypropyleneBarrel: PolycarbonateGrip: PolycarbonateNeedle Hub: PolycarbonateSafety Activation Button: PolycarbonateCatheter Adapter: PolypropyleneCatheter Wedge: Stainless SteelNeedle: Stainless SteelCatheter Tubing: Polyurethane withradiopaque barium sulfateLubricants: SiliconeSpring: Stainless SteelPorous Flow Plug: Porous Polyethylenewith Carboxymethyl Cellulose (CMC) | Needle Cover: PolypropyleneCatheter Tubing: RadiopaquePolyurethane (PUR) or Teflon(FEP)Catheter Adapter: PolypropyleneNeedle: Chrome-Nickel steelNeedle Hub: ABSCatheter Wedge: Stainless SteelSafety Clip: Stainless steelLubricants: Silicone | Substantially EquivalentThe subject and predicate BD Insyte™Autoguard™ Shielded IV Cathetermaterials are the same except the barrelmaterial. The change in barrel material(non-patient contacting) does not alter orraise new questions of safety and efficacy.Subject device material differencescompared to the predicate BBraunIntrocan® Safety™ IV Catheter (K021094)are non-significant relative to the catheterintroducer indication. Materials contactingand interfacing with the guidewire or othervascular access device include cathetertubing, catheter adapter and catheter wedge.These materials are substantially equivalentto the predicate BBraun Introcan® Safety™IV Catheter. |
| Attribute | SUBJECTBD Insyte™ Autoguard™ Shielded IVCatheter | PREDICATEBD Insyte™ Autoguard™ Shielded IVCatheter(K952861) | PREDICATEBBraun Introcan® Safety™ IVCatheter(K021094) | Substantial Equivalence |
| CatheterDimensions | Catheter Diameters14 GA, 16 GA, 18 GA, 20 GA, 22 GA,24 GACatheter Lengths0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN,1.75 IN, 1.77 IN, 1.88 INCatheter ID0.0190 IN - 0.0705 IN | Catheter Diameters14 GA, 16 GA, 18 GA, 20 GA, 22 GA,24 GACatheter Lengths0.56 IN, 0.75 IN, 1.00 IN, 1.16 IN,1.75 IN, 1.77 IN, 1.88 INCatheter ID0.0190 IN - 0.0705 IN | Catheter Diameters14 GA, 16 GA, 18 GA, 20 GA,22 GA, 24 GACatheter Lengths0.55 IN, 0.75 IN, 1.00 IN, 1.25 IN,1.75 IN, 2.00 IN, 2.50 INCatheter ID0.018 IN - 0.064 IN | Substantially EquivalentThe subject device and predicate BDInsyte™ Autoguard™ Shielded IV Catheterdimensions are identical. The subject andpredicate devices are available inwinged/non-winged configurations withsimilar gauges, lengths, and sizes.Catheter ID dimensions allow passage ofvascular access devices, including astandard appropriately sized guidewire orcatheter through the lumen of thesubject/predicate devices. |
| Performance | Power InjectionThe 22-18 GA (0.9-1.3 mm) devices aresuitable for use with power injectors setto a maximum pressure of 300 psi (2068kPa)Flashback Chamber / TechnologyYesSafety DesignYesRadiopaqueYesMust allow passage of appropriate sizeguide wire or catheterYes | Power InjectionThe 22-18 GA (0.9-1.3 mm) devices aresuitable for use with power injectors setto a maximum pressure of 300 psi (2068kPa)Flashback Chamber / TechnologyYesSafety DesignYesRadiopaqueYes | Power InjectionThe 22-18 GA power injectionmax pressure 300 psi (2068 kPa)Flashback Chamber / TechnologyYesSafety DesignYesRadiopaqueYesMust allow passage of appropriatesize guide wire or catheterYes | Same |
| Attribute | SUBJECTBD Insyte™ Autoguard™ Shielded IVCatheter | PREDICATEBD Insyte™ Autoguard™ Shielded IVCatheter(K952861) | PREDICATEBBraun Introcan® Safety™ IVCatheter(K021094) | Substantial Equivalence |
| StandardsCompliance | ISO 594-1ISO 594-2ISO 10555-1ISO 10555-5ISO 23908ISO 11070 | ISO 594-1ISO 594-2ISO 10555-1ISO 10555-5ISO 23908 | Unknown | Substantially EquivalentThe subject device was evaluated to currentFDA recognized and industry consensusstandards applicable to the deviceclassification and FDA product codes. |
| Attribute | SUBJECTBD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATEBD Insyte™ Autoguard™ BC Shielded IVCatheter(K110443) | Substantial Equivalence | |
| Classification | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | Same | |
| Indications for Use | BD Insyte™ Autoguard™ BC Shielded IV Catheter:BD Insyte™ Autoguard™ BC shielded IV catheters areintended to be inserted into a patient's peripheral vascularsystem for short term use to sample blood, monitor bloodpressure, or administer fluids. These devices may be used forany patient population with consideration given to adequacy ofvascular anatomy, procedure being performed, fluids beinginfused, and duration of therapy. The 22-18 GA (0.9-1.3 mm)devices are suitable for use with power injectors set to amaximum pressure of 300 psi (2068 kPa).BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter:BD Insyte™ Autoguard™ BC Pro shielded IV catheters areintended to be inserted into a patient's peripheral vascularsystem for short term use to sample blood, monitor bloodpressure, or administer fluids. These devices may be used forany patient population with consideration given to adequacy ofvascular anatomy, procedure being performed, fluids beinginfused, and duration of therapy. The 22-18 GA (0.9-1.3 mm)devices are suitable for use with power injectors set to amaximum pressure of 300 psi (2068 kPa). | The BD Insyte™ Autoguard™ BC catheter isinserted into a patient's vascular system to sampleblood, monitor blood pressure, or administerfluids. | Substantially EquivalentThe subject device Indication for Use has beenmodified to clarify vascular insertion location,duration of use, patient population, powerinjection capabilities and to align with currentindustry standards and FDA expectationsThese revisions serve to clarify product use anddo not change the intended use of the product orintroduce new features or functionality;therefore, there are no new questions of safetyor effectiveness when considering a claim ofsubstantial equivalence. | |
| Attribute | SUBJECTBD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATEBD Insyte™ Autoguard™ BC Shielded IVCatheter(K110443) | Substantial Equivalence | |
| FundamentalScientificTechnology | Peripheral intravascular catheter designed with an activeneedlestick safety mechanism and a one-time use bloodcontrol septum. Incorporates BD Instaflash™ technology toassist with flashback visualization. | Peripheral intravascular catheter designed with anactive needlestick safety mechanism and a one-time use blood control septum. Incorporates BDInstaflash™ technology to assist with flashbackvisualization. | Substantially EquivalentThere are no significant design differencesbetween the subject devices and BD Insyte™Autoguard™ BC Shielded IV Catheterpredicate. | |
| Primary DeviceComponents /Materials | Needle Cover: PolypropyleneBarrel: PolypropyleneGrip: PolycarbonateNeedle Hub: PolycarbonateSafety Activation Button: PolycarbonateCatheter Adapter: PolypropyleneCatheter Wedge: Stainless SteelNeedle: Stainless SteelCatheter Tubing: Polyurethane with radiopaque bariumsulfateLubricants: SiliconeSpring: Stainless SteelPorous Flow Plug: Porous Polyethylene withCarboxymethyl Cellulose (CMC)Septum: SiliconeSeptum Actuator: Polypropylene | Needle Cover: PolypropyleneBarrel: PolycarbonateGrip: PolycarbonateNeedle Hub: PolycarbonateSafety Activation Button: PolycarbonateCatheter Adapter: PolypropyleneCatheter Wedge: Stainless SteelNeedle: Stainless SteelCatheter Tubing: Polyurethane with radiopaquebarium sulfateLubricants: SiliconeSpring: Stainless SteelPorous Flow Plug: Porous Polyethylene withCarboxymethyl Cellulose (CMC)Septum: SiliconeSeptum Actuator: Polypropylene | Substantially EquivalentThe subject and predicate device materials arethe same except for the barrel change frompolycarbonate to polypropylene (non-patientcontacting). The change in barrel material doesnot alter or raise new questions of safety andefficacy; therefore, it is substantially equivalent. | |
| CatheterDimensions | Catheter Diameters16 GA, 18 GA, 20 GA, 22 GA, 24 GACatheter Lengths0.75 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 Diameters16 GA, 18 GA, 20 GA, 22 GA, 24 GACatheter Lengths0.75 IN, 1.00 IN, 1.16 IN, 1.77 IN, 1.88 IN | Substantially EquivalentNew 1.25 IN configuration was introduced forBD Insyte™ Autoguard™ BC Pro Shielded IVCatheter ONLY.This 1.25 IN length falls within the range of theexisting predicate, the new length does not raiseany new or different questions of safety or | |
| Attribute | SUBJECTBD Insyte™ Autoguard™ BC Shielded IV CatheterBD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | PREDICATEBD Insyte™ Autoguard™ BC Shielded IVCatheter(K110443) | Substantial Equivalence | |
| effectiveness as demonstrated through designverification testing; therefore, it is substantiallyequivalent. | ||||
| Performance | Power InjectionThe 22-18 GA (0.9-1.3 mm) devices are suitable for use withpower injectors set to a maximum pressure of 300 psi (2068kPa)Flashback Chamber / TechnologyYesBlood Control MechanismYesNeedle Safety DesignYesRadiopaqueYes | Power InjectionThe 22-18 GA (0.9-1.3 mm) devices are suitablefor use with power injectors set to a maximumpressure of 300 psi (2068 kPa)Flashback Chamber / TechnologyYesBlood Control MechanismYesNeedle Safety DesignYesRadiopaqueYes | Same | |
| StandardsCompliance | ISO 594-1ISO 594-2ISO 10555-1ISO 10555-5ISO 23908 | ISO 594-1ISO 594-2ISO 10555-1ISO 10555-5ISO 23908 | Same |
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bd.com
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 ofPerformanceTests | A risk analysis per ISO 14971:2007 “Medical Devices-Application of risk managementto medical devices” was conducted to assess the impact of the proposed modificationsto the predicate devices.Performance tests completed on the subject devices were limited to those tests requiredto support a determination of substantial equivalence to the predicate devices. There areno 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 andcertain other medical equipment – Part 1: General Requirements ISO 594-2:1998 Conical Fittings with a 6% (Luer) Taper for syringes, needlessand 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 forcatheters and needles used for blood sampling ISO 11070:2014 "Sterile single-use intravascular introducer, dilators andguidewires 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 forgenotoxicity, carcinogenicity and reproductive toxicity ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection oftests for interactions with blood ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for localeffects after implantation ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity |
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| • ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Samplepreparation and reference materials• Particulate Matter per USP <788> | |
| 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 sterilizationprocess 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: Ethyleneoxide sterilization residuals | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and results ofperformance testing, the subject BD Insyte™ Autoguard™ Shielded IV Catheter, BDInsyte™ Autoguard™ BC Shielded IV Catheter, and BD Insyte™ Autoguard™ BC ProShielded IV Catheter have been demonstrated to be substantially equivalent to thelegally marketed predicate devices. |
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§ 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).