(135 days)
No
The description focuses on mechanical and material properties of the IV catheter and does not mention any computational or data-driven features.
No
The device is used to insert into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids; these functions are diagnostic and supportive, not therapeutic.
No
Explanation: The device is an IV catheter used for administering fluids, sampling blood, or monitoring blood pressure. While blood sampling can be part of diagnostic processes, the device itself does not perform any diagnostic function; it is a tool for accessing the vascular system.
No
The device description clearly outlines physical components like a catheter, needle, grip, shield, and flash chamber, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "inserting into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids." This describes a device used in vivo (within the body) for direct patient care and procedures.
- Device Description: The description details an "over-the-needle, intravascular (IV) catheter" with components like a catheter, needle, safety shield, and flash chamber. These are all components of a device used for accessing the vascular system directly.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The description and intended use do not mention any analysis of samples or diagnostic purposes performed on the device itself or in conjunction with it in an in vitro setting.
The device is a medical device used for accessing the bloodstream for various clinical purposes, but it does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
BD Cathena™ Safety 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These 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. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices are available with or without multi-access BD Multiguard technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.
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). These devices are not made with natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's peripheral vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets pre-determined design requirements:
BD Internal Specification
- Time to visualize flashback in flash chamber
- Force to break adhesion between catheter unit and needle (initial adhesion)
- Force to remove needle from catheter unit (average system drag)
- Device burst pressure
- Catheter separation force
- Time to visualize flashback in catheter adapter
- Procedural leak time
Standards Compliance
- Flow rate (ISO 10555-1 Intravascular catheters - Sterile and single-use catheters -Part 1: General requirements)
- Power injection (ISO 10555-1 Intravascular catheters — Sterile and single-use catheters -Part 1: General requirements)
The subject device complies with sterilization requirements of ISO 11135:2014. Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
The subject device complies with particulate testing - USP Particulate Matter in Injections.
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. Biocompatibility data was leveraged from the reference device in addition to performing additional endpoints when required.
Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
January 24, 2020
Becton Dickinson Infusion Therapy Systems, Inc. Henry Boland Staff Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070
Re: K192493
Trade/Device Name: BD Cathena™ Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: December 19, 2019 Received: December 20, 2019
Dear Henry Boland:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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.
for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192493
Device Name BD Cathena™ Safety IV Catheter
Indications for Use (Describe)
BD Cathena™ Safety 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 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 BD logo. The logo consists of an orange circle with white rays emanating from the center, resembling a sun. To the right of the circle are the letters "BD" in a bold, blue font. The letters are large and easily readable.
510(k) Summary (21 CFR §807.92)
BD Cathena™ Safety IV Catheter
| Submitter | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|---|
| Information | Submitter Address: | 9450 South State Street |
| Sandy, UT 84070 | ||
| Contact Person: | Henry Boland | |
| Staff Regulatory Affairs Specialist | ||
| Email Address: | henry.boland@bd.com | |
| Phone Number: | (801) 565-2550 | |
| Date of Preparation: | January 23, 2020 | |
| Subject Device | Trade Name: | BD Cathena™ Safety IV Catheter |
| 510(k) Reference: | K192493 | |
| 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 | Trade Name: | BD Cathena™ Safety IV Catheter |
| Device | 510(k) Reference: | K172506, cleared 17 September 2017 |
| 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 | |
| Reference | Trade Name: | BD Insyte™ Autoguard™ BC Safety IV Catheter |
| Device | 510(k) Reference: | K110443, cleared 19 July 2011 |
| 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 | |
| Reason for Submission | The reason for this submission is the introduction of a performance specification | |
| (due to a change in material supplier and grade of silicone lubricant), | ||
| modification of catheter tubing dimensions, and modifications to product | ||
| labeling. | ||
| Device Description | BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) | |
| catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, | ||
| passive safety needle shield, and flash chamber with removable vent plug. The | ||
| needle and catheter are protected by a needle cover. These 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. The needle tip is passively protected when the needle is | ||
| removed, reducing the risk of accidental needlestick injury. |
These devices are available with or without multi-access BD Multiguard
technology, which is designed to stop the flow of blood from the catheter hub
until a Luer connection is made. Once a connection is made, fluids or blood can
flow through the catheter hub in either direction.
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). These devices are not made with natural rubber latex. | |
| Indications for Use
(21 CFR §
807.92(a)(5)) | The subject device Indications for Use is identical to the predicate BD Cathena™
Safety IV Catheter, with the exception that 'catheters' was changed to 'devices'
in some cases.
BD Cathena™ Safety 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. These devices are
suitable for use with power injectors set to a maximum pressure of 325 psi (2240
kPa) | |
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bd.com
Technological characteristics of the subject device are substantially equivalent to the subject Technological Characteristics BD Cathena™ Safety IV Catheter achieves its intended use based on the same technology and principles of operation as the predicate device.
The changes to the device include the introduction of a performance specification (due to a change in material supplier and grade of the needle lubricant from a 2-part silicone material), modification of catheter tubing dimensions for the 18, 20, 22, and 24G catheters, and modifications to product labeling. There were no changes to the product performance specifications as a result of the catheter tubing dimension changes. Biocompatibility evaluation was performed for the change in silicone, performance testing was performed to support the modifications in the catheter tubing.
A comparison of the subject and predicate device technological characteristics is provided in the table below.
| Attribute | SUBJECT
BD Cathena™ Safety IV Catheter | PREDICATE (K172506)
BD Cathena™ Safety IV Catheter | Comparison |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Classification | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter | 21 CFR §880.5200
Class II
FOZ - Intravascular Catheter | Identical |
| Indication for
Use | BD Cathena™ Safety 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. These
devices are suitable for use with power
injectors set to a maximum pressure of 325 psi
(2240 kPa). | BD Cathena™ Safety 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 catheters 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 catheters are
suitable for use with power injectors set to a
maximum pressure of 325 psi (2240 kPa). | Identical, with the exception that 'catheters'
was changed to 'devices' in some cases. |
| Attribute | SUBJECT
BD Cathena™ Safety IV Catheter | PREDICATE (K172506)
BD Cathena™ Safety IV Catheter | Comparison |
| Fundamental
Scientific
Technology | Peripheral intravascular catheter designed
with a passive needlestick safety mechanism
and a multi-use blood control septum.
Incorporates BD Instaflash™ technology to
assist with flashback visualization. | Peripheral intravascular catheter designed
with a passive needlestick safety mechanism
and a multi-use blood control septum.
Incorporates BD Instaflash™ technology to
assist with flashback visualization. | Identical |
| Primary
Device
Components /
Materials | Safety Shield
Acrylonitrile Butadiene Styrene | Safety Shield
Polystyrene | Change in safety shield and silicone lubricant
materials |
| | Grip / Needle Hub
Polypropylene | Grip / Needle Hub
Polypropylene | |
| | Needle
Stainless Steel | Needle
Stainless Steel | |
| | Needle Lubricant
1-part Silicone | Needle Lubricant
2-part Silicone | |
| | Catheter Adapter
Polypropylene
Catheter Tubing
Polyurethane with radiopaque barium sulfate | Catheter Adapter
Polypropylene
Catheter Tubing
Polyurethane with radiopaque barium sulfate | |
| Catheter
Dimensions | Catheter Diameters
16 G, 18 G, 20 G, 22 G, 24 G
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN, 2.00 IN | Catheter Diameters
16 G, 18 G, 20 G, 22 G, 24 G
Catheter Lengths
0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN, 2.00 IN | Change in catheter tubing dimensions for the
18 G, 20 G, 22 G, and 24 G catheters |
| Shelf-Life | 3 years | 1 year | Change in shelf life from 1 year to 3 years. |
| Attribute | SUBJECT
BD Cathena™ Safety IV Catheter | PREDICATE (K172506)
BD Cathena™ Safety IV Catheter | Comparison |
| Sterilization
Method | EO (SAL 10^-6) | EO (SAL 10^-6) | Identical |
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Performance tests completed on the subject device were limited to those tests Summary of Performance required to support a determination of substantial equivalence to the predicate Tests device. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets pre-determined design requirements:
BD Internal Specification
- . Time to visualize flashback in flash chamber
- Force to break adhesion between catheter unit and needle (initial adhesion) ●
- Force to remove needle from catheter unit (average system drag) .
- Device burst pressure
- Catheter separation force
- Time to visualize flashback in catheter adapter ●
- Procedural leak time
Standards Compliance
- . Flow rate (ISO 10555-1 Intravascular catheters - Sterile and single-use catheters -Part 1: General requirements)
- . Power injection (ISO 10555-1 Intravascular catheters — Sterile and single-use catheters -Part 1: General requirements)
The subject device complies with sterilization requirements of ISO 11135:2014. Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
The subject device complies with particulate testing - USP Particulate Matter in Injections.
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. Biocompatibility data was leveraged from the reference device in addition to performing additional endpoints when required.
9
| Per design control requirements specified in 21 CFR 820.30, the subject device | |
|---|---|
| met all predetermined acceptance criteria for the above-listed performance tests, | |
| demonstrating substantial equivalence to the predicate device. | |
| Summary of | Based on the indications for use, technological characteristics, and results of |
| Substantial | performance testing, the subject BD Cathena™ Safety IV Catheters has been |
| Equivalence | demonstrated to be substantially equivalent to the predicate device. |