(91 days)
No
The device description and performance studies focus on mechanical and material properties of the IV catheter, with no mention of AI or ML technologies.
No
The device is used for administering fluids, which is a therapeutic action, but it is an IV catheter, specifically for accessing the vascular system, not a device that itself provides therapy.
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 a diagnostic process, the device itself does not perform any diagnostic function (e.g., analyzing the blood or interpreting physiological signals). 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, the BD Cathena™ Safety IV Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into a patient's peripheral vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids. These are all procedures performed on the patient's body, not on samples outside the body.
- Device Description: The description details a physical device for accessing the vascular system (catheter, needle, safety features). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to access the body, not to analyze samples from it.
Therefore, the BD Cathena™ Safety IV Catheter is a medical device used for accessing the vascular system, not an IVD device.
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
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. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate device 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 Studies
- Force to break adhesion between catheter unit and needle (initial o adhesion)
- Force to remove needle from catheter unit (average system drag) o
- Catheter separation force o
- Blood escape time O
- Procedural leak time O
- Testing per ISO 10555-1:2014 ●
The following data testing was leveraged from the predicate device:
- . Testing per ISO 10555-5:2013 and ISO 23908:2011
- EO residuals per ISO 10993-7:2008 ●
- . Sterilization validation per ISO 11135:2014
A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, and 2) FDA guidance Use of harmonized 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. Based on the assessment, biocompatibility data was leveraged from the predicate devices.
Per design control requirements specified in 21 CFR 820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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".
September 22, 2020
Becton Dickinson Infusion Therapy Systems Inc. Paul Holman Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070
Re: K201717
Trade/Device Name: BD Cathena TM Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 25, 2020 Received: August 27, 2020
Dear Paul Holman:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 medical devices and radiation-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 Payal Patel 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K201717 510(k) Summary (21 CFR §807.92) BD Cathena™ Safety IV Catheter
| Submitter
| Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|---|
| 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) 834-3607 | |
| Date of Preparation: | July 20, 2020 | |
| Subject Device | Trade Name: | BD Cathena™ Safety IV Catheter |
| Common Name: | Peripheral Intravascular or IV Catheter | |
| 510(k) Reference: | K201717 | |
| 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: | 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 | |
| Reason for | ||
| Submission | The purpose of this submission is to notify the FDA of the following changes: | |
| • Introduction of BD Cathena™ Safety IV Catheter 16 GA configurations | ||
| with BD Multiguard™ Technology; | ||
| • Modification of the initial adhesion specification for all BD Cathena™ | ||
| Safety IV Catheter 16 GA configurations; |
4
| bd.com |
|---|
| | Use of universal blood control adapter in all BD Cathena™ Safety IV
Catheter 16 GA catheter configurations; and Updates to the BD Cathena™ Safety IV Catheter Instructions for Use to
improve clarity, reflect current clinical practice, and include flow rates for
the new 16 GA configurations. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
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). |
| Technological
Characteristics | Technological characteristics of the subject device are substantially equivalent to
the predicate device. The subject BD Cathena™ Safety IV Catheter achieves its
intended use based on the same technology and principles of operation as the
predicate device.
A comparison of the subject and predicate device technological characteristics is
provided in the table below. |
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| Attribute | SUBJECT
BD Cathena™ Safety IV Catheter | PREDICATE (K192493)
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 |
| 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). | 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). | Identical |
| 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
Acrylonitrile Butadiene Styrene | Identical |
| | Grip / Needle Hub
Polypropylene | Grip / Needle Hub
Polypropylene | Identical |
| | Needle
Stainless Steel | Needle
Stainless Steel | Identical |
| | Catheter Adapter
Polypropylene | Catheter Adapter
Polypropylene | Identical |
| | Catheter Tubing
Polyurethane with radiopaque
barium sulfate | Catheter Tubing
Polyurethane with radiopaque
barium sulfate | Identical |
| Catheter
Dimensions | Catheter Diameters
16 GA, 18 GA, 20 GA, 22 GA, 24
GA
Catheter Lengths | Catheter Diameters
16 GA, 18 GA, 20 GA, 22 GA, 24
GA
Catheter Lengths | Identical |
| Attribute | SUBJECT
BD Cathena™ Safety IV Catheter | PREDICATE (K192493)
BD Cathena™ Safety IV Catheter | Comparison |
| | 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN,
2.00 IN | 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN,
2.00 IN | |
| Shelf Life | 3 years | 3 years | Identical |
| Sterilization
Method | EO (SAL 10-6) | EO (SAL 10-6) | Identical |
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A Risk Analysis in accordance with ISO 14971:2007 was conducted to assess the Summary of Performance impact of the proposed modifications to the predicate device.
Tests
Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate device 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 Studies
- Force to break adhesion between catheter unit and needle (initial o adhesion)
- Force to remove needle from catheter unit (average system drag) o
- Catheter separation force o
- Blood escape time O
- Procedural leak time O
- Testing per ISO 10555-1:2014 ●
The following data testing was leveraged from the predicate device:
- . Testing per ISO 10555-5:2013 and ISO 23908:2011
- EO residuals per ISO 10993-7:2008 ●
- . Sterilization validation per ISO 11135:2014
A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, and 2) FDA guidance Use of harmonized 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. Based
7
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| Summary of
Substantial
Equivalence | on the assessment, biocompatibility data was leveraged from the predicate
devices.
Per design control requirements specified in 21 CFR 820.30, the subject devices
met all predetermined acceptance criteria for the above-listed performance tests,
demonstrating substantial equivalence to the predicate devices.
Based on the indications for use, technological characteristics, and results of
performance testing, the subject BD Cathena™ Safety IV Catheter is substantially
equivalent to the predicate device. |
| ------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|