(30 days)
Not Found
No
The summary describes a physical medical device (IV catheter) and its mechanical and material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for "administer fluids" which is a therapeutic intervention, and also for "short term use to sample blood, monitor blood pressure" which provides diagnostic information.
No
Explanation: The device is a safety IV catheter used for administering fluids, monitoring blood pressure, and sampling blood, not for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, needle, grip, shield, and flash chamber. The performance studies also focus on physical characteristics and material properties, not software functionality.
Based on the provided text, the BD Cathena Safety IV Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "inserted 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 monitoring.
- Device Description: The description details a catheter, needle, and related components for accessing the vascular system. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. The BD Cathena Safety IV Catheter is a device used directly on the patient for accessing their vascular system.
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 catheters may be used for any patient 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).
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular 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 (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (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
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 those tests required to support a determination of substantial equivalence to the predicate devices. Design verification tests were performed based on the risk analysis. Results of these tests demonstrate that the BD Cathena™ Safety IV Catheter is substantially equivalent to the predicate devices. Design verification testing included the following:
- Package maintains integrity ●
- Needle cover does not fall off
- Force to remove needle cover
- Incremental force to decouple shielded needle from catheter adapter ● during safety activation
- System penetration force
- Needle to needle hub pull force
- Time to visualize flashback in flash chamber ●
- Catheter average drag force ●
- Force to break adhesion between catheter unit and needle (initial ● adhesion)
- Force to remove needle from catheter unit (average system drag)
- Force to prematurely decouple tip-shield from adapter ●
- Needle is not re-exposed upon application of compressive force .
- . Tensile force to defeat safety system
- No air leakage from device in a connected state at low pressure less than ● 30 psi
- Device burst pressure ●
- Catheter separation force
- Blood escape time ●
- . Force to connect Luer to catheter adapter
- Time to visualize flashback in catheter adapter
Biocompatibility testing was conducted on the BD Cathena™ Safety IV Catheters in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. Testing included cytotoxicity, sensitization, intracutaneous reactivity, acute svstemic toxicity, subchronic toxicity (subacute toxicity), genotoxicity, implantation, and haemocompatibility. Additionally, material-mediated pyrogenicity was also performed.
Simulated clinical use testing was performed on the device, per FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015 Medical devices - Part 1:Application of usability engineering to medical devices.
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 devices.
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.
Not Found
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2018
Becton, Dickinson and Company % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172506
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: July 19, 2017 Received: August 18, 2017
Dear Mark Job:
This letter corrects our substantially equivalent letter of September 17th, 2017
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the name "Geeta K. Pamidimukkala -S" in a simple, sans-serif font. The text is arranged in two lines, with "Geeta K." on the first line and "Pamidimukkala -S" on the second line. The text is black against a white background.
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure:
2
Indications for Use
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 catheters may be used for any patient 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).
| 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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3
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510(k) Summary (21 CFR §807.92)
BD Cathena™ Safety IV Catheter
| Submitter
Information | Submitter Name:
Submitter Address: | Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, UT 84070 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person:
Email Address:
Phone Number:
Fax Number
Date of Preparation: | Henry Boland
Staff Regulatory Affairs Specialist
henry.boland@bd.com
(801) 565-2550
(801) 304-3963
September 14, 2017 |
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Cathena™ Safety IV Catheter
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital |
| Predicate
Device
(BD Insyte
Autoguard BC) | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Insyte™ Autoguard™ BC
K110443
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital |
| Predicate
Device
(Introcan Safety
3) | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | Introcan Safety® 3 Closed IV Catheter
K111236
Peripheral Intravascular or IV Catheter
21 CFR §880.5200
Intravascular Catheter
II
FOZ
General Hospital |
4
| Reason for
Submission | The purpose of this Traditional 510(k) premarket notification is to notify CDRH of
the introduction of the BD Cathena™ Safety IV Catheter device that has been
demonstrated to be substantially equivalent to the predicate devices listed above. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | BD Cathena™ Safety IV Catheters are over-the-needle, intravascular 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 (24GA (0.7 mm)=Yellow, 22GA (0.9
mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (1.7 mm)=Grey).
These devices are not made with natural rubber latex. |
5
| Indications for Use
(21 CFR §
807.92(a)(5)) | SUBJECT
BD Cathena™ Safety IV
Catheter | PREDICATE
(K110443)
BD Insyte™ Autoguard™
BC | PREDICATE
(K111236)
Introcan Safety® 3 Closed
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 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). | The BD Insyte Autoguard
BC catheter is inserted into
a patient's vascular system
to sample blood, monitor
blood pressure, or
administer fluids. | Introcan Safety 3 Closed
Intravascular Catheter is
inserted into a patient's
vascular system for short
term use (less than 30
days) to sample blood,
monitor blood pressure or
administer fluids and blood
intravascularly.
The 18-22 gauge catheter
may be used with power
injectors at a maximum
pressure of 300 psi with a
luer lock connection only. |
| The subject and predicate devices have the same intended use. Both the subject
and predicate devices are peripheral intravascular catheters intended to be inserted
into the vascular system for short term use to sample blood, monitor blood
pressure, or administer fluids intravenously. Patient population information was
added to the subject device indication for use to clarify the patient population for
which these devices can be used. The power injection pressure was also increased
to 325psi to align with current power injector capabilities. The differences between
the subject and predicate devices' indications for use do not change the intended
use and do not raise different questions of safety and effectiveness. | | | |
| Technological
Characteristics | | Technological characteristics of the subject and predicate devices are substantially
equivalent with respect to the device design and materials. The subject
BD Cathena™ Safety IV Catheter achieves its intended use based on the same
technology and principles of operation as the predicate BD Insyte™ Autoguard™
BC and Introcan Safety® 3 Closed IV Catheter, respectively. | |
| A comparison of the subject and predicate device technological characteristics is
provided in the table below. | | | |
| Attribute | SUBJECT
BD Cathena™ Safety IV
Catheter | PREDICATE
(K110443)
BD Insyte™ Autoguard™ BC | PREDICATE
(K111236)
Introcan Safety® 3 Closed IV
Catheter |
| | 21 CFR 8880-5200 | 21 CFR 8880.5200 | 21 CFR 8880.5200 |
| Technology | passive needlestick safety
mechanism and a multi-use
blood control septum.
Incorporates BD Instaflash™
technology to assist with
flashback visualization. | active needlestick safety
mechanism and a one-time
use blood control septum.
Incorporates BD Instaflash™
technology to assist with
flashback visualization. | passive needlestick safety
mechanism and a multi-use
blood control septum.
Incorporates catheter
flashback technology to assist
with flashback visualization. |
| | Safety Shield
Polystyrene | Barrel
Polypropylene or
Polycarbonate | |
| Primary | Grip / Needle Hub
Polypropylene | Needle Hub
Polycarbonate | |
| Device
Components
/ Materials | Needle
Stainless Steel | Needle
Stainless Steel | Unknown |
| | Catheter Adapter
Polypropylene | Catheter Adapter
Polypropylene | |
| | Catheter Tubing
Polyurethane with radiopaque
barium sulfate | Catheter Tubing
Polyurethane with radiopaque
barium sulfate | |
| | Catheter Diameters | Catheter Diameters | Catheter Diameters |
| Catheter | 16 G, 18 G, 20 G, 22 G, 24 G
Catheter Lengths | 16G, 18 G, 20 G, 22 G, 24 G
Catheter Lengths | 18 G, 20 G, 22 G, 24 G
Catheter Lengths |
| Dimensions | 0.75 IN, 1.00 IN, 1.25 IN, 1.75
IN, 2.00 IN | 0.75 IN, 1.00 IN, 1.16 IN, 1.77
IN, 1.88 IN | 0.75 IN, 1.00 IN, 1.25 IN, 1.75
IN |
6
Summary of Performance tests completed on the subject device were those tests required to Performance support a determination of substantial equivalence to the predicate devices. Tests Design verification tests were performed based on the risk analysis. Results of these tests demonstrate that the BD Cathena™ Safety IV Catheter is substantially equivalent to the predicate devices. Design verification testing included the following:
- Package maintains integrity ●
- Needle cover does not fall off
- Force to remove needle cover
- Incremental force to decouple shielded needle from catheter adapter ● during safety activation
- System penetration force
- Needle to needle hub pull force
- Time to visualize flashback in flash chamber ●
- Catheter average drag force ●
- Force to break adhesion between catheter unit and needle (initial ● adhesion)
- Force to remove needle from catheter unit (average system drag)
- Force to prematurely decouple tip-shield from adapter ●
- Needle is not re-exposed upon application of compressive force .
- . Tensile force to defeat safety system
7
- No air leakage from device in a connected state at low pressure less than ● 30 psi
- Device burst pressure ●
- Catheter separation force
- Blood escape time ●
- . Force to connect Luer to catheter adapter
- Time to visualize flashback in catheter adapter
Standards Compliance
- Gauging (ISO 594-1) ●
- Liquid leakage (ISO 594-1,-2, ISO 10555-1) ●
- Air leakage (ISO 594-1,-2) .
- Separation force (ISO 594-1.-2) ●
- Stress cracking (ISO 594-2)
- Unscrewing torque (ISO 594-2)
- Ease of assembly (ISO 594-2) ●
- Resistance to overriding (ISO 594-2) ●
- Radio detectability (ISO 10555-1)
- Surface (ISO 10555-1. -5) ●
- . Corrosion resistance (ISO 10555-1)
- Peak tensile force (ISO 10555-1) ●
- Flow rate (ISO 10555-1)
- Power injection (ISO 10555-1) ●
- Distal tip (ISO 105551-1) ●
- Needle point (ISO 10555-5)
- Strength of union between needle hub and needle tube (ISO 10555-5)
- Vent fitting (ISO 10555-1) ●
- Activation of the sharps injury protection feature (ISO 23908)
- Security of safe mode protection (ISO 23908) ●
In addition, biocompatibility testing was conducted on the BD Cathena™ Safety IV Catheters in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. Testing included cytotoxicity, sensitization, intracutaneous reactivity, acute svstemic toxicity, subchronic toxicity (subacute toxicity), genotoxicity, implantation, and haemocompatibility. Additionally, material-mediated pyrogenicity was also performed.
Simulated clinical use testing was performed on the device, per FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1:2015 Medical devices - Part 1:Application of usability engineering to medical devices.
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 devices.
Summary of Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Cathena™ Safety IV Catheters have been Substantial Equivalence demonstrated to be substantially equivalent to the predicate devices.