(30 days)
Not Found
No
The description focuses on mechanical and material properties of the catheter and needle, with no mention of computational analysis, algorithms, or learning capabilities.
No
The device is an IV catheter used for administering fluids, sampling blood, or monitoring blood pressure. While it facilitates the delivery of therapeutic agents, it is not a therapeutic device itself but rather a delivery system.
No
The device is an IV catheter used for sampling blood, monitoring blood pressure, or administering fluids, which are clinical interventions, not diagnostic processes. While it can "sample blood," the device itself does not analyze the blood to determine a diagnosis.
No
The device description clearly outlines physical components like a catheter, needle, grip, shield, and flash chamber, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
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.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a physical catheter inserted into a vein, not a device for analyzing samples in a lab.
The device is a medical device used for direct patient care, not for laboratory testing of samples.
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 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 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 cather direction.
These devices are available with or without wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.3 mm) = Green, 16 GA (1.7 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
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
Performance tests completed on the subject device were limited 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:
· Testing per ISO 10555-1:2013 o Gravity Flow Rate
Key Metrics
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).
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Becton Dickinson Infusion Therapy Systems Inc. Paul Holman Regulatory Affairs Specialist 9450 South State Street Sandy, Utah 84070
March 31, 2022
Re: K220584
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: February 28, 2022 Received: March 1, 2022
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.
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
1
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.
Payal Patel 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
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Indications for Use
510(k) Number (if known) K220584
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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510(k) Summarv Prepared on: 2022-02-28 Contact Details 21 CFR 807.92(a)(1) Becton Dickinson Infusion Therapy Systems Inc. Applicant Name Applicant Address 9450 South State Street Sandy UT 84070 United States 8015225132 Applicant Contact Telephone Applicant Contact Mr. Paul Holman Applicant Contact Email paul.holman@bd.com Device Name 21 CFR 807.92(a)(2) BD Cathena™ Safety IV Catheter Device Trade Name Common Name Intravascular catheter
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Classification Name
Requlation Number
Product Code
Predicate #
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
Predicate Trade Name (Primary Predicate is listed first)
BD Cathena™ Safety IV Catheter
880.5200
FOZ
Product Code
FOZ
21 CFR 807 92(a)(4)
Device Description Summary
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters 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 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 cather direction.
These devices are available with or without wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
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).
4
Indications for Use Comparison
21 CFR 807.92(a)(5)
10 Is the predicate device legally marketed? Yes. The predicate device, BD Cathena™ Safety IV Catheter, was cleared under K201717.
& Do the devices have the same intended use? Yes. The subject and predicate devices have the same intended use.
Technological Comparison
@ Do the devices have the same technological characteristics? Yes. The subject and predicate devices have the same technological characteristics.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
A Risk Analysis in accordance with ISO 14971:2019 was conducted to assess the impact of the proposed modifications to the predicate device.
Performance tests completed on the subject device were limited 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:
· Testing per ISO 10555-1:2013 o Gravity Flow Rate
Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Cathena™ Safety W Catheter is substantially equivalent to the predicate device.