(111 days)
Not Found
No
The summary describes a mechanical medical device (IV catheter system) and does not mention any AI or ML components or functionalities.
No
The device is used to administer fluids and monitor blood pressure, which are supportive functions for patient care rather than directly treating a medical condition or disease.
No
The device is used to monitor blood pressure or administer fluids intravascularly, which are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly outlines physical components such as a catheter, needle, septum, clamp, extension tubing, and Luer connector, 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 is to be inserted into a patient's vascular system for monitoring blood pressure or administering fluids intravascularly. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical device (catheter, needle, tubing, etc.) designed for insertion into the vascular system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens outside the body.
Therefore, the BD Intima II Closed IV Catheter System is a medical device used in vivo (within the body), not an IVD.
N/A
Intended Use / Indications for Use
The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, and duration of therapy.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter. The closed system is designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque VialonTM material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp), extension tubing and Luer connector. It incorporates an integrated extension set which is available in two configurations: Y Connection (dual port) and Straight Connection (single port). The Luer connector is color-coded to indicate catheter gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain the sterility during its specified shelf life of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Pursuant to 21 CFR 820.30, Design Controls, design verification tests were performed based on the risk analysis, and the results of these tests demonstrate that the BD Intima II TM Closed IV Catheter System is substantially equivalent manner to the predicate device. Design Verification testing included the following:
Biocompatibility - Per ISO 10993 (Pass)
Needle/Paddle Hub Pull Force - Same Methodology as Predicate (Pass)
Catheter/Catheter Adaptor Pull Force - Same Methodology as Predicate (Pass)
Extension Tubing/Catheter Adapter Pull Force - Same Methodology as Predicate (Pass)
Septum Burst Test - Same Methodology as Predicate (Pass)
Catheter Burst Test - Same Methodology as Predicate (Pass)
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Becton Dickinson Infusion Therapy Systems Inc. Mr. John Roberts Manager, Regulatory Affairs 9450 South State Street Sandy, UT 84070
Re: K143610
Trade/Device Name: BD Intima IITM Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 12, 2015 Received: March 13, 2015
Dear Mr. Roberts:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Division 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143610
Device Name BD Intima II Closed IV Catheter System
Indications for Use (Describe)
The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, and duration of therapy.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street 0406 South State of
Sandy, Utah 84070
USA tel: 801.565.2300
fax: 801.304.3963 www.bd.com
Image /page/3/Picture/1 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized graphic on the left and the letters "BD" on the right. Below the letters, there is a tagline that reads "Helping all people live healthy lives."
510(k) Summary
21 CFR §807.92
BD Intima IITM Closed IV Catheter System
| Submitter
Information | Submitter Name:
Submitter Address:
Contact Person:
Date of Preparation: | Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, UT 84070
John Roberts
Regulatory Affairs Manager
Phone: 801.565.2673
Fax: 801.304.3963
Email: john_w_roberts@bd.com
9 April 2015 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Devices | Trade Name:
Common Name:
Classification Name:
CFR Reference:
Classification Panel: | BD Intima IITM Closed IV Catheter System
Peripheral Intravascular or IV Catheter
FOZ - Intravascular Catheter
21 CFR 880.5200 - Class II
General Hospital |
| Predicate
Devices | Trade Name:
510(k) Reference:
Common Name:
Classification Name:
CFR Reference:
Classification Panel: | BD Intima IITM Closed IV Catheter System
K100775
Peripheral Intravascular or IV Catheter
FOZ - Intravascular Catheter
21 CFR 880.5200 - Class II
General Hospital |
| Device
Description | The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter.
The closed system is designed to keep blood contained within the device
throughout the insertion process. The system consists of a radiopaque VialonTM
material catheter, a notched needle for flashback visualization, a septum to
remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp),
extension tubing and Luer connector. It incorporates an integrated extension set
which is available in two configurations: Y Connection (dual port) and Straight
Connection (single port). The Luer connector is color-coded to indicate catheter
gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of
10-6. The package system is able to maintain the sterility during its specified shelf
life of 3 years. | |
4
| Indications for
Use | The BD Intima II Closed IV Catheter System is inserted into a patient's vascular
system for short-term use to monitor blood pressure or administer fluids
intravascularly. 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. |
| ------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Technological Technological characteristics of the subject device are equivalent to the predicate. Characteristics The BD Intima IITM Closed IV Cather System achieves its intended use based on the same technology and principles of operation. The subject device has been modified from the predicate as listed below. The results of design verification demonstrate that these changes are substantially equivalent to the predicate device. All other aspects of the subject device are identical to those of the predicate device.
· Change to various adhesives and lubricants utilized during assembly
- Qualification of new pinch clamp as alternate to the current slide clamp;
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|---|
| Indications | |||
| for Use | BD Intima II TM Closed IV Catheter | ||
| System is inserted into a patient's | |||
| vascular system for short-term use to | |||
| monitor blood pressure or administer | |||
| fluids intravascularly. | BD Intima II TM Closed IV Catheter | ||
| System is inserted into a patient's | |||
| vascular system for short-term use to | |||
| monitor blood pressure or administer | |||
| fluids intravascularly. | |||
| Design | A single-winged, polyurethane IV | ||
| Catheter with an integrated extension | |||
| set incorporating either a single port | |||
| or Y (dual)-port injection site. | |||
| Incorporates BD Instaflash technology | |||
| to assist with flashback visualization | A single-winged, polyurethane IV | ||
| Catheter with an integrated extension | |||
| set incorporating either a single port or | |||
| Y (dual)-port injection site. Incorporates | |||
| BD Instaflash technology to assist with | |||
| flashback visualization | |||
| Materials | Component | Subject Device | Predicate Device |
| Catheter Tubing | BD Vialon | BD Vialon | |
| Catheter Tipping | |||
| Lubricant | Silicone | Silicone | |
| Catheter Lubricant | Silicone | Silicone | |
| Metal Wedge | Stainless Steel | Stainless Steel | |
| Y-Adapter | Propionate | Propionate | |
| Septum/Sleeve | |||
| Stopper | Polyisoprene | Polyisoprene | |
| Needle | Stainless Steel | Stainless Steel | |
| Needle Cover | Polyethylene | Polyethylene | |
| Extension Tubing | Polyvinyl Chloride | Polyvinyl Chloride | |
| Pinch Clamp | Polyoxymethylene | Not applicable | |
| Slide Clamp | Polystyrene | Polystyrene | |
| Luer Connection Site | Polypropylene | Polypropylene | |
| PRN Body | Polycarbonate | Polycarbonate |
5
| PRN Injection Port | Polyisoprene | Polyisoprene | ||
|---|---|---|---|---|
| PRN Shrink Wrap | ||||
| Band | Polyvinyl Chloride | Polyvinyl Chloride | ||
| Cap | Acrylonitrile Butadiene | |||
| Styrene | Acrylonitrile Butadiene | |||
| Styrene | ||||
| Extension Tubing | ||||
| Adhesive | UV-Cured Epoxy | UV-Cured Epoxy | ||
| Needle Adhesive | UV-Cured Epoxy | 2-Part Epoxy | ||
| Septum Adhesive | UV-Cured Epoxy | UV-Cured Epoxy | ||
| Paddle Hub | Polystyrene | Polystyrene | ||
| SUBJECT DEVICE | PREDICATE DEVICE | |||
| Physical / | ||||
| Mechanical | ||||
| Specifications | Catheter Diameters: | Catheter Diameters: | ||
| 18G, 20G, 22G, 24G | 18G, 20G, 22G, 24G | |||
| Catheter Lengths: | Catheter Lengths: | |||
| 0.75", 1.00", 1.16" | 0.75", 1.00", 1.16" |
Summary of Pursuant to 21 CFR 820.30, Design Controls, design verification tests were Performance performed based on the risk analysis, and the results of these tests demonstrate that the BD Intima II ™ Closed IV Catheter System is substantially equivalent Tests manner to the predicate device. Design Verification testing included the following:
| Characteristic / Test
| Performed | Test Method | Results |
|---|---|---|
| Biocompatibility | Per ISO 10993 | Pass |
| Needle/Paddle Hub Pull Force | Same Methodology as Predicate | Pass |
| Catheter/Catheter Adaptor | ||
| Pull Force | Same Methodology as Predicate | Pass |
| Extension Tubing/Catheter | ||
| Adapter Pull Force | Same Methodology as Predicate | Pass |
| Septum Burst Test | Same Methodology as Predicate | Pass |
| Catheter Burst Test | Same Methodology as Predicate | Pass |
Summary of Based on the indications for use, technological characteristics, and safety and
performance testing, the subject BD Intima II™ Closed IV Catheter meets all Substantial Equivalence predetermined requirements in accordance with 21 CFR 820.30, Design Controls, and demonstrates that the subject device is substantially equivalent to the predicate devices.