BD INTIMA II CLOSED IV CATHETER
Device Facts
| Record ID | K143610 |
|---|---|
| Device Name | BD INTIMA II CLOSED IV CATHETER |
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Apr 9, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Closed IV catheter system; designed to contain blood during insertion. Components: radiopaque Vialon catheter, notched needle for flashback visualization (BD Instaflash), septum, clamp (slide or pinch), extension tubing, Luer connector. Configurations: Y-connection (dual port) or straight (single port). Used in clinical settings for short-term vascular access; operated by healthcare professionals. Device facilitates fluid administration or blood pressure monitoring. Benefits: reduced blood exposure during insertion via closed system design.
Clinical Evidence
Bench testing only. No clinical data provided. Design verification included biocompatibility per ISO 10993, pull force testing (needle/paddle hub, catheter/adaptor, extension tubing), and burst testing (septum, catheter). All tests passed.
Technological Characteristics
Radiopaque Vialon catheter; stainless steel needle; polyisoprene septum; PVC extension tubing; polycarbonate PRN body. Sterilized via EO (SAL 10^-6). Integrated extension set with single or Y-port. Color-coded Luer connectors. Mechanical design includes BD Instaflash technology for flashback visualization. No software or electronic components.
Indications for Use
Indicated for any patient requiring short-term vascular access for blood pressure monitoring or fluid administration, contingent upon vascular anatomy, procedure, and therapy duration.
Regulatory Classification
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.
Predicate Devices
- BD Intima IITM Closed IV Catheter System (K100775)
Submission Summary (Full Text)
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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.
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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
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# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143610
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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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<br>Information | Submitter Name:<br>Submitter Address:<br><br>Contact Person:<br><br><br><br>Date of Preparation: | Becton Dickinson Infusion Therapy Systems Inc.<br>9450 South State Street<br>Sandy, UT 84070<br><br>John Roberts<br>Regulatory Affairs Manager<br>Phone: 801.565.2673<br>Fax: 801.304.3963<br>Email: john_w_roberts@bd.com<br><br>9 April 2015 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Devices | Trade Name:<br>Common Name:<br>Classification Name:<br>CFR Reference:<br>Classification Panel: | BD Intima IITM Closed IV Catheter System<br>Peripheral Intravascular or IV Catheter<br>FOZ - Intravascular Catheter<br>21 CFR 880.5200 - Class II<br>General Hospital |
| Predicate<br>Devices | Trade Name:<br>510(k) Reference:<br>Common Name:<br>Classification Name:<br>CFR Reference:<br>Classification Panel: | BD Intima IITM Closed IV Catheter System<br>K100775<br>Peripheral Intravascular or IV Catheter<br>FOZ - Intravascular Catheter<br>21 CFR 880.5200 - Class II<br>General Hospital |
| Device<br>Description | The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter.<br>The closed system is designed to keep blood contained within the device<br>throughout the insertion process. The system consists of a radiopaque VialonTM<br>material catheter, a notched needle for flashback visualization, a septum to<br>remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp),<br>extension tubing and Luer connector. It incorporates an integrated extension set<br>which is available in two configurations: Y Connection (dual port) and Straight<br>Connection (single port). The Luer connector is color-coded to indicate catheter<br>gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of<br>10-6. The package system is able to maintain the sterility during its specified shelf<br>life of 3 years. | |
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| Indications for<br>Use | The BD Intima II Closed IV Catheter System is inserted into a patient's vascular<br>system for short-term use to monitor blood pressure or administer fluids<br>intravascularly. These devices may be used for any patient population with<br>consideration given to adequacy of vascular anatomy, procedure being<br>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<br>for Use | BD Intima II TM Closed IV Catheter<br>System is inserted into a patient's<br>vascular system for short-term use to<br>monitor blood pressure or administer<br>fluids intravascularly. | BD Intima II TM Closed IV Catheter<br>System is inserted into a patient's<br>vascular system for short-term use to<br>monitor blood pressure or administer<br>fluids intravascularly. | |
| Design | A single-winged, polyurethane IV<br>Catheter with an integrated extension<br>set incorporating either a single port<br>or Y (dual)-port injection site.<br>Incorporates BD Instaflash technology<br>to assist with flashback visualization | A single-winged, polyurethane IV<br>Catheter with an integrated extension<br>set incorporating either a single port or<br>Y (dual)-port injection site. Incorporates<br>BD Instaflash technology to assist with<br>flashback visualization | |
| Materials | Component | Subject Device | Predicate Device |
| | Catheter Tubing | BD Vialon | BD Vialon |
| | Catheter Tipping<br>Lubricant | Silicone | Silicone |
| | Catheter Lubricant | Silicone | Silicone |
| | Metal Wedge | Stainless Steel | Stainless Steel |
| | Y-Adapter | Propionate | Propionate |
| | Septum/Sleeve<br>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 | |
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| | PRN Injection Port | Polyisoprene | Polyisoprene | |
|--------------------------------------------|------------------------------|------------------------------------|------------------------------------|--|
| | PRN Shrink Wrap<br>Band | Polyvinyl Chloride | Polyvinyl Chloride | |
| | Cap | Acrylonitrile Butadiene<br>Styrene | Acrylonitrile Butadiene<br>Styrene | |
| | Extension Tubing<br>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 /<br>Mechanical<br>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<br>Performed | Test Method | Results |
|-------------------------------------------------|-------------------------------|---------|
| Biocompatibility | Per ISO 10993 | Pass |
| Needle/Paddle Hub Pull Force | Same Methodology as Predicate | Pass |
| Catheter/Catheter Adaptor<br>Pull Force | Same Methodology as Predicate | Pass |
| Extension Tubing/Catheter<br>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.
