K Number

Device Name

BD Intima II PLUS Closed IV Catheter System

Manufacturer

Becton, Dickinson and Company

Date Cleared

2017-08-17

(27 days)

Product Code

FOZ

Regulation Number

880.5200

Intended Use

The BD Intima II PLUS 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, fluids being infused, and duration of therapy.

Device Description

The BD Intima II PLUS™ Closed IV Catheter System is a closed system IV catheter designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque Vialon™ material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a pinch clamp, extension tubing and Luer connector. The system incorporates an integrated extension set which is available in three configurations: 1) Y Connection (dual port) with PRN adapter and end cap; 2) Y Connection (dual port) with two PRN adapters; and 3) Straight Connection (single port) with PRN adapter. The Luer connector is color-coded to indicate catheter gauge size. The system is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain product sterility during its specified shelf life of 3 years.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K143610

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and material properties of the catheter system, with no mention of AI or ML technologies.

Therapeutic

No.
The device is used for monitoring blood pressure or administering fluids, which are supportive functions, not direct therapeutic interventions aimed at treating a disease or condition.

Diagnostic

The device is used to monitor blood pressure or administer fluids, but not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical medical device consisting of a catheter, needle, tubing, and other hardware components. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

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 short-term use to monitor blood pressure or administer fluids intravascularly." This describes a device used in vivo (within the body) for direct patient care, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor a condition.
Device Description: The description details a catheter system designed for insertion into the vascular system, with components like a catheter, needle, tubing, and connectors. This aligns with an in vivo medical device.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any processes typically associated with in vitro diagnostics.

Therefore, the BD Intima II PLUS Closed IV Catheter System is an in vivo medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FOZ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's 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)

Summary of Performance Tests: Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed modifications to the subject devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were identified to ensure that specified design requirements were met:

Extension Tubing / Catheter Adapter Pull Force
Extension Tubing / Catheter Adapter Joint Leakage Pressure
Extension Tubing Pull Out Force
Clamp Seal Pressure
Package Integrity

In addition, the following biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process:

Cytotoxicity
Sensitization
Intracutaneous Reactivity
Systemic Toxicity (Acute)
Haemocompatibility
Pyrogenicity (Material-Mediated Rabbit Pyrogen)

Finally, particulate analysis of the surface and fluid path was conducted.

Key Results: Per the 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)

K143610

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2017

Becton, Dickinson and Company % Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K172204

Trade/Device Name: BD Intima II PLUS Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: July 19, 2017 Received: July 21, 2017

Dear Mark Job:

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.

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 devicerelated 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 Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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.

Tara A. Ryan -S

for

Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

Device Name

BD Intima II PLUS Closed IV Catheter System

Indications for Use (Describe)

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)

|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.

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K172204 510(k) Summary

21 CFR §807.92

BD Intima II PLUS™ Closed IV Catheter System

| Submitter

Information	Submitter Name:	Becton Dickinson Infusion Therapy Systems Inc.
	Submitter Address:	9450 South State Street
Sandy, UT 84070
	Contact Person:	Henry Boland
Staff Regulatory Affairs Specialist
henry.boland@bd.com
(801) 565-2550 (phone)
	Date of Preparation:	June 30, 2017
Subject Device	Trade Name:	BD Intima II PLUS™ Closed IV Catheter System
	Common Name:	Peripheral Intravascular or IV Catheter
	Regulation Number:	21 CFR §880.5200
	Regulation Name:	Intravascular Catheter
	Regulatory Class:	II
	Product Code:	FOZ
	Classification Panel:	General Hospital
Predicate
Device	Trade Name:	BD Intima II™ Closed IV Catheter System
	510(k) Reference:	K143610
	Common Name:	Peripheral Intravascular or IV Catheter
	Regulation Number:	21 CFR §880.5200
	Regulation Name:	Intravascular Catheter
	Regulatory Class:	II
	Product Code:	FOZ
	Classification Panel:	General Hospital
Reason for
Submission	The reason for his submission is to notify CDRH of modifications to the BD Intima II™ Closed IV Catheter System, including: 1) a change to extension tubing and PRN shrink wrap band from PVC to non-PVC materials; 2) the removal of the slide clamp option (only a pinch clamp option will be available); 3) the addition of new Y connection (dual port) with dual PRN adapter configurations; 4) the addition 0.56" length catheter configurations.
Device
Description	The BD Intima II PLUS™ Closed IV Catheter System is a closed system IV catheter designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque Vialon™ material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a pinch clamp, extension tubing and Luer connector. The system incorporates an integrated extension set which is available in three configurations: 1) Y Connection (dual port) with PRN adapter and end cap; 2) Y Connection (dual port) with two PRN adapters; and 3) Straight Connection (single port) with PRN adapter. The Luer connector is color-coded to indicate catheter gauge size. The system is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain
	SUBJECT DEVICE	PREDICATE DEVICE (K143610)
Indications for
Use
(21 CFR
§807.92(a)(5))	The subject device Indications for Use is the same as the predicate BD Intima II
Closed IV Catheter System (K143610), with the exception of the device trade
name. As such, the differences between the subject and predicate device
Indications for Use do not change the intended use of the predicate devices or
raise different questions of safety and effectiveness.
product sterility during its specified shelf life of 3 years.

SUBJECT DEVICE	PREDICATE DEVICE (K143610)
The BD Intima II PLUS™ 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.	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 substantially equivalent to Characteristics the predicate device. The subject BD Intima II PLUS™ Closed IV Cather System achieves its intended use based on the same technology and principles of operation as the predicate BD Intima IITM Closed IV Cather System. The subject device has been modified from the predicate device 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 Extension Tubing and PRN Shrink Wrap Band materials from PVC to non-PVC materials
· Removal of slide clamp component (only pinch clamp provided)
· Qualification of new product configurations:
- o Y Connection (dual port) with two pre-attached PRN adapters
  - o 0.56" length catheter configuration

Attribute	SUBJECT DEVICE	PREDICATE DEVICE (K143610)
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	PREDICATE DEVICE
	Catheter Tubing	BD Vialon™ Polyurethane
	Catheter Tipping Lubricant	Silicone
	Catheter Lubricant	Silicone
	Metal Wedge	Stainless Steel
	Y-Adapter	Propionate
	Septum/Sleeve Stopper	Polyisoprene
	Needle	Stainless Steel

	Needle Cover	Same as predicate	Polyethylene
	Extension Tubing	Thermoplastic Polyurethane	Polyvinyl Chloride
	Pinch Clamp	Same as predicate	Polyoxymethylene
	Slide Clamp	No slide clamp option	Polystyrene
	Luer Connection Site	Same as predicate	Polypropylene
	PRN Body	Same as predicate	Polycarbonate
	PRN Injection Port	Same as predicate	Polyisoprene
	PRN Shrink Wrap Band	Polyethylene Terephthalate	Polyvinyl Chloride
	Cap	Same as predicate	Acrylonitrile Butadiene Styrene
	Extension Tubing Adhesive	Same as predicate	UV-Cured Epoxy
	Needle Adhesive	Same as predicate	UV-Cured Epoxy
	Septum Adhesive	Same as predicate	UV-Cured Epoxy
	Paddle Hub	Same as predicate	Polystyrene
Physical /
Mechanical
Specifications	SUBJECT DEVICE		PREDICATE DEVICE
	Catheter Diameters
18G, 20G, 22G, 24G
1.16"	Catheter Lengths
0.56", 0.75", 1.00",	Catheter Diameters
Catheter Lengths
18G, 20G, 22G, 24G
0.75", 1.00", 1.16"
Product
Configurations	• Y Connection (dual port) with PRN
adapter and end cap
• Y Connection (dual port) with two PRN
adapters
• Straight Connection (single port) with
PRN adapter		• Y Connection (dual port) with PRN adapter
and end cap
• Straight Connection (single port) with PRN
adapter

Summary of Performance tests completed on the subject device were limited to those tests Performance required to support a determination of substantial equivalence to the predicate devices. A risk analysis was conducted to assess the impact of the proposed Tests modifications to the subject devices. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were identified to ensure that specified design requirements were met:

Extension Tubing / Catheter Adapter Pull Force .
. Extension Tubing / Catheter Adapter Joint Leakage Pressure
Extension Tubing Pull Out Force .
Clamp Seal Pressure ●
Package Integrity .

. Cytotoxicity
Sensitization .
. Intracutaneous Reactivity
Systemic Toxicity (Acute) .
. Haemocompatibility

		Pyrogenicity (Material-Mediated Rabbit Pyrogen)
--	--	-------------------------------------------------	--

Finally, particulate analysis of the surface and fluid path was conducted.

Per the 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
Substantial
Equivalence | Based on the indications for use, technological characteristics, and performance
testing, the subject BD Intima II PLUS™ Closed IV Catheter meets all pre-
determined requirements in accordance with 21 CFR §820.30, Design Controls,
and demonstrates that the subject device is substantially equivalent to the
predicate BD Intima II™ Closed IV Catheter System. |

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