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 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.

AI/ML Overview

This document describes the BD Intima II™ Closed IV Catheter System and compares it to a predicate device, also named BD Intima II™ Closed IV Catheter System (K100775). The key takeaway is that the new device is a modified version of the predicate device, specifically regarding some adhesives, lubricants, and the addition of a new pinch clamp option. Because this document focuses on establishing substantial equivalence to another device and the described modifications are minor, the "study" referred to is a series of design verification tests, not a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Characteristic / Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meets ISO 10993	Pass
Needle/Paddle Hub Pull Force	Meets predicate's performance	Pass
Catheter/Catheter Adaptor Pull Force	Meets predicate's performance	Pass
Extension Tubing/Catheter Adapter Pull Force	Meets predicate's performance	Pass
Septum Burst Test	Meets predicate's performance	Pass
Catheter Burst Test	Meets predicate's performance	Pass

Note: The document states "Same Methodology as Predicate" for most tests, implying the acceptance criteria would be to perform equivalently to the predicate device, or meet established internal specifications derived from the predicate's performance.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test. It refers to "design verification tests" without providing details on the number of units tested. The data provenance is internal design verification data from Becton Dickinson Infusion Therapy Systems Inc. (USA), for modifications made to an existing device. It is retrospective in the sense that it's comparing a new version to an existing design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The "ground truth" for a medical device such as an IV catheter is typically established through established engineering principles, international standards (like ISO 10993 for biocompatibility), and internal quality control specifications. These are objective measures, not subjective interpretations by experts in the same way clinical diagnoses would be.

4. Adjudication method for the test set

Not applicable. The tests are objective and quantitative (e.g., Pass for biocompatibility, pull force tests). There's no subjective interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an IV catheter, a physical medical device, not an AI-powered diagnostic or decision support system that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The ground truth used for these tests is based on:

Engineering specifications and performance characteristics of the predicate device.
International standards (e.g., ISO 10993 for biocompatibility).
Internal quality control and design requirements for medical devices.
Objective physical and chemical properties.

8. The sample size for the training set

Not applicable. This device does not use an AI model or machine learning, therefore there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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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)

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."

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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

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510(k) Summary

21 CFR §807.92

BD Intima IITM Closed IV Catheter System

SubmitterInformation	Submitter Name:Submitter Address:Contact Person:Date of Preparation:	Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070John RobertsRegulatory Affairs ManagerPhone: 801.565.2673Fax: 801.304.3963Email: john_w_roberts@bd.com9 April 2015
SubjectDevices	Trade Name:Common Name:Classification Name:CFR Reference:Classification Panel:	BD Intima IITM Closed IV Catheter SystemPeripheral Intravascular or IV CatheterFOZ - Intravascular Catheter21 CFR 880.5200 - Class IIGeneral Hospital
PredicateDevices	Trade Name:510(k) Reference:Common Name:Classification Name:CFR Reference:Classification Panel:	BD Intima IITM Closed IV Catheter SystemK100775Peripheral Intravascular or IV CatheterFOZ - Intravascular Catheter21 CFR 880.5200 - Class IIGeneral Hospital
DeviceDescription	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 devicethroughout the insertion process. The system consists of a radiopaque VialonTMmaterial catheter, a notched needle for flashback visualization, a septum toremove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp),extension tubing and Luer connector. It incorporates an integrated extension setwhich is available in two configurations: Y Connection (dual port) and StraightConnection (single port). The Luer connector is color-coded to indicate cathetergauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of10-6. The package system is able to maintain the sterility during its specified shelflife of 3 years.

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Indications forUse	The BD Intima II Closed IV Catheter System is inserted into a patient's vascularsystem for short-term use to monitor blood pressure or administer fluidsintravascularly. These devices may be used for any patient population withconsideration given to adequacy of vascular anatomy, procedure beingperformed, fluids being infused, and duration of therapy.
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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
Indicationsfor Use	BD Intima II TM Closed IV CatheterSystem is inserted into a patient'svascular system for short-term use tomonitor blood pressure or administerfluids intravascularly.	BD Intima II TM Closed IV CatheterSystem is inserted into a patient'svascular system for short-term use tomonitor blood pressure or administerfluids intravascularly.
Design	A single-winged, polyurethane IVCatheter with an integrated extensionset incorporating either a single portor Y (dual)-port injection site.Incorporates BD Instaflash technologyto assist with flashback visualization	A single-winged, polyurethane IVCatheter with an integrated extensionset incorporating either a single port orY (dual)-port injection site. IncorporatesBD Instaflash technology to assist withflashback visualization
Materials	Component	Subject Device	Predicate Device
	Catheter Tubing	BD Vialon	BD Vialon
	Catheter TippingLubricant	Silicone	Silicone
	Catheter Lubricant	Silicone	Silicone
	Metal Wedge	Stainless Steel	Stainless Steel
	Y-Adapter	Propionate	Propionate
	Septum/SleeveStopper	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 WrapBand	Polyvinyl Chloride	Polyvinyl Chloride
	Cap	Acrylonitrile ButadieneStyrene	Acrylonitrile ButadieneStyrene
	Extension TubingAdhesive	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 /MechanicalSpecifications	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 / TestPerformed	Test Method	Results
Biocompatibility	Per ISO 10993	Pass
Needle/Paddle Hub Pull Force	Same Methodology as Predicate	Pass
Catheter/Catheter AdaptorPull Force	Same Methodology as Predicate	Pass
Extension Tubing/CatheterAdapter 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.

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).