The BD Intima II IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.

Device Description

The Intima II IV Catheter consists of a Vialon® material catheter, a notched needle to enhance flashback visualization, septum, extension tubing and either a straight or Y Luer connector. A needle-accessed PRN is attached to the Luer connector. An end cap is attached to the second Luer connector on the Y design. Blood is contained within the device. A slide clamp is provided on the extension tube. A notched needle resides within the catheter until it is withdrawn through the septum after the catheter has been threaded into the vein. The needle unit includes a paddle that is held during the insertion process. This device does not include a needle-shielding mechanism.

AI/ML Overview

The provided 510(k) summary for the BD Intima II™ IV Catheter (K100775) describes non-clinical tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting with defined performance metrics for AI.

Therefore, the requested information elements related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to this document. This submission focuses on traditional medical device testing for safety and effectiveness.

However, I can extract information regarding the non-clinical test results which serve as the "acceptance criteria" and "reported device performance" in the context of this traditional device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BD Intima II™ IV Catheter are based on compliance with various ISO standards and in-house protocols. The reported device performance is indicated by "Passed" for each test.

Test	Test Method	Acceptance Criteria (Implied by Standard Compliance)	Reported Device Performance
Cytotoxicity	ISO 10993-5	Conformance to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity). This standard specifies methods to assess the in vitro cytotoxicity of medical devices. The implied acceptance criterion is no cytotoxic effect beyond acceptable limits, as defined by the standard.	Passed
Sensitization	ISO 10993-10	Conformance to ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). This standard specifies tests for the assessment of irritation and skin sensitization potential of medical devices. The implied acceptance criterion is no significant sensitization reaction beyond acceptable limits.	Passed
Irritation or Intracutaneous Reactivity	ISO 10993-10	Conformance to ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). This standard specifies tests for the assessment of irritation and skin sensitization potential of medical devices, including intracutaneous reactivity. The implied acceptance criterion is no significant irritation or intracutaneous reactivity beyond acceptable limits.	Passed
Acute Systemic Toxicity	ISO 10993-11	Conformance to ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity). This standard specifies procedures for the assessment of systemic toxicity produced by medical devices. The implied acceptance criterion is no acute systemic toxic effects beyond acceptable limits.	Passed
Subacute or Subchronic Toxicity	ISO 10993-11	Conformance to ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity). This standard specifies procedures for the assessment of systemic toxicity produced by medical devices, including subacute/subchronic effects. The implied acceptance criterion is no subacute or subchronic systemic toxic effects beyond acceptable limits.	Passed
Genotoxicity	ISO 10993-3	Conformance to ISO 10993-3 (Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity). This standard covers the assessment of genotoxic potential. The implied acceptance criterion is no genotoxic effects beyond acceptable limits.	Passed
Implantation	ISO 10993-6	Conformance to ISO 10993-6 (Biological evaluation of medical devices - Part 6: Tests for local effects after implantation). This standard specifies methods for the assessment of local tissue responses to medical devices after implantation. The implied acceptance criterion is an acceptable local tissue response.	Passed
Hemocompatibility	ISO 10993-4	Conformance to ISO 10993-4 (Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood). This standard provides guidance for assessing the interaction of medical devices with blood. The implied acceptance criterion is no adverse interactions with blood that would lead to safety concerns.	Passed
Biocompatibility (overall)	ISO 10993-1	Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) and FDA Blue Book Memorandum #G95-1. The implied acceptance criterion is that the device material is biologically safe for its intended use.	Passed (Overall Statement)
Distal end configuration	ISO 10555-5	Conformance to ISO 10555-5 (Sterile, single-use intravascular catheters - Part 5: Peripheral intravascular catheters). This standard covers various physical characteristics of these catheters, including distal end configuration. The implied acceptance criterion is that the configuration meets the specified requirements of the standard.	Determined substantially equivalent
Minimum catheter/adapter bond strength	In-house protocol	Demonstrated bond strength comparable or superior to the predicate devices and sufficient for safe use. (Specific values not provided in summary).	Determined substantially equivalent
Maximum cannula penetration force	In-house protocol	Penetration force comparable or superior to the predicate devices, ensuring ease of insertion without excessive force/damage. (Specific values not provided in summary).	Determined substantially equivalent
Maximum catheter tip penetration	In-house protocol	Tip penetration characteristics comparable or superior to predicate devices, ensuring proper and safe insertion. (Specific values not provided in summary).	Determined substantially equivalent
Maximum catheter drag	In-house protocol	Catheter drag force comparable or superior to predicate devices, ensuring smooth insertion and removal. (Specific values not provided in summary).	Determined substantially equivalent
Luer Lock fittings	ISO 594/2	Conformance to ISO 594-2 (Conical fittings with 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock fittings). This ensures proper and secure connection with other Luer fittings. The acceptance criterion is compliance with the dimensional and performance requirements of this standard.	Conformed with all sections
General Requirements for Catheters	ISO 10555-1	Conformance to ISO 10555-1 (Sterile, single-use intravascular catheters -. Part 1 General Requirements). This standard specifies general requirements for single-use intravascular catheters. The acceptance criterion is compliance with all sections of this standard.	Conformed with all sections
Shelf Life (Stability)	In-house protocol	The device must maintain its safety and effectiveness characteristics over a specified period. The acceptance criterion is demonstration of these characteristics for the claimed shelf life.	Supported a shelf life of 3 years

Study Details (Relevant to this Traditional Device Submission)

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of catheters tested for bond strength). It refers to "in-house protocol" for some tests and specifies compliance with ISO standards, which typically outline sample size requirements, but the specifics are not detailed in this summary.
- All data provenance is in vitro or in vivo animal testing (for biocompatibility components like implantation, sensitization), conducted by the submitting company (Becton Dickinson Infusion Therapy Systems Inc.) or their contracted labs. This is not human clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this non-clinical submission. "Ground truth" in this context is defined by objective measurements against established international standards (ISO) and internal protocols. Expert opinion is not used to establish truth for these performance metrics.
Adjudication method for the test set:
- Not applicable. Results are typically based on quantitative measurements and pass/fail criteria defined by the test methods and standards, not human adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a non-clinical submission for a physical medical device, not an AI software.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
The type of ground truth used:
- The "ground truth" for the non-clinical tests is established by objective measurements against the specified requirements and methodologies of international standards (ISO) and validated in-house protocols. For biocompatibility, this includes biological responses observed in in vitro or in vivo models according to the relevant ISO 10993 parts.
The sample size for the training set:
- Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established:
- Not applicable. This is not an AI algorithm.

Conclusion:

The BD Intima II™ IV Catheter's substantial equivalence was demonstrated through non-clinical testing against established physical, chemical, and biological performance standards (primarily ISO standards) and validated in-house protocols. All enumerated tests "Passed" or were "Determined substantially equivalent," indicating that the device meets the defined acceptance criteria for safety and effectiveness in a non-clinical context. No clinical studies or AI-related evaluations were conducted or are relevant to this 510(k) submission.

Summary

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K100775 p. lot 3

Becton Dickinson Infusion Therapy Systems Inc. Sandy UT 84070

	BD Intima II™ IV Catheter510(k) Summary
Submitter:	Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070	JUN - 3 2010
Contact person:	Jane Stickel, Director, Regulatory Affairs
Telephone number:	(801) 565-2686
FAX number:	(801) 565-2749
Date summary prepared:	April 9, 2010
Trade name:	BD Intima II™ IV Catheter
Common name:	Peripheral Intravascular Catheter or IV Catheter
Classification name:	Intravascular Catheter 21 CFR § 880.5200
Panel and product code:	80FOZ
Predicate devices:	BD Intima™ Catheter System K833657BD Insvte-N ™ IV Catheter K843033

Product description:

Catalog Number	Product Description
383400	18G x 1.16" (1.3mm x 30mm) Straight luer connection site
383401	20G x 1.16" (1.1mm x 30mm) Straight luer connection site
383402	22G x 1.00" (0.9mm x 25mm) Straight luer connection site
383403	24G x 0.75" (0.7mm x 19mm) Straight luer connection site
383404	22G x 0.75" (0.9mm x 19mm) Straight luer connection site
383405	18G x 1.16" (1.3mm x 30mm) Y luer connection site
383406	20G x 1.16" (1.1mm x 30mm) Y luer connection site
383407	22G x 1.00" (0.9mm x 25mm) Y luer connection site
383408	24G x 0.75" (0.7mm x 19mm) Y luer connection site
383409	22G x 0.75" (0.9mm x 19mm) Y luer connection site

Indications for Use:

510(k) Summary 4/9/10 rev 3

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K100775 p. 2 of 3

Becton Dickinson Infusion Therapy Systems Inc. Sandy UT 84070

The BD Intima II™ IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.

Nonclinical test results and technological characteristic comparisons submitted to determine substantial equivalence:

The following technological characteristics of the BD Intima II IV Catheter are substantially equivalent per gauge size to the two predicate devices, the BD Insyte IV Catheter and BD Intima Catheter System:

Biocompatibility ISO 10993 Intended use 이
Distal end configuration l according to ISO 10555-5
. Minimum catheter/adapter bond strength
Vialon™ material catheter .
No needle-shielding mechanism
r Gauge sizes color coded
. Maximum cannula penetration force
l Maximum catheter tip penetration
l Maximum catheter drag
. EtO sterilization

Due to product design and/or customer requirements, the following technological characteristics of the BD Intima II IV Catheter differ from the two predicate devices:

1 Effective catheter lengths and gauge sizes
1 Integrated PVC extension tubing with PRN
프 Nominal water flow rate
트 Flexible wings on catheter adapter
1 Notched needle
I Flexible wings on catheter adapter
1 Minimum cannula/cannula hub bond strength
Catheter lie distance ■
Component materials 트

In determining substantial equivalence between the subject and predicate devices, testing was done per in-house protocol and according with the following standards, when applicable:

ISO 10555-1:1995/AMD2:2004 Sterile, single-use intravascular catheters -. Part 1 General Requirements: Testing conformed with all sections of this standard.
ISO 10555-5 Amd 1:1999, Corr 1:2002 Sterile, single-use intravascular 다 catheters - Part 5: Testing conformed to all sections of this standard with the exception of Sections 4.3 and 4.4.4. Section 4.3 relates to the identification

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K100775 p. 3 of 3

Becton Dickinson Infusion Therapy Systems Inc. Sandy UT 84070

of lumens on a multilumen catheter and does not apply to the Intima II device since it is a single lumen catheter. Section 4.4.4 states that a vent fitting shall be provided. This requirement does not apply to the Intima II device since it is vented via a notch in the needle cannula, not a vent fitting.

ISO 594/2:1998 Conical fittings with 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2 Lock fittings: Testing conformed with all sections of this standard.
The initial biocompatibility testing of the intima II device conformed to ISO 10993 Part 1:1992 and revisions (1997), and FDA Blue Book Memorandum #G95-1 pertaining to the selection of tests and overall assessment. Various sub-parts of the ISO 10993 standard are updated on independent cycles. To address these changes to the ISO standards, all internal protocols and methods are reviewed and updated as necessary to ensure continued compliance with the standard. Additional testing is performed in the case of significant changes to the standard which may have the potential to impact the test results. In the case of the lintima Which may nave nave parts which were re-issued in 2009 (e.g. 10993 Part 1, Part 3, and Part 5) have been addressed and the product remains in compliance with these requirements.

Test	Test Method	Results
Cytotoxicity	ISO 10993-5	Passed
Sensitization	ISO 10993-10	Passed
Irritation or Intracutaneous Reactivity -	ISO 10993-10	Passed
Acute Systemic Toxicity	ISO 10993-11	Passed
Subacute or Subchronic Toxicity	ISO 10993-11	Passed
Genotoxicity	ISO 10993-3	Passed
Implantation	ISO 10993-6	Passed
Hemocompatibility	ISO 10993-4	Passed

The stability test report included in the 510(k) submission supports a shelf life of 3 years.

Clinical tests submitted:

No clinical test results were included in this submission.

Conclusions drawn from nonclinical tests to demonstrate that the device is safe and effective as the legally marketed devices:

Performance testing was conducted in accordance with consensus standards and design control requirements. Nonclinical test results and technological and dosign control require size catheters were shown to be equivalent between the subject device and the two predicate devices. The differences among the subject do not raise any new issues of safety or effectiveness. Refer to the two actious tables for the testing conducted to determine substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that appears to represent a person or family.

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

Becton Dickinson Infusion Therapy Systems Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

JUN - 3 2010

Re: K100775

Trade/Device Name: BD Intima IITM Closed IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 21, 2010 Received: May 24, 2010

Dear Mr. 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.

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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Page 2-Mr. Mark Job

" 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

timper WDEr

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	Becton Dickinson Infusion Therapy Systems Inc.
	Sandy, UT 84070

INDICATIONS FOR USE

Device Name:	Intima II™ IV Catheter
Indications for Use:

The BD Intima II IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.

Prescription Use:	X	AND/OR	Over-the-Counter Use:
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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _______

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

510(k) Number	K100775
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のお気になるということです。

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).