The AccuCath™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath™ IV Catheter is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.

Device Description

The AccuCath™ Intravascular Catheter has usable length catheters of 1.25 and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The AccuCath™ IV Catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. The AccuCath™ IV Catheter is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, and a guidewire within the lumen of the needle which is connected to a slider, spring and release button.

AI/ML Overview

The acceptance criteria and study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Effective Length of Catheter	Test and report catheter length	The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device."
Safety Activation	After deployment of the needle safety feature, the needle tip shall be sub-flush with the distal end of the housing	The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device."
Gravity Flow	Test and report gravity flow rate with a 1000mm head pressure of water	The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device."
Bleedback	No egress of blood over a period of 15 seconds	The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device."
Guidewire Deployment/Retraction	Guidewire to deploy and retract smoothly per predetermined force requirements	The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device."
Catheter Flashback	Flash is visible inside the catheter within a predetermined amount of time	The device met the acceptance criteria, as indicated by the statement: "The subject device met all predetermined acceptance criteria... and demonstrated substantially equivalent performance as compared to the cited predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test set. However, it indicates that "Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30." The data provenance is implied to be from in-house testing conducted by Bard Access Systems, Inc., as the tests were performed "in conjunction with in-house protocols." The country of origin of the data is not explicitly stated. It is a prospective study as tests were actively performed to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described appears to be primarily laboratory-based performance testing rather than studies requiring expert interpretation or ground truth establishment based on clinical data.

4. Adjudication Method for the Test Set

This information is not provided in the document, as the described tests are objective performance evaluations rather than judgmental assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes engineering and performance verification tests for the medical device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device (AccuCath™ Intravascular Catheter) is a physical medical device, not an algorithm or AI system. The tests performed are on the physical properties and functionality of the catheter.

7. The Type of Ground Truth Used

For the performance tests conducted, the "ground truth" refers to the established engineering specifications, performance standards (e.g., ISO, ASTM), and in-house protocols by which the device's physical and functional characteristics were objectively measured and compared. It is not an expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device evaluation.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical catheter, not an AI or machine learning model that requires a training set. The "training" in the context of device development would refer to the iterative design and development process, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for this physical medical device. The "ground truth" for the device's design and manufacturing would be established through engineering principles, regulatory standards, and established material science, which guided its development.

Summary

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

December 10, 2015

C.R. Bard, Inc. Mr. Casey Coombs Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K153298

Trade/Device Name: Accucath™ Intravascular Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 12, 2015 Received: November 13, 2015

Dear Mr. Coombs:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 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. 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

510(k) Number (if known) K153298

Device Name AccuCath Intravascular Catheter

Indications for Use (Describe)

The AccuCath Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath IV Catheter is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.

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)

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Image /page/3/Picture/2 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with the "A" stylized as an inverted "V". Below "BARD" is the text "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white.

510(k) Summary

21 CFR 807.92(a)

GeneralProvisions	Submitter Name:	Bard Access Systems, Inc.
	Submitter Address:	605 North 5600 WestSalt Lake City, UT 84116
	Contact Person:	Mr. Casey CoombsRegulatory Affairs Specialist
	Telephone Number:Fax Number:Date of Preparation:	(801) 522-5869(801) 522-54259 December 2015
SubjectDevice	Trade Name:	AccuCath™ Intravascular Catheter
	Common Name:	Intravascular Catheter
	Classification Name:	Intravascular Catheter
	Product Code/Regulation:	FOZ/21 CFR §880.5200
PredicateDevices	Predicate Trade Name:	AccuCath™ BC Intravascular Catheter System
	Classification Name:	Intravascular Catheter
	Premarket Notification:Manufacturer:	K140504Bard Access Systems, Inc.
DeviceDescription	The AccuCath™ Intravascular Catheter has usable length catheters of 1.25and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use,sterile intravascular catheters designed to be inserted into a patient's vascularsystem to sample blood, monitor blood pressure, or administer fluidsintravenously. The AccuCath™ IV Catheter's hub has a built in blood controlseptum. The blood control feature is a single-use septum that automaticallyactivates to stop the blood flow in the catheter hub when the needle isremoved from the catheter during initial insertion by the clinician. Blood flowfrom the catheter hub will be restricted immediately after the needle retractionuntil a secure luer connection is made. The flow path is permanently openedonce a secure luer connection has been made. The AccuCath™ IV Catheteris provided with a safety mechanism which allows the needle to be shieldedfollowing placement of the catheter. All devices have the basic structure of aprotective cover, a catheter with a luer lock fitting, a needle connected to aflashback chamber, a safety container, and a guidewire within the lumen ofthe needle which is connected to a slider, spring and release button.
Intended Use	The AccuCath™ Intravascular Catheter is intended to be inserted in thepatient's vascular system for short term use (less than 30 days) to sampleblood, monitor blood pressure, or administer fluids intravenously.
Indications For Use	The AccuCath™ Intravascular Catheter is inserted into a patient's vascularsystem to sample blood, monitor blood pressure, or administer fluidsintravenously. This device may be used with consideration given to adequacyof vascular anatomy, appropriateness of the solution being infused, andduration of therapy. The AccuCath™ IV Catheter is suitable for use with lowpressure power injectors having a maximum pressure setting of 300 psi andmaximum flow rate of 6mL/second.
	Technological characteristics of the subject AccuCath™ IntravascularCatheter are substantially equivalent with respect to basic design and functionto those of the cited predicate device.
	Key modifications made to the subject device when compared to the predicatedevice are as follows:Dimensional modifications to introduce a 1.25 inch AccuCath™ Intravascular Catheter Modifications to the guidewire and seal components Dimensional modifications to the needle Modifications made to the guidewire, needle, and catheter interfaces Labeling and packaging modifications made due to subject 1.25 inch device, commercial name change, and packaging kit configurations Qualified additional sterilization locations The following table provides a comparison between the subject and predicate device.

TechnologicalCharacteristics	Attribute	Subject Device – AccuCath™Intravascular Catheter	Predicate Device –AccuCath™ BCIntravascular CatheterSystem (K140504)
	Owner	Same	Bard Access Systems, Inc.
	Classification	Same	FOZ - 21 CFR 880.5200 -Short-term - IntravascularCatheter
	510(k) Status	Subject of this PremarketNotification	K140504 - Concurrence dateJuly 17, 2014
	Indications forUse	Same as predicate with theexception of the commercialname:The AccuCath™ IntravascularCatheter is inserted into apatient's vascular system tosample blood, monitor bloodpressure, or administer fluidsintravenously. This device maybe used with consideration givento adequacy of vascularanatomy, appropriateness of thesolution being infused, andduration of therapy. TheAccuCath™ IV Catheter is	The AccuCath™ BCIntravascular Catheter Systemis inserted into a patient'svascular system to sampleblood, monitor blood pressure,or administer fluidsintravenously. This device maybe used with considerationgiven to adequacy of vascularanatomy, appropriateness ofthe solution being infused, andduration of therapy. TheAccuCath™ BC is suitable foruse with low pressure powerinjectors having a maximum
Subject and Predicate Device Comparison Table
	Attribute	Subject Device – AccuCath™ Intravascular Catheter	Predicate Device – AccuCath™ BC Intravascular Catheter System (K140504)
TechnologicalCharacteristics	Commercial Name	AccuCath™ Intravascular Catheter	AccuCath™ BC Intravascular Catheter System
	Catheter Dimensions	Length: 1.25 and 2.25 inchesDiameter: 18, 20, 22 gauge	Length: 2.25 inchesDiameter: 18, 20, 22 gauge
	Duration of Use	Same	Short term (<30 days)
	Primary Device Components	Same	NeedleGuidewireCatheter
	Means of Insertion	Same	Percutaneous, over a Guidewire
	Insertion Site	Same	Peripheral
	Primary Device Materials	Same	Catheter Base Materials• Shaft Tubing:Pebax®• Luer Connector:PolyurethaneNeedle• Stainless SteelGuidewire• Nitinol
	Catheter Proximal Configuration	Same	Luer Connection
	Catheter Distal Configuration	Same	Open Ended
	Number of Lumens	Same	Single Lumen
	Power Injection Maximum Flow Rate	Same	6 mL/s
	Sterility	Same	Provided Sterile
	Packaging Configurations	Standalone ConfigurationBasic ConfigurationIntermediate Configuration	Standalone Configuration

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Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with inhouse protocols to determine appropriate methods for evaluating the performance of the device:

Test	Acceptance Criteria
Effective Length of Catheter	Test and report catheter length
Safety Activation	After deployment of the needle safetyfeature, the needle tip shall be sub-flush withthe distal end of the housing
Gravity Flow	Test and report gravity flow rate with a1000mm head pressure of water
Bleedback	No egress of blood over a period of 15seconds
GuidewireDeployment/Retraction	Guidewire to deploy and retract smoothly perpredetermined force requirements
Catheter Flashback	Flash is visible inside the catheter within apredetermined amount of time

The following quidance documents and standards in coniunction with in-house protocols were used to determine the appropriate methods for evaluating the performance of the device:

Performance

Tests

. ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10555-1:2013, Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements
. ISO 10555-5:2013, Intravascular Catheters - Sterile and Single-Use Catheters - Part 5: Over-Needle Peripheral Catheters
ISO 7864:1993, Sterile Hypodermic Needles for Single Use ●
ISO 9626:1991, Stainless Steel Needle Tubing for the Manufacture of Medical Devices
. ISO 594-1:1986, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Equipment - Part 1: General Requirements
ISO 594-2:1998, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Equipment - Part 2: Lock Fittings
. ASTM F640:2012, Standard Test Methods for Determining Radiopacity for Medical Use
ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
. ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
. ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals

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PerformanceTests	• ISO 11135:2014, Sterilization of Health-Care Products, EthyleneOxide – Requirements for the Development, Validation and RoutineControl of a Sterilization Process for Medical Devices• FDA Guidance: Medical Devices with Sharps Injury PreventionFeatures, August 9, 2005• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995• Design Control Guidance for Medical Device Manufacturers, March11, 1997The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device.
Summary ofSubstantialEquivalence	Based on the indications for use, technological characteristics, andperformance testing, the subject AccuCath™ Intravascular Catheter meets therequirements that are considered sufficient for its intended use anddemonstrates that the subject device is substantially equivalent to the cited predicate device.

PerformanceTests

• ISO 11135:2014, Sterilization of Health-Care Products, EthyleneOxide – Requirements for the Development, Validation and RoutineControl of a Sterilization Process for Medical Devices• FDA Guidance: Medical Devices with Sharps Injury PreventionFeatures, August 9, 2005• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995• Design Control Guidance for Medical Device Manufacturers, March11, 1997The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device.

Summary ofSubstantialEquivalence

Based on the indications for use, technological characteristics, andperformance testing, the subject AccuCath™ Intravascular Catheter meets therequirements that are considered sufficient for its intended use anddemonstrates that the subject device is substantially equivalent to the cited predicate device.

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).