The AccuCath Ace™ Intravascular Catheter is indicated for vascular access, including both the external and internal jugular veins, 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 Ace™ IV Catheter is suitable for use with power injectors.

Device Description

The AccuCath Ace™ Intravascular Catheter consists of a radiopaque catheter with a valve mechanism delivered over a guidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries. The AccuCath Ace™ Intravascular Catheter is designed to reduce blood exposure during insertion. The devices are single use, sterile, intravascular catheters offered in 18, 20, and 22 gauge configurations. All lumens are power injectable at their labeled flow rate. The AccuCath Ace™ Intravascular Catheter is offered in Emergent Access Kit configurations with various components provided for the convenience of the end user.

AI/ML Overview

The provided text describes the AccuCath Ace™ Intravascular Catheter, which is a medical device for vascular access. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are typically framed in terms of meeting established industry standards and functional requirements that are substantially equivalent to the predicate.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" as a pass/fail threshold for a specific performance metric in a clinical study. Instead, it demonstrates compliance with recognized standards and performs a series of engineering tests to show substantial equivalence to a predicate device.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary of Test Results)
Biocompatibility	Met ISO 10993-1. Leveraged from predicate (K162894) and reference (K153280) devices.
Sterility	Met AAMI/ANSI/ISO 11135:2014.
Risk Analysis	Performed per ISO 14971. Changes assessed, no new/different safety/effectiveness questions.
General Catheter Requirements	Met ISO 10555-1:2013.
Power Injection Conditioning	Catheter does not leak or burst at maximum indicated flow rate during power injections.
Hydraulic Catheter Burst Test	Catheter burst pressure exceeds peak pressure at maximum flow conditions when distal end is occluded.
Shaft Tensile Test	Peak tensile force of each test piece exceeds the minimum peak tensile force.
Technological Equivalence	Basic design and function are substantially equivalent to the predicate device (AccuCath™ Intravascular Catheter K162894). Materials are biologically safe, and design changes are substantially equivalent.
Intended Use/Indications	Modifications to indications for use and instructions have no impact on intended use or technological characteristics.

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

The document describes engineering bench tests and compliance with standards, not a clinical study on human subjects with a "test set" in the sense of patient data.

Sample size for bench tests: Not explicitly stated for each test (e.g., number of catheters tested for burst pressure).
Data provenance: Not applicable in terms of country of origin or retrospective/prospective, as these are lab-based engineering performance tests, not clinical data sets.

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

This is not applicable as the submission focuses on functional and safety performance, not diagnostic accuracy where expert ground truth would be needed. The "ground truth" for these tests are the defined parameters and methodologies of the relevant ISO standards.

4. Adjudication method for the test set

Not applicable for engineering bench tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to assess human performance with and without AI assistance. This device is an intravascular catheter, and the submission is for substantial equivalence based on safety and functional performance, not diagnostic accuracy or AI assistance.

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

This question is not applicable to an intravascular catheter. There is no algorithm for this device that would operate standalone or with human-in-the-loop.

7. The type of ground truth used

The "ground truth" for the tests performed are the specifications and requirements defined by recognized consensus standards (e.g., ISO 10993-1, AAMI/ANSI/ISO 11135:2014, ISO 14971, ISO 10555-1:2013) as well as internal engineering specifications for functional parameters like burst pressure and tensile strength.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm or diagnostic tool that requires a "training set."

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

Not applicable, as there is no "training set" for this device.

Summary

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September 18, 2019

C.R. Bard, Inc. Mona Shahrebani Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K191232

Trade/Device Name: AccuCath Ace™ Intravascular Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 16, 2019 Received: August 19, 2019

Dear Mona Shahrebani:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Nikhil Thakur Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191232

Device Name AccuCath Ace™ Intravascular Catheter

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)
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510(k) Summary for AccuCath Ace™ Intravascular Catheter

K191232

21 CFR 807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part(l)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based on is presented in the following table:

GeneralProvisions	Submitter Name:	Bard Access Systems, Inc. (Bard has joined BD)
	Submitter Address:	605 North 5600 WestSalt Lake City, UT 84116
	Contact Person:	Mona ShahrebaniRegulatory Affairs Specialist
	Telephone Number:	801.522.5967
	Fax Number:	801.522.4907
	Date of Preparation:	9/18/2019
Subject Device	Trade Name(s):	AccuCath Ace™ Intravascular Catheter
	Common Name:	Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days
	Regulation Name:	Intravascular Catheter
	Class:	2
	Regulation Number:	21 CFR 880.5200
	Product Code:	FOZ
	Classification Panel	General Hospital

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PredicateDevice	Predicate Trade Name:	AccuCath™ Intravascular Catheter
	Regulation Name:	Intravascular Catheter
	Class:	2
	Product Code:	FOZ
	Regulation Number:	21 CFR 880.5200
	Premarket Notification #:	K162894
	Manufacturer:	Bard Access Systems, Inc.
	Classification Panel	General Hospital
ReferenceDevice	Reference Trade Name:	PowerGlide Pro™ Midline Catheter
	Classification Name:	Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days
	Class:	2
	Product Code:	FOZ
	Regulation Number:	21 CFR 880.5200
	Premarket Notification #:	K153280
	Manufacturer:	Bard Access Systems, Inc.
	Classification Panel	General Hospital
DeviceDescription	The AccuCath Ace™ Intravascular Catheter consists of a radiopaque catheter with a valve mechanism delivered over aguidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container thatprevents sharp injuries. The AccuCath Ace™ Intravascular Catheter is designed to reduce blood exposure during insertion.
	The devices are single use, sterile, intravascular catheters offered in 18, 20, and 22 gauge configurations. All lumens arepower injectable at their labeled flow rate.
	The AccuCath Ace™ Intravascular Catheter is offered in Emergent Access Kit configurations with various componentsprovided for the convenience of the end user.
Intended Use	The AccuCath Ace™ Intravascular Catheter is intended to be inserted in the patient's vascular system for short term use tosample blood, monitor blood pressure, or administer fluids intravenously.
Indications forUse	The AccuCath Ace™ Intravascular Catheter is indicated for vascular access, including both the external and internal jugularveins, to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with considerationgiven to adequacy of vascular anatomy, appropriateness of the solution being infused and duration of therapy. The AccuCath

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TechnologicalCharacteristics	Attribute	Subject Device – AccuCath Ace™Intravascular Catheter	Predicate Device – AccuCathIntravascular Catheter
	Owner	Same as predicate	Bard Access Systems
	Classification	Same as predicate	FOZ – 21 CFR 880.5200
	510(k) Status	Subject of this Premarket Notification	K162894 – Concurrence date November 15, 2016
	Indications forUse	The AccuCath Ace™ Intravascular Catheteris indicated for vascular access, includingboth the external and internal jugular veins, tosample blood, monitor blood pressure, oradminister fluids intravenously. This devicemay be used with consideration given toadequacy of vascular anatomy,appropriateness of the solution being infused,and duration of therapy. The AccuCath Ace™IV Catheter is suitable for use with powerinjectors.	The AccuCath™ Intravascular Catheter isinserted into a patient's vascular system tosample blood, monitor blood pressure, oradminister fluids intravenously. This devicemay be used with consideration given toadequacy of vascular anatomy,appropriateness of the solution beinginfused, and duration of therapy. TheAccuCath™ IV Catheter is suitable for usewith power injectors.
	CommercialName	AccuCath Ace™ Intravascular CatheterEmergent Access Kits	AccuCath™ Intravascular Catheter
	CatheterDimensions	Same as predicate	Gauge / Length18 gauge, 1.25 & 2.25 inches20 gauge, 1.25 & 2.25 inches22 gauge, 1.25 inches
	Duration of Use	Same as predicate	Short term (<30 days)
	Means of	Same as predicate	Percutaneous, over a Guidewire
insertion
Insertion Site		Central, peripheral	peripheral
Primary DeviceMaterials		Same as predicate	Catheter Base Materials:• Shaft Tubing: Polyurethane• Luer Connector: PolyurethaneNeedle:• Stainless SteelGuidewire:• Nitinol
Catheter ProximalConfiguration		Same as predicate	Luer connection
Catheter DistalConfiguration		Same as predicate	Open ended
Number ofLumens		Same as predicate	Single Lumen
Power InjectionMaximum FlowRate		Same as predicate	6 mL/s
Sterility		Same as predicate	Provided Sterile
Safety &PerformanceTests	The technological characteristics listed above were evaluated using industry consensus standards, and as defined in the RiskAssessment. The change in insertion site reflects the use of the device in emergent situations where central access isnecessary. A risk analysis was performed to assessed the changes and there were no new or different questions of safety andeffectiveness. Therefore, these technological characteristics substantially equivalent to the predicate device and do not raisenew or different questions of safety or effectiveness.The following performance tests were conducted in determining substantial equivalence of the AccuCath Ace™ IntravascularCatheter to the predicate AccuCath™ Intravascular Catheter:• Biocompatibility per ISO 10993-1

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Biocompatibility was leveraged from the sponsor's own devices-Predicate device (K162894) and Reference device (K153280) Sterility per AAMI/ANSI/ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices. Risk Analysis per ISO 14971
Reference Standard: ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements
Power Injection Conditioning	Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate.
Hydraulic Catheter Burst Test	Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded.
Shaft Tensile Test	Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
Technological Comparison to Predicate Device	Technological characteristics of the subject AccuCath AceTM Intravascular Catheter are substantially equivalent with regard to the basic design and function of the predicate device, AccuCathTM Intravascular Catheter (K162894). All changes to materials are determined to be biologically safe for use, and the changes in design are considered substantially equivalent to the predicate device.
Summary of Substantial Equivalence	The modifications to the indications for use and product instructions for use has no impact on the intended use or the technological characteristics of the device. The results of the risk analysis as well as functional performance testing determined that the subject AccuCath AceTM Intravascular Catheter has demonstrated to be 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).