K Number

Device Name

AccuCath Intravascular Catheter

Manufacturer

C.R. Bard, Inc.

Date Cleared

2015-12-10

(27 days)

Product Code

FOZ

Regulation Number

880.5200

Intended Use

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.

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

K140504

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and structural features of the catheter and its blood control mechanism. There is no mention of any computational or algorithmic components, let alone AI/ML.

Therapeutic

No.
The device's stated uses are for sampling blood, monitoring blood pressure, and administering fluids, which are diagnostic and supportive functions rather than direct treatment or therapy.

Diagnostic

This device is primarily used for sampling blood, monitoring blood pressure, or administering fluids. While blood sampling and blood pressure monitoring can be part of diagnostic processes, the device itself is a tool for accessing the vascular system and facilitating these actions, rather than directly performing a diagnostic analysis or providing a diagnosis.

SaMD (Software as a Medical Device)

The device description clearly details physical components like catheters, needles, hubs, septums, and safety mechanisms, indicating it is a hardware medical 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 purposes like sampling blood, monitoring blood pressure, or administering fluids. These are direct interventions on the patient's body.
Device Description: The description details a physical catheter designed for insertion and manipulation within the vascular system.
Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.

The device is a medical device used in vivo (within the body) for therapeutic and diagnostic purposes (sampling blood, monitoring blood pressure).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

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, Peripheral

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinician

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)

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 in-house protocols to determine appropriate methods for evaluating the performance of the device:

Tests:

Effective Length of Catheter: Test and report catheter length
Safety Activation: After deployment of the needle safety feature, the needle tip shall be sub-flush with the distal end of the housing
Gravity Flow: Test and report gravity flow rate with a 1000mm head pressure of water
Bleedback: No egress of blood over a period of 15 seconds
Guidewire Deployment/Retraction: Guidewire to deploy and retract smoothly per predetermined force requirements
Catheter Flashback: Flash is visible inside the catheter within a predetermined amount of time

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

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
ISO 11135:2014, Sterilization of Health-Care Products, Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
FDA Guidance: Medical Devices with Sharps Injury Prevention Features, 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, March 11, 1997

Key results: The 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140504

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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.

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

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)

| General

Provisions	Submitter Name:	Bard Access Systems, Inc.
	Submitter Address:	605 North 5600 West
Salt Lake City, UT 84116
	Contact Person:	Mr. Casey Coombs
Regulatory Affairs Specialist
	Telephone Number:
Fax Number:
Date of Preparation:	(801) 522-5869
(801) 522-5425
9 December 2015
Subject
Device	Trade Name:	AccuCath™ Intravascular Catheter
	Common Name:	Intravascular Catheter
	Classification Name:	Intravascular Catheter
	Product Code/
Regulation:	FOZ/21 CFR §880.5200
Predicate
Devices	Predicate Trade Name:	AccuCath™ BC Intravascular Catheter System
	Classification Name:	Intravascular Catheter
	Premarket Notification:
Manufacturer:	K140504
Bard Access Systems, Inc.
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.
Intended Use	The AccuCath™ Intravascular Catheter is intended to be inserted in the
patient's vascular system for short term use (less than 30 days) to sample
blood, monitor blood pressure, or administer fluids intravenously.
Indications For Use	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.
	Technological characteristics of the subject AccuCath™ Intravascular
Catheter are substantially equivalent with respect to basic design and function
to those of the cited predicate device.
	Key modifications made to the subject device when compared to the predicate
device 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.

Technological
Characteristics	Attribute	Subject Device – AccuCath™
Intravascular Catheter	Predicate Device –
AccuCath™ BC
Intravascular Catheter
System (K140504)
	Owner	Same	Bard Access Systems, Inc.
	Classification	Same	FOZ - 21 CFR 880.5200 -
Short-term - Intravascular
Catheter
	510(k) Status	Subject of this Premarket
Notification	K140504 - Concurrence date
July 17, 2014
	Indications for
Use	Same as predicate with the
exception of the commercial
name:
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	The AccuCath™ BC
Intravascular Catheter System
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™ BC is suitable for
use with low pressure power
injectors having a maximum
Subject and Predicate Device Comparison Table
	Attribute	Subject Device – AccuCath™ Intravascular Catheter	Predicate Device – AccuCath™ BC Intravascular Catheter System (K140504)
Technological
Characteristics	Commercial Name	AccuCath™ Intravascular Catheter	AccuCath™ BC Intravascular Catheter System
	Catheter Dimensions	Length: 1.25 and 2.25 inches
Diameter: 18, 20, 22 gauge	Length: 2.25 inches
Diameter: 18, 20, 22 gauge
	Duration of Use	Same	Short term (