K Number
K162894
Device Name
AccuCath Intravascular Catheter
Manufacturer
Date Cleared
2016-11-15

(29 days)

Product Code
Regulation Number
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 power injectors.
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 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

Not Found

No
The provided text describes a standard intravascular catheter with a blood control feature and safety mechanism. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies section also indicates no changes to design, materials, or performance, further suggesting the absence of new, complex technologies like AI/ML.

No.
The device is used for sampling blood, monitoring blood pressure, or administering fluids, which are diagnostic or supportive functions, not therapeutic in nature.

No
The device is described as an intravascular catheter for sampling blood, monitoring blood pressure, or administering fluids intravenously; these are therapeutic and monitoring functions, not primarily diagnostic in the sense of identifying a disease or condition through analysis or imaging.

No

The device description clearly details physical components such as catheters, needles, hubs, septums, safety mechanisms, and guidewires, indicating it is a hardware medical device.

Based on the provided text, 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 interactions with the patient's body for therapeutic or monitoring purposes.
  • Device Description: The description details a physical catheter designed for insertion into the vascular system. It focuses on features related to insertion, blood control during insertion, and safety mechanisms for the needle.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any analysis or testing of specimens outside the body.

The device is a medical device used in vivo (within the body) for direct patient care.

N/A

Intended Use / 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 power injectors.

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

FOZ

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

As part of Bard Access Systems, Inc.'s design controls, a risk analysis was conducted to assess the impact of the proposed subject device labeling modifications. The results of the risk analysis determined that no verification or validation activities were required because the subject device labeling modifications to the Indications for use and instructions for use do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation.

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.

K153298

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

§ 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).

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

November 15, 2016

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

Re: K162894

Trade/Device Name: AccuCath™ Intravascular Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 13, 2016 Received: October 17, 2016

Dear Mr. Jacob Lee:

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.

1

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 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/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 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,

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Tina Kiang, Ph.D. Acting 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)

K162894

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 power injectors.

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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K162894

510(k) Summary 21 CFR 807.92(a)
General
ProvisionsSubmitter Name:
Submitter Address:
Contact Person:
Telephone Number:
Fax Number:
Date of Preparation:Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116
Jacob Lee
Regulatory Affairs Specialist
(801) 522-5823
(801) 522-5425
October 13, 2016
Subject
DeviceTrade Name:
Common Name:
Regulation Name:
Product Code:
Regulation:
Regulatory Class:
Classification Panel:AccuCath™ Intravascular Catheter
Intravascular Catheter
Intravascular Catheter
FOZ
21 CFR §880.5200
Class II
General Hospital
Predicate
DevicesPredicate Trade Name:
Premarket Notification:
Manufacturer:
Common Name:
Regulation Name:
Regulation:
Regulatory Class:
Classification Panel:AccuCath™ Intravascular Catheter
K153298 (cleared December 10, 2015)
Bard Access Systems, Inc.
Intravascular Catheter
Intravascular Catheter
21 CFR §880.5200
Class II
General Hospital
Device
DescriptionThe 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 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 UseThe AccuCath™ Intravascular Catheter is intended to be inserted in the
patient's vascular system for short term use to sample blood, monitor blood
pressure, or administer fluids intravenously.
AttributeSubject Device - AccuCath™ Intravascular CatheterPredicate Device – AccuCath™ Intravascular Catheter (K153298)
OwnerSame as predicateBard Access Systems, Inc.
ClassificationSame as predicateFOZ - 21 CFR 880.5200 -
Short-term - Intravascular
Catheter
510(k) StatusSubject of this Premarket
NotificationK153298 - Concurrence date
December 10, 2015
Indications for
UseProposed Indications for Use to
remove the pressure setting and
flow rate:
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. TheThe 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
Technological
CharacteristicsNameCatheter
Catheter
DimensionsSame as predicate
Duration of
UseSame as predicate
Primary Device
ComponentsSame as predicate
Means of
InsertionSame as predicate
Insertion SiteSame as predicate
Primary Device
MaterialsSame as predicate
Catheter
Proximal
ConfigurationSame as predicate
Catheter Distal
ConfigurationSame as predicate
Number of
LumensSame as predicate
Power Injection
Maximum Flow
RateSame as predicate
SterilitySame as predicate
Packaging
ConfigurationsBasic Configuration
Intermediate Configuration
Performance
TestsAs part of Bard Access Systems, Inc.'s design controls, a risk analysis was
conducted to assess the impact of the proposed subject device labeling
modifications. The results of the risk analysis determined that no verification
or validation activities were required because the subject device labeling
modifications to the Indications for use and instructions for use do not include
any changes to the design, materials, performance, or risk profile of the cited
predicate device. Therefore, it is not necessary to conduct additional
performance tests including verification and validation.
Summary of
Substantial
EquivalenceThe modification to the indications for use and product instructions for use
has no impact on the intended use, technological characteristics, or risk
profile of the subject device because there are no changes to the design or
performance of the predicate device. Therefore, the subject AccuCathTM
Intravascular Catheter is substantially equivalent to the cited predicate
device.

4

AccuCath™ IV Catheter is
suitable for use with power

Same as predicate

injectors.

Commercial

setting of 300 psi and maximum flow rate of

AccuCath™ Intravascular

6mL/second.

5