(29 days)
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.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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,
Image /page/1/Picture/8 description: The image shows a signature followed by the name "Tina Kiang". Below the name is the letter "S" preceded by a hyphen. The signature is a complex, looping design to the left of the name.
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
2
Indications for Use
510(k) Number (if known)
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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Image /page/3/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in a bold, sans-serif font, with each letter outlined in black. Below the word "BARD" is the text "ACCESS SYSTEMS", also in a bold, sans-serif font.
510(k) Summary 21 CFR 807.92(a) | |||
---|---|---|---|
General | |||
Provisions | Submitter 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 | |||
Device | Trade 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 | |||
Devices | Predicate 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 | |||
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. | |||
Intended Use | The 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. | |||
Attribute | Subject Device - AccuCath™ Intravascular Catheter | Predicate Device – AccuCath™ Intravascular Catheter (K153298) | |
Owner | Same as predicate | Bard Access Systems, Inc. | |
Classification | Same as predicate | FOZ - 21 CFR 880.5200 - | |
Short-term - Intravascular | |||
Catheter | |||
510(k) Status | Subject of this Premarket | ||
Notification | K153298 - Concurrence date | ||
December 10, 2015 | |||
Indications for | |||
Use | Proposed 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. The | 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 | |||
Technological | |||
Characteristics | Name | Catheter | |
Catheter | |||
Dimensions | Same as predicate | ||
Duration of | |||
Use | Same as predicate | ||
Primary Device | |||
Components | Same as predicate | ||
Means of | |||
Insertion | Same as predicate | ||
Insertion Site | Same as predicate | ||
Primary Device | |||
Materials | Same as predicate | ||
Catheter | |||
Proximal | |||
Configuration | Same as predicate | ||
Catheter Distal | |||
Configuration | Same as predicate | ||
Number of | |||
Lumens | Same as predicate | ||
Power Injection | |||
Maximum Flow | |||
Rate | Same as predicate | ||
Sterility | Same as predicate | ||
Packaging | |||
Configurations | Basic Configuration | ||
Intermediate Configuration | |||
Performance | |||
Tests | 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. | |||
Summary of | |||
Substantial | |||
Equivalence | The 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