(133 days)
No
The summary describes a standard intravascular catheter and its physical components and performance testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is used for vascular access to sample blood, monitor blood pressure, or administer fluids, which are diagnostic and supportive functions, not primary therapeutic treatment.
No
The device is described as an intravascular catheter used for vascular access to "sample blood, monitor blood pressure, or administer fluids intravenously," which are interventional or monitoring functions, not diagnostic ones.
No
The device description clearly outlines physical components such as a catheter, guidewire, flashback chamber, and safety container, indicating it is a hardware medical device.
Based on the provided information, the AccuCath Ace™ Intravascular Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "vascular access... to sample blood, monitor blood pressure, or administer fluids intravenously." These are all procedures performed on the patient's body, not on samples outside the body.
- Device Description: The description details a catheter, guidewire, flashback chamber, and safety container – components used for inserting a device into a blood vessel. This aligns with an in-vivo (within the living body) procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status. IVD devices are designed for testing samples in vitro (in glass, or outside the body).
Therefore, the AccuCath Ace™ Intravascular Catheter is a medical device used for direct patient care and procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access, including both the external and internal jugular veins
Central, peripheral (under "Insertion Site" in Technological Characteristics table)
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)
The following performance tests were conducted in determining substantial equivalence of the AccuCath Ace™ Intravascular Catheter to the predicate AccuCath™ Intravascular Catheter:
• Biocompatibility per ISO 10993-1
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.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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
1
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
2
Indications for Use
510(k) Number (if known) K191232
Device Name AccuCath Ace™ Intravascular Catheter
Indications for Use (Describe)
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.
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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3
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:
| General
| Provisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Mona Shahrebani | |
| Regulatory 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 |
4
| Predicate
| Device | 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 | |
| Reference | ||
| Device | 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 | |
| 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. | ||
| Intended Use | The AccuCath Ace™ 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. | ||
| Indications for | ||
| Use | 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 |
5
| Technological
Characteristics | Attribute | Subject Device – AccuCath Ace™
Intravascular Catheter | Predicate Device – AccuCath
Intravascular 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 for
Use | 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. | 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. |
| | Commercial
Name | AccuCath Ace™ Intravascular Catheter
Emergent Access Kits | AccuCath™ Intravascular Catheter |
| | Catheter
Dimensions | Same as predicate | Gauge / Length
18 gauge, 1.25 & 2.25 inches
20 gauge, 1.25 & 2.25 inches
22 gauge, 1.25 inches |
| | Duration of Use | Same as predicate | Short term (