(205 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The performance studies focus on risk analysis and verification/validation of design changes, not algorithmic performance.
No.
The device is used for diagnostic purposes like sampling blood and monitoring blood pressure, and for administering fluids, but not directly for treating a disease or condition. While some fluid administration may be therapeutic in nature, the device itself is a delivery or measurement tool rather than a therapeutic agent.
No
Explanation: The device is an intravascular catheter used for sampling blood, monitoring blood pressure, or administering fluids. While these actions might facilitate diagnosis, the device itself does not perform any analytical or interpretive diagnostic function.
No
The device description clearly outlines physical components like a catheter, guidewire, flashback chamber, and safety container, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. These are all direct interactions with the patient's body for therapeutic or monitoring purposes.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical components and features of the catheter for insertion and use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro, using reagents, or providing diagnostic information based on laboratory analysis of specimens.
The AccuCath Ace™ Intravascular Catheter is a medical device used for direct patient care and intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AccuCath Ace™ 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 for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, 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 system 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 IV Catheter is designed to reduce blood exposure during insertion, for use with ultrasound, and for use with the Cue Needle Tracking System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
vascular system (Peripheral)
Indicated Patient Age Range
adult and pediatric patients
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 indications for use modifications. The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling 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.
Since clearance of the predicate, several additional changes were made to the device and documented via Letter to File. Verification, sterilization, biocompatibility, and packaging testing was carried out as necessary for each of these changes at the time of the change. In each case, the changed device was found to be as safe and as effective and introduced no new or modified risks. These historic changes are currently implemented in the marketed predicate devices.
There is a body of literary evidence demonstrating that the AccuCath Ace Intravascular Catheter has equivalent or better outcomes in DIVA patients compared to catheters with no guidewire. These outcomes include improved first attempt success, reduction of insertion complications, improved completion of therapy, increased dwell time of the catheter, and overall patient and clinician satisfaction. AccuCath Ace includes features that improve ease of insertion and limit vessel damage making the AccuCath Ace Intravascular Catheter an ideal option for DIVA patients.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 19, 2024
Bard Access Systems, Inc. (C.R. Bard, Inc.) Samira Saeed Regulatory Affairs Specialist I 605 N 5600 W Salt Lake City, Utah 84116
Re: K233106
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: April 4, 2024 Received: April 16, 2024
Dear Samira Saeed:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices,
2
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
3
Indications for Use
510(k) Number (if known) K233106
Device Name AccuCath Ace™ Intravascular Catheter
Indications for Use (Describe)
The AccuCath Ace™ 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 for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, 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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4
Bard Access Systems, Inc. 605 North 5600 West
Salt Lake City, UT 84116 USA
Phone: +1-801-5222-50000
Fax: +1-801-5222-50000
Fax: +1-801-522-4948
Image /page/4/Picture/1 description: The image shows the logos of two companies, BD and BARD. The BD logo is on the left and consists of an orange sun-like symbol and the letters BD in blue. The BARD logo is on the right and consists of the word BARD in green, with the text "has joined BD" below it.
AccuCath Ace™ Intravascular Catheter Traditional 510(k) Premarket Notification
| General
Provisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined
BD) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West
Salt Lake City, Utah 84116 |
| | Contact Person: | Samira Saeed
Regulatory Affairs Specialist |
| | Telephone Number: | 801.522.5000 |
| | Date of Preparation: | April 19th 2024 |
| | Trade Name: | AccuCath Ace™ Intravascular Catheter |
| | Common Name: | catheter, intravascular, therapeutic, short-
term less than 30 days |
| Subject
Device: | Classification Name: | Intravascular catheter |
| | Class: | Class II |
| | Regulation Number: | 880.5200 |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| Predicate
Device | Trade Name: | AccuCath™ Intravascular Catheter |
| | Common Name | catheter, intravascular, therapeutic, short-
term less than 30 days |
| | Classification Name: | Intravascular catheter |
| | Class: | Class II |
| | Regulation Number: | 880.5200 |
| | Product Code: | FOZ |
| | Premarket Notification Number: | K162894 |
| Device
Description | The AccuCath Ace™ Intravascular Catheter system 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 IV Catheter is designed to reduce blood exposure during
insertion, for use with ultrasound, and for use with the Cue Needle Tracking System. | |
| Indications for
Use | The AccuCath Ace™ 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 for adult and pediatric patients, including those patients with difficult
intravascular access who may have small, fragile, and/or non-palpable vessels, 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. | |
| Technological
Characteristics | Technological characteristics of the subject AccuCath Ace™ Intravascular Catheter are
substantially equivalent with respect to design and function to those of the cited
predicate device. | |
K233106 - 510(k) Summary 21 CFR 807.92(a)
5
Image /page/5/Picture/1 description: The image shows two company logos. The first logo consists of an orange circular graphic with radiating lines, followed by the blue letters "BD". The second logo features the green letters "BARD" in a stylized font, with the text "has joined BD" underneath in a smaller font.
AccuCath Ace™ Intravascular Catheter Traditional 510(k) Premarket Notification
The following table provides a comparison between the subject and predicate device:
| Attribute | Predicate Device
AccuCath™
Intravascular
Catheter (K162894) | Subject Device
AccuCath Ace™
Intravascular Catheter | Comparison |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner | Bard Access
Systems, Inc. | Bard Access Systems,
Inc. | Same |
| Classification | Class II | Class II | Same |
| 510(k) Status | K162894 | Subject of this
Premarket Notification | - |
| 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. | The AccuCath Ace™
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 for
adult and pediatric
patients, including
those patients with
difficult intravascular
access who may have
small, fragile, and/or
non-palpable vessels,
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. | Different
Added
indication for
patients with
DIVA which is
a subset of
general use
population -
no effect on
device safety
or
effectiveness
or change in
risk. |
| Commercial
Name | AccuCath™
Intravascular
Catheter | AccuCath Ace™
Intravascular Catheter | Different
The minor
name change
has no effect
on device
safety or
effectiveness |
| | | | and results in
no new or
modified risks |
| Catheter
Dimensions | Length: 1.25 & 2.25 inches
Diameter: 18, 20, 22 gauge | Length: 1.25 & 2.25 inches
Diameter: 18, 20, 22 gauge | Same |
| Durations of
Use | Short term (