Who is the manufacturer of AccuCath Ace Intravascular Catheter?

Bard Access Systems, Inc. (C.R. Bard, Inc.) filed the 510(k) submission for AccuCath Ace Intravascular Catheter (K233106).

What is the FDA product code for AccuCath Ace Intravascular Catheter?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for AccuCath Ace Intravascular Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AccuCath Ace Intravascular Catheter?

AccuCath™ Intravascular Catheter (K162894).

Who can help prepare an FDA 510(k) submission like AccuCath Ace Intravascular Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AccuCath Ace Intravascular Catheter

K233106 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · FOZ · Apr 19, 2024 · General Hospital

Device Facts

Record ID	K233106
Device Name	AccuCath Ace Intravascular Catheter
Applicant	Bard Access Systems, Inc. (C.R. Bard, Inc.)
Product Code	FOZ · General Hospital
Decision Date	Apr 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

AccuCath Ace™ is a short-term (<30 days) intravascular catheter system; consists of radiopaque catheter with valve mechanism, guidewire with atraumatic tip, flashback chamber, and safety container to prevent sharps injuries. Used by clinicians in clinical settings for peripheral vascular access. Designed for use with ultrasound and Cue Needle Tracking System; compatible with power injectors (max flow 6 mL/s). Facilitates insertion in patients with difficult intravascular access (DIVA) by reducing vessel trauma and improving first-attempt success. Output is established vascular access for therapy delivery or monitoring.

Clinical Evidence

No new clinical testing was performed for this submission. Literature evidence supports the use of the AccuCath Ace in DIVA patients, demonstrating improved first-attempt success, reduced insertion complications, increased dwell time, and higher patient/clinician satisfaction compared to non-guidewire catheters.

Technological Characteristics

Single-lumen, open-ended peripheral catheter. Materials: Pebax® shaft tubing, polyurethane luer connector, stainless steel needle, nitinol guidewire. Features integrated valve mechanism and safety sharps container. Compatible with power injectors (6 mL/s). Provided sterile.

Indications for Use

Indicated for adult and pediatric patients requiring vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration, including patients with difficult intravascular access (DIVA) characterized by small, fragile, or non-palpable vessels.

Regulatory Classification

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.

Predicate Devices

AccuCath™ Intravascular Catheter (K162894)

Related Devices

K142136 — ACCUCATH MIDLINE CATHETER SYSTEM · Vascular Pathways, Inc. · Jan 8, 2015
K191232 — AccuCath Ace Intravascular Catheter · C.R. Bard, Inc. · Sep 18, 2019
K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Dec 20, 2024
K162894 — AccuCath Intravascular Catheter · C.R. Bard, Inc. · Nov 15, 2016
K183066 — The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model · Access Scientific, LLC · Jul 25, 2019

Submission Summary (Full Text)

{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) | | |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 (<30 days) | Short term (<30 days) | Same | | Primary Device Components | Needle Guidewire Catheter | Needle Guidewire Catheter | Same | | Means of Insertion | Percutaneous, over a guidewire | Percutaneous, over a guidewire | Same | | Insertion Site | Peripheral | Peripheral | Same | | Primary Device Materials | Catheter Base Materials: • Shaft Tubing: Pebax® • Luer Connector: Polyurethane Needle: Stainless Steel Guidewire: Nitinol | Catheter Base Materials: • Shaft Tubing: Pebax® • Luer Connector: Polyurethane Needle: Stainless Steel Guidewire: Nitinol | Same | | Catheter Proximal Configuration | Luer Connection | Luer Connection | Same | | Catheter Distal Configuration | Open Ended | Open Ended | Same | | Number of Lumens | Single Lumen | Single Lumen | Same | | Power Injection Maximum Flow Rate | 6 mL/s | 6 mL/s | Same | | Sterility | Provided Sterile | Provided Sterile | Same | | Available Configurations | Standalone Basic Kit | Standalone Basic Kit Intermediate Kit | Different The addition of the intermediate kit configuration has no effect | | Cue Needle Tracking System Compatibility | None | 2.25" AccuCath Ace IV Catheters | on device safety or effectiveness and results in no new or modified risks. Different The addition of Cue compatibility has no effect on device safety or effectiveness and results in no new or modified risks. Verification testing was carried out on all changed aspects: the needle, packaging, ultrasound system/Cue compatibility, tracking accuracy, and magnetization. All acceptance criteria was met | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows two company logos. The first logo is for BD, with an orange sun-like symbol to the left of the blue letters "BD". The second logo is for BARD, with the green letters "BARD" stacked above the phrase "has joined BD" in a smaller font. AccuCath Ace™ Intravascular Catheter Traditional 510(k) Premarket Notification {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logos of 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. Below the BARD logo, it says "has joined BD" in a smaller font. AccuCath Ace™ Intravascular Catheter Traditional 510(k) Premarket Notification The key modification made to the subject device when compared to the predicate device is the specification of a difficult intravascular access (DIVA) indication to the indications for use. As a result, the indications for use in the product instructions for use were updated to reflect the modification. Previously, several design, packaging, and labeling changes were made to the AccuCath Ace IV Catheter. These changes are currently implemented in the marketed predicate devices. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logos of BD and BARD. The BD logo is in blue, and the BARD logo is in green. Underneath the BARD logo, the text "has joined BD" is written in a smaller font. The logos are placed side by side. AccuCath Ace™ Intravascular Catheter Traditional 510(k) Premarket Notification | 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 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. | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical Literature | 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. | | Summary of Substantial Equivalence | The modification to the indications for use and resulting modifications to the product instructions for use and labeling 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. Previous minor changes made to the device have been documented and the necessary testing carried out. The changes were found to have no impact on the safety and effectiveness of the device, nor did they introduce new risks or modify existing risks. Therefore, the subject AccuCath Ace™ Intravascular Catheter is substantially equivalent to the predicate AccuCath™ Intravascular Catheter. |