(205 days)
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.
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.
The information provided indicates that the AccuCath Ace™ Intravascular Catheter did not undergo a new study to prove it meets acceptance criteria for its current submission. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AccuCath™ Intravascular Catheter, K162894) based on a modification to its Indications for Use, which now explicitly includes patients with difficult intravascular access (DIVA).
The document states that a risk analysis determined that no verification or validation activities were required because the modifications to the Indications for Use and labeling "do not include any changes to the design, materials, performance, or risk profile of the cited predicate device."
Therefore, the "acceptance criteria" and "device performance" described below are in reference to the previous clearance of the predicate device and the modifications that had been made to it, for which "Verification, sterilization, biocompatibility, and packaging testing was carried out as necessary for each of these changes at the time of the change." The current submission does not detail these specific tests, their criteria, or results, but rather asserts that the changes "were found to be as safe and as effective and introduced no new or modified risks."
The table below summarizes the information provided regarding the comparison between the subject device (AccuCath Ace™ Intravascular Catheter) and its predicate device (AccuCath™ Intravascular Catheter, K162894), highlighting what is considered "met" based on the substantial equivalence argument rather than new primary testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by Comparison) | Predicate Device Performance / Characteristic | Subject Device Performance / Characteristic | Comparison / Status |
|---|---|---|---|
| Primary Indication for Use | Insertion into vascular system for blood sampling, BP monitoring, fluid administration. | Insertion into vascular system for blood sampling, BP monitoring, fluid administration. | Same |
| Additional Indication for Use | General Use Patients | Adult and pediatric patients, including those with difficult intravascular access (DIVA). | Met (New indication supported by external literature, no design change, no new risk) |
| 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 |
| Duration 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: Pebax®, Polyurethane; Needle: Stainless Steel; Guidewire: Nitinol | Catheter Base: Pebax®, 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 | Met (Addition of intermediate kit, no effect on safety/effectiveness, no new risk) |
| Cue Needle Tracking System Compatibility | None | 2.25" AccuCath Ace IV Catheters | Met (Addition of compatibility, no effect on safety/effectiveness, no new risk. Verification testing done on aspects related to this change: needle, packaging, ultrasound system/Cue compatibility, tracking accuracy, magnetization. All acceptance criteria met.) |
| Safety and Effectiveness | Found to be safe and effective | Found to be safe and effective | Met (Based on predicate's performance and prior verification for incremental changes) |
| Risk Profile | Acceptable risk profile | Acceptable risk profile | Met (No new or modified risks identified) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "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."
This means there was no new test set specifically for this 510(k) submission to assess the AccuCath Ace™ in the context of the DIVA indication. The claim of equivalence is based on the previously cleared predicate device and earlier incremental changes.
However, the document mentions: "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".
- Sample Size: Not specified.
- Data Provenance: Not specified, but these prior tests would likely have been internal validation tests conducted by the manufacturer.
The submission also cites "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." This refers to clinical literature, not a new test set conducted by the manufacturer for this submission. The specifics of this literature (e.g., sample sizes, countries of origin, retrospective/prospective) are not provided within this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as a new test set requiring expert ground truth establishment was not conducted for this 510(k) submission. For the "body of literary evidence," the ground truth would be established by the clinicians and researchers involved in those studies, but their specific numbers and qualifications are not detailed here.
4. Adjudication Method for the Test Set
Not applicable, as a new test set was not conducted for this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done as part of this submission. The submission relies on existing clinical literature (not a new study conducted for this submission) that suggests improved outcomes for DIVA patients with the AccuCath Ace™ Intravascular Catheter compared to catheters without a guidewire. No "effect size of how much human readers improve with AI vs without AI assistance" is relevant or provided, as this is a medical device, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device (intravascular catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the previously conducted "verification testing" for incremental changes (e.g., Cue compatibility), the ground truth would have been established through objective measurement and engineering standards.
For the claim regarding DIVA patients, the submission refers to "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." This implies that the ground truth for these claims comes from outcomes data reported in clinical literature.
8. The Sample Size for the Training Set
Not applicable, as this is a medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a medical device, not a machine learning model.
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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"
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(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,
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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
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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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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
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joinedBD) |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, Utah 84116 | |
| Contact Person: | Samira SaeedRegulatory 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 | |
| SubjectDevice: | Classification Name: | Intravascular catheter |
| Class: | Class II | |
| Regulation Number: | 880.5200 | |
| Product Code: | FOZ | |
| Classification Panel: | General Hospital | |
| PredicateDevice | 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 | |
| DeviceDescription | The AccuCath Ace™ Intravascular Catheter system consists of a radiopaque catheter witha valve mechanism delivered over a guidewire with an atraumatic tip design; a flashbackchamber to enhance flashback visualization, and a safety container that prevents sharpinjuries. The AccuCath Ace IV Catheter is designed to reduce blood exposure duringinsertion, for use with ultrasound, and for use with the Cue Needle Tracking System. | |
| Indications forUse | The AccuCath Ace™ Intravascular Catheter is inserted into a patient's vascular system tosample blood, monitor blood pressure, or administer fluids intravenously. This devicemay be used for adult and pediatric patients, including those patients with difficultintravascular access who may have small, fragile, and/or non-palpable vessels, withconsideration given to adequacy of vascular anatomy, appropriateness of the solutionbeing infused, and duration of therapy. The AccuCath Ace™ IV Catheter is suitable for usewith power injectors. | |
| TechnologicalCharacteristics | Technological characteristics of the subject AccuCath Ace™ Intravascular Catheter aresubstantially equivalent with respect to design and function to those of the citedpredicate device. |
K233106 - 510(k) Summary 21 CFR 807.92(a)
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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 DeviceAccuCath™IntravascularCatheter (K162894) | Subject DeviceAccuCath Ace™Intravascular Catheter | Comparison |
|---|---|---|---|
| Owner | Bard AccessSystems, Inc. | Bard Access Systems,Inc. | Same |
| Classification | Class II | Class II | Same |
| 510(k) Status | K162894 | Subject of thisPremarket Notification | - |
| Indications forUse | The AccuCath™IntravascularCatheter is insertedinto a patient'svascular system tosample blood,monitor bloodpressure, oradminister fluidsintravenously. Thisdevice may be usedwith considerationgiven to adequacy ofvascular anatomy,appropriateness ofthe solution beinginfused, andduration of therapy.The AccuCath IVCatheter is suitablefor use with powerinjectors. | The AccuCath Ace™Intravascular Catheter isinserted into a patient'svascular system tosample blood, monitorblood pressure, oradminister fluidsintravenously. Thisdevice may be used foradult and pediatricpatients, includingthose patients withdifficult intravascularaccess who may havesmall, fragile, and/ornon-palpable vessels,with considerationgiven to adequacy ofvascular anatomy,appropriateness of thesolution being infused,and duration of therapy.The AccuCath Ace™ IVCatheter is suitable foruse with powerinjectors. | DifferentAddedindication forpatients withDIVA which isa subset ofgeneral usepopulation -no effect ondevice safetyoreffectivenessor change inrisk. |
| CommercialName | AccuCath™IntravascularCatheter | AccuCath Ace™Intravascular Catheter | DifferentThe minorname changehas no effecton devicesafety oreffectiveness |
| and results inno new ormodified risks | |||
| CatheterDimensions | Length: 1.25 & 2.25 inchesDiameter: 18, 20, 22 gauge | Length: 1.25 & 2.25 inchesDiameter: 18, 20, 22 gauge | Same |
| Durations ofUse | Short term (<30 days) | Short term (<30 days) | Same |
| PrimaryDeviceComponents | NeedleGuidewireCatheter | NeedleGuidewireCatheter | Same |
| Means ofInsertion | Percutaneous, overa guidewire | Percutaneous, over aguidewire | Same |
| Insertion Site | Peripheral | Peripheral | Same |
| PrimaryDeviceMaterials | Catheter BaseMaterials:• Shaft Tubing: Pebax®• Luer Connector:PolyurethaneNeedle: Stainless SteelGuidewire: Nitinol | Catheter BaseMaterials:• Shaft Tubing: Pebax®• Luer Connector:PolyurethaneNeedle: Stainless SteelGuidewire: Nitinol | Same |
| CatheterProximalConfiguration | Luer Connection | Luer Connection | Same |
| CatheterDistalConfiguration | Open Ended | Open Ended | Same |
| Number ofLumens | Single Lumen | Single Lumen | Same |
| PowerInjectionMaximumFlow Rate | 6 mL/s | 6 mL/s | Same |
| Sterility | Provided Sterile | Provided Sterile | Same |
| AvailableConfigurations | StandaloneBasic Kit | StandaloneBasic KitIntermediate Kit | DifferentThe additionof theintermediatekitconfigurationhas no effect |
| Cue NeedleTrackingSystemCompatibility | None | 2.25" AccuCath Ace IVCatheters | on devicesafety oreffectivenessand results inno new ormodified risks.DifferentThe additionof Cuecompatibilityhas no effecton devicesafety oreffectivenessand results inno new ormodified risks.Verificationtesting wascarried out onall changedaspects: theneedle,packaging,ultrasoundsystem/Cuecompatibility,trackingaccuracy, andmagnetization.All acceptancecriteria wasmet |
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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
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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.
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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
| PerformanceTests | As part of Bard Access Systems, Inc.'s design controls, a risk analysis wasconducted to assess the impact of the proposed subject device indications for usemodifications. The results of the risk analysis determined that no verification orvalidation activities were required because the subject device modifications to theIndications for use and resulting modifications to the instructions for use and labelingdo not include any changes to the design, materials, performance, or risk profile ofthe cited predicate device. Therefore, it is not necessary to conduct additionalperformance tests including verification and validation.Since clearance of the predicate, several additional changes were made to the deviceand documented via Letter to File. Verification, sterilization, biocompatibility, andpackaging testing was carried out as necessary for each of these changes at the timeof the change. In each case, the changed device was found to be as safe and aseffective and introduced no new or modified risks. These historic changes arecurrently implemented in the marketed predicate devices. |
|---|---|
| ClinicalLiterature | There is a body of literary evidence demonstrating that the AccuCath Ace IntravascularCatheter has equivalent or better outcomes in DIVA patients compared to catheters withno guidewire. These outcomes include improved first attempt success, reduction ofinsertion complications, improved completion of therapy, increased dwell time of thecatheter, and overall patient and clinician satisfaction. AccuCath Ace includes featuresthat improve ease of insertion and limit vessel damage making the AccuCath AceIntravascular Catheter an ideal option for DIVA patients. |
| Summary ofSubstantialEquivalence | The modification to the indications for use and resulting modifications to the productinstructions for use and labeling has no impact on the intended use, technologicalcharacteristics, or risk profile of the subject device because there are no changes to thedesign or performance of the predicate device.Previous minor changes made to the device have been documented and the necessarytesting carried out. The changes were found to have no impact on the safety andeffectiveness of the device, nor did they introduce new risks or modify existing risks.Therefore, the subject AccuCath Ace™ Intravascular Catheter is substantially equivalent tothe predicate AccuCath™ Intravascular Catheter. |
§ 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).