AccuCath Ace Intravascular Catheter

K191232 · C.R. Bard, Inc. · FOZ · Sep 18, 2019 · General Hospital

Device Facts

• Record ID: K191232
• Device Name: AccuCath Ace Intravascular Catheter
• Applicant: C.R. Bard, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Radiopaque intravascular catheter with valve mechanism; delivered over guidewire with atraumatic tip; includes flashback chamber and safety container for sharps injury prevention. Used for short-term (<30 days) vascular access, including central (jugular) and peripheral sites. Operated by clinicians for blood sampling, pressure monitoring, or fluid/power-injected medication administration. Reduces blood exposure during insertion. Single-use, sterile device.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility (ISO 10993-1), sterility (ISO 11135:2014), power injection conditioning, hydraulic catheter burst testing, and shaft tensile testing. Risk analysis performed per ISO 14971.

Technological Characteristics

Polyurethane shaft/luer, stainless steel needle, nitinol guidewire. Single lumen, open-ended distal configuration. 18, 20, 22 gauge. Power injectable up to 6 mL/s. Sterile (Ethylene Oxide). Standards: ISO 10555-1, ISO 10993-1, ISO 14971, AAMI/ANSI/ISO 11135:2014.

Indications for Use

Indicated for vascular access, including both external and internal jugular veins, to sample blood, monitor blood pressure, or administer fluids intravenously. Suitable for use with power injectors. Consideration given to vascular anatomy, solution appropriateness, and therapy duration.

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)

Reference Devices

• PowerGlide Pro™ Midline Catheter (K153280)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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<br>Provisions | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|-----------------------|----------------------|--------------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Mona Shahrebani<br>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 |

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| Predicate<br>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<br>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<br>Description | The AccuCath Ace™ Intravascular Catheter consists of a radiopaque catheter with a valve mechanism delivered over a<br>guidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container that<br>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<br>power injectable at their labeled flow rate. | |
| | The AccuCath Ace™ Intravascular Catheter is offered in Emergent Access Kit configurations with various components<br>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<br>sample blood, monitor blood pressure, or administer fluids intravenously. | |
| Indications for<br>Use | The AccuCath Ace™ Intravascular Catheter is indicated for vascular access, including both the external and internal jugular<br>veins, to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration<br>given to adequacy of vascular anatomy, appropriateness of the solution being infused and duration of therapy. The AccuCath | |

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| Technological<br>Characteristics | Attribute | Subject Device – AccuCath Ace™<br>Intravascular Catheter | Predicate Device – AccuCath<br>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<br>Use | The AccuCath Ace™ Intravascular Catheter<br>is indicated for vascular access, including<br>both the external and internal jugular veins, to<br>sample blood, monitor blood pressure, or<br>administer fluids intravenously. This device<br>may be used with consideration given to<br>adequacy of vascular anatomy,<br>appropriateness of the solution being infused,<br>and duration of therapy. The AccuCath Ace™<br>IV Catheter is suitable for use with power<br>injectors. | The AccuCath™ Intravascular Catheter is<br>inserted into a patient's vascular system to<br>sample blood, monitor blood pressure, or<br>administer fluids intravenously. This device<br>may be used with consideration given to<br>adequacy of vascular anatomy,<br>appropriateness of the solution being<br>infused, and duration of therapy. The<br>AccuCath™ IV Catheter is suitable for use<br>with power injectors. |
| | Commercial<br>Name | AccuCath Ace™ Intravascular Catheter<br>Emergent Access Kits | AccuCath™ Intravascular Catheter |
| | Catheter<br>Dimensions | Same as predicate | Gauge / Length<br>18 gauge, 1.25 & 2.25 inches<br>20 gauge, 1.25 & 2.25 inches<br>22 gauge, 1.25 inches |
| | Duration of Use | Same as predicate | Short term (<30 days) |
| | Means of | Same as predicate | Percutaneous, over a Guidewire |
| insertion | | | |
| Insertion Site | | Central, peripheral | peripheral |
| Primary Device<br>Materials | | Same as predicate | Catheter Base Materials:<br>• Shaft Tubing: Polyurethane<br>• Luer Connector: Polyurethane<br>Needle:<br>• Stainless Steel<br>Guidewire:<br>• Nitinol |
| Catheter Proximal<br>Configuration | | Same as predicate | Luer connection |
| Catheter Distal<br>Configuration | | Same as predicate | Open ended |
| Number of<br>Lumens | | Same as predicate | Single Lumen |
| Power Injection<br>Maximum Flow<br>Rate | | Same as predicate | 6 mL/s |
| Sterility | | Same as predicate | Provided Sterile |
| Safety &<br>Performance<br>Tests | The technological characteristics listed above were evaluated using industry consensus standards, and as defined in the Risk<br>Assessment. The change in insertion site reflects the use of the device in emergent situations where central access is<br>necessary. A risk analysis was performed to assessed the changes and there were no new or different questions of safety and<br>effectiveness. Therefore, these technological characteristics substantially equivalent to the predicate device and do not raise<br>new or different questions of safety or effectiveness.<br>The following performance tests were conducted in determining substantial equivalence of the AccuCath Ace™ Intravascular<br>Catheter to the predicate AccuCath™ Intravascular Catheter:<br>• Biocompatibility per ISO 10993-1 | | |

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| 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. |
| Technological Comparison to Predicate Device | Technological characteristics of the subject AccuCath AceTM Intravascular Catheter are substantially equivalent with regard to the basic design and function of the predicate device, AccuCathTM Intravascular Catheter (K162894). All changes to materials are determined to be biologically safe for use, and the changes in design are considered substantially equivalent to the predicate device. |
| Summary of Substantial Equivalence | The modifications to the indications for use and product instructions for use has no impact on the intended use or the technological characteristics of the device. The results of the risk analysis as well as functional performance testing determined that the subject AccuCath AceTM Intravascular Catheter has demonstrated to be substantially equivalent to the cited predicate device. |