AccuCath Intravascular Catheter

K153298 · C.R. Bard, Inc. · FOZ · Dec 10, 2015 · General Hospital

Device Facts

• Record ID: K153298
• Device Name: AccuCath Intravascular Catheter
• Applicant: C.R. Bard, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AccuCath™ Intravascular Catheter is intended to be inserted in the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

Device Story

The AccuCath™ Intravascular Catheter is a sterile, single-use peripheral catheter used by clinicians for vascular access. The device consists of a catheter with a luer lock fitting, a needle with a flashback chamber, a guidewire, and a safety mechanism to shield the needle post-placement. A built-in blood control septum automatically restricts blood flow upon needle removal until a secure luer connection is established. The device is inserted percutaneously over the guidewire. It enables blood sampling, blood pressure monitoring, and intravenous fluid administration. The safety feature reduces the risk of sharps injury to the clinician. The device is available in 1.25 and 2.25-inch lengths and 18, 20, and 22 gauge sizes.

Clinical Evidence

Bench testing only. Performance was evaluated against ISO 10555-1/5, ISO 7864, ISO 9626, ISO 594-1/2, and ASTM F640. Tests included effective catheter length, safety activation, gravity flow rate, bleedback prevention, guidewire deployment/retraction, and catheter flashback visibility. All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: Pebax® (shaft tubing), Polyurethane (luer connector), Stainless Steel (needle), Nitinol (guidewire). Design: Single lumen, over-the-needle peripheral catheter with integrated guidewire and blood control septum. Dimensions: 18, 20, 22 gauge; 1.25 and 2.25-inch lengths. Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None (mechanical device).

Indications for Use

Indicated for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. Suitable for use with low pressure power injectors (max 300 psi, max 6mL/second). Use requires consideration of vascular anatomy, infusion solution, 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™ BC Intravascular Catheter System (K140504)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 10, 2015

C.R. Bard, Inc. Mr. Casey Coombs Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K153298

Trade/Device Name: Accucath™ Intravascular Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 12, 2015 Received: November 13, 2015

Dear Mr. Coombs:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known) K153298

Device Name AccuCath Intravascular Catheter

#### Indications for Use (Describe)

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 low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.

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
21 CFR 807.92(a)

| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 | |
| | Contact Person: | Mr. Casey Coombs<br>Regulatory Affairs Specialist | |
| | Telephone Number:<br>Fax Number:<br>Date of Preparation: | [phone]<br>[phone]<br>9 December 2015 | |
| Subject<br>Device | Trade Name: | AccuCath™ Intravascular Catheter | |
| | Common Name: | Intravascular Catheter | |
| | Classification Name: | Intravascular Catheter | |
| | Product Code/<br>Regulation: | FOZ/21 CFR §880.5200 | |
| Predicate<br>Devices | Predicate Trade Name: | AccuCath™ BC Intravascular Catheter System | |
| | Classification Name: | Intravascular Catheter | |
| | Premarket Notification:<br>Manufacturer: | K140504<br>Bard Access Systems, Inc. | |
| Device<br>Description | The AccuCath™ Intravascular Catheter has usable length catheters of 1.25<br>and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use,<br>sterile intravascular catheters designed to be inserted into a patient's vascular<br>system to sample blood, monitor blood pressure, or administer fluids<br>intravenously. The AccuCath™ IV Catheter's hub has a built in blood control<br>septum. The blood control feature is a single-use septum that automatically<br>activates to stop the blood flow in the catheter hub when the needle is<br>removed from the catheter during initial insertion by the clinician. Blood flow<br>from the catheter hub will be restricted immediately after the needle retraction<br>until a secure luer connection is made. The flow path is permanently opened<br>once a secure luer connection has been made. The AccuCath™ IV Catheter<br>is provided with a safety mechanism which allows the needle to be shielded<br>following placement of the catheter. All devices have the basic structure of a<br>protective cover, a catheter with a luer lock fitting, a needle connected to a<br>flashback chamber, a safety container, and a guidewire within the lumen of<br>the needle which is connected to a slider, spring and release button. | | |
| Intended Use | The AccuCath™ Intravascular Catheter is intended to be inserted in the<br>patient's vascular system for short term use (less than 30 days) to sample<br>blood, monitor blood pressure, or administer fluids intravenously. | | |
| Indications For Use | The AccuCath™ Intravascular Catheter is inserted into a patient's vascular<br>system to sample blood, monitor blood pressure, or administer fluids<br>intravenously. This device may be used with consideration given to adequacy<br>of vascular anatomy, appropriateness of the solution being infused, and<br>duration of therapy. The AccuCath™ IV Catheter is suitable for use with low<br>pressure power injectors having a maximum pressure setting of 300 psi and<br>maximum flow rate of 6mL/second. | | |
| | Technological characteristics of the subject AccuCath™ Intravascular<br>Catheter are substantially equivalent with respect to basic design and function<br>to those of the cited predicate device. | | |
| | Key modifications made to the subject device when compared to the predicate<br>device are as follows:<br>Dimensional modifications to introduce a 1.25 inch AccuCath™ Intravascular Catheter Modifications to the guidewire and seal components Dimensional modifications to the needle Modifications made to the guidewire, needle, and catheter interfaces Labeling and packaging modifications made due to subject 1.25 inch device, commercial name change, and packaging kit configurations Qualified additional sterilization locations The following table provides a comparison between the subject and predicate device. | | |
| | | | |
| Technological<br>Characteristics | Attribute | Subject Device – AccuCath™<br>Intravascular Catheter | Predicate Device –<br>AccuCath™ BC<br>Intravascular Catheter<br>System (K140504) |
| | Owner | Same | Bard Access Systems, Inc. |
| | Classification | Same | FOZ - 21 CFR 880.5200 -<br>Short-term - Intravascular<br>Catheter |
| | 510(k) Status | Subject of this Premarket<br>Notification | K140504 - Concurrence date<br>July 17, 2014 |
| | Indications for<br>Use | Same as predicate with the<br>exception of the commercial<br>name:<br>The AccuCath™ Intravascular<br>Catheter is inserted into a<br>patient's vascular system to<br>sample blood, monitor blood<br>pressure, or administer fluids<br>intravenously. This device may<br>be used with consideration given<br>to adequacy of vascular<br>anatomy, appropriateness of the<br>solution being infused, and<br>duration of therapy. The<br>AccuCath™ IV Catheter is | The AccuCath™ BC<br>Intravascular Catheter System<br>is inserted into a patient's<br>vascular system to sample<br>blood, monitor blood pressure,<br>or administer fluids<br>intravenously. This device may<br>be used with consideration<br>given to adequacy of vascular<br>anatomy, appropriateness of<br>the solution being infused, and<br>duration of therapy. The<br>AccuCath™ BC is suitable for<br>use with low pressure power<br>injectors having a maximum |
| Subject and Predicate Device Comparison Table | | | |
| | Attribute | Subject Device – AccuCath™ Intravascular Catheter | Predicate Device – AccuCath™ BC Intravascular Catheter System (K140504) |
| Technological<br>Characteristics | Commercial Name | AccuCath™ Intravascular Catheter | AccuCath™ BC Intravascular Catheter System |
| | Catheter Dimensions | Length: 1.25 and 2.25 inches<br>Diameter: 18, 20, 22 gauge | Length: 2.25 inches<br>Diameter: 18, 20, 22 gauge |
| | Duration of Use | Same | Short term (<30 days) |
| | Primary Device Components | Same | Needle<br>Guidewire<br>Catheter |
| | Means of Insertion | Same | Percutaneous, over a Guidewire |
| | Insertion Site | Same | Peripheral |
| | Primary Device Materials | Same | Catheter Base Materials<br>• Shaft Tubing:<br>Pebax®<br>• Luer Connector:<br>Polyurethane<br>Needle<br>• Stainless Steel<br>Guidewire<br>• Nitinol |
| | Catheter Proximal Configuration | Same | Luer Connection |
| | Catheter Distal Configuration…