BENELLI ACCESS DEVICE

K111334 · Vascular Solutions, Inc. · DQY · Aug 1, 2011 · Cardiovascular

Device Facts

• Record ID: K111334
• Device Name: BENELLI ACCESS DEVICE
• Applicant: Vascular Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Benelli is intended for use in accessing the peripheral vasculature.

Device Story

Benelli Access Device is a 4 F intravascular over-the-needle catheter used for peripheral vascular access. System includes 6.9 cm high-density polyethylene shaft, polypropylene hub, rotating suture wing for securement, sidearm with extension tubing, and three-way stopcock for flushing, fluid delivery, and blood sampling. Kit components include needleless access port, 21 G x 9 cm echogenic needle, and 0.018" x 40 cm guidewire. Device is used by clinicians to facilitate vascular access; output is physical access to the patient's peripheral vasculature for therapeutic or diagnostic purposes.

Clinical Evidence

Bench testing only. Design verification included insertion force, radiopacity, liquid leak, aspiration, tensile, corrosion, and kink testing. Biocompatibility testing per ISO 10993-1 included cytotoxicity, acute systemic toxicity, sensitization, hemocompatibility, and irritation/intracutaneous reactivity.

Technological Characteristics

4 F over-the-needle catheter; 6.9 cm high-density polyethylene shaft; polypropylene hub; rotating suture wing; sidearm with extension tubing and three-way stopcock. Biocompatibility per ISO 10993-1. Mechanical design features include tapered distal tip for vascular entry.

Indications for Use

Indicated for accessing the peripheral vasculature in patients requiring vascular access.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Arrow Arterial Catheterization Device (K021120)
• Nexiva Closed IV Catheter System (K032843)

Submission Summary (Full Text)

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#### 510(k) Summary 2

Date Prepared: May 11, 2011

# 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

### Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: [phone]; Fax: [phone] Establishment Registration # 2134812

Contact Person Jennifer Ruether Sr. Regulatory Product Specialist

#### General Information

| Trade Name | Benelli Access Device |
|---------------------|-----------------------------------------------------------------------------------------------|
| Common / Usual Name | Catheter, percutaneous |
| Classification Name | 870.1250; DQY; Percutaneous catheter; Class II |
| Predicate Devices | K021120 Arrow Arterial Catheterization Device (Arrow<br>International, Inc. |
| Predicate Devices | K032843 Nexiva Closed IV Catheter System (Becton<br>Dickinson Infusion Therapy Systems, Inc.) |

#### Device Description

The Benelli Access Device is a 4 F intravascular over-the-needle catheter consisting of a 6.9 cm high-density polyethylene shaft and a polypropylene hub. The distal end of the shaft terminates in a tapered tip for smooth entry into the vasculature. A polypropylene rotating suture wing is provided on the distal end of the hub and is used to secure the catheter to the patient and prevent dislodgement. The catheter hub has a sidearm that attaches to extension tubing. A three-way stopcock is attached to the distal end of the extension tubing to provide multiple access points to the catheter lumen, allowing for easier flushing, fluid delivery, and blood sampling.

The Benelli Access Device is sold as part of an intravascular catheterization kit. This kit includes the following components:

- . Benelli Access Device (4 F x 6.9 cm catheter with sidearm tubing and 3-way stopcock)
- Intraluminal protection system (needleless access port)
- 21 G x 9 cm echogenic needle .
- . 0.018" x 40 cm guidewire.

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#### Intended Use / Indications

The Benelli is intended for use in accessing the peripheral vasculature.

#### Technological Characteristics

The Benelli Access Device is similar to the predicate devices in design and performance. The three devices consist of the over-the-needle catheter design and are available in similar dimensions. The Benelli Access Device and the Nexiva Closed IV Catheter System both have additional access points to allow for device flushing and fluid delivery. The Benelli Access Device utilizes different materials of construction from the predicate devices; however, these materials are commonly used in vascular access devices. Material suitability for the intended clinical use was evaluated through bench testing and biomaterial assessments.

#### Substantial Equivalence and Summary of Studies

The Benelli Access Device is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:

- . Insertion force
- Radiopacity .
- . Liquid leak
- Aspiration .
- Tensile
- Corrosion
- Kink

Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:

- . Cytotoxicity
- Acute systemic toxicity .
- Sensitization .
- Hemocompatibility ●
- Irritation/intracutaneous . reactivity
Results of the design verification testing and biomaterial assessments did not raise new safety or performance questions.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MI) 20993-0002

Vascular Solutions, Inc. c/o Ms. Jennifer Ruether Sr. Regulatory Product Specialist 6464 Sycamore Court Minneapolis, MN 55369

AUG - 1 2011

Re: K111334

Trade/Device Name: Benelli Access Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 11, 2011 Received: May 12, 2011

Dear Ms. Ruether:

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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Page 2 - Ms. Jennifer Ruether

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K111334

Device Name: Benelli Access Device Kit

Indications for Use:

The Benelli is intended for use in accessing the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K111334

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