ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT

K071998 · Arrow Intl., Inc. · FMI · Sep 26, 2007 · General Hospital

Device Facts

• Record ID: K071998
• Device Name: ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
• Applicant: Arrow Intl., Inc.
• Product Code: FMI · General Hospital
• Decision Date: Sep 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.

Device Story

Arrow Echogenic Introducer Needle provides vascular access for guidewire insertion; facilitates catheter placement. Features grit-blast echogenic surface treatment to enhance visibility under ultrasound guidance. Used by clinicians in clinical settings. Device consists of single lumen needle (18Ga-21Ga); utilizes standard needle lubricant. Output is physical access to vascular system; aids clinician in accurate needle placement via ultrasound visualization.

Clinical Evidence

Bench testing only. Tests included needle penetration and hub bond tensile strength to verify performance against predicate devices.

Technological Characteristics

Single lumen hypodermic needle; 18Ga-21Ga diameter; 3.81-7cm length. Features grit-blast echogenic surface treatment for ultrasound visibility. Uses standard needle lubricant. Class II device (21 CFR 880.5570).

Indications for Use

Indicated for patients requiring vascular access for guidewire introduction to facilitate catheter placement.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Arrow Echogenic Needle (K040100)
• Arrow Extended Vascular Access Needle (K924338)
• Radial Artery Catheterization Set with integral needle protection (K021120)
• PICC Two-Lumen Peripherally Inserted Central Catheter Kit with Blue FlexTip® Catheter and Integral Needle Protection (K003006)

Submission Summary (Full Text)

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SEP 26 0007

## 510(k) Summary – K071998

In accordance with 21 CFR 807.87(h), the following 510(k) summary has been prepared per 21 CFR 807.92.

## Echogenic Introducer Needle 510(k) Summary

| Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Kirsten Stowell<br>Regulatory Affairs Specialist<br>Phone: [phone], ext. 3514<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | August 30, 2007 |
| Device trade name: | Arrow Echogenic Introducer Needle |
| Device common name: | Introducer Needle |
| Device classification: | Hypodermic single lumen needle; Product Code FMI;<br>21 CFR 880.5570, Class II |
| Legally marketed devices to<br>which the device is<br>substantially equivalent: | Arrow Echogenic Needle (K040100, SE date 3/1/2004)<br>Arrow Extended Vascular Access Needle (K924338, SE<br>date 3/18/1993)<br>Radial Artery Catheterization Set with integral needle<br>protection (K021120, SE date: 5/2/2002)<br>PICC Two-Lumen Peripherally Inserted Central Catheter<br>Kit with Blue FlexTip® Catheter and Integral Needle<br>Protection (K003006, SE date: 10/27/2000) |
| Description of the device: | The Arrow Echogenic Introducer Needle has the following<br>characteristics:<br><ul><li>Outside Diameter = 18Ga - 21Ga</li><li>Inside Diameter = 0.0240 - 0.042 in.</li><li>Usable lengths of 1 ½ - 2 ¾ in. (3.81 - 7cm)</li><li>Grit-blast echogenic surface treatment</li></ul> |
| Intended use of the device: | The intended use is the same as the predicate devices. |
| Indications for use: | The Indication for Use is the same as the predicate device. |

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| Technological<br>characteristics: | The proposed echogenic introducer needle has the same<br>technological design characteristics as the predicate<br>echogenic introducer needle devices. This design<br>includes the same needle lubricant as the predicate<br>introducer needles with integral needle protection. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance tests: | The following tests were performed to demonstrate<br>substantial equivalence:<br>• Needle penetration test<br>• Hub bond tensile strength test |
| Assessment of non-clinical<br>performance data: | The results of the bench tests demonstrate that Arrow's<br>echogenic introducer needle is as safe and effective as<br>compared to the currently marketed predicate introducer<br>needle. |
| Summary | Arrow International's echogenic introducer needle has the<br>same intended use as the predicate devices. Based on the<br>assessment of non-clinical performance data to verify the<br>intended use, and the technological characteristic<br>comparison, Arrow's echogenic introducer needle is<br>substantially equivalent to the legally marketed predicate<br>device. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract representation of a human form or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kirsten Stowell Regulatory Affairs Specialist ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607

SFP 26 2007

Re: K071998

Trade/Device Name: Arrow Echogenic Introducer Needle Component Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 28, 2007 Received: August 29, 2007

Dear Ms. Stowell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Stowell

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Arrow Echogenic Introducer Needle Component

The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Intre 20m

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Arrow International, Inc.