ARROW ECHOGENIC INTRODUCER NEEDLE

K040100 · Arrow Intl., Inc. · DQX · Mar 1, 2004 · Cardiovascular

Device Facts

• Record ID: K040100
• Device Name: ARROW ECHOGENIC INTRODUCER NEEDLE
• Applicant: Arrow Intl., Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

An introducer needle allows access to the vasculature for introduction of a guidewire. A peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein.

Device Story

Echogenic introducer needle used to gain initial venous access; guidewire inserted through needle to establish track; needle removed; dilator/peel-away introducer assembly advanced to enlarge subcutaneous track; dilator removed; PICC inserted through peel-away introducer; catheter positioned; guidewire and peel-away introducer removed; Stat-Lock device secures catheter. Used in clinical settings by healthcare professionals for central venous access.

Clinical Evidence

Bench testing only. Testing included needle penetration and hub bond tensile strength to demonstrate performance equivalence.

Technological Characteristics

Echogenic introducer needle; stainless steel construction; manual operation; non-powered; sterile; single-use.

Indications for Use

Indicated for adult and pediatric patients requiring venous access to the central circulation via peripheral vein for intravenous therapy; used for vascular access to introduce a guidewire.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Arrow International, Inc.'s PICC Two-Lumen Peripherally Inserted Central Catheter Set (K930129)
• Cook's 21Ga needle (510(k) number unknown)

Submission Summary (Full Text)

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| 510(k) Summary | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
| Contact person: | William G. McLain<br>Manager, Regulatory Affairs<br>Phone: [phone], ext. 3323<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | January 16, 2004 |
| Device trade name: | Arrow Echogenic Introducer Needle, a component of Peripherally<br>Inserted Central Catheter Sets |
| Device common name: | Introducer Needle |
| Device classification<br>name: | DQX; 21 CFR Part 870.1330; Accessory to Catheter Guidewire |
| Legally marketed<br>devices to which the<br>device is substantially<br>equivalent: | Arrow International, Inc.'s PICC Two-Lumen Peripherally Inserted<br>Central Catheter Set (K930129).<br>Cook's 21Ga needle will also be used as a predicate. 510(k)<br>number unknown. |
| Description of the<br>device: | The Peripherally Inserted Central Catheter Kits contains many of<br>the components required for the user to place the PICC. An<br>introducer needle is used to gain access to the vein. A guidewire is<br>then placed through the introducer to provide a track for the<br>remaining devices. After removal of the introducer needle from the<br>vein, the guide wire is left in place and a dilator/peel-away<br>introducer assembly is advanced into the vessel thereby enlarging<br>the subcutaneous track. When positioned, the dilator is removed<br>and the peel-away introducer remains along with the guide wire.<br>The PICC is placed through the introducer catheter. After catheter<br>positioning is confirmed, the guide wire and peel-away introducer<br>are removed. A "Stat-Lock" catheter fixation device secures the<br>catheter during use. |
| Intended use of the<br>device: | An introducer needle allows access to the vasculature for<br>introduction of a guidewire. |
| | A peripherally inserted Central Catheter permits venous access to<br>the central circulation through a peripheral vein. |
| Technological<br>characteristics: | The proposed device has the same technological characteristics as<br>the predicate device(s). |
| Performance tests: | Tests were performed to demonstrate substantial equivalence in the<br>following areas:<br>- Needle penetration<br>- Hub bond tensile strength test |
| Conclusions: | The results of the laboratory tests demonstrate that the device is as<br>safe and effective as the legally marketed predicate devices. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing protection and service. The eagle is stylized with three distinct lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Mr. William G. McLain Manager, regulatory Affairs ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607

Re: K040100

Trade/Device Name: Arrow Echogenic Introducer Needle a Component of Peripherally Inserted Cental Catheter Sets Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: January 20, 2004 Received: January 20, 2004

Dear Mr. McLain:

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 - Mr. McLain

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 vour 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/dsma/dsmamain.html

Sincerely yours,

Chiu-Ling, Ph.D.

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: K040100 Arrow Echogenic Introducer Needle, a component of Device Name: Peripherally Inserted Central Catheter Sets Indications for Use: The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire. A peripherally inserted central catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.

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

Irene Naveran for WMB

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

510(k) Number: K040100

PRESCRIPTION USE X