RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP

K021120 · Arrow Intl., Inc. · DQY · May 2, 2002 · Cardiovascular

Device Facts

• Record ID: K021120
• Device Name: RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
• Applicant: Arrow Intl., Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

Device Story

Device is a radial artery catheter-over-needle assembly featuring an integral, passive needle protection mechanism. Used by clinicians to access peripheral arterial circulation. Safety feature minimizes risk of sharps injuries during catheterization. Device functions as a standard catheterization set with added sharps protection. No electronic or software components.

Clinical Evidence

Bench testing only. Performance tests included device reliability, clinical simulation, deactivation force of safety feature, safeguard interference fit, tensile testing, and corrosion testing.

Technological Characteristics

Radial artery catheter-over-needle assembly with integral passive needle protection. Materials, design, packaging, and sterilization methods are identical to predicate devices. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring access to the peripheral arterial circulation. No specific age or gender restrictions stated. Contraindications not specified.

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 Radial Artery Catheterization Set (K810675)
• Arrow PICC Two-lumen Peripherally-inserted Central Catheter Kit with Blue Flex Tip® Catheter and Integral Needle Protection (K003006)

Submission Summary (Full Text)

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MAY 0 2 2002

ecial 510(k)

## SECTION 3 -- 510K SUMMARY Arrow International, Inc. Submitter: 2400 Bemville Road Reading, PA 19605 Contact person: Debra A. Peacock Regulatory Associate Phone: [phone], ext. 3368 Fax: [phone] E-mail: [e-mail] April 3, 2002 Date summary prepared: Device trade name: Radial Artery Catheterization Set with Integral Needle Protection. Device common name: Radial artery catheterization set. Device classification name: Percutaneous catheter Legally marketed devices to Arrow Radial Artery Catheterization Set (K810675), and the Arrow PICC Two-lumen which the device is substantially equivalent: Peripherally-inserted Central Catheter Kit with Blue Flex Tip® Catheter and Integral Needle Protection (K003006). Description of device: The proposed device is a sharps-protected version of the Arrow Radial Artery Catheterization Set. It contains a radial artery catheter-over-needle assembly with an integral, passive needle protection feature. Intended use of the device: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device. Technological characteristics: The proposed needle-protected RA device has the same technological characteristics as the predicate devices including design, packaging, sterilization and labeling. Performance Tests The following tests were performed to demonstrate substantial equivalence: · Device reliability · Clinical simulation · Deactivation force of safety feature · Safeguard interference fit · Tensile · Corrosion

Arrow International, Inc., April 2002

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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 0 2 2002

Ms. Debra A. Peacock Regulatory Associate Arrow International, Inc. 2400 Bernville Road Reading, PA 19605

> K021120 Radial Artery Catheterization Set with Integral Needle Protection Regulation Number: 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: April 3, 2002 Received: April 8, 2002

Dear Ms. Peacock: .

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.

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.

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Page 2 - Ms. Debra A. Peacock

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,

V. Dale Tull

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Radial Artery Catheterization Set with Integral Needle Protection

Special 510(k)

## SECTION 7 - INDICATIONS FOR USE STATEMENT

Page of

510(k) Number:

02/120

Device Name: Radial Artery Catheterization Set with integral needle protection

Indications for Use: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

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

**Prescription Use**
**(Per 21 CFR 801.109)**

Division of Cardiovascular & Respiratory Devices
510(k) Number K21120