ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520

K093050 · Arrow Intl., Inc. · DQY · Dec 18, 2009 · Cardiovascular

Device Facts

• Record ID: K093050
• Device Name: ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
• Applicant: Arrow Intl., Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.

Device Story

The Arrow Seldinger Arterial Catheterization Device is a percutaneous catheterization system consisting of an introducer needle, a spring wire guide, and a polyurethane arterial catheter assembly. The catheter features a winged juncture hub, an extension tubing segment, a luer-locking hub, and a slide clamp. Used by clinicians to access peripheral arterial circulation or small vessels. The device facilitates vascular access via the Seldinger technique. It is a mechanical device; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Verification and validation testing included needle penetration, component compatibility, leak test, package integrity, tensile test, and pull testing.

Technological Characteristics

Polyurethane arterial catheter; winged catheter juncture hub; extension tubing; luer-locking hub; slide clamp; introducer needle; spring wire guide. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring access to the peripheral arterial circulation or other small vessels for catheterization.

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)

Submission Summary (Full Text)

{0}------------------------------------------------

1/09 30 56

## 510(k) Summary

| | DEC 1 8 2009 |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
| Contact person: | Christine Ford, Sr. Regulatory Affairs Specialist<br>Phone: [phone], ext. 3338<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | September 29, 2009 |
| Device trade name: | Arrow® Seldinger Arterial Catheterization Device |
| Device common name: | Arterial catheterization device |
| Device classification name: | Class II, DQY, Catheter, Percutaneous, 21 CFR 870.1250<br>Class II, DQX, Wire, Guide, Catheter, 21 CFR 870.1330 |
| Legally marketed device to which the device is<br>substantially equivalent: | Arrow Radial Artery Catheterization Set, K810675 |
| Description of the device: | The Arrow Seldinger arterial catheterization devices are comprised of an<br>introducer needle, a spring wire guide, and an arterial catheter assembly.<br>The catheter assembly consists of a polyurethane arterial catheter<br>molded to a winged catheter juncture hub. An extension tubing segment<br>is molded to the proximal end of the winged catheter hub. The proximal<br>end of the extension tubing segment is molded to a luer-locking hub. A<br>slide clamp is provided on the extension segment. |
| Intended use of the device: | The Arrow Seldinger arterial catheterization devices permit access to the<br>peripheral arterial circulation or to other small vessels. |
| Technological<br>characteristics: | The proposed arterial catheterization devices use the same fundamental<br>technology as the predicate arterial catheterization device. |
| Performance tests: | Verification and validation testing to support safety and efficacy<br>included the following:<br>- Needle penetration - Component compatibility<br>- Leak test - Package integrity<br>- Tensile test - Pull testing |
| Conclusions: | The results of verification testing demonstrate substantial equivalence of<br>the Arrow Seldinger Arterial Catheterization device to the legally<br>marketed predicate Arrow Radial Artery Catherization device. The<br>differences between the proposed and predicate devices do not raise new<br>issues of safety and effectiveness. |

.

.

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles, possibly suggesting care and community. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Arrow International, Inc. c/o Ms. Christine Ford Sr. Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605

DEC 1 8 2009

Re: K093050

Arrow Seldinger Arterial Catheterization Devices Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY, DQX Dated: November 25, 2009 Received: November 27, 2009

Dear Ms. Ford:

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 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.

{2}------------------------------------------------

Page 2 - Ms. Christine Ford

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,

Duma R. Vainer

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

Enclosure

{3}------------------------------------------------

## Attachment 2

| Indications for Use Statement | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K093050 |
| Device Name | Arrow ^® Seldinger Arterial Catheterization Devices |
| Indications for Use | The Arrow ^® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels. |

Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use __________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K093050

-

·