ANGIODYNAMICS, INC., MICRO ACCESS KITS

K051655 · AngioDynamics, Inc. · DQR · Sep 12, 2005 · Cardiovascular

Device Facts

• Record ID: K051655
• Device Name: ANGIODYNAMICS, INC., MICRO ACCESS KITS
• Applicant: AngioDynamics, Inc.
• Product Code: DQR · Cardiovascular
• Decision Date: Sep 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1300
• Device Class: Class 2

Intended Use

The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

Device Story

Micro Access Kit facilitates percutaneous vascular access; utilizes 21-gauge needle for initial vessel puncture; allows subsequent introduction of guidewire or catheter into vascular system. Used by clinicians in clinical settings; provides minimally invasive entry point for interventional procedures. Benefits patient by reducing trauma associated with initial vascular access compared to larger gauge needles.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components include catheter cannula, guide wire, trocar, and catheter introducer. Classified under 21 CFR 870.1300, 870.1330, 870.1390, 870.1340. Class II device.

Indications for Use

Indicated for percutaneous vascular access via 21-gauge needle stick for the introduction of guidewires or catheters in patients requiring vascular access.

Regulatory Classification

Identification

A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

SEP 1 2 2005

Food and Drug Administratior 9200 Corporate Boulevard Rockville MD 20850

AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensburg Avenue Queensburg, NY 12804

> K051655 Micro Access Kits Nicio Access Rirs
> Regulation Number: 21 CFR 870.1300, 870.1330, 870.1390, 870.1340 Regulation Name: Catheter Cannula, Catheter Guide Wire, Trocar, Catheter Introducer Regulatory Class: II Product Code: DQR, DQX, DRC, DYB Dated: June 20, 2005 Received: June 21, 2005

Dear Ms. Juckett:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalled is reley presses is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provision to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been reclasined in assee approval of a premarket approval application (PMA). and Cosmetic Act (110) market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market and act include requirements for annual registration, listing of general controls provisions of the ties, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back acceral 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. Teri Juckett

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,

Duna R. Vochner

( ) 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

1051655

510(k) Application: New Application

Device Name:

:

.

AngioDynamics, Inc. Micro Access Kit

## Indications for Use:

The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

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)

Duna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 051655

AngioDynamics Micro Access Kit 510(k) Design History File 377

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