ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER

K061680 · Atrium Medical Corp. · DQY · Dec 15, 2006 · Cardiovascular

Device Facts

• Record ID: K061680
• Device Name: ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
• Applicant: Atrium Medical Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Atrium ClearWay™ RX Catheter is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.

Device Story

Atrium ClearWay™ RX Catheter is a percutaneous catheter designed for localized delivery of diagnostic or therapeutic agents. Used by physicians in clinical settings (e.g., cath lab) to target specific sites within coronary or peripheral vasculature. Device facilitates precise infusion/irrigation, potentially improving therapeutic efficacy or diagnostic accuracy by concentrating agents at the treatment site. Operates via standard percutaneous catheterization techniques.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Percutaneous catheter for localized infusion/irrigation. Class II device (21 CFR 870.1250). Design intended for coronary and peripheral vascular access.

Indications for Use

Indicated for localized infusion or irrigation of diagnostic and therapeutic agents into coronary and peripheral vasculature. Contraindicated for use in neurovasculature.

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.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2006

Atrium Medical Corporation c/o Mr. Joseph P. De Paolo VP Regulatory and Clinical Affairs 5 Westworth Drive Hudson, NH 03051

Re: K061680

Atrium ClearWay™ RX Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: November 8, 2006 Received: November 13, 2006

Dear Mr. De Paolo:

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. Joseph P. De Paolo

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,

Dorthy B. Ahl

61 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 STATEMENT

K061680

510(k) Number (if known)

Device Name:

Atrium ClearWay™ RX Catheter

:"

Indications for Use:

Atrium ClearWay™ RX Catheter is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.

It is not indicated for use in the neurovasculature.

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

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)

Duff B. Atwell Jr. AZ

510(k) Number K061680

Atrium Medical Corporation

CONFIDENTIAL