IVENA VASCULAR PATCH

K060396 · Atrium Medical Corp. · DXZ · May 12, 2006 · Cardiovascular

Device Facts

• Record ID: K060396
• Device Name: IVENA VASCULAR PATCH
• Applicant: Atrium Medical Corp.
• Product Code: DXZ · Cardiovascular
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iVena Vascular Patch is indicated for use in the repair and closure of the vascular system.

Device Story

The iVena Vascular Patch is a surgical implant used for the repair and closure of the vascular system. It is intended for use by surgeons in a clinical or operating room setting. The device functions as a patch to reinforce or close vascular defects. It is provided to the healthcare provider as a sterile implantable material. The patch benefits patients by facilitating the structural repair of blood vessels during surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Class II intracardiac patch or pledget (21 CFR 870.3470); product code DXZ. Device is an implantable vascular patch.

Indications for Use

Indicated for repair and closure of the vascular system in patients requiring vascular surgical intervention.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 12 2006

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

K060396 Re:

> iVena Vascular Patch Regulation Number: 21CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: II (two) Product Code: DXZ Dated: February 10, 2006 Received: February 15, 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,

Donna R. Lochner

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

Enclosure

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## Indications For Use

510(k) Number (if known):___ Ko603916

Device Name: Atrium Medical iVena Vascular Patch

Indications For Use:

The iVena Vascular Patch is indicated for use in the repair and closure of the vascular system.

Prescription Use X

AND/OR

Over-The-Counter Use

Page 1 of

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. Wachner

ion Sian-(Division Olgh Sign Scular Devices

510(k) Number K060396

Atrium Medical Corporation

CONFIDENTIAL