(86 days)
The iVena Vascular Patch is indicated for use in the repair and closure of the vascular system.
Not Found
This document is a 510(k) clearance letter from the FDA for the Atrium Medical iVena Vascular Patch. It does not contain information about acceptance criteria or specific study details proving a device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the provided text. The document is administrative in nature, granting permission to market the device, rather than detailing the technical studies and their outcomes.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the 510(k) submission itself, where such details would typically be found.
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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 (240) 276-0120 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 (800) 638-2041 or (301) 443-6597 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
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
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.(b)
Classification. Class II (performance standards).