(36 days)
The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Not Found
The provided FDA 510(k) summary only includes the regulatory approval status and indications for use of the Atrium iCAST Covered Stent. It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence/machine learning device evaluation (such as sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot provide the requested information based on the given document.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
NOV - 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atrium Medical Corporation % Mr. Joseph P. De Paolo VP Regulatory and Clinical Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K050814
Trade/Device Name: Atrium ICAST Covered Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: March 29, 2005 Received: March 31, 2005
Dear Mr. De Paolo:
This letter corrects our substantially equivalent letter of May 6, 2005.
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 (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.
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
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Page 2 - Mr. Joseph P. De Paolo
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 continue 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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Lewins
✔ Mark N. Melkerson
Director
Division of General, Re
and Neurological Devi
Office of Device Evalua
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K04/269
INDICATIONS FOR USE STATEMENT
510(k) Number (if known) K041269 and K050814
Atrium iCAST Covered Stent Device Name:
The iCAST Covered Stent is indicated for the treatment of Indications for Use: tracheobronchial strictures produced by malignant neoplasms.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-The-Counter Use
ver-The-Counter Use __
Hubert Leuen
Division of General. Restorati and Neurological Devices
510(k) Number K050814
Atrium Medical Corporation
Prescription Use
CONFIDENTIAL
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”