ATRIUM MEDICAL CORPORATION ICAST COVERED STENT

K041269 · Atrium Medical Corp. · JCT · Sep 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041269
• Device Name: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
• Applicant: Atrium Medical Corp.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Story

The iCAST Covered Stent is a medical device designed for the treatment of tracheobronchial strictures resulting from malignant neoplasms. It is deployed by a physician in a clinical setting to restore airway patency. The device functions as a mechanical stent to provide structural support to the airway, alleviating obstruction caused by tumors. By maintaining airway patency, the device aims to improve patient respiratory function and quality of life. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review.

Technological Characteristics

The device is a covered stent designed for tracheobronchial application. It functions as a mechanical prosthesis to maintain airway patency. No specific materials, software, or energy sources are detailed in the provided text.

Indications for Use

Indicated for patients with tracheobronchial strictures caused by malignant neoplasms.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

Atrium Medical Corporation % Mr. Joseph P. DePaolo VP Regulatory and Clinical Affairs 5 Wentworth Drive . Hudson. New Hampshire 03051

Re: K041269

Trade/Device Name: ICAST Covered Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: August 13, 2004 Received: August 17, 2004

Dear Mr. DePaolo:

This letter corrects our substantially equivalent letter of September 14, 2004.

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. DePaolo

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 [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/dsma/dsmamain.html

Sincerely yours,

Herbert Lewendus

Mark N. Melkerson Director Division of Genera. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K050814

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known) K041269 and K050814

Device Name:

Atrium iCAST Covered Stent

Indications for Use:

The iCAST Covered Stent is indicated for the treatment of 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

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** k041269

Prescription Use

CONFIDENTIAL