ATRIUM MEDICAL CORPORATION ICAST COVERED STENT by ATRIUM MEDICAL CORP.

The provided text is a 510(k) clearance letter from the FDA for the Atrium iCAST Covered Stent, not a study report or clinical trial document. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

A 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device, and while it confirms the device is safe and effective for its indicated use, it does not typically include the specifics of a clinical study or performance data in the level of detail requested.

Therefore, based solely on the provided text, I cannot answer the questions. The document does not contain information on:

Acceptance criteria and reported device performance: This letter is a regulatory clearance, not a performance report.
Sample size, data provenance: Not mentioned.
Number/qualifications of experts, ground truth establishment: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: Not mentioned and not typically part of a 510(k) summary for this type of device.
Standalone performance study: Not mentioned.
Type of ground truth: Not mentioned.
Training set sample size: Not mentioned.
Ground truth for training set: Not mentioned.

To obtain this information, one would typically need to review the premarket notification (510(k) submission) itself, including any clinical data or bench testing summaries submitted by the manufacturer to the FDA.

Summary

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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 (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 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

Regulation Number and Section

§ 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.”