(131 days)
The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
The IntraCoil® Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. Upon deployment the stent expands to conform to the bronchial lumen surface. The stent's purpose is to increase or maintain the inner lumenal diameter of the bronchial passage.
I am sorry, but there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) premarket notification summary for a medical device (IntraCoil® Peripheral Stent), which focuses on establishing substantial equivalence to previously cleared devices rather than presenting the results of a primary clinical study with acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
ev3 Inc. % Mr. David Worrell, MS, RAC Manager, Regulatory Affairs 9600 54th Avenue North Plymouth, Minnesota 55442-2111
Re: K990221
Trade/Device Name: Intracoil® Peripheral Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: March 25, 1999 Received: March 29, 1999
Dear Mr. Worrell:
This letter corrects our substantially equivalent letter of June 2, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the we nave referenced above and have determined the device is substantially equivalent (for the actions 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 the Foderal Pood, Drog, al (PMA). You may, therefore, market the device, subject to the general promation approvisions 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 (1 wir you may be basjon of ade 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. David Worrell, MS, RAC
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 manufacturing practice requirements as estronic 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 This letter will anow you to continue maxing of substantial equivalence of your device 510(K) predicate nothreation: "The I Drives 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), If you desire specific at rios for your corporation of (240) 276-0115. Also, please note the picase contact the Office of economic by reference to premarket notification" (21CFR Part regulation chitted, "Wholananing of responsibilities under responsibilities under the Act 807.77). Tou may obtain only generals and Consumer Assistance at its noll als Drieson or (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Lewerenz
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number: K990221
IntraCoil® Peripheral Stent Device Name:
Indication For Use:
The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTIUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Humphrey
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K990221
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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990221 p. lof/
Premarket Notification (510(k)) Summary
K990221 510(k) Number:
IntraCoil® Self-expanding Peripheral Stent Product Name:
Tracheal prosthesis Common Name:
II per 21 CFR 878.3720 (tracheal prosthesis) Class:
Submitter's Name: ev3 Inc. 9600 54th Avenue North Plymouth, MN 55442
Official Contact: David Worrell Regulatory Affairs Manager Telephone: 763-398-7000 Fax: 763-398-7200
Summary Preparation Date:
May 1, 2006
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission. Substantial equivalence is claimed to the Boston Scientific, Inc. Ultraflex™ and Wallstent® selfexpanding tracheobronchial stents (K963241 and K982184, respectively).
The IntraCoil® Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. The stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms. Upon deployment the stent expands to conform to the bronchial lumen surface. The stent's purpose is to increase or maintain the inner lumenal diameter of the bronchial passage.
Summary of technological characteristics: the stent and predicate stents are all self-expanding Summary of technological enariologicon elgiloy) into a tubular configuration, packaged and sterilized. The stent and predicate stents are ethylene oxide (ETO) sterilized. In vitro tests to assess performance characteristics were performed as outlined in FDA document "Guidance for the content of premarket notifications for esophageal and tracheal prostheses", dated April 28, 1998 and biocompatibility standard ISO 10993 using finished product.
As demonstrated the stent is identical in materials, and equivalent for indication for use and technological characteristics. The collective evidence therefore provides assurance that the IntraCoil peripheral stent meets the requirements for the stated intended use.
§ 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.”