(28 days)
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium and fully covered with ePTFE sleeve. The ePTFE is sealed at the proximal and distal ends completely encapsulating the Nickel Titanium. The Controlled Expansion® Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.
This document is a 510(k) summary for a medical device (a stent) and does not describe an AI/ML powered device or a study involving such a device. Therefore, it is not possible to extract the requested information about acceptance criteria and a study proving device conformance using AI/ML specific metrics.
The document focuses on demonstrating substantial equivalence of a new stent length to a previously cleared predicate device, based on materials, mode of action, and intended use. The "Testing Summary" section mentions simulated use and performance testing to demonstrate mechanical integrity and device performance, but this is traditional bench testing, not an AI/ML study.
Therefore, I cannot provide the requested information.
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NOV - 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Wallace Enterprises, Inc. DBA Vascular Architects % Mr. Kevin F. MacDonald Regulatory Consultant 229 Marvilla Circle Pacifica. California 94044
Re: K030567
Trade/Device Name: Vascular Architects aSpire® Covered Stent and Controlled Expansion" Delivery System
Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: February 21, 2003 Received: February 24, 2003
Dear Mr. MacDonald:
This letter corrects our substantially equivalent letter of March 24, 2003.
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 manufacturing practice requirements as set
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Page 2 -- Mr. Kevin F. MacDonald
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 Lewin md
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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Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Prescription Use X
OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
luation (ODE)
(Per 21 CFR 801.109)
and Neurological Devices
510(k) Number K030567
Page 7
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030567 f. lot 2
Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K030567.
General Information
| Date Amended: | July 28, 2006 |
|---|---|
| Classification | Class II, Tracheal Prosthesis per 21 CFR § 878.3720 |
| Product Code | JCT |
| Common Name: | Tracheal Stent |
| Trade Name | Vascular Architects aSpire® Covered Stent andControlled Expansion® Delivery System |
| Submitter | Wallace Enterprises, Inc. DBA Vascular Architects1650 Elm Hill PikeNashville, TN 37210 |
| Contact | Kevin F. MacDonaldRegulatory ConsultantTel 415 609 9875 |
Intended Use
The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.
Predicate Devices
K012544 - Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery Catheter
Performance Standards
Performance Standards have not yet been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act.
Device Description
The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium and fully covered with ePTFE sleeve. The ePTFE is sealed at the proximal and distal ends completely encapsulating the Nickel Titanium. The Controlled Expansion®
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K030567 p. dot 2
Vascular Architects aSpire® Covered Stent Amendment to K012544, K030567, K031641 July 28, 2006
Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.
Comparison To Predicate Device
The 15 cm Vascular Architects aSpire® Covered Stent shares the same intended use as the predicate device and is identical to the predicate device in materials and mode of action. production and is neem the subject device and the predicate device is in the length of the stent.
Testing Summary
Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device is substantially equivalent to that of the predicate device.
Statement of Substantial Equivalence
The 15cm Vascular Architects aSpire® Covered Stent is substantially equivalent to the legally marketed 2.5cm, 5.0cm and 10cm Vascular Architects aSpire® Covered Stent sizes.
§ 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.”