(93 days)
The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice consists of the exact same stent as the AERO™ predicate stent (K082284) but with an alternate delivery system. The Direct Visualization (DV) delivery system of AERO DV™ allows the physician to use a bronchoscope to directly view the stent as it is being positioned and deployed at the tarqet implant site. This direct visualization is made possible with a slightly larger delivery catheter lumen that allows passage of a flexible bronchoscope through the delivery catheter.
The provided text describes a medical device called the Alveolus AERO DV™ Tracheobronchial Stent System, which is a stent used to treat tracheobronchial strictures. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about acceptance criteria and a dedicated study to prove that the device meets those criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies, and training set information is not available in the provided document.
The document primarily states:
- The AERO DV™ Tracheobronchial Stent System uses the exact same stent as a predicate device (AERO™ K082284) but with an alternate delivery system (Direct Visualization (DV) delivery system).
- The delivery system allows direct visualization using a bronchoscope.
- Substantial equivalence is claimed based on:
- Using the same stent as K082284.
- Materials meeting biocompatibility requirements of the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document.
- Same indications for use.
- Same principle of operation as the AERO DV™ Tracheobronchial Stent System predicate device (K071604).
- Physical test results for the delivery system were performed as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (April 28, 1998). These tests "demonstrate that the device is suitable for its indicated use." Specific acceptance criteria or reported performance from these tests are not detailed.
In summary, the document asserts that the device meets regulatory requirements through substantial equivalence, supported by physical testing of the delivery system and biocompatibility data. However, the specific, quantitative acceptance criteria and detailed results of performance studies are not provided.
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MAR 1 1 2009
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Alveolus, Inc. 9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA
510(K) SUMMARY 15
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Alveolus, Inc. |
|---|---|
| Contact: | Tony AlexanderVice President RA/QA |
9013 Perimeter Woods, Suite A Address: Charlotte, NC 28216
| Telephone: | (704) 926 - 4837 |
|---|---|
| Fax: | (704) 926 - 4838 |
Date Prepared: December 05, 2008
General Device Information
AERO DV™ Tracheobronchial Stent System Product Name: Classification: "Tracheal Prosthesis." Product code: JCT 21 CFR 878.3720 - Class II
Predicate Devices
Alveolus AERO DV™ Tracheobronchial Stent System (510(k) Number: K071604)
Alveolus AERO™ Tracheobronchial Stent System (510(k) Number: K082284)
Rusch International (owned by Boston Scientific) Polyflex Airway Stent (510(k) Number: K013266)
Description
CONFIDENTIAL
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AlveollUs
The Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice consists of the exact same stent as the AERO™ predicate stent (K082284) but with an alternate delivery system.
The Direct Visualization (DV) delivery system of AERO DV™ allows the physician to use a bronchoscope to directly view the stent as it is being positioned and deployed at the tarqet implant site. This direct visualization is made possible with a slightly larger delivery catheter lumen that allows passage of a flexible bronchoscope through the delivery catheter.
Intended Use (Indications)
The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Substantial Equivalence
This Notice supports the position that the Subject Device is substantially equivalent to AERO DV™ Tracheobronchial Stent System predicate device (K071604). The stent used with the delivery system is the exact same stent cleared under 510(k) K082284.
This 510(k) Notice contains summaries of physical test results for the delivery system as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (April 28, 1998).
The data presented demonstrate that the device is suitable for its indicated use.
The single-patient-use components of the AERO DV™ Tracheobronchial Stent System are provided non-sterile.
Conclusions
In summary, the Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice has the same stent as the AERO™ predicate stent (K082284), is made of materials that have met the biocompatibility requirements of FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (issued on April 28, 1998), has the same indications for use, and has the same principle of operation as those of the AERO DV™ Tracheobronchial Stent System predicate device (K071604). Therefore, the AERO DV™ device does not raise any new issues regarding safety and effectiveness. Therefore, Alveolus believes that the
CONFIDENTIAL
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system is substantially equivalent to currently marketed tracheobronchial stent systems.
The test data provided in this Notice shows that the Subject Device is substantially equivalent to the AERO DV™ Tracheobronchial Stent System predicate (K071604). The AERO DV™ Tracheobronchial Stent System has been tested in accordance with applicable FDA guidelines.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2009
Mr. Tony Alexander Executive Vice President Alveolus, Incorporated 9013 Perimeter Woods Drive, Suite A Charlotte, North Carolina 28216
Re: K083625
Trade/Device Name: Alveolus, AERO DVTM Tracheobronchial Stent Technology System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: II Product Code: JCT Dated: February 25, 2009 Received: March 2, 2009
Dear Mr. Alexander:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling immediately following the Indications for Use section, and on the carton pouch labeling in a font-size that is easy to read:
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Page 3 - Mr. Alexander
If you desire specific information about the application or other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Christy Youman for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
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INTENDED USE STATEMENT 12
Device Name: Alveolus, AERO DV™ Tracheobronchial Stent System .
Indications for Use:
The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Turner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083625
§ 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.”