(101 days)
No
The device description focuses on the physical properties and design of the stent and delivery system, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for use in the "treatment of tracheobronchial strictures," which is a therapeutic action.
No
The device is a tracheobronchial stent system used for treatment, not for diagnosing conditions. Its description focuses on its physical structure and function in expanding strictures.
No
The device description explicitly states it is comprised of a radiopaque stent and a delivery system, which are physical hardware components, not software.
Based on the provided information, the Alveolus AERO™ Tracheobronchial Stent Technology System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health by analyzing samples like blood, urine, tissue, etc.
- The Alveolus AERO™ is a medical device implanted directly into the body. Its purpose is to physically treat tracheobronchial strictures by providing structural support. It does not analyze any biological samples.
The description clearly indicates it's a stent and delivery system intended for implantation to treat a physical condition within the tracheobronchial tree. This falls under the category of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Alveolus AERO™ is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT
Device Description
The Alveolus AERO™ is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is self-expanding. The stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration (2mm for bronchus stent sizes and 3mm for tracheal stent sizes). The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. The single-patient-use components of the AERO™ Tracheobronchial Stent Technology System are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheobronchial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
K082284
page 1 of 2
15 510(K) SUMMARY
NOV 2 0 2008
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Alveolus Inc. |
|---|---|
| Contact: | Tony Alexander |
| Executive Vice President |
Address: 9013-A Perimeter Woods Drive Charlotte, NC 28216
- Telephone: (704) 926-4846 Fax: (704) 926-4895
Date Prepared August 8, 2008
15.1 General Device Information
| Product Name: | AERO™ Tracheobronchial Stent Technology System |
|---|---|
| Classification: | "Tracheal Prosthesis", Product code: JCT |
| 21 CFR 878.3720 - Class II |
15.2 Predicate Devices
Alveolus, Inc. TB-STS™ Tracheobronchial Stent Technology System [510(k) Numbers K062511]
Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent Technology System [501(k) Number K963241]
Rusch International Polyflex Stent Kit [510(k) Number K013266]
1
KOS 2284
page 2 of 2
15.3 Description
The Alveolus AERO™ is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is self-expanding. The stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration (2mm for bronchus stent sizes and 3mm for tracheal stent sizes). The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
15.4 Intended Use (Indications)
The Alveolus AERO™ is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
15.5 Substantial Equivalence
This submission supports the position that the Alveolus Tracheobronchial Stent is substantially equivalent to a number of previously cleared devices, including the Alveolus TB-STS™ Tracheobronchial Stent Technology System [510(k) K062511], the Boston Scientific Corp, Inc. Ultraflex™ Tracheobronchial Stent Technology System [501(k) Number K963241], the Rusch International Polyflex Stent Kit [510(k) Number K0132661 and the Novatech S.A. Endoxane® Stent [510(k) Number K971509].
The single-patient-use components of the AERO™ Tracheobronchial Stent Technology System are provided non-sterile.
15.6 Conclusions
Alveolus Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Alveolus Tracheobronchial Stent. The materials from which the Alveolus device is fabricated have an established history of use in clinical applications, and the devices produced by Alveolus have been tested in accordance with applicable FDA guidelines.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, bold line style, and the text is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tony Alexander Executive Vice President Alvcolus, Incorporated 9013 Perimeter Woods Drive, Suite A Charlotte, North Carolina 28216
NOV 20 2008
Rc: K082284
Trade/Device Name: AERO™ Tracheobronchial Stent Technology System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: II Product Code: JCT Dated: October 24, 2008 Received: October 27; 2008
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:
Warning: The safety and effectiveness of this device for use in the vascular system has not been established and can result in serious harm and/or death.
Furthermore, the indication for tracheal use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
3
Page 2 - Mr. Alexander
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 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.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
12 INTENDED USE STATEMENT
510(k) Number (if known):
Device Name: Alveolus AERO™ Tracheobronchial Stent Technology System
Indications For Use:
The Alveolus AERO™ Tracheobronchial Stent Technology System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clu
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
10(k) Number: