(93 days)
No
The summary describes a stent and a delivery system that allows for direct visualization via a bronchoscope. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the treatment of tracheobronchial strictures, which means it addresses a medical condition or disease.
No
Explanation: The device is a stent system used for the treatment of tracheobronchial strictures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "Tracheobronchial Stent System" consisting of a stent and a delivery system, which are physical components, not software. The performance studies also focus on physical test results for the delivery system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The AERO DV™ Tracheobronchial Stent System is a physical implantable device (a stent) used to treat strictures in the trachea and bronchi. It is used in vivo (within the body) during a medical procedure.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic testing performed on specimens outside the body.
The device is a therapeutic device used for direct treatment within the patient's airway.
N/A
Intended Use / Indications for Use
The AERO DV™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes
JCT
Device Description
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 single-patient-use components of the AERO DV™ Tracheobronchial Stent 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
Physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 1 2009
Image /page/0/Picture/2 description: The image shows the word "Alveollus" in a simple, sans-serif font. A curved line is drawn beneath the word, emphasizing it. The text is clear and easy to read, with a clean and minimalist design.
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 Alexander |
| Vice 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
1
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
2
Image /page/2/Picture/1 description: The image shows the logo for Alveolis. The logo is in black and white and features the word "Alveolis" in a sans-serif font. Below the word is a curved line, and below that is the phrase "INSPIRING THE BREATH OF LIFE" in a smaller font. The logo is simple and modern.
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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird-like figure with three overlapping, curved shapes representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
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:
ា
4
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
5
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