(70 days)
Not Found
No
The device description focuses on the mechanical 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
Explanation: The device is a tracheobronchial stent system used in the treatment of tracheobronchial strictures, which directly addresses a medical condition.
No
Explanation: The device description states that the Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures, and the device itself is a stent designed to expand and maintain an open airway. It is a therapeutic device, not one used for diagnosis.
No
The device description explicitly states it is comprised of two physical components: a radiopaque stent and a delivery system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Alveolus TB-STS™ Tracheobronchial Stent System is a physical implantable device (a stent) designed to be placed within the tracheobronchial airways.
- Intended Use: Its intended use is to treat physical strictures (narrowing) in the airways caused by malignant neoplasms. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a device that is physically inserted into the body for treatment, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes
JCT
Device Description
The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The stent expansion results from the mechanical 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. The overall stent geometry is designed to maintain a constant length over the range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the selection.
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
The 510(k) Notice contains summaries of physical test results, and biocompatibility test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses. The data presented demonstrate that the device is biocompatible and is suitable for its indicated use.
Key Metrics
Not Found
Predicate Device(s)
Alveolus, Inc. TB-STS™ Tracheobronchiai Stent System [510(k) Numbers K030947], Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [510(k) Number K963241], Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery Stem and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Alveolus, Inc. % Mr. Donald Canal Vice President RA/QA 9013 Perimeter Woods Drive, Suite A Charlotte, North Carolina 28216
Re: K032744
Trade/Device Name: Alveolus TB-STS™ Tracheobronchial Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: September 3, 2003 Received: September 11, 2003
Dear Mr. Canal:
This letter corrects our substantially equivalent letter of November 13, 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 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.
1
Page 2 - Mr. Donald Canal
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 Lemmo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
INSPIRING THE BREATH OF LIFE
Indications for Use
510(k) Number (if known): K032744
Device Name: Alveolus, TB-STS™ Tracheobronchial Stent System
Indications For Use:
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of
tracheobronchial strictures produced by malignant neoplasms, the street on as TD-STS "" Tracheobronchial Stent System is includes
tracheobronchial strictures produced by malignant neoplasms.
Prescription Use (Part 21 CFR 80I 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)
(Division Division of General, Restorat and Neurological Devices
510(k) Number K032744
3
32744 p. 20fa
Image /page/3/Picture/1 description: The image shows the word "Alveolus" in a stylized font, with a line drawn through the middle of the word. Below the word is a curved line, and below that is the phrase "INSPIRING THE BREATH OF LIFE" in a smaller font. The text and design elements are all in black and white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
-
Name: Alveolus, Inc. Contact: Don Canal
Address: 9013 Perimeter Woods Dr Suite A Charlotte, NC 28216 -
Telephone: (704) 926 - 4850 Fax: (704) 926 - 4895
General Device Information
| Product Name: | TB-STS™ Tracheobronchial Stent System |
|---|---|
| Classification: | "Tracheal Prosthesis", Product code: JCT |
| Class II |
Predicate Devices
Alveolus, Inc. TB-STS™ Tracheobronchiai Stent System [510(k) Numbers K030947]
Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [510(k) Number K963241]
Vascular Architects, Inc. a Spire™ Covered Stent and CONTROLLED EXPANSION™ Delivery Stem and
CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]
Description
The Alveolus Tracheobronchial Stent Technology System is comprised of two
components: the radiopague stept and the delivery of the radional components: the radiopaque stent and the delivery system is comprised of two
completely covered with a biocompatible nol tradition is and (Chromation the radiopaque stell and the delivery system. The nitinol stent is
completely covered with a biocompatible polyurehane (ChronoFlex™) membrane and e supportuges for ou with a blocompatible polyurethane (ChronoFlex™) membrane and
is self-expanding. The stent expansion results from the mechanical properties of the
4
032744p.1 of 2.
Alveollus
metal and the proprietary geometry. The stent is designed with a slightly larger
diameter near the distal and proximal ends to minimize the nessibility of an and and the distal and proximal ends to mimize the possiblity of migralion. The stends are and the stress are signity vauled inwardly in one minimize possible armany industry. The stent edges
the stent edges. The overall sterk gesuble omanization a comments of this over the ranges. The overall stert geometry is designed to maintain a constant lengther homen over the stom
has virtually no foreshorters. As a result of this unique done th to the resortire range of possible diameters. As a result of this unique design the steam.
This virtually no foreshortening, thus facilitating the selection of the selection
Indications
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the in
treatment of tracheobronchial strictures produced by malignant people the 11-513-13-15-15-15-15-15-15-15-15-15-15-11-11-2019-11-11
treatment of tracheobronchial strictures produced by malignant neoplasms.
Substantial Equivalence
This submission supports the position that the Alveolus Tracheobronchial Stent is
substantially equivalent to a number of previously cleared devices in the least and in Stilleonison stipping the Alveolus Tracheobronchial Stent is
Stiefitially equivalent to a number of previously cleared devices, including the Boston
1982年11, the Vascu Sciencelling Oquivalent of newolds Tracheoronomial Stentifical Stentific Stentific Stentific Stentific Stentific Stentific Stentific Corp. Includion (Sentifical Number
K003 (1) and Sorp: fifc. Uitrailex™ Trached devices, including the Bor
K963241), the Vascular Architects, Inc. aSpire® Covered Stent System [510(k) Number
K003173 and K012544]
The 510(k) Notice contains summaries of physical test results, and biocompatibility test
results as specified in the FDA Guidance Document for Testing Franks and Prostheses and be (1) Notice contains summaries of physical test results, and biocompatibile
results as specified in the FDA Guidance Document for Testing Esophageal and
Tracheal Prost
The data presented demonstrate that the device is biocompatible and is suitable for its
indicated use.
The single-patient-use components of the TB-STS™ Tracheobronchial Stent System
are provided sterile. are provided steriled
Conclusions
Alveolus Inc. believes that the information provided establishes that similar legally
marketed devices have been used for the same clinical annlications well a and and the believes that the information provided establishes that similar legally
Tracked devices have been used for the same clinical applications as the Alveolus
the an The lose downes nave been used for the come callisors that similar legally
Tracheobronchial Stent. The materialshe same clinical applications as the Alvestigated
Alveolus ha the see betablished history of use in clinical applications, and the device is
Alveolus have been tested in accordance with applications, and the devices in