(141 days)
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
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 inner lumen of the expanded stent is coated with a hydrophilic polymer to improve lubricity. 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 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 provided text is a 510(k) premarket notification for a medical device (Alveolus, TB-STS™ Tracheobronchial Stent System) and focuses on establishing substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics.
However, based on the text, I can extract information related to the device and the general approach to demonstrating its safety and effectiveness:
Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices, which implies the new device performs at least as well as the predicates for its intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified as quantitative metrics) | The data presented demonstrate that the device is biocompatible and is suitable for its indicated use. |
| (Implied: Mechanical properties similar to predicates) | Stent expansion results from the mechanical properties of the metal and the proprietary geometry. Stent designed with a slightly larger diameter near the distal and proximal ends to minimize migration. Stent ends slightly vaulted inwardly to minimize airway injury. Stent geometry designed to maintain constant length over entire range of possible diameters, resulting in virtually no foreshortening. |
| (Implied: Biocompatibility) | The device is biocompatible. |
Study Information (Based on available text):
- Sample size used for the test set and the data provenance: Not explicitly mentioned. The document refers to "summaries of physical test results, and biocompatibility test results" but does not detail the specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document does not describe a clinical study with ground truth established by experts. It refers to "physical test results" and "biocompatibility test results."
- Adjudication method for the test set: Not applicable. No clinical study with adjudication is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a tracheobronchial stent system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used: For physical and biocompatibility testing, the "ground truth" would be established according to standard testing methodologies and regulatory guidelines (e.g., ISO standards for biocompatibility). The document states the tests were conducted "as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)."
- The sample size for the training set: Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable. (See above)
Summary of Device and Evidence:
The Alveolus, TB-STS™ Tracheobronchial Stent System is described as a self-expanding nitinol stent, completely covered with a biocompatible polyurethane membrane, and coated with a hydrophilic polymer. Its design aims to minimize migration, airway injury, and foreshortening.
The device's safety and effectiveness were demonstrated by showing substantial equivalence to a number of previously cleared predicate devices, including:
- Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) K030947]
- Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241]
- Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]
The submission included "summaries of physical test results, and biocompatibility test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)." These tests established that the device is biocompatible and suitable for its indicated use. The materials used have an "established history of use in clinical applications."
In essence, the "study" demonstrating the device meets "acceptance criteria" is a demonstration of substantial equivalence through physical and biocompatibility testing consistent with FDA guidance, rather than a clinical trial with specific performance metrics and ground truth established by experts.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains an image of a stylized eagle with its wings spread.
3 2006 NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alveolus, Inc. % Mr. Donald Canal Vice President RA/OA 9013 Perimeter Woods Drive Suite A Charlotte, North Carolina 28216
Re: K033990
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: April 9, 2004 Received: April 12, 2004
Dear Mr. Canal:
This letter corrects our substantially equivalent letter of May 12, 2004.
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. Donald Canal
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,
Mark N. Malkerson
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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Image /page/2/Picture/0 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 lines are all in black and white.
Indications for Use
510(k) Number (if known): K033990
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 and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
Prescription Use______________________________________________________________________________________________________________________________________________________________ V (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number L033660
Page 10 of 24
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Alveolus.
INSPIRING THE BREATH OF LIFE
SUMMARY OF SAFETY AND EFFECTIVENESS
General Company Information
- Alveolus, Inc. Name: Don Canal Contact:
- 9013 Perimeter Woods Dr Address: Suite A Charlotte, NC 28216
Telephone: (704) 926 - 4850 Fax: (704) 926 - 4895
General Device Information
TB-STS™ Tracheobronchial Stent System Product Name: Classification: "Tracheal Prosthesis", Product code: JCT
- Class II
Predicate Devices
Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) Numbers K030947]
Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241]
Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]
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 inner lumen of the expanded stent is coated with a hydrophilic polymer to improve lubricity. 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 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
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Image /page/4/Picture/0 description: The image shows the logo for Alveolus. The logo consists of the word "Alveolus" in a stylized font, with a horizontal line running 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 smaller letters. The logo is black and white.
unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
Indications
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
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 System previously approved [510(k) K030947], the Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241], the Vascular Architects, Inc. aSpire® Covered Stent® [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 Esophageal and Tracheal Prostheses (April 28, 1998).
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.
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.
§ 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.”