(149 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 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. This feature facilitates the selection of the appropriate stent length.
The provided text is a 510(k) summary for the Alveolus TB-STS™ Tracheobronchial Stent System. While it discusses the device's design, intended use, and substantial equivalence to predicate devices, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or ground truth establishment methods.
Therefore, I cannot directly extract the detailed table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies as requested. The document focuses on demonstrating substantial equivalence rather than presenting an efficacy study with specific performance targets.
Here's what can be inferred and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated or quantified in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
- Reported Device Performance: The document mentions "an in vivo animal (porcine) study that demonstrates that the completely covered stent is removable like the silicone stent predicates up to 28 days." This is a performance characteristic, but it's not presented with specific acceptance criteria (e.g., "removable in X% of cases within Y days").
2. Sample size used for the test set and the data provenance:
- The text mentions "an in vivo animal (porcine) study."
- Sample Size: Not specified.
- Data Provenance: In vivo animal (porcine) study. The country of origin is not specified but it's part of a US FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable based on the provided text. The animal study is observational for removability, not diagnostic, so a "ground truth" established by experts in the context of diagnostic accuracy is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to diagnostic studies with multiple readers, which is not described.
5. 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:
- No MRMC study mentioned. This device is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the animal study on removability, the "ground truth" would likely be the direct observation/outcome of whether the stent was successfully removed or not, as assessed by the researchers/veterinarians involved in the study. No mention of expert consensus, pathology, or separate outcomes data in this context.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is mentioned.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence to legally marketed predicate devices, not a detailed clinical study report with a focus on specific performance criteria and efficacy endpoints.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
NOV 3 2006
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: K033053
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: January 7, 2004 Received: January 8, 2004
Dear Mr. Canal:
This letter corrects our substantially equivalent letter of February 25, 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
Sincer
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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INSPIRING THE BREATH OF LIFE
Indications for Use
510(k) Number (if known): K033053
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)
Res
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K033657
Page 6 of 24
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Alveolljs
INSPIRING THE BREATH OF LIFE
510(k) SUMMARY (Per 21 CFR 807.92)
1023053
of
General Company Information
- Alveolus, Inc. Name: Don Canal Contact:
- 9013 Perimeter Woods Dr Address: Suite A Charlotte, NC 28216
- (704) 926 4850 Telephone: (704) 926 - 4895 Fax:
- February 17, 2004 Date Prepared
General Device Information
TB-STS™ Tracheobronchial Stent System Trade Name:
- "Tracheal Prosthesis", Product code: JCT Classification: 21 CFR 878.3720 - Class II
Predicate Devices
Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k Numbers K030947]
Rusch International Polyflex Stent Kit [510(k) Number K013266]
Novatech S.A. Endoxane® Stent [510(k) Number K971509]
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 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 handwritten text. The first line reads "K033053". The second line reads "P. 2 of 2". The text appears to be written with a dark marker or pen, and the handwriting is somewhat rough.
Image /page/4/Picture/1 description: The image contains a text excerpt describing a stent design. The text states that the stent has virtually no foreshortening. This feature facilitates the selection of the appropriate stent length. The design is described as unique.
Intended Use (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 Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241], the Rusch International Polyflex Stent Kit [510(k) Number K013266] and the Novatech S.A. Endoxane® Stent [510(k) Number K971509].
The 510(k) Notice contains a report of an in vivo animal (porcine) study that demonstrates that the completely covered stent is removable like the silicone stent predicates up to 28 days.
The single-patient-use components of the TB-STS™ Tracheobronchial Stent System are provided sterile.
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.
§ 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.”