(50 days)
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
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 the possible airway injury from the stent edges. The overall stent geometry is designed to maintain a constant length and has virtually no foreshortening, thus facilitating the selection of the appropriate stent length.
This document is a 510(k) summary for the Alveolus TB-STS™ Tracheobronchial Stent System. It details the device's description, indications for use, and a claim of substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria.
Instead, the document states:
"The 510(K) Notice contains summaries of physical test results, and bio-compatibility results as specified in the FDA Guidance Document for Testing Tracheal and Bronchial Stents. The data presented demonstrate that the device is biocompatible and is suitable for its indicated use."
This indicates that testing was performed, and the results summarized in the full 510(k) Notice were deemed sufficient by the FDA to demonstrate biocompatibility and suitability for intended use, leading to substantial equivalence to legally marketed predicate devices. However, the details of those tests, specific acceptance criteria, or a "study that proves the device meets acceptance criteria" as requested in the prompt, are not provided within this 510(k) summary document.
Therefore, I cannot populate the table or answer the subsequent questions directly from the provided text.
Based on the provided text, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in this summary document. The summary states that "summaries of physical test results, and biocompatibility results as specified in the FDA Guidance Document for Testing Tracheal and Bronchial Stents" were presented in the full 510(k) Notice. It concludes that "The data presented demonstrate that the device is biocompatible and is suitable for its indicated use." | Not provided in this summary document. The summary only states that "the device is biocompatible and is suitable for its indicated use" based on the "physical test results, and biocompatibility results." Specific performance metrics tied to acceptance criteria are not detailed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified. The document states "physical test results, and biocompatibility results" indicating lab-based testing rather than patient data for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable and not provided. The testing discussed refers to physical and biocompatibility tests, not clinical evaluations requiring expert interpretation of a test set for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided.
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. An MRMC study was not done, as this is a medical device (stent system) and the performance evaluation discussed involves physical and biocompatibility testing, not an AI or imaging diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance would be established by validated physical and chemical testing methods as per FDA guidance for tracheal and bronchial stents. This is not clinical ground truth in the sense of diagnosis.
8. The sample size for the training set:
- Not applicable; this is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" surrounding it.
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: K030947
.
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: March 24, 2003 Received: March 26, 2003
Dear Mr. Canal:
This letter corrects our substantially equivalent letter of May 15, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 vours.
Helbert Lemmens
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 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 a smaller font. The logo is black and white.
Indications for Use
510(k) Number (if known): K030947
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.
Prescription Use
(Part 21 CFR 801 Subpart D)
X
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 K630947
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Alveolus.
INSPIRING THE BREATH OF LIFE
030947 p. lo f2
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
Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [510(k) Number K963241]
Vascular Architects, Inc. a Spire™ 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 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 the possible airway injury from
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030747 p. 2 of 2
Alveolus
the stent edges. The overall stent geometry is designed to maintain a constant length
has virtually no foreshortening. As a result of this unique desimely and r in Stont edges. The overall stent geometry is designed to maintain a constant length
has virtually no foreshortening, thus facilitating the selection of this unique desig the wire range of possible diametry is designed to mintain a constant length length length
has vitually no freshortening, thus facilitating the selection of the appropriate
Indications
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the
treatment of tracheobronchial strictures produced by malignant peoples the concreation TB-STS™ Tracheobronchial Stent System is indicated for use.
treatment of tracheobronchial strictures produced by malignant neoplasms.
P
Substantial Equivalence
This submission supports the position that the Alveolus Tracheobronchial Stent is
substantially equivalent to a number of previously cleared devices including to and oublinssion supports the Alveolus Tracheobronchial Stent is
Stientificaly euports the position that the Alveolus , including the Boston
Scientific Cop. Inc. Ultraflex™ Tr Stentific Copp. Inc. Inc. Inc. Inc. Inc. Inc. Alveous Tracheoloronchial Stent
Scientific Copp. Inc. Ultraflex Tracted Created devises, including including in the United Co rent in Corp. Inc. Ultrallex™ Trached Stent System (11.1 Stiller Stein (11.1 Stenit Stein (1.6 St.
K963241), the Vascular Architects, Inc. aSpire® Covered Stent® (510(k) Numb K003173 and K012544].
The 510(K) Notice contains summanies of physical test results, and birony numbler
results as specified in the FDA Guidance Document for Testing Franches of and and
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.
Conclusions
Alveolus Inc. believes that the :
Alveolus Inc. believes that the information provided establishes that similar legally
Tracheobronchial Stent. The materials for the same clinical anniles on the security more of the information provided establishes that similar legally
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§ 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.”