(156 days)
The Alveolus AERO™ 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 membrane and is selfexpanding. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Alveolus AERO™ Tracheobronchial Stent System:
Based on the provided K062511 510(k) summary and FDA letter, there is no specific information detailing a study with acceptance criteria and reported device performance in the format of a table as requested for an AI/CADe device.
The document describes a medical device, a tracheobronchial stent, not an AI/CADe system. Therefore, many of the requested elements pertaining to AI/CADe studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or present in this submission.
However, I can extract the relevant information that is present and explain why other requested details are absent for this type of medical device submission.
Analysis based on a Medical Device (Tracheobronchial Stent) Submission:
1. A table of acceptance criteria and the reported device performance
The submission for the Alveolus AERO™ Tracheobronchial Stent System does not include a table of acceptance criteria and reported device performance in the context of an AI/CADe study. Instead, a 510(k) submission for a non-AI medical device focuses on demonstrating substantial equivalence to predicate devices. This involves comparing technological characteristics, intended use, and performance data from studies (often non-clinical or limited clinical, if required for a modified device).
The document states:
- "The 510(k) Notice references a report of a study conducted under IDE G040202 that was completed to demonstrate safety and efficacy of the modified device."
- "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."
This implies that the "acceptance criteria" were met through the demonstration of safety and efficacy via the IDE study and adherence to FDA guidelines for material testing and manufacturing, rather than statistical performance metrics against a defined ground truth as would be seen for an AI diagnostic device. Specific numerical performance values or statistical criteria are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary for the IDE study (G040202). The document only mentions "a report of a study conducted under IDE G040202 that was completed to demonstrate safety and efficacy of the modified device." It does not specify sample size, study design (retrospective/prospective), or data provenance.
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 or provided for this type of medical device submission. Ground truth establishment by experts is typically a requirement for AI diagnostic device studies, where algorithm output needs to be compared against a definitive human interpretation. For a physical device like a stent, "ground truth" is typically established through clinical outcomes, imaging follow-up, and physiological measurements to assess safety and efficacy, often by treating physicians, not a panel of independent readers defining a "ground truth" for a test set in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations during ground truth establishment for AI/CADe performance studies.
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
An MRMC comparative effectiveness study is not applicable for this medical device. MRMC studies are used to assess the impact of an AI system on human reader performance. This submission is for a physical stent, not an AI assistance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical stent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the IDE study referenced, "ground truth" for a stent would typically involve clinical outcomes data (e.g., patency of the airway, reduction of stricture, adverse events, patient symptoms, survival) assessed through clinical examination, endoscopy, and/or imaging. The document doesn't specify the exact type of outcome data used, but it states the study was "to demonstrate safety and efficacy."
8. The sample size for the training set
This is not applicable as the device is a physical stent and does not involve AI model training.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical stent and does not involve AI model training or a training set in that context.
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K062511
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Alveolus. Inc 9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA
16 510(K) SUMMARY
JAN 3 1 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name:Contact: | Alveolus Inc.Donald V. CanalVice President RAQA |
|---|---|
| Address: | 9013-A Perimeter Woods DriveCharlotte, NC 28216 |
| Telephone:Fax: | (704) 926-4850(704) 926-4895 |
| Date Prepared | August 15, 2006 |
General Device Information 16.1
| Product Name: | AERO™ Tracheobronchial Stent System |
|---|---|
| Classification: | "Tracheal Prosthesis", Product code: JCT21 CFR 878.3720 - Class II |
Predicate Devices 16.2
Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) Numbers K030947, K033053, K033990]
Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241]
Rusch International Polyflex Stent Kit [510(k) Number K013266]
16.3 Description
The Alveolus Tracheobronchial Stent Technology System is comprised of two
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K062511
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9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA
components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is selfexpanding. 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.
16.4 Intended Use (Indications)
The Alveolus AERO™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Substantial Equivalence 16.5
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 references a report of a study conducted under IDE G040202 that was completed to demonstrate safety and efficacy of the modified device.
The single-patient-use components of the AERO™ Tracheobronchial Stent System are provided non-sterile.
16.6 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alveolus, Inc. % Donald V. Canal Vice President RA/QA 9013 Perimeter Woods, Suite A Charlotte, North Carolina 28216
JAN 3 1 7007
Re: K062511 Trade Name: AERO Tracheobronchial Stent System Regulation Number: 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: II Product Code: JCT Dated: January 16, 2007 Received: January 17, 2007
Dear Mr. Canal:
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:
Warning: The safety and effectiveness of this device for use in the vascular system has not been established and can result in serious harm and/or death.
Furthermore, the indication for tracheal use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Qatan
onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K062511
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Alveollus
Alveolus, Inc. 9013 Perimeter Woods, Suite A Charlotte, NC 28216, USA
13 INTENDED USE STATEMENT
510(k) Number (if known): K062511
Device Name: Alveolus, AERO™ Tracheobronchial Stent System
Indications For Use:
The Alveolus AERO™ 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OCETM
'1/29/07
CONFIDENTIAL
Alveolus AERO™ Premarket Notification
§ 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.”