The Alveolus ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors and for occlusion of esophageal fistulae.

Device Description

The Alveolus ALIMAXX-E™ Esophageal Stent System is comprised of two components: the completely covered, self-expanding Nitinol stent and the delivery system. The ALIMAXX-E™ Esophageal Stent System is available in several diameters and lengths. The single-patient-use components of the ALIMAXX-E™ Esophageal Stent System are provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (ALIMAXX-E™ Esophageal Stent System) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that a modified device is as safe and effective as a previously cleared device, primarily through performance testing and comparison of technological characteristics. It does not include a clinical study with acceptance criteria and reported device performance in the way a de novo or PMA submission might.

Therefore, I cannot directly extract the table of acceptance criteria and reported device performance that would typically come from a clinical trial demonstrating efficacy against specific endpoints. Similarly, information such as sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not present in this 510(k) summary because it is not a study of a new AI/software device or a clinical trial of a novel therapy.

Instead, the document focuses on demonstrating substantial equivalence through:

Comparison of technological characteristics: Materials, biocompatibility, performance properties, sterilization, and packaging are compared to the predicate device.
Physical test results: These were performed to show that the modified device performs similarly to the predicate.
Biocompatibility test results: These were conducted according to FDA guidance.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred): For a 510(k) submission seeking substantial equivalence for a physical device modification, the "acceptance criteria" are not reported as specific clinical endpoints. Instead, they are implicitly related to demonstrating that the modified device's performance (mechanical, material, biological) is as good as or equivalent to the predicate device. This means the modified device must:
- Maintain lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
- Occlude esophageal fistulae.
- Exhibit comparable physical properties (e.g., radial force, flexibility, fatigue resistance, deployment characteristics) to the predicate.
- Have equivalent or acceptable biocompatibility.
Reported Device Performance: The document states: "Physical test results were performed and biocompatibility test results included tests recommended in FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" (issued on April 28, 1998)." The specific quantitative results of these tests are not provided in this summary. The conclusion is that these tests support substantial equivalence.

Aspect	Acceptance Criteria (Inferred/Guidance)	Reported Device Performance (Summary)
Intended Use Performance	Maintain esophageal lumen patency; occlude esophageal fistulae (same as predicate).	"Alveolus believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the subject device." (Implies the modified device is expected to meet these clinically, based on equivalence).
Physical/Mechanical Properties	Comparable performance properties to the predicate device, demonstrated through physical testing (e.g., materials, flexibility, radial force, fatigue).	"Physical test results were performed... showing that technological characteristics such as materials, biocompatibility, performances properties... are substantially equivalent to the currently marketed predicate device." Specific quantitative results are not in the summary.
Biocompatibility	Meets established biocompatibility standards and specific tests recommended in FDA guidance for esophageal prostheses.	"Biocompatibility test results included tests recommended in FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" (issued on April 28, 1998)." Specific quantitative results or detailed findings are not in the summary. (Implies acceptable results).
Material/Design	Similar materials and design characteristics to the predicate, with modifications justified as not raising new safety/effectiveness questions.	"Comparisons... show that technological characteristics such as materials... are substantially equivalent to the currently marketed predicate device."

Study Information (As per the provided 510(k) summary):

Sample size used for the test set and the data provenance: Not applicable. This document refers to physical and biocompatibility testing in a lab setting, not a clinical "test set" in the context of an AI/diagnostic study. The provenance of material or device samples for physical testing is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of submission which focuses on device engineering and biological performance testing.
Adjudication method for the test set: Not applicable. No human expert adjudication of clinical outcomes 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 is a physical medical device, not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical and biocompatibility testing, the "ground truth" would be the established engineering specifications for the predicate device, and the relevant ISO/ASTM standards for material properties and biological safety.
The sample size for the training set: Not applicable. There is no AI algorithm or machine learning model described that would require a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) pertains to a physical medical device modification seeking substantial equivalence and therefore does not contain the detailed clinical study information relevant to software/AI devices or new clinical indications that your questions imply. The "study" here consists of engineering tests and biocompatibility assessments to confirm the modified device's equivalence to a cleared predicate.

Summary

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14 510(k) SUMMARY

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

APR 2 4 2008

General Company Information

Name:	Alveolus, Inc.
Contact:	Tony Alexander
	EVP Corporate Compliance

Address:

9013 Perimeter Woods, Suite A Charlotte, NC 28216

Telephone:	(704) 926 - 4864
Fax:	(704) 926 - 4838

Date Prepared: March 24, 2008

General Device Information

Product Name:	ALIMAXX-E™ Esophageal Stent System
Classification:	"Esophageal Prosthesis", Product code: ESW21 CFR 878.3610 - Class II

Predicate Device

Alveolus ALIMAXX-E™ Esophageal Stent System [510(k) Number K051621]

Description

The Alveolus ALIMAXX-E™ Esophageal Stent System is designed to maintain lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.

Alveolus ALIMAXX-E Device Modification: Premarket Notification Page 67 of 73

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K080838
Page 2 of 2

The single-patient-use components of the ALIMAXX-E™ Esophageal Stent System are provided non-sterile.

Intended Use (Indications)

Substantial Equivalence

This Notice supports the position that the modified Alveolus ALIMAXX-E™ Esophageal Stent is substantially equivalent to the Alveolus ALIMAXX-E™ Esophageal Stent System [510(k) Number K051621].

Comparisons of the modified Alveolus ALIMAXX-E™ Esophageal Stent System and the ALIMAXX-E™ Stent System predicate device (K051621) show that technological characteristics such as materials, biocompatibility, performances properties, sterilization and packaging are substantially equivalent to the currently marketed predicate device. Physical test results were performed and i biocompatibility test results included tests recommended in FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" (issued on April 28, 1998).

Conclusions

Alveolus believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the subject 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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2008

Mr. Tony Alexander Chief Legal Officer Alveolus®, Inc. 9013-A Perimeter Woods Drive CHARLOTTE NC 28216

K080838 Re:

Trade/Device Name: ALIMAXX-E" Esophagea1 Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: March 24, 2008 Received: March 25, 2008

Dear Mr. Alexander:

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 application (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 such 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.

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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.

This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter,

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INTENDED USE STATEMENT 1

There are no changes in the Intended Use.

The Intended Use for the Subject Device is the same as the Intended Use for the ALIMAXX-E™ predicate system (K051621).

Device Name: Alveolus, ALIMAXX-E™ Esophageal Stent System

Indications for Use:

Prescription Use (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)

Huld Leun
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K080838

Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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.”