The ALIMAXX-B Uncovered biliary stent is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the delivery catheter. The delivery device is available for endoscopic placement (working length is 185 cm), and transhepatic placement (working length 80 cm).

AI/ML Overview

The provided text is a 510(k) summary for the ALIMAXX-B™ Uncovered Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a specific study proving the device meets them.

The submission refers to "physical test results for the delivery system as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)" to demonstrate that the device is suitable for its intended use. However, these specific tests and their acceptance criteria are not directly stated in the provided text, nor are the detailed results of such tests.

Therefore, much of the requested information cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided based on the given text. The document states that physical test results were conducted "as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)" but does not list these specific criteria or the reported performance values.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided based on the given text. The document does not describe a clinical study or a test set in the context of device performance. It only mentions "physical test results for the delivery system."

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)

Not applicable / Cannot be provided. There's no mention of a clinical test set or ground truth establishment by experts in the context of evaluating device performance in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. No clinical test set where adjudication would be relevant is 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

Not applicable. This device is a physical medical stent, not an AI-assisted diagnostic tool. An MRMC study is not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical stent, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Cannot be provided. No clinical ground truth establishment is described for device performance. The "ground truth" for physical device performance would typically be defined by engineering specifications and validated through bench testing, which is referred to but not detailed.

8. The sample size for the training set

Not applicable. The device is a physical stent; the concept of a "training set" is not relevant here as it would be for an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary based on the provided text:

The submission for the ALIMAXX-B™ Uncovered Biliary Stent System demonstrates "substantial equivalence" to predicate devices (Bard® LUMINEXX™, Cook® Zilver™, ABSOLUTE™ Biliary Self-Expanding Stent). The safety and effectiveness are supported by "summaries of physical test results for the delivery system as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)." However, specific acceptance criteria and the detailed results of these tests are not included in this 510(k) summary. The document does not describe any human-observer performance studies or data collection from patient cohorts in a way that would require statistical sample sizes, expert ground truth, or adjudication methods for performance evaluation.

Summary

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K072720
PAGE 1 OF 2

APR 1 1 2008

15.510K SUMMARY

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

General Company Information

Name:	Alveolus, Inc.
Contact:	Rita H. Lee PhDMedical and Technical Writer
Address:	9013 Perimeter Woods, Suite FCharlotte, NC 28216

Telephone:	(704) 926 - 4837
Fax:	(704) 926 - 4838

Date Prepared: September 24, 2007

General Device Information

ALIMAXX-B™ Uncovered Biliary Stent System Product Name: "Biliary Catheter and Accessories" Product code: Classification: FGE 21 CFR 876.5010 - Class II

Predicate Devices

This Notice supports the position that the ALIMAXX-B Uncovered Biliary Stent is substantially equivalent to previously cleared devices, including the Bard® LUMINEXX™ Biliary Stent and Delivery Catheter cleared by FDA under 510(k) number K031186, and the Cook® Zilver™ Biliary Stent cleared by FDA under 510(k) number K020788, and the Absolute™ Biliary Self-Expanding Stent cleared by FDA under 510(k) number K033393.

Description

The ALIMAXX-B Uncovered biliary stent is a sterile, single-use, self-

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K072720
PAGE 2 OF 2

expanding Nitinol stent that is supplied with the stent pre-loaded on the delivery catheter. The delivery device is available for endoscopic placement (working length is 185 cm), and transhepatic placement (working length 80 cm).

Intended Use (Indications)

The stent is indicated for palliation of malignant neoplasms in the biliary tree.

Substantial Equivalence

This Notice supports the position that the ALIMAXX-B Uncovered Biliary Stent is substantially equivalent to previously cleared devices, including the Bard® LUMINEXX™ Endoscopic Biliary Stent cleared by FDA under 510(k) number K031186, and the Cook® Zilver™ Biliary Stent cleared by FDA under 510(k) number K020788, and the ABSOLUTE™ .035 Biliary Self-Expanding Stent cleared by FDA under K033393.

This 510(k) Notice contains summaries of physical test results for the delivery system as specified in the FDA "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents" document (February 5, 1998).

The data presented demonstrate that the device is suitable for its indicated use.

The ALIMAXX-B Uncovered Biliary Stent System is provided sterile and for single use only.

Conclusions

In summary, Alveolus has provided the required tests, assessments, and comparisons to demonstrate that the Alveolus ALIMAXX-B Biliary Stent System is substantially equivalent to the above referenced predicate devices in terms of composition, design, intended use and performance attributes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2008

Mr. Tony D. Alexander Exec. VP, Chief Legal Officer & Corporate Secretary, Quality Executive Alveolus", Inc. 9013 Perimeter Woods Drive, Suite A CHARLOTTE NC 28216

Re: K072720

Trade/Device Name: Alveolus, ALIMAXX-B™ Uncovered Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: January 11, 2008 Received: January 14, 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). 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 Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary 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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Page 2 - Mr. Tony Alexander

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.

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.

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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1 of 1

510(k) Number: K072720

Device Name: Alveolus, ALIMAXX-B™ Uncovered Biliary Stent System

FDA's Statement of the Indications for Use for device:

. . . . . .

The Alveolus, ALIMAXX-B™ Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Verlin

productive. Abdominal and Radiological Devic 510(k) Number

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.