The ALIMAXX-B™ Uncovered Biliary Stent System is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the triaxial delivery catheter of the delivery system. The delivery system is available in two designs, one for endoscopic placement (working length is 185 cm) and another for transhepatic placement (working length is 80 cm).

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the ALIMAXX-B™ Uncovered Biliary Stent System, with modifications to its endoscopic delivery system catheter. The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic accuracy or a specific AI-driven medical device. Therefore, many of the requested categories (like AI improvement effect size, ground truth for training data, etc.) are not applicable in this context.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The submission states that "Design verification and design validation studies have been completed. The results demonstrate that the risks associated with the design modifications, as identified in Merit's ALIMAXX-B™ uncovered biliary stent system Clinical Risk Assessment (CRA), have met all of their pre-determined acceptance criteria."

However, specific numerical acceptance criteria (e.g., a required performance metric like sensitivity or specificity) and their corresponding reported device performance values are not provided in the text. The acceptance criteria relate to risk mitigation and design specifications rather than clinical performance metrics typically associated with AI or diagnostic devices.

The modifications are described as improving "visibility during stent placement" for the endoscopic delivery system catheter.

Acceptance Criteria Category	Reported Device Performance
Risk Mitigation (from CRA)	"Met all of their pre-determined acceptance criteria."
Design Specifications	"Acceptable controls used to mitigate the identified risks have been incorporated into the devices specifications."
Visibility during placement	Improved endoscopic and fluoroscopic visibility of the position of the stent during placement. (No specific quantifiable metric provided)

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document refers to "Design verification and design validation studies" but does not provide details on the sample size of any test sets used in these studies.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. "Ground truth" in the context of device design verification and validation typically refers to engineering specifications, safety standards, and functional performance, rather than clinical diagnostic ground truth established by experts.

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

Not applicable/Not specified. This typically applies to studies where expert consensus is used to establish ground truth for classification tasks.

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. This is a submission for a stent delivery system, not an AI-driven diagnostic or assistive device. An MRMC study is not relevant here.

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

Not applicable. This device does not involve an algorithm.

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

For "Design verification and design validation studies," the "ground truth" would be engineering specifications, safety standards, performance requirements, and clinical risk assessment criteria. The document explicitly states that the studies addressed "risks identified in Merit's Risk Assessment," indicating that adherence to a risk management framework and meeting predefined safety and performance parameters served as the ground truth.

8. The sample size for the training set:

Not applicable. There is no AI or machine learning component requiring a training set.

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

Not applicable.

Summary

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SECTION 5: 510(k) SUMMARY

Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

CONTACT: Carol Holloway, RAC, Director of Regulatory Affairs 801.208.4389 phone: 801.253.6962 fax Email cholloway@merit.com

JAN 2 1 2010

DATE PREPARED: December 21, 2009

TRADE OR PROPRIETARY NAME: ALIMAXX-BTM Uncovered Biliary Stent System

CLASSIFICATION/ NAME: Class II, Biliary Cathefer and Accessories (21CFR §876.5010), Product Code FGE

PREDICATE DEVICES: ALIMAXX-BTM Uncovered Biliary Stent System (K072720)

DEVICE DESCRIPTION:

The ALIMAXX-BTM Uncovered Biliary Stent System is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the triaxial delivery catheter of the delivery system. The delivery system is available in two designs, one for endoscopic placement (working length is 185 cm) and another for transhepatic placement (working length is 80 cm).

INTENDED USE:

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

TECHNOLOGICAL COMPARISON:

The modifications proposed are being made to the endoscopic delivery system catheter to improve visibility during stent placement. These changes are not being made to the transhepatic delivery system catheter. The modified device has the identical intended use and employs the same fundamental technology as the predicate device.

The proposed design, material, and labeling changes that triggered the submission of this notification consist of the following:

. Segments of the endoscopic delivery system catheter shall have material and colorant changes made to improve the endoscopic and fluoroscopic visibility of the position of the stent during placement.
Changes have been made to the Instructions for Use to identify Merit Medical Systems, Inc. . (Merit) as the manufacturer of the device, as Alveolus Inc., the submitter of the original 510(k), is no longer the legal manufacturer. Additional changes in instruction have been added to address the modifications made to the delivery system catheter's increased visibility during endoscopic placement of the stent.

013

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Merit MedicalSystems, Inc.	ALIMAXX-B Uncovered Biliary Stent Device ModificationSpecial 510(k)	Page 14 of 40
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Note that the proposed modifications are only to be made to the endoscopic delivery system catheter. Neither the transhepatic delivery system catheter nor the biliary stent will be modified.

PERFORMANCE TESTING:

Design verification and design validation studies have been completed. The results demonstrate that the risks associated with the design modifications, as identified in Merit's ALIMAXX-B™ uncovered biliary stent system Clinical Risk Assessment (CRA), have met all of their pre-determined acceptance criteria. Additionally, acceptable controls used to mitigate the identified risks have been incorporated into the devices specifications.

SUMMARY OF SUBSTANTIAL EQUIVALENCE:

Based on:

. Merit's conformance with Design Control requirements;
Analyses of risks associated with the modified device; and .
Results of verification and validation tests performed to address risks identified in Merit's Risk . Assessment demonstrating that predetermined acceptance criteria have been met and risks have been adequately controlled,

Merit concludes that the modified devices are as safe and effective as, and perform as well as, or better than, the predicate devices.

014

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms, often referred to as the "Human Services Symbol" or "Helping Hand" symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 1 2010

Ms. Carol Holloway, RAC Director of Regulatory Affairs Merit Medical Systems, Inc. 1600 West Merit Parkway SOUTH JORDAN UT 84095

Re: K093947

Trade/Device Name: 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 6, 2010 Received: January 8, 2010

Dear Ms. Holloway:

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 - Ms. Carol Holloway

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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 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(301) 796-5484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ALIMAXX-B TM Uncovered Biliary Stent System

Indications For Use:

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

X 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)

Jubair Kumar

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K093947

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.