K Number

Device Name

ENDOMAXX FULLY COVERED ESOPHAGEAL STENT

Manufacturer

MERIT MEDICAL SYSTEMS, INC.

Date Cleared

2011-07-29

(50 days)

Product Code

ESW REV

Regulation Number

878.3610

Intended Use

The MERIT ENDOTEK™ EndoMAXX™ Fully Covered Esophageal Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

Device Description

The MERIT ENDOTEK™ EndoMAXX Fully Covered Esophageal Stent is comprised of two components: the radiopaque self-expanding Nitinol stent and the deployment catheter. The stent is completely covered with a biocompatible silicone membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter at the distal and proximal ends to reduce the possibility of migration. The overall stent geometry is designed to minimize foreshortening upon expansion, thus facilitating improvement in deployment accuracy. The proximal and distal ends of the stent are threaded with a suture intended for use in proximal and distal repositioning of the stent. The stent is deployed with a dedicated deployment catheter. The deployment catheter consists of two coaxial sheaths attached to a deployment handle. The handle permits one-handed positioning and deployment via a trigger mechanism. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. A radiopaque tip and marker on the inner shaft proximal to the stent aid the operator in determining stent position to the deployment threshold. Once deployment is initiated, the stent cannot be reconstrained. The stent can be repositioned proximally until the first deployment trigger is deployed for a two deployment trigger device or until the second deployment trigger is deployed for a three deployment trigger device. The inner tube of the coaxial sheath catheter contains a central lumen that will accommodate a 0.035" (0.89mm) guide wire. This feature is designed to allow safe guidance of the deployment catheter to the intended implant site while minimizing the risk of esophageal injury from the deployment catheter tip.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K051621, K080838

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and deployment mechanism of a physical stent, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes.
The device is intended for "maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae," which are therapeutic applications.

Diagnostic

Explanation: This device, an esophageal stent, is intended for maintaining esophageal lumen patency and occluding fistulae. Its purpose is therapeutic and palliative, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components including a Nitinol stent, a silicone membrane, and a deployment catheter with a handle and sheaths. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is to maintain esophageal luminal patency and occlude fistulae within the body. This is a therapeutic and interventional use, not a diagnostic test performed on samples outside the body.
Device Description: The device is a physical stent designed to be implanted in the esophagus. It is deployed using a catheter. This is consistent with an implantable medical device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Anatomical Site: The device is used directly on the esophageal anatomical site, not on a sample taken from that site.

In summary, the MERIT ENDOTEK™ EndoMAXX™ Fully Covered Esophageal Stent is a medical device intended for therapeutic intervention within the body, not for performing diagnostic tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

ESW

Device Description

The MERIT ENDOTEK™ EndoMAXX Fully Covered Esophageal Stent is comprised of two components: the radiopaque self-expanding Nitinol stent and the deployment catheter. The stent is completely covered with a biocompatible silicone membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter at the distal and proximal ends to reduce the possibility of migration. The overall stent geometry is designed to ninimize foreshortening upon expansion, thus facilitating improvement in deployment accuracy. The proximal and distal ends of the stent are threaded with a suture intended for use in proximal and distal repositioning of the stent. The stent is deployed with a dedicated deployment catheter. The deployment catheter consists of two coaxial sheaths attached to a deployment handle. The handle permiss one-handed positioning and deployment via a trigger mechanism. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. A radiopaque tip and marker on the inner shaft proximal to the stent aid the operator in determining stent position to the deployment threshold. Once deployment is initiated, the stent cannot be reconstrained. The stent can be repositioned proximally until the first deployment trigger is deployed for a two deployment trigger device or until the second deployment trigger is deployed for a three deployment trigger device. The inner tube of the coaxial sheath catheter contains a central lumen that will accommodate a 0.035" (0.89mm) guide wire. This feature is designed to allow safe guidance of the deployment catheter to the intended implant site while minimizing the risk of esophageal injury from the deployment catheter tip.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Esophageal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of the following documents, and were shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device:

ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems, . 2009
. ASTM D-4332-01, Standard practice for conditioning containers, packages, or packaging components for testing, 2006
ASTM F2052-06e1 Measurement of Magnetically Induced Displacement Force on Medical . Devices in the MR Environment, 2006
. ASTM F2119-07, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, 2007
ASTM F2129-08, Conducting Cyclic Potentiodynamic Polarization Measurements to Determine . the Corrosion Susceptibility ,2008
ASTM F2182-09, Measurement of Radio Frequency Induced Heating Near Passive Implants . During MR Imaging, 2009
. ASTM F2213-06, Method for Measurement of Magnetically Induced Torque on Passive Implants in MR Environment, 2006
ASTM F2503-08 Marking Medical Devices and Other Items for Safety in the Magnetic Resonance ● Environment, 2008
ASTM G71-81, Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in . Electrolytes, 2009
ISO 2233:00; Packaging Complete, filled transport packages and unit loads conditioning for ● testing
. USP34 NF29, U.S. Pharmacopeia-National Formulary (Simulated Gastric Fluid Test Solution Only)
. ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
. ISO 10993-6: Biological Evaluation of Medical Devices - Tests for Local Effects after Implantation; 2007-04-15
ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing . Within a Risk Management Process
ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and . Skin Sensitization

The following tests were successfully conducted as per FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prosthesis, April 28, 1998:

Deployment Testing. ●
. Expansion Force Testing.
. Compression Force Testing.
. Dimensional Testing.
. Corrosion Testing.
. Tensile Strength Tests.

The following list details significant testing that was successfully completed:

. Guidewire compatibility
. Distal Tip Insertion
. Stent foreshortening
. Deployment Catheter Profile
Deployment Trigger Stroke ◆
. Trigger safety
. Stent Deployment Force
. Stent Repositioning after partial deployment.
. Deployment Accuracy
. Stent repositioning, after full deployment
. Stent expansion and condition after deployment
. System integrity
. Radius of leading stent struts
Stent Springback after purse stringing suture
Compression Force Pre-fatigue .
. Expansion Force Pre-fatigue
. Stent in-fold distance
. Stent in-fold force
. Stent flexibility
. Suture cutting with forceps
. Suture tensile
. Stent Fatigue
. Cover Integrity after Fatigue
. Stent Springback after Fatigue (dimensional)
. Compression Force after Fatigue
. Expansion Force after Fatigue
. Stent Tensile
First trigger to floater tensile .
. Floater to internal connector tensile
Second trigger to internal connector tensile .
. For 3-trigger device, 1st trigger to second trigger tensile
. Handle to outer support tensile
. Handle to metal hypotube and inner shaft bond tensile
Outer shaft to internal connector bond tensile ●
. Outer shaft tensile
Pod to outer shaft tensile
. Tip to inner sheath bond
. Visualize stent with fluoroscopy
. Fluoroscopic visibility of deployment catheter
. Packaging Condition
. Stent Anti-migration Strut Height
. Corrosion
. MR Compatibility

The following biocompatibility tests were successfully completed:

Cytotoxicity
. Sensitization
. Implantation
Sub-Chronic Toxicity .

Packaging performance before and after exposure to accelerated aging and simulated shipping and handling conditions was successfully completed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051621, K080838

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.”

Summary

Image /page/0/Picture/0 description: The image shows the logo for Merit Medical Endotek. The logo consists of two parts: a stylized "M" symbol on the left and the text "MERITMEDICAL ENDOTEK" on the right. The text is in a bold, sans-serif font, with "MERITMEDICAL" on the top line and "ENDOTEK" on the bottom line.

KIIII611
pg 1 of 4

JUL 2 9 2011

MERIT MEDICAL SYSTEMS, INC

ENDOTEK Division

1600 West Merit Parkuar

SCUTH JORDAN, UTAH 84095

1.801 257 1000 1 Institu

6789.016, 108.1 144

www.merit.com/endotek

510(k) Summary

General Provisions Submitter: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 Telephone No .: 801-208-4389 FAX No .: 801-826-4157 Contact Person: John C. Knorpp, Director, Regulatory Affairs - Endotek Division Email: jknorpp@merit.com Date of Preparation: July 18, 2011 Registration No .: 1721504

Subject Device

Trade Name: Common/Usual Name: Classification Name:

EndoMAXX™ Fully Covered Esophageal Stent Esophageal Stent Prosthesis, Esophageal

Predicate Device

Trade Name: ALIMAXX-ESTM Esophageal Stent Classification Name: Prosthesis, Esophageal Premarket Notification: ・K051621 & K080838

Classification

CFR Listing: Product Code: Review Branch: Class II per 21 CFR 878.3610 ESW General & Plastic Surgery (Review Panel: Gastroenterology/Urology)

Indications for Use

Device Description

one-handed positioning and deployment via a trigger mechanism. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. A radiopaque tip and marker on the inner shaft proximal to the stent aid the operator in determining stent position to the deployment threshold. Once deployment is initiated, the stent cannot be reconstrained. The stent can be repositioned proximally until the first deployment trigger is deployed for a two deployment trigger device or until the second deployment trigger is deployed for a three deployment trigger device. The inner tube of the coaxial sheath catheter contains a central lumen that will accommodate a 0.035" (0.89mm) guide wire. This feature is designed to allow safe guidance of the deployment catheter to the intended implant site while minimizing the risk of esophageal injury from the deployment catheter tip.

Comparison to the Predicate

Both the subject and predicate devices are self expanding, fully covered Nitinol stents preloaded on a deployment catheter. The EndoMAXX Stent incorporates modifications to the cover, suture and stent lattice.

Both the subject and predicate deployment catheters are user controlled, single handed mechanisms designed for endoscopic placement of the stent over a guidewire. The EndoMAXX deployment catheter has been modified to fit the EndoMAXX Stent.

Safety & Performance Testing

ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems, . 2009
. ASTM D-4332-01, Standard practice for conditioning containers, packages, or packaging components for testing, 2006
ASTM F2052-06e1 Measurement of Magnetically Induced Displacement Force on Medical . Devices in the MR Environment, 2006
. ASTM F2119-07, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, 2007
ASTM F2129-08, Conducting Cyclic Potentiodynamic Polarization Measurements to Determine . the Corrosion Susceptibility ,2008
ASTM F2182-09, Measurement of Radio Frequency Induced Heating Near Passive Implants . During MR Imaging, 2009
. ASTM F2213-06, Method for Measurement of Magnetically Induced Torque on Passive Implants in MR Environment, 2006
ASTM F2503-08 Marking Medical Devices and Other Items for Safety in the Magnetic Resonance ● Environment, 2008
ASTM G71-81, Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in . Electrolytes, 2009
ISO 2233:00; Packaging Complete, filled transport packages and unit loads conditioning for ● testing
. USP34 NF29, U.S. Pharmacopeia-National Formulary (Simulated Gastric Fluid Test Solution Only)
. ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
. ISO 10993-6: Biological Evaluation of Medical Devices - Tests for Local Effects after Implantation; 2007-04-15

K112611
pg 3 of 4

ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing . Within a Risk Management Process
ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and . Skin Sensitization

The following tests were successfully conducted as per FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prosthesis, April 28, 1998:

Deployment Testing. ●
. Expansion Force Testing.
. Compression Force Testing.
. Dimensional Testing.
. Corrosion Testing.
. Tensile Strength Tests.

The following list details significant testing that was successfully completed:

. Guidewire compatibility
. Distal Tip Insertion
. Stent foreshortening
. Deployment Catheter Profile
Deployment Trigger Stroke ◆
. Trigger safety
. Stent Deployment Force
. Stent Repositioning after partial deployment.
. Deployment Accuracy
. Stent repositioning, after full deployment
. Stent expansion and condition after deployment
. System integrity
. Radius of leading stent struts
Stent Springback after purse stringing suture
Compression Force Pre-fatigue .
. Expansion Force Pre-fatigue
. Stent in-fold distance
. Stent in-fold force
. Stent flexibility
. Suture cutting with forceps
. Suture tensile
. Stent Fatigue
. Cover Integrity after Fatigue
. Stent Springback after Fatigue (dimensional)
. Compression Force after Fatigue
. Expansion Force after Fatigue
. Stent Tensile
First trigger to floater tensile .
. Floater to internal connector tensile
Second trigger to internal connector tensile .
. For 3-trigger device, 1st trigger to second trigger tensile
. Handle to outer support tensile
. Handle to metal hypotube and inner shaft bond tensile

K111611
pg 4 of 4

Outer shaft to internal connector bond tensile ●
. Outer shaft tensile
Pod to outer shaft tensile
. Tip to inner sheath bond
. Visualize stent with fluoroscopy
. Fluoroscopic visibility of deployment catheter
. Packaging Condition
. Stent Anti-migration Strut Height
. Corrosion
. MR Compatibility

The following biocompatibility tests were successfully completed:

Cytotoxicity
. Sensitization
. Implantation
Sub-Chronic Toxicity .

Packaging performance before and after exposure to accelerated aging and simulated shipping and handling conditions was successfully completed.

Summary of Substantial Equivalence

Based on the indications for use, design, and safety and performance test results, the subject EndoMAXX™ Fully Covered Esophageal Stent meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the ALIMAXX-ES™ Esophageal Stent manufactured by Merit Medical Systems, Inc.

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that converge at the top and then separate into three distinct shapes at the bottom.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. John C. Knorpp Director, Regulatory Affairs Merit Medical System, Inc. 1600 W. Merit Parkway SOUTH JORDAN UT 84095

JUL 2 9 2011

Re: K111611

Trade/Device Name: EndoMAXX™ Fully Covered Esophageal Stent Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: July 25, 2011 Received: July 26, 2011

Dear Mr. Knorpp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Page 2

adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Huker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

5 Indications for Use

Indications for Use

510(k) Number (if known): J | | |(ø ||

EndoMAXX™ Fully Covered Esophageal Stent Device Name:

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sianroductive.

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