(137 days)
The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polvurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. 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. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.
The stent and delivery system are provided sterile using ethylene oxide (EO) process.
This document describes a 510(k) premarket notification for the AEROmini Tracheobronchial Stent System, manufactured by Merit Medical Systems, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K140382) to allow the device to be marketed.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly numerical targets in the provided text. Instead, the document states that the device "met the standards' established acceptance criteria applicable to the substantial equivalence of the device" and "met the predetermined acceptance criteria applicable to the performance of the device" for various tests. The general acceptance criterion is demonstrating that the new AEROmini device, with its new sizes and a new delivery system, performs equivalently to the predicate device and national/international standards without raising new questions of safety or effectiveness.
Below is a table summarizing the types of tests conducted (representing the indirectly stated acceptance criteria categories) and the reported device performance. No specific numerical thresholds or performance metrics are provided in this summary.
| Acceptance Criteria Category (Test Type) | Reported Device Performance |
|---|---|
| Mechanical Performance (Stent) | |
| Deployment Testing | Successfully conducted. |
| Expansion Force Testing | Successfully conducted. |
| Compression Force Testing | Successfully conducted. |
| Dimensional Testing | Successfully conducted. |
| Tensile Strength Tests | Successfully conducted. |
| Stent Expansion & Condition After Deployment | Successfully completed. |
| Stent Foreshortening | Successfully completed. |
| Stent Dimensions | Successfully completed. |
| Migration & Removal Force | Successfully completed. |
| AM-Strut Height | Successfully completed. |
| Stent Compression | Successfully completed. |
| Stent Expansion | Successfully completed. |
| Suture Purse String | Successfully completed. |
| Stent Dimensions Post Suture Purse String – 12F and 16F only | Successfully completed. |
| Suture Tensile Strength | Successfully completed. |
| Stent Tensile | Successfully completed. |
| Stent Fatigue | Successfully completed. |
| Cover Integrity After Fatigue | Successfully completed. (Implies cover remained intact and functional) |
| Coating Integrity After Fatigue | Successfully completed. (Implies coating remained intact and functional) |
| Stent Spring Back After Fatigue | Successfully completed. |
| Compression Force After Fatigue | Successfully completed. |
| Expansion Force After Fatigue | Successfully completed. |
| Mechanical Performance (Delivery System) | |
| Guide Wire Compatibility | Successfully completed. |
| Delivery Device Working Length | Successfully completed. |
| Delivery Device Stent Pod OD | Successfully completed. |
| Delivery Device Shaft OD - 7.9F | Successfully completed. |
| Trigger Stroke | Successfully completed. |
| Insertion Force | Successfully completed. |
| Deployment Force | Successfully completed. |
| Distal Tip Insertion & Flexibility/Kink Resistance | Successfully completed. |
| Repositioning | Successfully completed. (Within the defined limits before the deployment threshold mark) |
| Delivery System Deployment Accuracy | Successfully completed. |
| System Integrity | Successfully completed. |
| Delivery System Tensile Strength Tests- 7.9 F only | Successfully completed. |
| Imaging Compatibility | |
| Fluoroscopic Visibility of Deployment Catheter | Successfully completed. |
| Endoscopic Visibility of Deployment Catheter | Successfully completed. |
| MR Compatibility (Magnetically Induced Displacement Force, RF Heating, Torque, Image Artifacts) | Successfully conducted according to ASTM standards, implying the device is safe and its presence does not unduly affect MR imaging. |
| Biocompatibility | |
| Cytotoxicity (for new 7.9F delivery system) | Successfully completed. |
| Sensitization (for new 7.9F delivery system) | Successfully completed. |
| Irritation (for new 7.9F delivery system) | Successfully completed. |
| Material Mediated Pyrogenicity (for new 7.9F delivery system) | Successfully completed. |
| Biocompatibility (general, for new 7.9F delivery system materials) | Successfully conducted according to ISO 10993 series and FDA guidance. |
| Sterilization & Packaging | |
| Sterilization (Ethylene Oxide Process) | Successfully conducted according to ISO 11135:2014, implying sterility is maintained. |
| Packaging Performance (Performance Testing of Shipping, Conditioning) | Successfully conducted according to ASTM D4169-16, ISO 2233:2000, and ISO 11607-1:2006, implying package integrity and sterility maintenance. |
| Seal Peel Strength | Successfully completed. |
| Visual Inspection | Successfully completed. |
| Bubble Emission | Successfully completed. (Implies package integrity) |
| Clinical/Procedural Compatibility | |
| Atraumatic Tip | Successfully completed. |
| Compatibility with 2.8mm working channel | Successfully completed. |
| Compatibility with Olympus BF-1TH190 Rotary Scope | Successfully completed. |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for each individual test. It lists a "battery of tests" that were performed based on recognized performance standards and guidance. The provenance of the data (e.g., country of origin) is not mentioned beyond the fact that it was conducted by the manufacturer, Merit Medical Systems, Inc., for a U.S. FDA submission. The nature of these tests (mechanical, biocompatibility, sterilization, etc.) implies laboratory or bench testing rather than human clinical data. Therefore, it is not retrospective or prospective in the clinical trial sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The "ground truth" for these engineering and materials tests is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, FDA guidance) and their specified methodologies, rather than expert consensus on individual cases. The manufacturers' internal experts and testing personnel would perform these tests and interpret the results against the standard criteria.
4. Adjudication method for the test set:
This is not applicable as the tests are primarily objective measurements against defined standards, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device described, the AEROmini Tracheobronchial Stent System, is a physical medical device (a stent and its delivery system), not an AI-powered diagnostic or assistive tool.
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 system, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance evaluations is based on adherence to:
- Recognized Performance Standards: e.g., ISO 11135:2014, ASTM D4169-16, ASTM F2052-15, ISO 10993 series.
- FDA Guidance: Specifically, "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses, April 28, 1998" and "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995."
- Internal specifications and risk analysis: "Performance testing was conducted based on the risk analysis."
These documents and standards define acceptable methods, materials properties, and performance limits for such devices.
8. The sample size for the training set:
This is not applicable. The device is a physical medical device and does not involve AI algorithms that require training sets.
9. How the ground truth for the training set was established:
This is not applicable.
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September 21, 2018
Merit Medical Systems, Inc David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K181200
Trade/Device Name: AEROmini Tracheobronchial Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: Class II Product Code: JCT Dated: August 21, 2018 Received: August 22, 2018
Dear David Thomas:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K181200 |
|---|---|
| Device Name | AEROmini Tracheobronchial Stent System |
| Indications for Use (Describe) | The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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5.0 510(k) Summary
| GeneralProvisions | Correspondent Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | 801-316-4956 | |
| Fax Number: | 801-253-6982 | |
| Contact Person: | David Thomas | |
| Date of Preparation: | August 21, 2018 | |
| Registration Number: | 1721504 | |
| Subject Device | Trade Name: | AEROmini® Tracheobronchial Stent System |
| Common/Usual Name: | Tracheobronchial Stent | |
| Classification Name: | Tracheal Prosthesis | |
| PredicateDevice | Trade Name: | AEROmini™ Tracheobronchial Stent System |
| Classification Name: | Tracheal Prosthesis | |
| Premarket Notification: | K140382 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR § 878.3720FDA Product Code: JCTReview Panel: Anesthesiology | |
| Indications ForUse | The Merit ENDOTEK AEROmini Tracheobronchial Stent System isindicated for use in the treatment of tracheobronchial strictures | produced by malignant neoplasms. |
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Device
Description
The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polvurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. 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. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.
The stent and delivery system are provided sterile using ethylene oxide (EO) process.
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| Comparison toPredicateDevice | The AEROmini is being offered in 6 new size configurations (6 x 10mm,6x15mm, 8 x 10mm, 10 x10mm, 12 x 10mm, and 14 x 10mm). Thecurrent AEROmini has sizes 8x15mm, 8x20mm, 10x15mm, 12x15mmand 14x15mm. The new stents are fabricated as a single, integralframework by laser-cutting a nitinol tube which is the same as thecurrent AEROmini stents. The new stents will be the same as thecurrent AEROmini stents in that a polyurethane polymer cover isapplied and a hydrophilic coating is added to the inner diameter surfaceof the stent. |
|---|---|
| For the 6x10mm and 6x15mm sizes, the ultra-high molecular weightpolyethylene/polypropylene suture is attached to a single suture eyeletinstead of woven through the eyelets as is done for the other sizesincluding the currently marketed sizes. | |
| The subject and predicate devices are preloaded on a flexible one-handed delivery system. An additional 7.9F delivery system for the 6mm stents is also added to the current 12F and 16F size deliverysystems. New materials (Pebax and Nylon) are used in the 7.9Fdelivery system for the inner assembly (tubing, marker band andanchor) and outer sheath (pod jacket, flex zone and shaft). This newdelivery system allows the stent to be introduced through a 2.8 mm orgreater working channel of the bronchoscope. | |
| The indications for use of the subject device and predicate device arethe same. | |
| Safety &PerformanceTests | FDA guidance and recognized performance standards have beenestablished for Tracheal Prosthesis under Section 514 of the Food,Drug and Cosmetic Act. A battery of tests was performed based on therequirements of the below recognized performance standards andguidance, as well as biocompatibility, sterilization, and labelingstandards and guidance. Conformity to these standards demonstratesthat the proposed AEROmini met the standards' establishedacceptance criteria applicable to the substantial equivalence of thedevice. Performance testing was conducted based on the risk analysisand based on the requirements of the following documents: |
| The following tests were successfully conducted as per FDA Guidancefor the Content of Premarket Notifications for Esophageal and TrachealProsthesis, April 28, 1998: | |
| Deployment Testing.Expansion Force Testing.Compression Force Testing.Dimensional Testing.Tensile Strength Tests. | |
| Guidance for Industry: Guidance for the Content of PremarketNotifications for Esophageal and Tracheal Prostheses (Issued April 28,1998) |
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ISO 11135:2014. Sterilization of health care products – routine control of a sterilization process for medical devices ASTM D4169 -16, Standard Practice for Performance Testing of Shipping Containers and Systems ASTM F2052-15:2015 Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment ASTM F2119-07:2013, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants ASTM F2182-11a:2011, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During MR Imaging ASTM F2213-06:2011, Method for Measurement of Magnetically Induced Torque on Medical Devices in MR Environment ASTM F2503-08:2013 Marking Medical Devices and Other Items for Safety in the Maqnetic Resonance Environment ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-7:2008 - Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals ISO 10993-11: 2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicitv Safety & ISO11607-1: 2006: Packaging for terminally sterilized medical devices Performance ISO 2233: 2000 Packaging — Complete, filled transport packages and Tests cont. unit loads - Conditioning for testing United States Pharmacopeia 40, National Formulary 35, 2017 <151> Pyrogen Test The following list details significant testing that was successfully completed: Guide Wire Compatibility Delivery Device Working Lenath Delivery Device Stent Pod OD Delivery Device Shaft OD - 7.9F Trigger Stroke Insertion Force Deployment Force Distal Tip Insertion & Flexibility/Kink Resistance Repositioning Delivery System Deployment Accuracy Stent Expansion & Condition After Deployment System Integrity Stent Foreshortening Removal Stent Dimensions
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| Safety &PerformanceTests cont. | Migration & Removal ForceAM-Strut HeightStent CompressionStent ExpansionSuture Purse StringStent Dimensions Post Suture Purse String – 12F and 16F onlySuture Tensile StrengthStent TensileStent FatigueCover Integrity After FatigueCoating Integrity After FatigueStent Spring Back After FatigueCompression Force After FatigueExpansion Force After FatigueDelivery System Tensile Strength Tests- 7.9 F onlyFluoroscopic Visibility of Deployment CatheterEndoscopic Visibility of Deployment CatheterAtraumatic TipCompatibility with 2.8mm working channelCompatibility with Olympus BF-1TH190 Rotary ScopeMR CompatibilityBiocompatibility (for new 7.9F delivery system)CytotoxicitySensitizationIrritationMaterial Mediated PyrogenicityPackaging PerformanceSeal Peel StrengthVisual InspectionBubble Emission |
|---|---|
| The results of the testing demonstrated that the subject AEROmini metthe predetermined acceptance criteria applicable to the performance ofthe device. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performancetesting, the subject AEROmini raises no new questions of safety oreffectiveness compared to the predicate device and is substantiallyequivalent to the predicate device, the AEROmini TracheobronchialStent Technology System, K140382 manufactured by Merit MedicalSystems, Inc. |
§ 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.”