(284 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 polyurethane 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. In addition, the procedure can be aborted and the entire system can be withdrawn en bloc at any time before the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. 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 provided text describes the regulatory clearance of the AEROmini™ Tracheobronchial Stent System, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets predefined acceptance criteria for AI/algorithm performance. Therefore, most of the requested information regarding AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, is not available in the given document.
However, the document does list the acceptance criteria in general terms, and states that studies were conducted to meet these criteria, thereby demonstrating substantial equivalence.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (as per FDA Guidance and Recognized Standards) | Reported Device Performance |
|---|---|
| Mechanical Performance (based on FDA Guidance for Esophageal and Tracheal Prosthesis) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Deployment Testing | Successfully conducted |
| Expansion Force Testing | Successfully conducted |
| Compression Force Testing | Successfully conducted |
| Dimensional Testing | Successfully conducted |
| Tensile Strength Tests | Successfully conducted |
| Guide Wire Compatibility | Successfully completed |
| Delivery Device Working Length | Successfully completed |
| Delivery Device Stent Pod OD | Successfully completed |
| Delivery Device Shaft OD | Successfully completed |
| Trigger Stroke | Successfully completed |
| Insertion Force | Successfully completed |
| Distal Tip Insertion & Flexibility/Kink Resistance Performance | Successfully completed |
| Repositioning Tests | Successfully completed |
| Delivery System Deployment Accuracy | Successfully completed |
| Stent Expansion & Condition After Deployment | Successfully completed |
| System Integrity | Successfully completed |
| Stent Foreshortening | Successfully completed |
| Removal Migration & Removal Force | Successfully completed |
| AM-Strut Height | Successfully completed |
| Suture Purse String Suture Tensile | Successfully completed |
| Stent Tensile | Successfully completed |
| Stent Fatigue | Successfully completed |
| Cover Integrity After Fatigue | Successfully completed |
| Coating Integrity After Fatigue | Successfully completed |
| Stent Spring Back After Fatigue | Successfully completed |
| Compression Force After Fatigue | Successfully completed |
| Expansion Force After Fatigue | Successfully completed |
| Trigger Safety | Successfully completed |
| Delivery System Tensile Strength Tests | Successfully completed |
| Imaging Compatibility | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Fluoroscopic Visibility of Deployment Catheter | Successfully completed |
| Endoscopic Visibility of Deployment Catheter | Successfully completed |
| MR Compatibility (ASTM F2052, F2119, F2182, F2213, F2503) | Successfully completed |
| Biocompatibility (ISO 10993 series) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Cytotoxicity (ISO 10993-5) | Successfully completed |
| Sensitization (ISO 10993-10) | Successfully completed |
| Implantation (ISO 10993-6) | Successfully completed |
| Irritation (ISO 10993-10) | Successfully completed |
| Material Mediated Pyrogenicity (USP 36) | Successfully completed |
| Chemical Characterization (ISO 10993-17, 10993-18) | Successfully completed |
| Sterilization (ISO 11135-1, ISO 10993-7) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Ethylene Oxide Sterilization Residuals | Successfully completed |
| Packaging Performance (ISO11607-1, ASTM D4169, ISO 2233) | All tests successfully conducted, demonstrating adherence to established criteria and substantial equivalence. Specific tests include: |
| Seal Peel Strength | Successfully completed |
| Visual Inspection | Successfully completed |
| Bubble Emission | Successfully completed |
| Atraumatic Tip | Successfully completed |
2. Sample size used for the test set and the data provenance:
- Not applicable as this document does not describe an AI/algorithm-based study. The performance testing refers to physical and material properties of the medical device itself. No specific sample sizes for these tests are provided in the summarized information beyond noting that "a battery of tests was performed."
- Data provenance: Not specified. This typically refers to laboratory testing of the physical device components and system.
3. 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 AI/algorithm performance is not relevant here. The "ground truth" for the device's performance is established by recognized performance standards and guidance documents (e.g., ISO, ASTM, FDA guidance), against which the device's physical and biological properties are measured.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert review processes for AI algorithms. Here, device performance is measured against objective technical standards.
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 document describes a traditional medical device (stent) and its physical, mechanical, and biological performance characteristics, not an AI or imaging diagnostic device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. Not an AI/algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is based on recognized performance standards and guidance documents (e.g., FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prosthesis, ISO, and ASTM standards) which define the expected physical, mechanical, and biological properties for tracheal prostheses.
8. The sample size for the training set:
- Not applicable. No AI/algorithm training set.
9. How the ground truth for the training set was established:
- Not applicable. No AI/algorithm training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
Merit Medical Systems, Inc. Dan Lindsay, RAC Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K140382
Trade/Device Name: AEROmini™ Tracheobronchial Stent System Regulation Number: 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: October 24, 2014 Received: October 27, 2014
Dear Mr. Lindsay,
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.
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Page 2 - Mr. Lindsay
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 (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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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4.0 Indications for Use
510(k) Number (if known): K140382
Device Name:
AEROmini™ Tracheobronchial Stent System
Indications for Use:
The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
AND/OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| GeneralProvisions | Correspondent Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | 801-208-4408 | |
| Fax Number: | 801-253-6945 | |
| Contact Person: | Dan W. Lindsay | |
| Date of Preparation: | June 3, 2014 | |
| Registration Number: | 1721504 | |
| Subject Device | Trade Name: | AEROmini™ |
| Common/Usual Name: | Tracheobronchial Stent | |
| Classification Name: | Tracheal Prosthesis | |
| PredicateDevice | Trade Name: | AERO™ Tracheobronchial Stent TechnologySystem |
| Classification Name: | Tracheal Prosthesis | |
| Premarket Notification: | K082284 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR § 878.3720FDA Product Code: JCTReview Panel: General and Plastic Surgery | |
| Intended Use | The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System isindicated for use in the treatment of tracheobronchial stricturesproduced by malignant neoplasms. | |
| DeviceDescription | The MERIT ENDOTEK AEROmini Tracheobronchial Stent System iscomprised of two components: the radiopaque self-expanding nitinolstent and the delivery system. The stent is completely covered with abiocompatible polyurethane membrane. The stent expansion resultsfrom the physical properties of the metal and the proprietary geometry.The overall stent geometry is designed to maintain a constant lengthover the entire range of possible diameters. As a result of this uniquedesign the stent has virtually no foreshortening, thus facilitating theselection of the appropriate stent length. The stent is deployedendoscopically with a dedicated delivery system with or without the aidof fluoroscopic imaging. The delivery system consists of two coaxialsheaths. The exterior sheath serves to constrain the stent until thesheath is retracted during deployment. The stent remains constrainedby the delivery system until the trigger is pulled beyond the whitedeployment threshold mark located between the trigger and hand grip.This feature allows for repositioning of the stent proximally. In addition,the procedure can be aborted and the entire system can be withdrawnen bloc at any time before the trigger is pulled beyond the whitedeployment threshold mark located between the trigger and hand grip.A radiopaque tip and marker on the inner shaft aid the operator indetermining stent position in relation to the deployment threshold mark,where repositioning or en bloc withdrawal is no longer possible. Theinner sheath of the delivery system contains a central lumen that willaccommodate a 0.035" guide wire. This feature is designed to allowguidance of the delivery system to the intended implant site whileminimizing the risk of airway injury from the delivery system tip. | |
| Comparison toPredicateDevice | The AEROmini is similar in design to the AERO Tracheobronchial StentTechnology System. Both stents are fabricated as a single, integralframework by laser-cutting a nitinol tube. A polyurethane polymercover is then applied and a hydrophilic coating is added to the innerdiameter surface of the stent. The subject and predicate devices arepreloaded on a flexible one-handed delivery system. | |
| The AEROmini is offered in 5 new sizes with diameters as small as8mm and lengths as short as 15mm. Other stent modifications include:changes to the stent flares, anti-migration struts, new proximal stentend suture eyelets. Changes to the delivery system include: materialchanges, smaller profile diameter, tapered tip, new trigger safety, anddesign changes intended to improve ergonomics. The AEROmini willbe provided sterile while the predicate was not. |
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FDA quidance and recognized performance standards have been established for Tracheal Prosthesis under Section 514 of the Food, Drug and Cosmetic Act. A battery of tests was performed based on the requirements of the below recognized performance standards and guidance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the proposed AEROmini met the standards' established acceptance criteria applicable to the substantial equivalence of the device. Performance testing was conducted based on the risk analysis and based on the requirements of the following documents:
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. Tensile Strength Tests.
Performance
Tests
Guidance for Industry: Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses (Issued April 28, 1998)
ISO 11135-1:2007, Sterilization of health care products - routine control of a sterilization process for medical devices ASTM D4169 - 09 Standard Practice for Performance Testing of
Shipping Containers and Systems ASTM F2052-06e1:2006 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 F2182-09:2011, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During MR Imaqinq
ASTM F2213-06:2011, Method for Measurement of Maqnetically Induced Torque on Medical Devices in MR Environment ASTM F2503-08:2013 Marking Medical Devices and Other Items for
Safety in the Magnetic 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 10993-17:2002, Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits
ISO 10993-18:2005, Biological evaluation of medical devices – Part 18: Chemical characterization of materials
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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ISO 10993-6. 2007. Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals ISO11607-1: 2006, Packaging for terminally sterilized medical devices United States Pharmacopeia 36, National Formulary 31, 2013. <151> Pyrogen Test ISO 2233: 2000, Packaging - Complete, filled transport packages and unit loads - Conditioning for testing 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 Trigger Stroke Insertion Force Distal Tip Insertion & Flexibility/Kink Resistance Performance Repositioning Tests cont. Delivery System Deployment Accuracy Stent Expansion & Condition After Deployment System Integrity Stent Foreshortening Removal Migration & Removal Force AM-Strut Height Suture Purse String Suture Tensile Stent Tensile Stent Fatique Cover Integrity After Fatigue Coating Integrity After Fatique Stent Spring Back After Fatique Compression Force After Fatigue Expansion Force After Fatique Trigger Safety Delivery System Tensile Strength Tests Fluoroscopic Visibility of Deployment Catheter Endoscopic Visibility of Deployment Catheter Atraumatic Tip MR Compatibility Biocompatibility Cytotoxicity Sensitization Implantation Irritation Material Mediated Pyrogenicity Chemical Characterization
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Performance Packaging Performance Tests cont. Seal Peel Strength Visual Inspection Bubble Emission The results of the testing demonstrated that the subject AEROmini met the predetermined acceptance criteria applicable to the substantial equivalence of the device. Based on the indications for use, design, and performance testing, the Summary of subject AEROmini meets the requirements that are considered Substantial essential for its intended use and is substantially equivalent to the Equivalence predicate device, the AERO Tracheobronchial Stent Technology System, K082284.
§ 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.”