(137 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of a stent, with no mention of AI or ML.
Yes
The device is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms, which is a therapeutic application.
No
Explanation: The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for treatment of strictures and is a device for deploying a stent. It does not perform any diagnostic function.
No
The device description clearly states it is comprised of a physical stent and a delivery system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the treatment of tracheobronchial strictures produced by malignant neoplasms." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a stent and a delivery system designed to be implanted in the tracheobronchial tree. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial
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)
FDA guidance 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.
Guidance for Industry: Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses (Issued April 28, 1998)
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
ISO11607-1: 2006: Packaging for terminally sterilized medical devices
ISO 2233: 2000 Packaging — Complete, filled transport packages and unit loads - Conditioning for testing
United States Pharmacopeia 40, National Formulary 35, 2017 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
Migration & Removal Force
AM-Strut Height
Stent Compression
Stent Expansion
Suture Purse String
Stent Dimensions Post Suture Purse String – 12F and 16F only
Suture Tensile Strength
Stent Tensile
Stent Fatigue
Cover Integrity After Fatigue
Coating Integrity After Fatigue
Stent Spring Back After Fatigue
Compression Force After Fatigue
Expansion Force After Fatigue
Delivery System Tensile Strength Tests- 7.9 F only
Fluoroscopic Visibility of Deployment Catheter
Endoscopic Visibility of Deployment Catheter
Atraumatic Tip
Compatibility with 2.8mm working channel
Compatibility with Olympus BF-1TH190 Rotary Scope
MR Compatibility
Biocompatibility (for new 7.9F delivery system)
Cytotoxicity
Sensitization
Irritation
Material Mediated Pyrogenicity
Packaging Performance
Seal Peel Strength
Visual Inspection
Bubble Emission
Key Results: The results of the testing demonstrated that the subject AEROmini met the predetermined acceptance criteria applicable to the performance of the device.
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.
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
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
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
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
3
5.0 510(k) Summary
| General
| Provisions | Correspondent Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit Parkway | |
| South 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 | |
| Predicate | ||
| Device | Trade Name: | AEROmini™ Tracheobronchial Stent System |
| Classification Name: | Tracheal Prosthesis | |
| Premarket Notification: | K140382 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II | |
| 21 CFR § 878.3720 | ||
| FDA Product Code: JCT | ||
| Review Panel: Anesthesiology | ||
| Indications For | ||
| Use | The Merit ENDOTEK AEROmini Tracheobronchial Stent System is | |
| indicated for use in the treatment of tracheobronchial strictures | produced by malignant neoplasms. |
4
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.
5
| Comparison to
Predicate
Device | 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). The
current AEROmini has sizes 8x15mm, 8x20mm, 10x15mm, 12x15mm
and 14x15mm. The new stents are fabricated as a single, integral
framework by laser-cutting a nitinol tube which is the same as the
current AEROmini stents. The new stents will be the same as the
current AEROmini stents in that a polyurethane polymer cover is
applied and a hydrophilic coating is added to the inner diameter surface
of the stent. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For the 6x10mm and 6x15mm sizes, the ultra-high molecular weight
polyethylene/polypropylene suture is attached to a single suture eyelet
instead of woven through the eyelets as is done for the other sizes
including 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 6
mm stents is also added to the current 12F and 16F size delivery
systems. New materials (Pebax and Nylon) are used in the 7.9F
delivery system for the inner assembly (tubing, marker band and
anchor) and outer sheath (pod jacket, flex zone and shaft). This new
delivery system allows the stent to be introduced through a 2.8 mm or
greater working channel of the bronchoscope. |
| | The indications for use of the subject device and predicate device are
the same. |
| Safety &
Performance
Tests | FDA guidance 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. |
| | Guidance for Industry: Guidance for the Content of Premarket
Notifications for Esophageal and Tracheal Prostheses (Issued April 28,
1998) |
6
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 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
7
| Safety &
Performance
Tests cont. | Migration & Removal Force
AM-Strut Height
Stent Compression
Stent Expansion
Suture Purse String
Stent Dimensions Post Suture Purse String – 12F and 16F only
Suture Tensile Strength
Stent Tensile
Stent Fatigue
Cover Integrity After Fatigue
Coating Integrity After Fatigue
Stent Spring Back After Fatigue
Compression Force After Fatigue
Expansion Force After Fatigue
Delivery System Tensile Strength Tests- 7.9 F only
Fluoroscopic Visibility of Deployment Catheter
Endoscopic Visibility of Deployment Catheter
Atraumatic Tip
Compatibility with 2.8mm working channel
Compatibility with Olympus BF-1TH190 Rotary Scope
MR Compatibility
Biocompatibility (for new 7.9F delivery system)
Cytotoxicity
Sensitization
Irritation
Material Mediated Pyrogenicity
Packaging Performance
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 performance of
the device. |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing, the subject AEROmini raises no new questions of safety or
effectiveness compared to the predicate device and is substantially
equivalent to the predicate device, the AEROmini Tracheobronchial
Stent Technology System, K140382 manufactured by Merit Medical
Systems, Inc. |