(392 days)
Not Found
No
The description focuses on the physical components and materials of the stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the treatment of tracheobronchial strictures caused by malignant neoplasms, which is a therapeutic purpose.
No.
The device description and intended use indicate that the Tracheal Stent System (OTW) is used for the treatment of tracheobronchial strictures by providing support and restricting tumor growth, not for diagnosing conditions.
No
The device description clearly details physical components like a flexible delivery system, a metallic stent made of Nitinol wire, silicone membrane, polymer coating, a retrieval loop, and radiopaque markers. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of tracheobronchial strictures caused by malignant neoplasms." This is a therapeutic intervention performed in vivo (within the body) to treat a medical condition.
- Device Description: The description details a physical implantable device (a stent) and its delivery system. It describes its materials, structure, and features designed for placement and function within the trachea and bronchi.
IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Tracheal Stent System (OTW) is a medical device used for treatment, not an IVD.
N/A
Intended Use / Indications for Use
The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
Product codes
JCT
Device Description
The Tracheal Stent System (OTW) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is partially or fully covered with silicone membrane and a polymer coating to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. To aid in visibility under fluoroscopy, there are Tantalum radiopaque markers at the body of the stent. The stent has flanges at the ends to aid in minimizing migration after the stent has been placed in the trachea. The stent has different dimension with the diameter ranging from 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, and 22mm, with the length ranging from 20mm, 30mm, 40mm, 50mm, 60mm, 70mm, 90mm, 90mm, and 100mm. The delivery system allows for desheathing, to deploy and recapture the stent during stent deployment. The delivery system consists of three coaxial sheaths. The outer sheath serves to constrain the stent until being retracted during the stent deployment. The middle sheath serves to support the delivery system. The inner sheath contains a central lumen that accommodates a 0.035 inch guide wire. The olive tip acts as a guide when the delivery system enters the body along the guide wire. The front handle is used for deploying the stent. The seal ring, locking ring, and safe lock work to lock the device and prevent the stent from being exposed. The decoration nut connects with the back handle. Different diameter delivery systems are applied to different diameter stents. There is an outer sheath diameter of 4 mm and 6 mm and a delivery system with the working length of 650 mm. The 4 mm diameter delivery system is applied to diameter 10 mm stent. The 6 mm diameter delivery system is applied to the 12 mm-22 mm diameter stent. The 6 mm diameter delivery system has one more repositioned function than the 4 mm diameter delivery system. Thus, the 6 mm diameter delivery system has one more positioning piece and visual marker than the 4 mm diameter delivery system. The 6 mm diameter delivery system has four markers and the 4 mm diameter delivery system has three markers. Radiopaque markers at both sheaths and stents can monitor the position under X-ray during the deployment operation.
The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.
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
trained healthcare professional
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)
The biocompatibility evaluation for the Tracheal Stent System (OTW) was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
Stent Biocompatibility Testing:
- a) Vitro Cytotoxicity
- b) Skin Sensitization
- c) Irritation
- d) Acute Systemic Toxicity
- e) Pyrogen
- f) Muscle Implant
- g) Chemical Characterization and Biological Risk Assessment
Delivery System Biocompatibility Testing:
- a) Vitro Cytotoxicity
- b) Skin Sensitization
- c) Irritation
The device specific guidance document was consulted in preparing this premarket submission, "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th,1998". The following tests were conducted and evaluated for the subject device:
- a) Visual Inspection
- b) Dimension Testing
- c) Deployment Force and Deployment Accuracy Testing
- d) Expansion Force Testing
- e) Compression Force Testing
- f) Tensile Strength Testing
- g) Corrosion Testing
- h) Fatigue testing
- i) Sterility Testing
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
MR compatibility was evaluated in accordance with ASTM F 2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging, ASTM F2119-07(2013)Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment, ASTM F2503 - 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021.
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device AERO™ Tracheobronchial Stent Technology System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road Nanjing, 210032 Cn
Re: K202204
Trade/Device Name: Tracheal Stent System (OTW) Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: July 30, 2020 Received: August 5, 2020
Dear Sally He:
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 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202204
Device Name Tracheal Stent System (OTW)
Indications for Use (Describe)
The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused 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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3
Image /page/3/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional block font. The letters are a solid blue color, and the logo has a registered trademark symbol (®) in the upper right corner. The logo has a modern and corporate look.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202204
1. Date of Preparation: 2021-09-01
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing,
Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Tracheal Stent System (OTW)
Common Name: Tracheal Stent
Regulatory Information
Classification Name: Tracheal Prosthesis
Classification: 2
Product Code: JCT
Regulation Number: 878.3720
Review Panel: Anesthesiology
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Image /page/4/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and appear to be three-dimensional. A registered trademark symbol (®) is located in the upper right corner of the logo.
4. Identification of Predicate Device
510(k) Number: K082284 Product Name: AERO™ Tracheobronchial Stent Technology System Manufacturer: Merit Medical Systems, Inc.
5. Indications for Use
The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
6. Device Description
The Tracheal Stent System (OTW) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is partially or fully covered with silicone membrane and a polymer coating to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. To aid in visibility under fluoroscopy, there are Tantalum radiopaque markers at the body of the stent. The stent has flanges at the ends to aid in minimizing migration after the stent has been placed in the trachea. The stent has different dimension with the diameter ranging from 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, and 22mm, with the length ranging from 20mm, 30mm, 40mm, 50mm, 60mm, 70mm, 90mm, 90mm, and 100mm. The delivery system allows for desheathing, to deploy and recapture the stent during stent deployment. The delivery system consists of three coaxial sheaths. The outer sheath serves to constrain the stent until being retracted during the stent deployment. The middle sheath serves to support the delivery system. The inner sheath contains a central lumen that accommodates a 0.035 inch guide wire. The olive tip acts as a guide when the delivery system enters the body along the guide wire. The front handle is used for deploying the stent. The seal ring, locking ring, and safe lock work to lock the device and prevent the stent from being exposed. The decoration nut connects with the back
5
Image /page/5/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly to the right, creating a sense of depth. A registered trademark symbol is located in the upper right corner of the logo.
handle. Different diameter delivery systems are applied to different diameter stents. There is an outer sheath diameter of 4 mm and 6 mm and a delivery system with the working length of 650 mm. The 4 mm diameter delivery system is applied to diameter 10 mm stent. The 6 mm diameter delivery system is applied to the 12 mm-22 mm diameter stent. The 6 mm diameter delivery system has one more repositioned function than the 4 mm diameter delivery system. Thus, the 6 mm diameter delivery system has one more positioning piece and visual marker than the 4 mm diameter delivery system. The 6 mm diameter delivery system has four markers and the 4 mm diameter delivery system has three markers. Radiopaque markers at both sheaths and stents can monitor the position under X-ray during the deployment operation.
The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.
7. Comparison of Technological Characteristics
The Tracheal Stent System (OTW) incorporates substantially equivalent device materials, design, configurations, packaging, sterilization processes, and intended use as the predicate device
AERO™ Tracheobronchial Stent Technology System.
| Item | Proposed Device
Tracheal Stent System (OTW) | Predicate Device
AERO™ Tracheobronchial
Stent Technology System
(K082284) | Remark |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | JCT | JCT | Same |
| Regulation No. | 878.3720 | 878.3720 | Same |
| Class | 2 | 2 | Same |
| Supplied Sterile | Yes | Yes | Similar |
| Configuration | Stent and delivery system | Stent and delivery system | Similar |
| Diameter of Stent
(mm) | 10,12,14,16,18,20,22 | 10,12,14,16,18,20 | Different |
| Length of Stent (mm) | 20,30,40,50,60,70,80,100 | 20,30,40,60,80 | Different |
| Maximum OD (D) of
Delivery System
(mm) | 4, 6 | 5.4, 7.4 | Different |
| | | Predicate Device | |
| Item | Proposed Device
Tracheal Stent System (OTW) | AEROTM Tracheobronchial
Stent Technology System
(K082284) | Remark |
| Working Length
(mm) | 650 | 560,590,610,620,630 | Different |
| Covering | Partially Covered,
Fully Covered | Fully Covered | Different |
| Main Stent material | Nitinol | Nitinol | Similar |
| Main Introduction
system materials | PTFE, Pebax, Peek | Nylon, PTFE | Different |
| Compatible
endoscopy working
channel | N/A, the device does not pass
through the working channel of
endoscopy. | N/A, the device does not pass
through the working channel of
endoscopy. | Similar |
| Surgical Technique | OTW: Over the Wire, insert the
delivery system through the
guidewire | Over the Wire (OTW), insert the
delivery system through the
guidewire | Similar |
| Indications for Use | The Tracheal Stent System is
indicated for use in the treatment
of tracheobronchial strictures
caused by malignant neoplasms. | The Merit ENDOTEK AEROTM
Tracheobronchial Stent System is
indicated for use in the treatment
of tracheobronchial strictures
produced by malignant neoplasms. | Similar |
| Stent function | Maintaining tracheal luminal
patency in tracheal strictures | Maintaining tracheal luminal
patency in tracheal strictures | Similar |
| Principle of operation | The proposed device consists of
the stent and delivery system. The
outer sheath of the delivery
system serves to constrain the
stent before deployment. Loosen
the safe lock, then withdraw the
front handle to deploy the stent. | The predicate device consists of
the stent and delivery system. The
outer sheath of the delivery system
serves to constrain the stent before
deployment. Loosen the safe lock,
then withdraw the front handle to
deploy the stent. | Similar |
| Single Use | Yes | Yes | Similar |
| Packaging | Single-use EO sterilized blister
with one device per blister | Single-use pouch with one device
per pouch | Similar |
| Shelf Life | Two years | Five years | Different |
| Item | Proposed Device
Tracheal Stent System (OTW) | Predicate Device
AERO™ Tracheobronchial
Stent Technology System
(K082284) | Remark |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Similar |
| Sterilization | EO Sterilized, SAL:10-6 | Non Sterile | Different |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Similar |
| MRI information | Comply with ASTM F 2503,
ASTM F 2052, ASTM F2119,
ASTM F2182, ASTM F2213 | Comply with ASTM F 2503,
ASTM F 2052, ASTM F2119,
ASTM F2182, ASTM F2213 | Similar |
Comparison to predicate Devices:
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Image /page/6/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A registered trademark symbol is located in the upper right corner of the logo.
7
Image /page/7/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected and appear to be made of blocks, giving them a pixelated or slightly retro look. A circled "R" symbol, indicating a registered trademark, is positioned in the upper right corner of the logo.
The proposed device Tracheal Stent System (OTW) is similar in design to AERO™
Tracheobronchial Stent Technology System, which consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. Both stents are made of Nitinol wire by fabricating as a single, integral framework tube and a covering is applied to the surface of the stent. Compared with the fully covered predicate device, the proposed device includes partially covered and fully covered configurations. The partially-covered stent is covered in the middle section, with only the flanges at the ends are not covered. The dimensions of proposed device are similar but not identical to the predicate device. All comparative nonclinical performance testing have been tested and have met the requirements of substantial equivalence to the predicate device. The proposed device is EO Sterilized and has a two year shelf life, the predicate device is non-sterilized and five years shelf life. After EQ sterilized and aging, the bench testing and sterility testing of the proposed device meet the requirements of substantial equivalence to the predicate device. Therefore, the difference between proposed device and predicated device is considered not to affect substantial equivalence between the proposed and predicate devices concerning safety and effectiveness.
8. Performance Data
The biocompatibility evaluation for the Tracheal Stent System (OTW) was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
8
Image /page/8/Picture/0 description: The image shows a stylized, three-dimensional logo with the letters 'MT' in a bold, sans-serif font. The letters are rendered in a solid blue color and appear to be constructed from thick blocks, giving them a geometric and modern look. A registered trademark symbol (®) is positioned in the upper right corner of the logo.
within a risk management process (issued on September 4, 2020,) the following tests were
conducted:
Stent Biocompatibility Testing:
- a) Vitro Cytotoxicity
- Skin Sensitization b)
- Irritation c)
- Acute Systemic Toxicity d)
- e) Pyrogen
- f) Muscle Implant
- Chemical Characterization and Biological Risk Assessment g)
Delivery System Biocompatibility Testing:
- Vitro Cytotoxicity a)
- b) Skin Sensitization
- c) Irritation
The device specific guidance document was consulted in preparing this premarket submission,
"Guidance for the content of premarket notifications for esophageal and tracheal prostheses
issued April 28th,1998". The following tests were conducted and evaluated for the subject
device:
- Visual Inspection a)
- Dimension Testing b)
- Deployment Force and Deployment Accuracy Testing c)
- Expansion Force Testing d)
- Compression Force Testing e)
- f) Tensile Strength Testing
- g) Corrosion Testing
- Fatigue testing h)
- i) Sterility Testing
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in
9
Image /page/9/Picture/0 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are primarily in a dark blue color, with the 'M' appearing larger and slightly behind the 'T'. The 'T' is positioned in front and to the right of the 'M', creating a sense of depth. A registered trademark symbol (®) is visible in the upper right corner of the logo.
accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
MR compatibility was evaluated in accordance with ASTM F 2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging, ASTM F2119-07(2013)Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment, ASTM F2503 - 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021.
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device AERO™ Tracheobronchial Stent Technology System.
9. Clinical Test Conclusion
No clinical study is included in this submission.
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Image /page/10/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected, with the "M" appearing to be in front of the "T". A small, circular "R" with a circle around it, indicating a registered trademark, is located in the upper right corner of the logo.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Tracheal Stent System (OTW) has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device AERO™ Tracheobronchial Stent Technology System (K082284).