Through the Scope Tracheal Stent System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu Province 210032 China Re: K220424 Trade/Device Name: Through the Scope Tracheal Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: June 9, 2022 Received: June 13, 2022 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. 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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 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 mediation-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, Ph.D. 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) K220424 Device Name Through the Scope Tracheal Stent System Indications for Use (Describe) The Through the Scope Tracheal Stent System is 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The assigned 510(k) Number: K220424 ## 1. Date of Preparation: 2022-07-07 ## 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: Through the Scope Tracheal Stent System Common Name: Tracheal Stent ## Regulatory Information Classification Name: Tracheal Prosthesis Classification: 2 Product Code: JCT Regulation Number: 878.3720 Review Panel: Anesthesiology {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional design. The letters are primarily blue, with white highlights that create a sense of depth and dimension. A registered trademark symbol is located in the upper right corner of the logo. #### Identification of Predicate Device 4. 510(k) Number: K202204 Product Name: Tracheal Stent System (OTW) Manufacturer: Micro-Tech (Nanjing) Co., Ltd. #### 5. Indications for Use The Through the Scope Tracheal Stent System is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms. ### Device Description 6. The Through the Scope Tracheal Stent System 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 fully covered with silicone membrane and a polymer coating. The Parylene N is added on the surface of silicone membrane 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. The stent has different dimension with the diameters of 10mm, 12mm, 16mm, 18mm, with the lengths of 20mm, 30mm, 40mm, 50mm, 60mm, 80mm. The stent is deployed through the endoscopy working channel and under direct vision of endoscopy. The delivery system allows for desheathing to deploy and reposition the stent during the placement procedure. The delivery system consists of two coaxial sheaths and one inner core. 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 round tip acts as a guide when the delivery system enters the body. 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. 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, suggesting depth. A small, circled "R" symbol, indicating a registered trademark, is positioned in the upper right corner of the logo. ## 7. Comparison of Technological Characteristics The Through the Scope Tracheal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Tracheal Stent System (OTW). | | Proposed Device | Predicate Device | | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Item | Through the Scope Tracheal | Tracheal Stent System (OTW) | Remark | | | | | Stent System | (K202204) | | | | | Product Code | JCT | JCT | Same | | | | Regulation No. | 878.3720 | 878.3720 | Same | | | | Class | 2 | 2 | Same | | | | Supplied in Sterile | Yes | Yes | Same | | | | Configuration | Stent and delivery system | Stent and delivery system | Same | | | | Diameter of Stent<br>(mm) | 10, 12, 14, 16, 18 | 10, 12, 14, 16, 18, 20, 22 | Similar | | | | Length of Stent (mm) | 20, 30, 40, 50, 60, 80 | 20, 30, 40, 50, 60, 70, 80, 100 | Similar | | | | Maximum OD (D) of<br>Delivery System<br>(mm) | 2.7 | 4, 6 | Different | | | | Working Length<br>(mm) | 1200 | 650 | Different | | | | Covering | Fully Covered | Partially Covered,<br>Fully Covered | Similar | | | | Main Stent material | Nitinol | Nitinol | Same | | | | Main Introduction<br>system materials | PTFE, Pebax, Peek | PTFE, Pebax, Peek | Same | | | | Compatible<br>endoscopy working<br>channel | ≥2.8mm<br>Olympus bronchoscope larger<br>than 2.8mm working channel is<br>recommended. | N/A, the device does not pass<br>through the working channel of<br>endoscopy. | Different | | | | Surgical Technique | The Through the Scope Tracheal<br>Stent System can be directly<br>implanted into the airways<br>through the flexible bronchoscopy | Over the Wire, insert the delivery<br>system through the guidewire | Different | | | | Item | Proposed Device<br>Through the Scope Tracheal<br>Stent System | Predicate Device<br>Tracheal Stent System (OTW)<br>(K202204) | Remark | | | | | working channel and the<br>deployment is under the direct<br>vision of bronchoscopy. | | | | | | Indications for Use | The Through the Scope Tracheal<br>Stent System is indicated for use<br>in the treatment of<br>tracheobronchial strictures caused<br>by malignant neoplasms. | The Tracheal Stent System (OTW)<br>is indicated for use in the<br>treatment of tracheobronchial<br>strictures caused by malignant<br>neoplasms. | Same | | | | | Stent function | Maintaining tracheal luminal<br>patency in tracheal strictures | Maintaining tracheal luminal<br>patency in tracheal strictures | Same | | | | | Principle of operation | The proposed device consists of<br>the stent and delivery system. The<br>outer sheath of the delivery<br>system serves to constrain the<br> | The proposed device consists of<br>the stent and delivery system. The<br>outer sheath of the delivery system<br>serves to constrain the stent before<br>deployment. Loosen the safe lock,<br>then withdraw the front handle to<br>deploy the stent. | Same | | | | | Single Use | Yes | Yes | | | Packaging | | Single-use EO sterilized blister<br>with one device per blister | Single-use EO sterilized blister<br>with one device per blister | Same | | Shelf Life | Two years | | Two years | Same | | | Biocompatibility | Conform to ISO 10993-1 | | Conform to ISO 10993-1 | Same | | | Sterilization | EO Sterilized, SAL:10-6 | | EO Sterilized, SAL:10-6 | Same | | | Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Same | | | | MRI information | Comply with ASTM F 2503,<br>ASTM F 2052, ASTM F2119,<br>ASTM F2182. ASTM F2213 | Comply with ASTM F 2503,<br>ASTM F 2052, ASTM F2119,<br>ASTM F2182. ASTM F2213 | Same | | | # Comparison to Predicate Devices: {6}------------------------------------------------ Image /page/6/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 in a three-dimensional perspective. A registered trademark symbol (®) is located in the upper right corner of the logo. The proposed device Through the Scope Tracheal Stent System is similar in design to Tracheal Stent System (OTW), 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 {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 bold and appear to be interconnected, creating a sense of unity and strength. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. framework tube and a covering is applied to the surface of the stent. The dimensions of proposed device are covered within the range of that of the predicate device. All comparative non-clinical performance testing have been tested and have met the requirements of substantial equivalence to the predicate device. Both the proposed device and predicated device is EO sterilized and has a two-year shelf life. After EO 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 Through the Scope Tracheal Stent System 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 - Skin Sensitization b) - Irritation c) - Acute Systemic Toxicity d) - Pyrogen e) - f) Muscle Implant - Chemical Characterization and Biological Risk Assessment g) Delivery System Biocompatibility Testing: - a) Vitro Cytotoxicity - Skin Sensitization b) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and appear to be interconnected, with the "M" slightly overlapping the "T". A registered trademark symbol (®) is located in the upper right corner of the logo. Irritation c) 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: - Dimension Testing a) - Silicone Thickness Test b) - c) Expansion Force Testing - Compression and Recoil Testing d) - Deployment Force Testing e) - f) Deployment Accuracy and Damage Testing - Dislodgement Testing g) - Migration Force and Removability Testing h) - i) Tensile Strength Testing - j) Repositioning Testing - k) Corrosion Testing - 1) Fatigue testing - m) Austenite Finish Temperature 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 was 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 {9}------------------------------------------------ Image /page/9/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" on the left and the "T" on the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern design. 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 Tracheal Stent System (OTW) cleared under K202204. ### 9. Clinical Test Conclusion No clinical study is included in this submission. ### Substantially Equivalent (SE) Conclusion 10. Based on the indications for use, technological characteristics, and safety and performance testing, the Through the Scope Tracheal Stent System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Tracheal Stent System (OTW) cleared under K202204.