Tracheal Stent System (Y-Shaped)
Device Facts
| Record ID | K212403 |
|---|---|
| Device Name | Tracheal Stent System (Y-Shaped) |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. |
| Product Code | JCT · General, Plastic Surgery |
| Decision Date | Oct 30, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3720 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Tracheal Stent System (Y-Shaped) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
Device Story
Tracheal Stent System (Y-Shaped) is a self-expanding, Y-shaped metallic stent preloaded in a flexible delivery system; used for maintaining tracheal luminal patency in patients with malignant tracheobronchial strictures. Stent is woven from Nitinol wire, partially covered with silicone to prevent tumor in-growth; features radiopaque markers for fluoroscopic visibility and retrieval loops for repositioning. Delivery system uses outer sheath to constrain stent; deployment via handle withdrawal. Intended for single-use by trained healthcare professionals in clinical settings. Device provides mechanical support to airway; benefits patient by relieving obstruction caused by neoplasms. Bench testing confirms performance, biocompatibility, and MR compatibility.
Clinical Evidence
Bench testing only. No clinical or animal studies were performed. Testing included biocompatibility (ISO 10993-1), deployment/expansion/compression/tensile force, guidewire compatibility, kink resistance, fluoroscopic/endoscopic visibility, sterility, shelf-life (accelerated aging), and MR compatibility (ASTM F2052, F2182, F2119, F2213, F2503).
Technological Characteristics
Self-expanding Y-shaped stent woven from Nitinol wire; partially covered with silicone (0.01-0.20 mm thickness). Delivery system materials: PTFE, Pebax, PEEK, ABS. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. MR compatible per ASTM F2503, F2052, F2119, F2182, F2213. Dimensions: Stent diameters 16-22 mm, branch diameters 12-14 mm.
Indications for Use
Indicated for patients with tracheobronchial strictures caused by malignant neoplasms.
Regulatory Classification
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.
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Predicate Devices
- TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent (K971509)
Reference Devices
- AERO™ Tracheobronchial Stent Technology System (K140382)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.
Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, 210032 Cn
Re: K212403
Trade/Device Name: Tracheal Stent System (Y-Shaped) Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: July 30, 2021 Received: August 2, 2021
# 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
{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/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)
K212403
Device Name Tracheal Stent System (Y -Shaped)
Indications for Use (Describe)
The Tracheal Stent System (Y -Shaped) 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)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/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 made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo, slightly above and to the right of the "T".
# 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: K212403
### 1. Date of Preparation: 2021-10-26
### 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 (Y-Shaped)
Common Name: Tracheal Stent
# Regulatory Information
Classification Name: Tracheal Prosthesis
Classification: 2
Product Code: NYT, JCT
Regulation Number: 878.3720
Review Panel: General & Plastic Surgery, Anesthesiology
{4}------------------------------------------------
Image /page/4/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 leaning slightly to the right. A registered trademark symbol is located in the upper right corner of the logo. The logo has a clean and modern design.
### Section 5 510k summary
#### 4. Identification of Predicate Device
### Predicate Device
510(k) Number: K971509
Product Name: TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent
Manufacturer: Novatech SA
### Reference Device
510(k) Number: K140382 Product Name: AERO™ Tracheobronchial Stent Technology System Manufacturer: Merit Medical Systems, Inc.
As the predicate device only have a Y stent, haven't delivery system, to prove the delivery system of Tracheal Stent System (Y-Shaped) is safe and effective, the reference device AERO™ Tracheobronchial Stent Technology System (K140382) is chosen as the reference device to compare the delivery system.
#### Indications for Use ട.
The Tracheal Stent System (Y-Shaped) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
#### 6. Device Description
The Tracheal Stent System (Y-Shaped) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire by weaving in a Y shaped. This structure design can make the stent more flexible, compliant and self-expanding. The stent is integrated Y-shaped stent, which include 1 main stent, 2 branch stents, the integrated Y-shaped stent can replace three straight shape stents, and the overall design of Y-shaped stent can also be used for the expansion of the carina if there are strictures at the carina. The stent is woven from Nitinol wire. The branch stent is formed with a flange at either end. The stent is partially covered with silicone to restrict tumor in-growth through the wire mesh. To aid in visibility under fluoroscopy
{5}------------------------------------------------
there are radiopaque markers at the stent. There are 3 retrieval loops at the end of stent which can be used to reposition the stent during the initial placement procedure if desired. 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 (Y-Shaped) incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent (K971509).
| Item | Proposed Device<br>Tracheal Stent System<br>(Y-Shaped) | Predicate Device<br>TRACHEOBRONXANETM<br>DUMON Tracheo-bronchial<br>Silicone Stent (K971509) | Remark |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | NYT, JCT | NWA | Different |
| Regulation No. | 878.3720 | 878.3720 | Same |
| Class | 2 | 2 | Same |
| Supplied in Sterile | Yes | Yes | Same |
| Configuration | Stent and delivery system | Stent | Different |
| Diameter of Stent<br>(mm) | 16,18,20,22 | 14,15,16,18 | Different |
| Diameter of branch<br>stent(mm) | 12, 14 | 10,12,13,14 | Different |
| Length of Stent<br>(mm) | 40,50,60 | 110 | Different |
| Diameter of branch<br>stent(mm) | 15,20,30,35 | 15,20,30,50 | Different |
| Maximum OD (D)<br>of Delivery System<br>(mm) | 8 | NA, the predicate device<br>haven't delivery system | Different |
| Working Length<br>(mm) | 650 | | Different |
| Covering | Silicone partially covered | Silicone | Different |
| Item | Proposed Device<br>Tracheal Stent System<br>(Y-Shaped) | Predicate Device<br>TRACHEOBRONXANE™<br>DUMON Tracheo-bronchial<br>Silicone Stent (K971509) | Remark |
| Thickness of<br>Silicone (mm) | 0.01-0.20 | Unknown | Different |
| Main Stent material | Nitinol + silicone covering | Silicone | Different |
| Main Introduction<br>system materials | PTFE, Pebax, Peek, ABS | No delivery system | Different |
| Compatible<br>endoscopy working<br>channel | N/A, the device does not pass<br>through the working channel of<br>endoscopy. | N/A, the device does not pass<br>through the working channel<br>of endoscopy. | Same |
| Indications for Use | The Tracheal Stent System is<br>indicated for use in the treatment<br>of tracheobronchial strictures<br>caused by malignant neoplasms. | 1.Tracheobronchial tumors<br>2.Tracheal stenosis with<br>scarring<br>3.Bronchial stenosis after<br>surgical anastomotic,<br>anastomoses resections or<br>pulmonary transplantation | Similar |
| Stent function | Maintaining tracheal luminal<br>patency in tracheal strictures | Maintaining tracheal luminal<br>patency in tracheal strictures | Same |
| Principle of<br>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>stent before deployment. Loosen<br>the safe lock, then withdraw the<br>front handle to deploy the stent. | The predicate device only<br>consists of the stent. The<br>deployment of the only Y stent<br>requires rigid bronchoscopy<br>and a transient cessation of<br>ventilation during the<br>procedure. | Different |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized blister<br>with one device per blister | Single-use pouch with one<br>device per pouch | Same |
| Shelf Life | Two years | Five years | Different |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Same |
| Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | Same |
| Item | Proposed Device<br>Tracheal Stent System<br>(Y-Shaped) | Predicate Device<br>TRACHEOBRONXANE™<br>DUMON Tracheo-bronchial<br>Silicone Stent (K971509) | Remark |
| 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, three-dimensional font. The letters are connected and appear to be stacked on top of each other. A small registered trademark symbol is visible in the upper right corner of the logo. The logo is simple and modern.
Section 5 510k summary
{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 connected and appear to be made of solid blocks. A registered trademark symbol is located in the upper right corner of the logo.
Section 5 510k summary
The proposed device Tracheal Stent System (Y-Shaped) is similar in design and dimension to TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent (K971509), both stents are Y -shaped stents, the diameter and length of stent is not exactly the same, but they are very similar, all the performances required for different dimension have been tested and meet the requirement; The proposed device consists of a flexible delivery system preloaded with the stent, the stent is woven from nitinol wire and a silicone covered. The predicate device only has a silicone Y stent, doesn't include delivery system. For the differences, we choose AERO™ Tracheobronchial Stent Technology System (K140382) as a reference device which consists of a flexible delivery system preloaded with the stent and the stent is nitinol stent and covered with a membrane, the related comparative performance testing to the reference device have been conducted, the test results meet the requirement. The proposed device is EO sterilized and have a two-years shelf life, the predicate device is sterilized and have a five-years shelf life. After EO sterilized and aging, the bench testing and sterility testing of proposed device meet the requirement.
Therefore, the difference between proposed device and predicated device is considered not to affect the Substantially Equivalency between the proposed and predicate devices concerning the safety and effectiveness.
#### 8. Performance Data
The biocompatibility evaluation for the Tracheal Stent System (Y-Shaped) was conducted in accordance with FDA 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:
{8}------------------------------------------------
Stent Biocompatibility Testing:
- Vitro Cytotoxicity a)
- Skin Sensitization b)
- Irritation c)
- d) Acute Systemic Toxicity
- Pyrogen e)
- Muscle Implant f)
- Chemical Characterization and Biological Risk Assessment g)
### Delivery System Biocompatibility Testing:
- Vitro Cytotoxicity a)
- b) Skin Sensitization
- Irritation c)
According to the FDA Guidance "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th,1998" and the reference device performance, the following performance tests were conducted for the subject device in this premarket submission:
- Visual Inspection a)
- b) Dimension Testing
- Deployment Force Testing c)
- Expansion Force Testing d)
- Compression Force Testing e)
- Tensile Strength Testing f)
- Guidewire Compatibility Testing g)
- h) Insertion Force
- Distal Tip Insertion & Flexibility / Kink Resistance Testing i)
- j) Repositioning Force Testing
- k) Removal, Migration and Removal Force Testing
- I) Fluoroscopic Visibility Testing
{9}------------------------------------------------
Image /page/9/Picture/1 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.
- Endoscopic Visibility Testing m)
- n) Deployment Accuracy Testing
- Tensile Strength Testing of the Retrieval Loops and Stent o)
- Sterility Testing p)
- q) Shelf Life Testing
- MR Compatibility Testing r)
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 the 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.
{10}------------------------------------------------
Image /page/10/Picture/1 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.
The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent and reference device AERO™ Tracheobronchial Stent Technology System.
#### Animal Test Conclusion 9.
No animal study is included in this submission.
## 10. Clinical Test Conclusion
No clinical study is included in this submission.
## 11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the
Tracheal Stent System (Y -Shaped) has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device
TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent (K971509).
