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 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.

AI/ML Overview

This document describes the Tracheal Stent System (Y-Shaped) and its substantial equivalence to a predicate device. However, the provided text does not describe acceptance criteria for a study proving device performance in the context of AI/ML or diagnostic accuracy, nor does it detail a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data related to an AI/ML component.

Instead, the document focuses on the substantial equivalence of a physical medical device (a tracheal stent system) to a predicate device, as required for a 510(k) premarket notification. The "performance data" sections list various engineering and biocompatibility tests conducted on the stent and its delivery system, ensuring its safety and functionality, not its diagnostic or interpretative accuracy in an AI context.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to diagnostic accuracy.
Sample size used for the test set or data provenance in an AI/ML context.
Number of experts or their qualifications for establishing ground truth in an AI/ML context.
Adjudication method for a test set in an AI/ML context.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of AI assistance.
Standalone (algorithm only) performance.
Type of ground truth (expert consensus, pathology, outcomes data) in an AI/ML context.
Sample size for the training set for an AI/ML model.
How ground truth for the training set was established for an AI/ML model.

The document states:

No animal study is included in this submission.
No clinical study is included in this submission.

This indicates that the evaluation primarily relies on bench testing, biocompatibility testing, and comparison of technological characteristics to already approved devices, rather than a clinical trial or a study assessing human or AI diagnostic performance.

Summary of what the document does provide regarding device acceptance and performance (not AI/ML related):

The device is a Tracheal Stent System (Y-Shaped) indicated for treating tracheobronchial strictures caused by malignant neoplasms.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "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."

While specific numerical acceptance criteria for each test (e.g., "Deployment Force shall be X to Y N") are not listed in this summary, the document broadly indicates that the device met these criteria. The "Performance Data" section lists the types of tests conducted:

Test Category	Specific Tests Conducted
Biocompatibility	Vitro Cytotoxicity, Skin Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen, Muscle Implant, Chemical Characterization and Biological Risk Assessment
Delivery System Biocompatibility	Vitro Cytotoxicity, Skin Sensitization, Irritation
Device Performance	Visual Inspection, Dimension Testing, Deployment Force Testing, Expansion Force Testing, Compression Force Testing, Tensile Strength Testing, Guidewire Compatibility Testing, Insertion Force, Distal Tip Insertion & Flexibility / Kink Resistance Testing, Repositioning Force Testing, Removal, Migration and Removal Force Testing, Fluoroscopic Visibility Testing, Endoscopic Visibility Testing, Deployment Accuracy Testing, Tensile Strength Testing of the Retrieval Loops and Stent, Sterility Testing, Shelf Life Testing, MR Compatibility Testing
Sterilization	Validated per ISO 11135:2014+A1:2018
Shelf-Life	Two-years aging test performed, packaging integrity studies done per ASTM F1980-16 and ISO 11607-1/2:2019
MR Compatibility	Evaluated per ASTM F 2052-15, ASTM F2182-19e2, ASTM F2119-07(2013), ASTM F2213 - 17, ASTM F2503 - 13, and FDA guidance.

2. Sample size used for the test set and the data provenance: Not applicable. These tests are primarily bench/lab tests, not studies on patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the defined specifications and physical properties of the device, assessed through engineering and biocompatibility standards, not expert interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used:
The "ground truth" for the performance evaluation of this physical medical device is based on engineering specifications and established international standards (e.g., ISO, ASTM standards for biocompatibility, sterility, MR compatibility, and mechanical properties). The device's performance is measured against these predetermined specifications.

8. The sample size for the training set: Not applicable (no AI/ML training involved).

9. How the ground truth for the training set was established: Not applicable (no AI/ML training involved).

Summary

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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

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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

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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)

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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

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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

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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.

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 DeviceTracheal Stent System(Y-Shaped)	Predicate DeviceTRACHEOBRONXANETMDUMON Tracheo-bronchialSilicone 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(mm)	16,18,20,22	14,15,16,18	Different
Diameter of branchstent(mm)	12, 14	10,12,13,14	Different
Length of Stent(mm)	40,50,60	110	Different
Diameter of branchstent(mm)	15,20,30,35	15,20,30,50	Different
Maximum OD (D)of Delivery System(mm)	8	NA, the predicate devicehaven't delivery system	Different
Working Length(mm)	650		Different
Covering	Silicone partially covered	Silicone	Different
Item	Proposed DeviceTracheal Stent System(Y-Shaped)	Predicate DeviceTRACHEOBRONXANE™DUMON Tracheo-bronchialSilicone Stent (K971509)	Remark
Thickness ofSilicone (mm)	0.01-0.20	Unknown	Different
Main Stent material	Nitinol + silicone covering	Silicone	Different
Main Introductionsystem materials	PTFE, Pebax, Peek, ABS	No delivery system	Different
Compatibleendoscopy workingchannel	N/A, the device does not passthrough the working channel ofendoscopy.	N/A, the device does not passthrough the working channelof endoscopy.	Same
Indications for Use	The Tracheal Stent System isindicated for use in the treatmentof tracheobronchial stricturescaused by malignant neoplasms.	1.Tracheobronchial tumors2.Tracheal stenosis withscarring3.Bronchial stenosis aftersurgical anastomotic,anastomoses resections orpulmonary transplantation	Similar
Stent function	Maintaining tracheal luminalpatency in tracheal strictures	Maintaining tracheal luminalpatency in tracheal strictures	Same
Principle ofoperation	The proposed device consists ofthe stent and delivery system. Theouter sheath of the deliverysystem serves to constrain thestent before deployment. Loosenthe safe lock, then withdraw thefront handle to deploy the stent.	The predicate device onlyconsists of the stent. Thedeployment of the only Y stentrequires rigid bronchoscopyand a transient cessation ofventilation during theprocedure.	Different
Single Use	Yes	Yes	Same
Packaging	Single-use EO sterilized blisterwith one device per blister	Single-use pouch with onedevice 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 DeviceTracheal Stent System(Y-Shaped)	Predicate DeviceTRACHEOBRONXANE™DUMON Tracheo-bronchialSilicone Stent (K971509)	Remark
Labeling	Conform to 21 CFR part 801	Conform to 21 CFR part 801	Same
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	Same

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 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

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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:

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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

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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.

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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).

Regulation Number and Section

§ 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.”