The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.

Device Description

The stent is provided pre-loaded in the delivery system. The stent is made up of several segments. The main frame is woven by Nitinol wire, and the connecting part is PTFE connecting loop. The stent with this segmented structure can flexibly conform to the curvature of the human body lumen, thereby reducing the stimulation of the end to the lumen. Silicone membrane applied to the stent covers the complete body of the stent along both flanges, which means the segmented esophageal stent is a fully covered stent. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. The covering is intended to reduce the risk of tissue ingrowth and provides a occlusion for esophageal fistulas. To aid in visibility under fluoroscopy there are 4 bands at either end of the stent and 2 bands at the middle of the stent. The stent has a retrieval loop which can be used to reposition the stent during the initial placement procedure if desired. The delivery system allows for desheathing to deploy the stent and recapturing the stent during stent deployment. 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

The provided document is a 510(k) Summary for the Segmented Esophageal Stent System (K182910), which is a medical device. This document describes the device's technical characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, not its performance against specific acceptance criteria in a clinical study for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document, as it pertains to a different type of medical device submission (510(k) for a physical stent, not an AI/CADe device).

The document focuses on demonstrating that the new stent device is substantially equivalent to a previously cleared predicate device (CHOOSTENT™ Covered Esophageal Stent, K072094) based on material, design, manufacturing, and general performance testing (bench tests and biocompatibility).

Although I cannot provide the requested information in the format of an AI/CADe device study, here's a summary of the performance data included in this 510(k) submission, which is primarily focused on demonstrating safety and efficacy for a physical implantable device:

Performance Data Summary (for the physical stent device):

The Segmented Esophageal Stent System underwent various performance tests to demonstrate its substantial equivalence to the predicate device.

Biocompatibility Testing:

Stent Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogen
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Cell Gene Mutation Test
- Muscle Implant
Delivery System Biocompatibility Testing:
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity

Device-Specific Performance Testing (Bench Tests):

Visual Inspection
Dimension Testing
Deployment Force Testing
Expansion Force Testing
Compression Force Testing
Corrosion Testing
Tensile Strength Testing
Sterility Testing
Shelf Life Testing
MR Compatibility Testing

Compliance Standards:

ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"
ISO 11135 "Sterilization of Health Care Products-Ethylene Oxide-Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"
FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices-7: Ethylene Oxide Sterilization Residuals"
Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses issued April 28th, 1998 (specifically "VIII Performance testing-Bench")

Conclusion of Testing:
The testing performed demonstrated that the proposed device and predicate device are equivalent in terms of performance characteristics relevant to their intended use (maintaining esophageal luminal patency).

Clinical Study:
No clinical study was included in this submission.

Regarding your specific points (and why they cannot be answered from this document):

Table of acceptance criteria and reported device performance: Not applicable for this type of submission. The document relies on equivalence to a predicate device, not predefined performance metrics for an AI/CADe system.
Sample size for test set and data provenance: No test set of medical images/data to assess AI performance. The "test sets" would refer to physical prototypes for bench testing.
Number of experts for ground truth and qualifications: Not applicable. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on image findings) is not relevant here.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This assesses human reader improvement with AI, which is irrelevant for a physical stent.
Standalone performance: Not applicable.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable, as there's no AI model being trained.
How ground truth for training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 29, 2019

Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director No. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China

Re: K182910

Trade/Device Name: Segmented Esophageal Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: April 29, 2019 Received: May 2, 2019

Dear Becky Li:

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Shani P. Haugen, Ph.D. Acting, Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K182910

Device Name Segmented Esophageal Stent System

Indications for Use (Describe)

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/2 description: The image shows a logo with the letters "MT" in a stylized, blocky font, colored in blue. A horizontal line is placed beneath the logo. Below the line, the text "Tab 2" is written in a large, bold font. The logo appears to be a trademarked symbol, indicated by the circled 'R' symbol in the upper right corner.

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: K182910

Date of Preparation: 1.

2019-05-22

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: Becky Li

Position: Quality & Regulatory Affairs Director

Tel: +86-25-58646378

Fax: +86-25-58350006

Email: Beckyli_mt@outlook.com

3. ldentification of Proposed Device

Trade Name: Segmented Esophageal Stent System

Common Name: Prosthesis, Esophageal

Regulatory Information

Classification Name: Esophageal Prosthesis

Classification: 2

Product Code: ESW

Regulation Number: 878.3610

Review Panel: Gastroenterology/Urology

ldentification of Predicate Device 4.

510(k) Number: K072094

Product Name: CHOOSTENT™ Covered Esophageal Stent

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Image /page/4/Picture/1 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 small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

510K Summary-2019-05-29 updated

Manufacturer: M. I. Tech Co., Ltd.

5. Indications for Use

The Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

6. Device Description

7. Comparison of Technological Characteristics with a Predicate Device

The Segmented Esophageal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and features the same intended use with the predicate device, namely the Esophageal Stent System manufactured by M. I. Tech Co., Ltd., under K072094.

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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are connected and appear to be leaning slightly to 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 look.

The proposal device is substantially equivalent to the currently marketed devices, CHOOSTENT™ covered esophageal stent, K072094.

The following table is the technological comparison between the proposed device and predicate device CHOOSTENT™ covered esophageal stent (K072094).

Table 2 Technological comparison between the proposed device and predicate device

ITEM	Proposed DeviceSegmentedEsophageal StentSystem	Predicate Device(K072094)CHOOSTENTTM coveredesophageal stent	Remark
Product Code	ESW	ESW	Same
Regulation No.	878.3610	878.3610	Same
Class	2	2	Same
Configuration	Stent and deliverysystem	Stent and delivery system	Same
Indications forUse	SegmentedEsophageal StentSystem is intendedfor maintainingesophageal luminalpatency inesophageal stricturescaused by intrinsic,or extrinsic malignanttumors only, andocclusion ofconcurrentesophageal fistula.	The CHOOSTENTTMcovered esophageal stentis intended formaintaining esophagealluminal patency inesophageal stricturescaused by intrinsic and orextrinsic malignanttumors only andocclusion of concurrentesophageal fistula.	Same
Single Use	Yes	Yes	Same
Diameter ofStent (mm)	18,20,22	18	Different
Length ofStent (mm)	60, 80, 100, 120, 140	80, 110, 140, 170	Different
Maximum OD(D) of DeliverySystem (mm)	6.7	6.0	Different
WorkingLength (mm)	650	700	Different
ITEM	Proposed DeviceSegmentedEsophageal StentSystem	Predicate Device(K072094)CHOOSTENT™ coveredesophageal stent	Remark
Covering	Fully Covered	Fully Covered	Same
Shelf life	2 years	3 years	Different
Packaging	EO sterilized pouchwith one device perpouch	EO sterilized pouch withone device per pouch	Same
Biocompatibility	Conform to ISO10993-1	Conform to ISO 10993-1	Same
Sterilization	EO Sterilized,SAL:10-6	EO Sterilized, SAL:10-6	Same
MRIinformation	Comply with ASTM F2503, ASTM F 2052,ASTM F2119, ASTMF2182, ASTM F2213	Comply with ASTM F2503, ASTM F 2052,ASTM F2119, ASTMF2182, ASTM F2213	Same
Labeling	Conform to 21 CFRpart 801	Conform to 21 CFR part801	Same

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Image /page/6/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional design. The "M" is formed by two angled lines that meet at a point, and the "T" is a vertical line with a horizontal line across the top. The logo has a three-dimensional effect, with the letters appearing to be raised and angled slightly. A circled "R" symbol is located in the upper right corner of the logo, indicating that it is a registered trademark.

510K Summary-2019-05-29 updated

8. Performance Data

The Segmented Esophageal 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", ISO 11135 'Sterilization of Health Care Products-Ethylene Oxide-Part 1:Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices', and FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices7: Ethylene Oxide Sterilization Residuals', the following tests were conducted:

Stent Biocompatibility Testing:

Vitro Cytotoxicity
Skin Sensitization
Irritation
Acute Systemic Toxicity

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Image /page/7/Picture/1 description: The image shows a blue logo with the letters 'MT' stacked on top of each other in a stylized, three-dimensional font. The 'M' is on the bottom and the 'T' is on the top. The logo has a registered trademark symbol '®' in the upper right corner. The logo appears to be for a company or organization with the initials 'MT'.

Pyrogen ●
Salmonella Reverse Mutation Test
In Vitro Mammalian Cell Gene Mutation Test
Muscle Implant

Delivery System Biocompatibility Testing:

Vitro Cytotoxicity
Skin Sensitization
Irritation
Acute Systemic Toxicity

The device specific guidance document was consulted in preparing this premarket submission, VIII Performance testing-Bench of Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses issued April 28th, 1998, the following tests were conducted for the subject device:

ゃ Visual Inspection
ゃ Dimension Testing
ゃ Deployment Force Testing
ゃ Expansion Force Testing
ゃ Compression Force Testing
ゃ Corrosion Testing
や Tensile Strength Testing
や Sterility Testing
ゃ Shelf Life Testing
ゃ MR Compatibility Testing

The testing performed demonstrated that the proposed device and predicate device are equivalent.

9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional design. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

510K Summary-2019-05-29 updated

performance testing, the Segmented Esophageal Stent System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the CHOOSTENT™ Covered Esophageal Stent (K072094).

Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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.”