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

Device Description

The Esophageal Stent System consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop 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

The provided text is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. Esophageal Stent System (K172813). It details the device, its intended use, comparison to a predicate device, and performance data. However, this document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based medical device.

The questions posed in the request (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth establishment) are relevant to the evaluation of AI/ML-based medical devices, which typically involve performance metrics like sensitivity, specificity, AUC, etc., derived from studies comparing algorithm output to established ground truth.

This 510(k) submission is for a physical medical device (an esophageal stent) and its material and mechanical properties. The "Performance Data" section in the document refers to:

Biocompatibility Testing: Evaluating the biological safety of the materials used in the stent.
Device-specific performance tests: Visual inspection, dimension testing, deployment force, expansion force, compression force, corrosion testing, tensile strength, sterility, shelf life, and MR compatibility.

There is no mention of an AI/ML algorithm, or any study design that would involve a "test set," "training set," "ground truth" derived from expert consensus, or "human readers improving with AI assistance."

Therefore, I cannot answer the specific questions about acceptance criteria for an AI device or a study proving its performance from the provided text. The document explicitly states: "No clinical study is included in this submission." This further indicates that the type of performance evaluation relevant to AI/ML devices (which often involves clinical data and observer studies) was not part of this 510(k) submission.

Summary

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June 21, 2018

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

Re: K172813 Trade/Device Name: Esophageal Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: April 13, 2018 Received: April 17, 2018

Dear Becky Li:

This letter corrects our substantially equivalent letter of May 18, 2018.

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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,

Image /page/1/Picture/6 description: The image shows the FDA logo on the left side. On the right side of the image, the text "Jeffrey W" is present, followed by the date "2018.06.2" and the time zone "-04'00'". The text is in a simple, sans-serif font and is aligned to the left.

Jeffrey W. Cooper -S 2018.06.21 16:26:16

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K172813

Device Name Esophageal Stent System

Indications for Use (Describe)

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

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."

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Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue 3D block letter "M" and "T" on the left, followed by the text "MICRO-TECH" in blue. There is a horizontal line under the text "MICRO-TECH". Below the line, there are two Chinese characters in blue.

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: K172813

1. Date of Preparation: 05/22/2018

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 & RA Director

Tel: +86-25-58646378

Fax: +86-25-58350006

Email: In@micro-tech.com.cn

3. Identification of Proposed Device

Trade Name: 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

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Image /page/4/Picture/1 description: The image shows a logo for MICRO-TECH. The logo consists of a blue 3D block letter "M" and "T" on the left, followed by the text "MICRO-TECH" in blue on the right. Below the text, there are two Chinese characters in blue.

4. Identification of Predicate Device

510(k) Number: K091510

Product Name: WallFlex Esophageal Fully Covered Stent System

5. Indications for Use

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

6. Device Description

The detail dimension information of the proposed device is as follows:

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510K Summary

No	Model	Diameterof Stent(D)	Diameterof Stent(D1,D2)	LengthofStent(L)	LengthofStent(LO)	MaximumOD(D) ofDeliverySystem	WorkingLength(L)	Covering
1	NST01-222-18.060	18	23	060	030	6.7	650	PartiallyCovered
2	NST01-222-18.080	18	23	080	050	6.7	650	PartiallyCovered
3	NST01-222-18.100	18	23	100	070	6.7	650	PartiallyCovered
4	NST01-222-18.120	18	23	120	090	6.7	650	PartiallyCovered
5	NST01-222-18.140	18	23	140	110	6.7	650	PartiallyCovered
6	NST01-222-18.150	18	23	150	120	6.7	650	PartiallyCovered
7	NST01-222-20.060	20	25	060	030	6.7	650	PartiallyCovered
8	NST01-222-20.080	20	25	080	050	6.7	650	PartiallyCovered
9	NST01-222-20.100	20	25	100	070	6.7	650	PartiallyCovered
10	NST01-222-20.120	20	25	120	090	6.7	650	PartiallyCovered
11	NST01-222-20.140	20	25	140	110	6.7	650	PartiallyCovered
12	NST01-222-20.150	20	25	150	120	6.7	650	PartiallyCovered
13	NST01-222-22.060	22	27	060	030	6.7	650	PartiallyCovered
14	NST01-222-22.080	22	27	080	050	6.7	650	PartiallyCovered
15	NST01-222-22.100	22	27	100	070	6.7	650	PartiallyCovered
16	NST01-222-22.120	22	27	120	090	6.7	650	PartiallyCovered
17	NST01-222-22.140	22	27	140	110	6.7	650	PartiallyCovered
18	NST01-222-22.150	22	27	150	120	6.7	650	PartiallyCovered
						510K Summary
19	NST01-224-18.060	18	23	060	030	6.7	650	Fully Covered
20	NST01-224-18.080	18	23	080	050	6.7	650	Fully Covered
21	NST01-224-18.100	18	23	100	070	6.7	650	Fully Covered
22	NST01-224-18.120	18	23	120	090	6.7	650	Fully Covered
23	NST01-224-18.140	18	23	140	110	6.7	650	Fully Covered
24	NST01-224-18.150	18	23	150	120	6.7	650	Fully Covered
25	NST01-224-20.060	20	25	060	030	6.7	650	Fully Covered
26	NST01-224-20.080	20	25	080	050	6.7	650	Fully Covered
27	NST01-224-20.100	20	25	100	070	6.7	650	Fully Covered
28	NST01-224-20.120	20	25	120	090	6.7	650	Fully Covered
29	NST01-224-20.140	20	25	140	110	6.7	650	Fully Covered
30	NST01-224-20.150	20	25	150	120	6.7	650	Fully Covered
31	NST01-224-22.060	22	27	060	030	6.7	650	Fully Covered
32	NST01-224-22.080	22	27	080	050	6.7	650	Fully Covered
33	NST01-224-22.100	22	27	100	070	6.7	650	Fully Covered
34	NST01-224-22.120	22	27	120	090	6.7	650	Fully Covered
35	NST01-224-22.140	22	27	140	110	6.7	650	Fully Covered
36	NST01-224-22.150	22	27	150	120	6.7	650	Fully covered

Table 1 Dimension information of proposed device (Unit: mm)

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4/8

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510K Summary

7. Comparison of Technological Characteristics with a Predicate Device

The Esophageal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific Corporation Predicate Device, WallFlex Esophageal Fully Covered Stent System, under K091510.

The proposal device is substantially equivalent to the currently marketed devices, WallFlex Esophageal Fully Covered Stent System, K091510 cleared June 26, 2009.

The following table is the technological comparison between the proposed device and predicate device WallFlex Esophageal Fully Covered Stent System (K091510).

ITEM	Proposed DeviceEsophageal Stent System	Predicate Device (K091510)WallFlex Esophageal FullyCovered Stent System	Remark
Diameter of Stent (mm)	18,20,22	18,23	One more differentdiameter thanpredicate device. Morediameter could providemore choices.
Length of Stent (mm)	60, 80, 100, 120, 140, 150	103, 123, 153105, 125, 155	More short lengthsthan predicate device.More length canprovide more choicesfor users
Maximum OD (D) ofDelivery System (mm)	6.7	6.17	Different but similar
Working Length (mm)	650	780	Different workinglength, but similar
Image: Logo			510K Summary
Covering	Partially Covered, FullyCovered	Fully Covered	The proposed deviceincludes partiallycovered and fullycovered. Thepredicate device onlyhas fully covered.
Main Stent material	Nitinol, Silicone	Nitinol, Silicone	Same
Main Introduction systemmaterials	PTFE, Pebax	PTFE, Pebax	Same
Indications for Use	Esophageal Stent Systemis intended for maintainingesophageal luminal patencyin esophageal stricturescaused by intrinsic and/orextrinsic malignant tumorsonly, and occlusion ofconcurrent esophagealfistula.	The WallFlex EsophagealFully Covered Stent Systemis intended for maintainingesophageal luminal patencyin esophageal stricturescaused by instrinsic and/orextrinsic malignant tumors,and occlusion of concurrentesophageal fistula.	Same
Stent function	maintaining esophagealluminal patency inesophageal strictures	maintaining esophagealluminal patency inesophageal strictures	Same
Shelf life	2 years	1.5 years	Different, longer shelflife than predicatedevice
Principle of operation	The proposed deviceconsists of the stent anddelivery system. The outertube of the delivery systemserves to constrain thestent before deploymentand reposition the stent, ifdesired, after partialdeployment. Loosen thesafe lock, then withdraw thefront handle to deploy thestent. Take the oppositeaction to reposition thestent	The proposed deviceconsists of the stent anddelivery system. The outertube of the delivery systemserves to constrain the stentbefore deployment andreposition the stent, ifdesired, after partialdeployment. Loosen thesafe lock, then withdraw thefront handle to deploy thestent. Take the oppositeaction to reposition the stent	Same
Single Use	Yes
MRI information	Comply with ASTM F 2503,ASTM F 2052, ASTMF2119, ASTM F2182,ASTM F2213	Comply with ASTM F 2503,ASTM F 2052, ASTMF2119, ASTM F2182, ASTMF2213	MR conditionalscanning parametersare different

Table 2 Technological comparison between the proposed device and predicate device

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Image /page/8/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the text "MICRO-TECH" in a similar blue font. Below the text "MICRO-TECH" are two Chinese characters.

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Image /page/9/Picture/2 description: The image contains the logo for Micro-Tech. The logo consists of a blue stylized "MT" symbol on the left, followed by the text "MICRO-TECH" in blue. Below the company name are two Chinese characters, also in blue. The logo appears to be for a technology-related company.

8. Performance Data

The biocompatibility evaluation for the 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" 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" (June 16, 2016), the following tests were conducted:

Biocompatibility Testing on Stent:

Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Material-mediated Pyrogenicity
Salmonella Reverse Mutation
Implantation
Toxicological Risk Assessment based on Chemical Characterization

Biocompatibility Testing on Introduction System:

Cytotoxicity
Sensitization
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 for the subject device:

ゃ Visual Inspection

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Image /page/10/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font, also in blue. Below the text "MICRO-TECH" are two Chinese characters.

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

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 performance testing, the 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 WallFlex Esophageal Fully Covered Stent System(K091510).

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.”