The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Device Description

This self-expanding tubular prosthesis is designed to maintain esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a through-the scope delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and repositioning lasso made of polyester. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The delivery system is compatible with a minimum 3.7mm working channel of a therapeutic endoscope. The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for single use only.

AI/ML Overview

This document describes the FDA 510(k) premarket notification for the HANAROSTENT Esophagus TTS (CCC) and HANAROSTENT Esophagus TTS (NCN) devices. This is a medical device, specifically an esophageal prosthesis, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing clinical performance data from studies involving AI or complex data analysis.

Therefore, many of the requested items (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI) are not applicable to this type of device submission. The information provided is primarily related to bench testing (physical and mechanical properties) to prove equivalence.

Here's a breakdown of the relevant information provided in the document based on your request:

1. A table of acceptance criteria and the reported device performance:

The document describes bench testing to demonstrate similarity to the predicate device. It doesn't explicitly state "acceptance criteria" in a numerical table form for each test, but it indicates that the subject devices "have equivalent" or "greater" performance in certain aspects compared to the predicate device. The underlying acceptance criterion for these tests would be "equivalent performance to the predicate device" or "acceptable performance within a given range" determined by the manufacturer and accepted by the FDA for substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent expansion forces to predicate device.	The subject and predicate devices have equivalent expansion forces.
Equivalent compression forces to predicate device.	The subject and predicate devices have equivalent compression forces.
Equivalent deployment forces for 1800mm delivery device to predicate device.	The subject device's 1800mm delivery device and the predicate device's 1800mm delivery device have equivalent deployment forces.
Acceptable deployment force for 2300mm delivery device (compared to predicate).	The subject device's 2300mm delivery device has greater deployment force than the predicate device's 1800mm delivery device. (Implies this "greater" force is acceptable or within safe parameters, though not explicitly stated as an "acceptance criterion" beyond being comparable to the predicate.)
Maintenance of esophageal luminal patency in esophageal strictures.	The device is intended for this purpose, and its substantial equivalence to a predicate device already cleared for this purpose is the basis for proving this. (No specific numerical performance data from human or animal studies is provided in this document as it's a 510(k) for substantial equivalence based on bench testing and mechanical/material properties).
Occlusion of concurrent esophageal fistulas.	The device is additionally indicated for this purpose (compared to the predicate). Substantial equivalence is asserted, implying sufficient functional performance for this new application. (No specific numerical performance data for this new indication from human or animal studies is provided in this document).
Meets safety and compatibility requirements for MR environment.	MR safety and compatibility testing was performed. (No specific numerical results provided, but the conclusion of substantial equivalence implies these were met.)
Meets requirements for: Deployment accuracy, Dimensions, Corrosion, Tensile strength, Foreshortening, Trackability, Repositioning force.	Testing was performed for these parameters. (No specific numerical results provided, but the conclusion of substantial equivalence implies these were met.)

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated. The "test set" here refers to the samples of the HANAROSTENT device used for bench testing. The testing would have involved a number of manufactured units, but the specific count is not provided.
Data provenance: The bench testing was performed by the manufacturer, M.I. Tech Co., Ltd., which is based in South Korea. The data is from prospective testing of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device relies on pre-clinical bench testing (mechanical and material properties) and substantial equivalence to a predicate device. There is no "ground truth" derived from expert interpretation of medical images or clinical outcomes in this submission.

4. Adjudication method for the test set:

Not applicable. As there are no human interpretations or clinical outcomes requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (stent) and relies on bench testing and substantial equivalence.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/algorithm-based device. It is a physical medical implant.

7. The type of ground truth used:

The "ground truth" for this submission comes from bench testing specifications, engineering principles, and comparison to the known performance of the predicate device. For example, the "ground truth" for expansion force is a measurable mechanical property verified against engineering standards and the predicate device's performance. There is no clinical "ground truth" (e.g., pathology, clinical outcomes, expert consensus) presented in this 510(k) summary.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

Summary

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May 20, 2020

M.I. Tech Co., Ltd % Beryl St. Jeanne, MS, RAC Regulatory Consultant Namsa 400 Highway 169 South Suite 500 Minneapolis, MN 55426

Re: K200860

Trade/Device Name: HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: March 31, 2020 Received: April 1, 2020

Dear Beryl St. Jeanne:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-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,

for

Shanil P. Haugen, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200860

Device Name

HANAROSTENT® Esophagus TTS (CCC); HANAROSTENT® Esophagus TTS (NCN)

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/1 description: The image shows the logo for M.I.Tech. The logo consists of the letters "MIT" in a stylized blue font, with a red dot above the "I". To the right of the logo is the text "M.I.Tech" in a larger, bolder blue font. Below the logo is the website address "www.mitech.co.kr".

HEAD OFFICE 174, HABUK2-GIL, JINWI-MYEON, PYEONGTAEK-SI, GYEONGGI-DO, 17706, REPUBLIC OF KOREA TEL +82 31 662 5645 FAX +82 31 662 5648

6 510(k) Summary

Preparation Date	March 31, 2020
Submitter	M.I. Tech Co., Ltd.174 Habuk 2-gil, Jinwi-myeon,Pyeongtaek-si, Gyeonggi-do17706, Republic of KoreaPhone: 82-31-662-5645Fax: 82-31-662-5648
Primary Contact	Inae KimMedical Affairs Team ManagerM.I. Tech Co., Ltd.174 Habuk 2-gil, Jinwi-myeon,Pyeongtaek-si, Gyeonggi-do17706, Republic of KoreaEmail: inae116@mitech.co.krPhone: 82-70-4304-7450Fax: 82-2-3463-4703
Subject Devices	Trade Name:	HANAROSTENT® Esophagus TTS (CCC)
	Device:	Prosthesis, Esophageal
	Regulation Description:	Esophageal prosthesis
	Review Panel:	Gastroenterology/Urology
	Regulation Number:	21 CFR 878.3610
	Device Class:	Class II
	Product Code:	ESW
	Regulation Medical Specialty:	General & Plastic Surgery
	Trade Name:	HANAROSTENT® Esophagus TTS (NCN)
	Device:	Prosthesis, Esophageal
	Regulation Description:	Esophageal prosthesis
	Review Panel:	Gastroenterology/Urology
	Regulation Number:	21 CFR 878.3610
	Device Class:	Class II
	Product Code:	ESW
	Regulation Medical Specialty:	General & Plastic Surgery

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Image /page/4/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the company name in blue letters, with a red dot above the "i" in "MIT". Below the logo is the company's website address, www.mitech.co.kr.

HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648

Intended Use /Indications for Use	The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT®Esophagus TTS (NCN) are intended for maintaining esophageal luminal patencyin esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, andocclusion of concurrent esophageal fistulas.	Technological	The subject devices and predicate device have substantially equivalent
Device Description	This self-expanding tubular prosthesis is designed to maintain esophageal luminalpatency in esophageal strictures caused by intrinsic and/or extrinsic malignanttumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a through-the scope delivery system. The self-expandablemetal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markersmade of gold wire, fully or partially covered silicone membrane, and repositioninglasso made of polyester. The delivery device is made of polymeric materials. Thestent is loaded into the distal part of the delivery device, and expanded in the bodyby pulling the outer sheath of the delivery device. The delivery system iscompatible with a minimum 3.7mm working channel of a therapeutic endoscope.The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT®Esophagus TTS (NCN) are intended for single use only.	Characteristics	technological characteristics with only minor differences regarding:
Predicate Device	Device Classification Name: Prosthesis, Esophageal510(k) Number: K123205Device Name: Esophageal TTS Stent(currently commercialized as theNiti-STM TTS Esophageal Stent)Applicant: Taewoong Medical Co., Ltd.Regulation Number: 21 CFR 878.3610Classification Product Code: ESWDecision Date: 10/09/2013Regulation Medical Specialty: General & Plastic Surgery510(k) Review Panel: Gastroenterology/UrologyDevice Class: Class II		Packaging: The subject devices do not have a Tyvek pouch. The predicate device has a Tyvek pouch. Radiopaque marker material and quantity: The subject devices have 12 gold radiopaque markers. The predicate device has 10 platinum-iridium radiopaque markers. Stent lengths: The subject device is offered in 60, 70, 80, 90, 100, 110, 120, 130, 140, and 150mm stent lengths. The predicate device is offered in 60, 80, 100, 120, 140, and 150mm stent lengths. Lasso materials: The subject devices use a polyester lasso material. The predicate device uses a nylon lasso material. Delivery device usable lengths: The subject devices offer an 1800mm or 2300mm delivery device. The predicate device offers an 1800mm delivery device. Performance – Bench: The subject and predicate devices have equivalent expansion forces. The subject and predicate devices have equivalent compression forces. The subject device's 1800mm delivery device and the predicate device's 1800mm delivery device have equivalent deployment forces. The subject device's 2300mm delivery device has greater deployment force than the predicate device's 1800mm delivery device.
Mechanism of Action	The stent is loaded by the delivery device. Upon deployment of the stent, itimparts an outward radial force on the luminal surface of the esophagus toestablish patency. The stent is constrained and loaded between the two sheaths.The delivery device and stent are introduced to the intended target locationthrough the use of a 0.035 inch guidewire. Radiopaque markers allow visualizingand measuring placement accuracy. The delivery device is removed and discardedafter deployment of the stent.

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Image /page/5/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features a stylized "MIT" with a red dot above the "I". Below the logo is the company's website address, www.mitech.co.kr.

HEAD OFFICE
174, HABUK2-GIL, JINWI-MYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA TEL +82 31 662 5645 FAX +82 31 662 5648

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Image /page/6/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features a stylized "M" with a red dot above it. Below the logo is the website address: www.mitech.co.kr.

HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648

FDA GuidanceDocuments	The following FDA guidance documents were consulted in preparing thispremarket submission:Shelf Life of Medical Devices, issued April 1991 Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 2016 Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June 2012 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016 Guidance for The Content of Premarket Notifications for Esophageal and Tracheal Prostheses, issued April 28, 1998 Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol, draft issued April 2019 Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 2014 Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, issued August 2019
Performance - Bench	Bench testing was performed to confirm the safety and effectiveness of theproposed subject devices as compared to the predicate devices. Performancetesting was performed as per the design control system. The following tests wereconducted:Deployment force Deployment accuracy Deployment in a simulated environment Expansion force Compression force Dimensions Corrosion Tensile strength Foreshortening Trackability Repositioning force MR safety and compatibility
Performance - Animal	No animal performance data is submitted in this 510(k).
Performance - Clinical	No clinical performance data is submitted in this 510(k).

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Image /page/7/Picture/1 description: The image shows the logo for M.I.Tech, a company with a website at www.mitech.co.kr. The logo features the company name in a stylized font, with the letters "MIT" connected and a red dot above the "I". The website address is printed in a smaller font below the logo.

HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648

SubstantialEquivalence	The subject devices are substantially equivalent to the predicate device whenevaluating intended use and technological characteristics. The subject devices have the identical intended use as the predicate device. There are no differences between the subject device and predicate device with respect to intended use. The subject devices have different indications for use than the predicate device. The subject devices are additionally indicated for occlusion of concurrent esophageal fistulas. The subject devices and predicate device are substantially equivalent with only minor technological differences. These differences do not raise new questions of safety and effectiveness.
Conclusion	This comparison demonstrates the subject devices are substantially equivalent to the predicate device. The subject devices are as safe and effective as the predicate device and will perform as intended. Therefore, M.I. Tech respectfully requests market clearance for the subject devices.

SubstantialEquivalence

The subject devices are substantially equivalent to the predicate device whenevaluating intended use and technological characteristics. The subject devices have the identical intended use as the predicate device. There are no differences between the subject device and predicate device with respect to intended use. The subject devices have different indications for use than the predicate device. The subject devices are additionally indicated for occlusion of concurrent esophageal fistulas. The subject devices and predicate device are substantially equivalent with only minor technological differences. These differences do not raise new questions of safety and effectiveness.

Conclusion

This comparison demonstrates the subject devices are substantially equivalent to the predicate device. The subject devices are as safe and effective as the predicate device and will perform as intended. Therefore, M.I. Tech respectfully requests market clearance for the subject devices.

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.”