The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (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 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 an over the wire (OTW) delivery device. 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 one repositioning lasso at each end of the stent made of polymeric materials. 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 HANAROSTENT® Esophagus (CCC) and the HANAROSTENT® Esophagus (NCN) are intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) devices. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than presenting a clinical study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for a study proving device performance against acceptance criteria cannot be fully extracted from the provided text. The document explicitly states:

"No animal performance data is submitted in this 510(k)."
"No clinical performance data is submitted in this 510(k)."

Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence.

Here's an analysis of what can be extracted or inferred based on the scope of the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way you've requested for a device proving study. It lists various bench tests performed and states:

"Bench testing was performed to confirm the safety and effectiveness of the proposed subject devices as compared to the predicate devices."
"Performance testing was performed as per the design control system."
"The subject and predicate devices have equivalent expansion forces."
"The subject and predicate devices have equivalent compression forces."
"The subject delivery device in both 6mm (18Fr) and 8mm (24Fr) diameters have lower deployment forces than the predicate delivery device when deploying the HANAROSTENT® Esophagus (CCC)."
"The subject delivery device in 6mm (18Fr) diameter has lower deployment force than the predicate delivery device when deploying the HANAROSTENT® Esophagus (NCN). The subject delivery device in 8mm (24Fr) diameter has equivalent deployment force to the predicate delivery device when deploying the HANAROSTENT® Esophagus (NCN)."

From this, we can infer that the acceptance criterion for many of these bench tests was "equivalence to the predicate device" or "lower than the predicate device" (for deployment force, which is a positive outcome). However, specific numerical acceptance thresholds or detailed performance metrics are not provided.

Inferred Table of Performance and Criteria (Based on Bench Testing for Substantial Equivalence):

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Foreshortening	Not explicitly stated; implied to meet design specifications.	Tested (specific results not provided, but deemed acceptable for substantial equivalence).
Expansion force	Equivalent to predicate device.	Equivalent to predicate device.
Compression force	Equivalent to predicate device.	Equivalent to predicate device.
Guidewire passage	Not explicitly stated; implied to meet design specifications.	Tested (specific results not provided, but deemed acceptable for substantial equivalence).
Deployment force (CCC)	Lower than or equivalent to predicate device.	Subject delivery device (6mm & 8mm) has lower deployment forces than the predicate delivery device.
Deployment force (NCN)	Lower than or equivalent to predicate device.	Subject delivery device (6mm) has lower deployment force than the predicate. Subject delivery device (8mm) has equivalent deployment force to the predicate.
Deploying accuracy	Not explicitly stated; implied to meet design specifications.	Tested (specific results not provided, but deemed acceptable for substantial equivalence).
Tensile strength	Not explicitly stated; implied to meet design specifications.	Tested (specific results not provided, but deemed acceptable for substantial equivalence).
Dimensions	Not explicitly stated; implied to meet design specifications.	Tested (specific results not provided, but deemed acceptable for substantial equivalence).
Corrosion	Not explicitly stated; implied to meet design specifications.	Tested (specific results not provided, but deemed acceptable for substantial equivalence).
MR Safety and Compatibility	Meet relevant standards (ISO 10993-1, guidance for MR environment).	Tested according to FDA guidance documents on MR safety and compatibility, deemed acceptable for substantial equivalence. The document explicitly lists "MR safety and compatibility" as a test performed and references guidance documents like "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes used for the bench tests. Since no clinical data was submitted, there is no "test set" in the context of patient data. The bench tests were presumably conducted internally by M.I.Tech Co., Ltd., based in the Republic of Korea. Therefore, the data provenance for these bench tests would be the Republic of Korea. It's not applicable to categorize bench testing as retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The submission relies entirely on bench testing for substantial equivalence, not on a clinical test set requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring adjudication.

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. This is not an AI/software device and no MRMC study was conducted.

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

Not applicable. This is a medical device (stent and delivery system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the bench tests, the "ground truth" would be the engineering specifications and established standards for material and device performance, against which the physical properties of the stent were tested.

8. The sample size for the training set

Not applicable, as no clinical study (and thus no training set) was conducted or submitted.

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

Not applicable, as there is no training set.

Summary

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July 23, 2021

M.I. Tech Co., Ltd % Heidi Busz Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K201160 Trade/Device Name: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: June 16, 2021 Received: June 21, 2021

Dear Heidi Busz:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

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) K201160

Device Name HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (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 text "MIT" in a stylized blue font, with a red dot above the "I". To the right of "MIT" is the text "M.I.Tech" in a larger, bolder blue font. Below the logo is the text "www.mitech.co.kr" in a smaller font.

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

www.mitech.co.kr

5 510(k) Summary

Preparation Date:	April 30, 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: 82-2-3473-4702
Subject Devices:	Trade Name:	HANAROSTENT® Esophagus (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
	Trade Name:	HANAROSTENT® Esophagus (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
Intended Use /Indications for Use:	The HANAROSTENT® Esophagus (CCC) and HANAROSTENT®Esophagus (NCN) are intended for maintaining esophageal luminalpatency in esophageal strictures caused by intrinsic and/or extrinsicmalignant tumors, and occlusion of concurrent esophageal fistula.
Device Description:	This self-expanding tubular prosthesis is designed to maintain patency inesophageal strictures caused by intrinsic and/or extrinsic malignanttumors, and occlusion of concurrent esophageal fistulas. It consists of aself-expandable metal stent and an over the wire (OTW) delivery device.The self-expandable metal stent is made of nickel titanium alloy (Nitinol)wire, radiopaque markers made of gold wire, fully or partially coveredsilicone membrane, and one repositioning lasso at each end of the stentmade of polymeric materials. The delivery device is made of polymericmaterials. The stent is loaded into the distal part of the delivery device,and expanded in the body by pulling the outer sheath of the deliverydevice. The HANAROSTENT® Esophagus (CCC) and theHANAROSTENT® Esophagus (NCN) are intended for single use only.
Predicate Device:	Trade Name:	Esophageal Stent System
	Applicant:	Micro-Tech (Nanjing) Co., Ltd.
	510(k) Number:	K172813
	Clearance Date:	June 21, 2018
	Device:	Prosthesis, Esophageal
	Regulation Description:	Esophageal prosthesis
	Review Panel:	Gastroenterology/Urology
	Regulation Number:	21 CFR 878.3610
	Device Class:	Class II
	Product Code:	ESW
	Reference Devices:	Merit Medical Systems, Inc.'s EndoMAXXTM Fully Covered EsophagealStent (K111611)
	Boston Scientific's WallFlexTM Esophageal Stents (K091510)
Mechanism of Action:	The stent is loaded by the delivery device. Upon deployment of the stent,it imparts an outward radial force on the luminal surface of the esophagusto establish patency. The stent is constrained and loaded between the twosheaths. The delivery device and stent are introduced to the intendedtarget location through the use of a 0.035 or 0.038 inch guidewire.Radiopaque markers allow visualizing and measuring placementaccuracy. The delivery device is removed and discarded after deploymentof the stent
TechnologicalCharacteristics:	The subject devices and predicate device have substantially equivalenttechnological characteristics with only minor differences regarding:• Packaging: The subject devices do not have a Tyvek pouch. Thepredicate device has a Tyvek pouch.• Shelf life: The subject device's shelf life is longer than the predicatedevice's shelf life.• Radiopaque marker material and quantity: The subject devices havea greater number of radiopaque markers and a different material thanthe predicate device.• Stent dumbbell diameters: The subject device has a larger dumbbelldiameter range than the predicate device.• Stent lengths: The subject devices are offered in a greater number ofstent lengths than the predicate device.• Lasso materials and quantity: The subject devices have two lassos ofdifferent materials than the predicate device.• Delivery device diameter: The subject devices offers delivery devicesin two diameters. The predicate device offers one delivery device inone diameter.• Delivery device lengths: The subject delivery devices are longer thanthe predicate delivery device.• Performance test:- The subject and predicate devices have equivalent expansionforces.- The subject and predicate devices have equivalentcompression forces.- The subject delivery device in both 6mm (18Fr) and 8mm(24Fr) diameters have lower deployment forces than thepredicate delivery device when deploying theHANAROSTENT® Esophagus (CCC).- The subject delivery device in 6mm (18Fr) diameter has lowerdeployment force than the predicate delivery device whendeploying the HANAROSTENT® Esophagus (NCN). Thesubject delivery device in 8mm (24Fr) diameter has equivalentdeployment force to the predicate delivery device whendeploying the HANAROSTENT® Esophagus (NCN)
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 PremarketNotification (510(k)) Submissions for Devices Labeled as Sterile,issued January 2016● Use of International Standard ISO 10993-1, "Biological evaluationof medical devices - Part 1: Evaluation and testing within a riskmanagement process", issued June 16, 2016● Guidance for The Content of Premarket Notifications for Esophagealand Tracheal Prostheses, issued April 28, 1998● Technical Considerations for Non-Clinical Assessment of MedicalDevices containing Nitinol, draft issued April 2019● Establishing Safety and Compatibility of Passive Implants in theMagnetic Resonance (MR) Environment, issued December 2014● Testing and Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, issued August 2019● Guidance for FDA, Assessment of Radiofrequency-Induced Heatingin the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices, issued on March 22, 2016.
Performance - Bench:	Bench testing was performed to confirm the safety and effectiveness ofthe proposed subject devices as compared to the predicate devices.Performance testing was performed as per the design control system. Thefollowing tests were conducted:● Foreshortening● Expansion force● Compression force● Guidewire passage● Deployment force● Deploying accuracy● Tensile strength● Dimensions● Corrosion● 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).
Substantial Equivalence:	The subject devices are substantially equivalent to the predicate devices when evaluating intended use and technological characteristics. The subject devices have the exact same intended use/indications for use as the predicate device. 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.J. Tech respectfully requests market clearance for the subject devices.

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Image /page/4/Picture/0 description: The image shows the logo for M.I.Tech. The logo consists of the letters "MIT" in a stylized font, with a red dot above the "I". To the right of the stylized letters is the text "M.I.Tech" in a more standard font. Below the logo is the website address "www.mitech.co.kr".

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www.mitech.co.kr

HEAD OFFICE
174, HABUK2-GLL, JINWHMYEON, 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 contains the logo for M.I.Tech. The logo consists of the letters "MIT" in a stylized font, with a red dot above the "I". To the right of "MIT" is the text "M.I.Tech" in a bold, sans-serif font. The logo is blue and white.

www.mitech.co.kr

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

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Image /page/7/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the letters "MIT" in a stylized font, with a red dot above the "I". To the right of the letters is the word "Tech" in a larger, bolder font. Below the logo is the website address "www.mitech.co.kr".

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

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.”