The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in palignant structures.

The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

Device Description

This self-expanding tubular prosthesis designed to maintain patency of colorectal or duodenal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intended for single use only.

AI/ML Overview

This document (a 510(k) summary) describes a submission for a medical device re-clearance rather than a de novo submission. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K180180), not to prove de novo clinical efficacy or safety of a fundamentally new device through extensive clinical trials.

Therefore, the typical components of acceptance criteria and the detailed study proving the device meets those criteria (especially regarding human-in-the-loop AI performance, ground truth establishment for large datasets, etc.) are not present in this type of regulatory document. The focus shifts to demonstrating that the new version of the device is essentially the same as the previously cleared version, with any minor changes like MR compatibility testing still ensuring safety and effectiveness.

Here's a breakdown based on the provided text, explaining why certain requested information is absent or not applicable:

Key Takeaway: The device in question (HANAROSTENT LowAx™ Colon/Rectum and Duodenum/Pylorus) is a self-expanding metal stent. Its performance is assessed through bench testing (physical and material properties) and by demonstrating identical characteristics to a previously cleared device, not through studies involving AI, human reader improvement, or large-scale clinical outcomes data in the way a diagnostic AI device would be.

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" and "Performance Testing" sections):

This submission leverages the substantial equivalence pathway. The primary "acceptance criteria" are demonstrating that the subject device is identical or nearly identical to its predicate device (K180180) in critical aspects, and that any small change (MR compatibility) does not compromise safety or effectiveness.

Here's a table reflecting what is implicitly stated as "met" by virtue of substantial equivalence and new testing:

Acceptance Criteria Category (Implicit)	Reported Device Performance (as stated or implied by Substantial Equivalence Claim)	Notes
Identical Intended Use/Indications for Use	"The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. There are no differences between the subject device and the predicate device with respect to indications and intended use."	The device is for palliative treatment of colorectal or pyloric/duodenal strictures caused by malignant neoplasms. For colorectal, also to relieve large bowel obstruction prior to colectomy.
Identical Device Description	"The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180."	The device is a self-expanding tubular prosthesis made of Nitinol with a delivery system.
Identical Mechanism of Action	"The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180."	The stent imparts outward radial force to maintain patency.
Identical Technological Characteristics (Biocompatibility, Stent/Delivery Design, Materials, Sterilization, Shelf Life)	"There have been no changes to the fundamental technological characteristics since K180180 received clearance. Therefore, the subject and predicate device have identical technological characteristics: - Biocompatible materials - Stent design - Delivery device design - Radiopaque markers - Single use - Method of placement - Method of deployment - Sterilization method - Packaging configuration and materials - Shelf life"	This is a key assertion for substantial equivalence.
Identical Performance Testing (Axial/Compression/Expansion Force, Corrosion, Deployment Accuracy, Dimensions, Repositioning Force, Stent Separation, Tensile Strength, Trackability)	"M.I. Tech intends to leverage the performance testing provided with K180180."	The results of these tests (from the predicate device's clearance) are implicitly deemed acceptable and met by the subject device. Actual quantitative results are not provided in this summary.
MR Compatibility (New Test)	"M.I. Tech is providing new bench testing with this Traditional 510(k) in support of its subject device: - MR compatibility"	This is the only new performance characteristic tested for this submission. The "acceptance criterion" would be meeting a recognized standard for MR Conditional labeling. No specific results are provided in this summary.
Overall Safety and Effectiveness	"Performance data supports the safety of the subject device and demonstrates that the HANAROSTENT® LowAx™ Colon/Rectum (NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are safe and effective and will perform as intended in the specified use conditions."	This is the overarching conclusion of the substantial equivalence claim.

Regarding the Absence of Specific Study Details (as related to AI/Diagnostic Devices):

This submission is for a medical device (physical stent), not a diagnostic algorithm or AI software for image analysis. Therefore, many of the requested details related to AI study design are not applicable or not part of this type of submission.

Sample sizes used for the test set and data provenance:
- N/A (for AI/diagnostic data). This device is a physical stent. Performance testing involves bench tests (e.g., force measurements, corrosion) on device samples, not patient data sets or images. The "test set" in this context refers to the physical devices or components tested. There are no "patients" or "data" in the sense of a diagnostic study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth for a physical stent is established by engineering specifications, material science, and established test methods (e.g., ASTM standards for mechanical properties). No human experts are adjudicating "ground truth" on images or clinical outcomes for this device in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Applies to human reading/AI performance studies, not physical device testing.
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:
- N/A. This device does not involve human readers, AI assistance, or image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm or AI device. Its "standalone performance" refers to its physical characteristics and functionality as a stand-alone stent and delivery system, assessed via bench tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical properties: Engineering specifications, established test methods (e.g., ISO, ASTM standards), and material science principles.
- For comparison to the predicate: The previously cleared predicate device (K180180) itself serves as the "ground truth" for substantial equivalence regarding its established safety and effectiveness.
The sample size for the training set:
- N/A. This is not an AI/machine learning device that requires a "training set."
How the ground truth for the training set was established:
- N/A. No training set is involved.

In summary, this 510(k) submission leverages the "Substantial Equivalence" pathway for a physical medical device. The "study that proves the device meets the acceptance criteria" primarily consists of:

A detailed comparison demonstrating identical technological characteristics to a previously cleared predicate device (K180180).
Reliance on the performance testing data submitted for that predicate device.
New bench testing specifically for MR compatibility to support new labeling.

The document explicitly states: "The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180." This claim, supported by the comparison of characteristics and leveraging prior testing, is the core of demonstrating it meets the implicit "acceptance criteria" for clearance via substantial equivalence.

Summary

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January 10, 2019

M.I. Tech Co., Ltd. % Beryl St. Jeanne Associate Regulatory Specialist NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K183616

Trade/Device Name: HANAROSTENT LowAxTM Colon/Rectum (NNN) HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: MQR, MUM Dated: December 21, 2018 Received: December 26, 2018

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 mav, 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 avare 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,

Daniel G. Walter Jr -S

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

510(k) Number (if known)

K183616

Device Name

HANAROSTENT LowAxTM Colon/Rectum (NNN) HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

Indications for Use (Describe)

The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions 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/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 text "M.I.Tech" in a bold, sans-serif font. Below the logo is the website address "www.mitech.co.kr".

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

5 510(k) Summary

510(k) Number	K183616	Intended Use /Indications for Use:	The HANAROSTENT® LowAx™ Colon/Rectum (NNN) is indicatedfor the palliative treatment of colorectal strictures produced bymalignant neoplasms and to relieve large bowel obstruction prior tocolectomy in patients with malignant structures.
Preparation Date:	December 21, 2018		The HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) isindicated for the palliative treatment of pyloric or duodenal obstructionscaused by malignant neoplasms.
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	Device Description:	This self-expanding tubular prosthesis designed to maintain patency ofcolorectal or duodenal obstructions caused by malignant tumors. Itconsists of a self-expandable metal stent and a delivery system. Theself-expandable metal stent is made of nickel titanium alloy (Nitinol)wire and the delivery system is made of polymeric materials. The stentis loaded into the distal part of the delivery system. TheHANAROSTENT® LowAx™ Colon/Rectum (NNN) andHANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intendedfor single use only.
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	Predicate Device:	HANAROSTENT® LowAx™ Colon/Rectum (NNN);HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN)510(k) Number: K180180Decision Date: 11/02/2018
Subject Device:	Trade Name:Common Name:Classification Regulation:Classification Name:Regulatory Class:Product Code:Classification Panel:Trade Name:Common Name:Classification Regulation:Classification Name:Regulatory Class:Product Code:Classification Panel:	HANAROSTENT® LowAx™Colon/Rectum (NNN)Colon/Rectum Stent21 CFR 878.3610Esophageal ProsthesisClass IIMQRGastroenterology/UrologyHANAROSTENT® LowAx™Duodenum/Pylorus (NNN)Duodenum/Pylorus Stent21 CFR 878.3610Esophageal ProsthesisClass IIMUMGastroenterology/Urology	Mechanism ofAction:	The delivery system is supplied for either endoscopic or fluoroscopicdelivery. The delivery system for use with endoscopes is mostly usedat the department of internal treatment. The stent and delivery systemare inserted through the channel of endoscopes and the stent isexpanded and deployed at the target region. The fluoroscopic deliverydevice is used for inserting the device at the target position duringfluoroscopic procedures.
	The stent is loaded by the delivery system and upon deployment of thestent it imparts an outward radial force on the luminal surface of thecolon to establish patency. The stent is constrained and loaded betweenthe two sheaths. Through the use of a 0.035 inch guidewire, the deliverysystem and stent are introduced to the intended target location.Radiopaque markers allow visualizing and measuring placementaccuracy. After deployment of the stent the delivery system is removedand discarded

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TechnologicalCharacteristics:	The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the identical technological characteristics provided with K180180. There have been no changes to the fundamental technological characteristics since K180180 received clearance. Therefore, the subject and predicate device have identical technological characteristics: - Biocompatible materials - Stent design - Delivery device design - Radiopaque markers - Single use - Method of placement - Method of deployment - Sterilization method - Packaging configuration and materials - Shelf life The only difference in technological characteristics between the subject and predicate device is that M.I. Tech is providing MR compatibility testing with this submission to support MR conditional labeling for the subject device.
Performance Testing:	The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the performance testing provided with K180180: - Axial force - Compression force - Corrosion - Deployment force - Deployment accuracy - Dimensions - Expansion force - Repositioning force - Stent separation - Tensile strength - Trackability M.I. Tech is providing new bench testing with this Traditional 510(k) in support of its subject device: - MR compatibility

TechnologicalCharacteristics:

The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the identical technological characteristics provided with K180180. There have been no changes to the fundamental technological characteristics since K180180 received clearance. Therefore, the subject and predicate device have identical technological characteristics: - Biocompatible materials - Stent design - Delivery device design - Radiopaque markers - Single use - Method of placement - Method of deployment - Sterilization method - Packaging configuration and materials - Shelf life The only difference in technological characteristics between the subject and predicate device is that M.I. Tech is providing MR compatibility testing with this submission to support MR conditional labeling for the subject device.

Performance Testing:

The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the performance testing provided with K180180: - Axial force - Compression force - Corrosion - Deployment force - Deployment accuracy - Dimensions - Expansion force - Repositioning force - Stent separation - Tensile strength - Trackability M.I. Tech is providing new bench testing with this Traditional 510(k) in support of its subject device: - MR compatibility

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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 the company name in a stylized font. Below the logo is the company's website address, www.mitech.co.kr.

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

Substantial	The subject device in this Traditional 510(k) submission is the exact
Equivalence:	same, identical device as predicate device K180180. There are nodifferences between the subject device and the predicate device withrespect to indications and intended use. The only difference intechnological characteristics between the subject and predicate deviceis that M.I. Tech is providing MR Compatibility testing with thissubmission to support MR Conditional labeling for the subject device.Therefore, the subject device and the predicate device are identicaldevices, and support M.I. Tech's claim of substantial equivalence.
Conclusion:	The subject and predicate devices have the identical intendeduse/indications for use, device description, mechanism of action,technological characteristics, and performance testing.The only difference in technological characteristics between the subjectand predicate device is that M.I. Tech is providing MR Compatibilitytesting with this submission to support MR Conditional labeling for thesubject device.Performance data supports the safety of the subject device anddemonstrates that the HANAROSTENT® LowAx™ Colon/Rectum(NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus(NNN) are safe and effective and will perform as intended in thespecified use conditions.

Substantial

The subject device in this Traditional 510(k) submission is the exact

Equivalence:

same, identical device as predicate device K180180. There are nodifferences between the subject device and the predicate device withrespect to indications and intended use. The only difference intechnological characteristics between the subject and predicate deviceis that M.I. Tech is providing MR Compatibility testing with thissubmission to support MR Conditional labeling for the subject device.Therefore, the subject device and the predicate device are identicaldevices, and support M.I. Tech's claim of substantial equivalence.

Conclusion:

The subject and predicate devices have the identical intendeduse/indications for use, device description, mechanism of action,technological characteristics, and performance testing.The only difference in technological characteristics between the subjectand predicate device is that M.I. Tech is providing MR Compatibilitytesting with this submission to support MR Conditional labeling for thesubject device.Performance data supports the safety of the subject device anddemonstrates that the HANAROSTENT® LowAx™ Colon/Rectum(NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus(NNN) are safe and effective and will perform as intended in thespecified use conditions.

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.”