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

Device Description

This self-expanding tubular prosthesis designed to maintain patency of colorectal 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® LowAxTM Colon/Rectum (NNN) is intended for single use only.

AI/ML Overview

The HANAROSTENT® LowAxTM Colon/Rectum (NNN) device is a self-expanding tubular prosthesis designed to maintain the patency of colorectal obstructions caused by malignant tumors. This device is an update to a previously cleared device (K183616) with the only difference being the inclusion of a 25mm diameter stent.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) submission for a device that is nearly identical to a previously cleared predicate (K183616), the acceptance criteria primarily focus on demonstrating that the expanded stent diameter range (to include 25mm) does not negatively impact the device's safety and effectiveness. The acceptance criteria and performance are derived from the existing predicate device and new bench testing for the expanded size.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material & Biocompatibility	Biocompatible materials (same as predicate K183616)	Confirmed to use same biocompatible materials as K183616.	Leveraged from predicate; no new testing required for materials.
Stent Design	Stent design (except for diameter size range) identical to predicate K183616	Confirmed identical stent design (except for the 25mm diameter addition).	Leveraged from predicate.
Delivery Device Design	Delivery device design identical to predicate K183616	Confirmed identical delivery device design.	Leveraged from predicate.
Radiopaque Markers	Presence and functionality of radiopaque markers (same as predicate K183616)	Confirmed identical radiopaque markers to predicate.	Leveraged from predicate; allow visualization and placement accuracy.
Single Use & Method of Placement/Deployment	Single use and method of placement/deployment identical to predicate K183616	Confirmed identical single-use and placement/deployment methods.	Leveraged from predicate.
Sterilization & Packaging	Sterilization method, processes, packaging configuration, and materials identical to predicate K183616	Confirmed identical sterilization methods, processes, and packaging.	Leveraged from predicate, with new packaging validation for the subject device.
Shelf Life	Shelf life identical to predicate K183616	Confirmed identical shelf life.	Leveraged from predicate.
Mechanical Performance (for 25mm stent)	Meet established standards for: - Axial force- Compression force- Deployment force- Deployment accuracy- Dimensions- Expansion force- Repositioning force- Stent separation- Tensile strength- Trackability	M.I. Tech performed new bench testing to support the subject device in these areas. The submission states these tests were performed and results support safety and effectiveness. (Specific values not provided in document)	New testing specifically conducted for the expanded 25mm diameter stent.
Corrosion Resistance	Meet established standards for corrosion (same as predicate K183616)	Testing provided with K183616 leveraged.	No new corrosion testing was required as the material is unchanged.
MR Compatibility	Meet established standards for MR compatibility (same as predicate K183616)	Testing provided with K183616 leveraged.	No new MR compatibility testing required.
Packaging Validation (for new 25mm stent)	Meet established standards for: - Dye penetration- Seal strength- Sterility	M.I. Tech performed new packaging validation testing to support the subject device in these areas. (Specific values not provided in document)	New packaging validation specific to the updated device configuration.

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

The document does not specify a "test set" in the context of clinical data or patient outcomes for this particular submission. The evaluation is primarily based on bench testing for the new 25mm stent diameter. The document states:

"M.I. Tech performed new bench testing to support the subject device."
"M.I. Tech performed new packaging validation testing to support the subject device."

The specific sample sizes for these bench tests (e.g., number of stents tested for axial force, compression force, etc.) are not provided in this summary. The provenance of this bench testing data would be from the manufacturer, M.I. Tech Co., Ltd., based in the Republic of Korea. It is lab-based, not patient-derived, and is considered prospective with respect to the design modifications.

The submission is a Special 510(k) which relies heavily on the substantial equivalence to a predicate device (K183616). Therefore, much of the underlying data and validation for the core device characteristics would have been part of the K183616 submission.

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

This information is not applicable and not provided in the document. The evaluation is focused on engineering and performance bench testing against established standards, not clinical ground truth established by medical experts for a diagnostic or predictive device. For device safety and performance evaluation, relevant engineers and quality control personnel within M.I. Tech would have performed and reviewed the bench testing.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. Adjudication methods (e.g., 2+1, 3+1) refer to clinical judgment by multiple experts to establish ground truth, typically for diagnostic studies. The testing described here is bench testing against specified engineering parameters.

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

There was no MRMC comparative effectiveness study done. This device is a medical implant (stent) and not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. The device is a physical medical device (stent), not an algorithm or software. Therefore, standalone performance of an algorithm is not a relevant concept for this submission.

7. The type of ground truth used

The "ground truth" for this submission is established through engineering standards and specifications for physical device performance. The bench testing performed for the 25mm diameter stent confirms that it meets these predefined performance criteria (e.g., axial force, compression force, deployment accuracy, dimensions). For the characteristics leveraged from the predicate device, the ground truth was established through similar engineering tests and potentially clinical data submitted with K183616.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML device that requires a training set. The "training set" concept is relevant for machine learning models, not for physical medical device engineering validation.

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

This information is not applicable. As stated above, this device does not utilize a training set in the context of AI/ML.

Summary

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March 15, 2019

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

Re: K190141

Trade/Device Name: HANAROSTENT® LowAxTM Colon/Rectum (NNN) Regulation Number: 21 CFR& 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR Dated: January 28, 2019 Received: January 29, 2019

Dear Beryl St. Jeanne:

This letter corrects our substantially equivalent letter of March 7, 2019.

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.

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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 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)

K190141

Device Name

HANAROSTENT® LowAxTM Colon/Rectum (NNN)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X 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 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 HEAD OF CONCLOSE
174, HABUK2-GL, JINWHMYEON, 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:	TBD
Preparation Date:	January 28, 2019
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 Device:	Trade Name: HANAROSTENT® LowAxTM Colon/Rectum (NNN)Common Name: Colon/Rectum StentClassification Name: Esophageal ProsthesisClassification Regulation: 21 CFR 878.3610Regulatory Class: Class IIProduct Code: MQRClassification Panel: Gastroenterology/Urology
Intended Use /Indications for Use:	The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicatedfor the palliative treatment of colorectal strictures caused by malignantneoplasms and to relieve large bowel obstruction prior to colectomy inpatients with malignant strictures.
Device Description:	This self-expanding tubular prosthesis designed to maintain patency ofcolorectal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandablemetal stent is made of nickel titanium alloy (Nitinol) wire and thedelivery system is made of polymeric materials. The stent is loaded intothe distal part of the delivery system. The HANAROSTENT®LowAxTM Colon/Rectum (NNN) is intended for single use only.
Predicate Device:	M.I. Tech Co., Ltd.HANAROSTENT® LowAxTM Colon/Rectum (NNN);HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN)510(k) Number: K183616Decision Date: 01/10/2019

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Image /page/4/Picture/1 description: The image shows the logo for M.I.Tech, with the company name in blue and the website address "www.mitech.co.kr" below it. The logo features a stylized "MIT" with a red dot above the "I", followed by the full name "M.I.Tech" in a larger, bolder font. The overall design is clean and corporate, suggesting a technology-oriented company.

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

Reference Devices:	Cook Ireland Ltd.Evolution Duodenal Stent System - Uncovered;Evolution Colonic Stent System - Uncovered510(k) Number: K163468Decision Date: 05/04/2017Boston Scientific Corp.Wallflex™™™ Enteral Colonic Stent with Anchor Lock Delivery System510(k) Number: K061877Decision Date: 09/15/2006M.I. Tech Co., Ltd.HANAROSTENT® Biliary (NNN)510(k) Number: K111149Decision Date: 12/30/2011
Mechanism of Action:	The delivery system is supplied for either endoscopic or fluoroscopic delivery. The delivery system for use with endoscopes is mostly used at the department of internal treatment. The stent and delivery system are inserted through the channel of endoscopes and the stent is expanded and deployed at the target region. The fluoroscopic delivery device is used for inserting the device at the target position during fluoroscopic procedures.The stent is loaded by the delivery system and upon deployment of the stent it imparts an outward radial force on the luminal surface of the colon to establish patency. The stent is constrained and loaded between the two sheaths. Through the use of a 0.035 inch guidewire, the delivery system and stent are introduced to the intended target location. Radiopaque markers allow visualizing and measuring placement accuracy. After deployment of the stent the delivery system is removed and discarded.
TechnologicalCharacteristics:	The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616. M.I. Tech intends to leverage the identical technological characteristics provided with K183616. There have been no changes to the fundamental technological characteristics since K183616 received clearance. Therefore, the subject and predicate devices have identical technological characteristics:- Biocompatible materials- Stent design (except stent diameter size range)- Delivery device design- Radiopaque markers- Single use- Method of placement
	- Method of deployment
	- Sterilization method and processes
	- Packaging configuration and materials
	- Shelf life
	The only difference between the subject and predicate devices is that
	M.I. Tech is proposing an expanded stent diameter range to include a
	25mm diameter stent with the subject device.
Performance Testing:	The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616 with the exception of the 25mm stent diameter proposed with the subject device. M.I. Tech intends to leverage the testing provided with K183616:- Corrosion- MR compatibility
	M.I. Tech performed new bench testing to support the subject device:- Axial force- Compression force- Deployment force- Deployment accuracy- Dimensions- Expansion force- Repositioning force- Stent separation- Tensile strength- Trackability
	M.I. Tech performed new packaging validation testing to support the subject device:- Dye penetration- Seal strength- Sterility
	The new testing reports are not provided in this submission. The proposed 25mm diameter stent is supported with design control activities.
SubstantialEquivalence:	The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616. There are no differences between the subject device and the predicate device with respect to indications and intended use. The only difference between the subject and predicate devices is that the subject device proposes a 25mm diameter stent. Therefore, the subject device and the predicate device are identical devices, with the exception of stent diameter size range
	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, andtechnological characteristics.
	The only difference between the subject and predicate devices is thatM.I. Tech is proposing an expanded stent diameter range to include a25mm diameter stent. Bench testing is being provided with thissubmission.
	Performance data supports the safety of the subject device anddemonstrates that the HANAROSTENT® LowAx™ Colon/Rectum(NNN) is safe and effective and will perform as intended in thespecified use conditions.

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Image /page/5/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the text "MIT" in a stylized font with a red dot above the "I", followed by the text "M.I.Tech" in a larger, bolder font. Below the logo is the website address "www.mitech.co.kr".

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

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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.”