The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designed to maintain patency of biliary obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire. 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 stent and delivery device are provided sterile and are intended for single use only.

AI/ML Overview

The provided document describes the HANAROSTENT® Benefit™ Biliary (NNN), a self-expanding tubular prosthesis intended for the palliation of malignant strictures in the biliary tree. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the acceptance criteria and study information provided in this document are focused on demonstrating this substantial equivalence through a combination of bench testing and comparison of technological characteristics with predicate and reference devices, rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance based on a clinical study or specify performance metrics for a diagnostic device. However, it implicitly uses the performance of the predicate device as the "acceptance criteria" through a direct comparison of technological characteristics and bench testing results. The goal is to demonstrate that the new device is as safe and effective as the predicate.

Performance Metric (Implied Acceptance Criteria)	Reported Device Performance
Design Verification Testing:
Foreshortening	Confirmed safety and effectiveness (as compared to predicate device)
Crossing Profile	Confirmed safety and effectiveness (as compared to predicate device)
Trackability	Confirmed safety and effectiveness (as compared to predicate device)
Deployment Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
Withdrawal (Repositioning) Force	Confirmed safety and effectiveness (as compared to predicate device)
Expansion Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
Stent Separation	Confirmed safety and effectiveness (as compared to predicate device)
Deployment Accuracy	Confirmed safety and effectiveness (as compared to predicate device)
Compression Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
Stent Integrity	Confirmed safety and effectiveness (as compared to predicate device)
Stent Dimensional Verification	Confirmed safety and effectiveness (as compared to predicate device)
Delivery System Tensile Strength	Confirmed safety and effectiveness (as compared to predicate device)
Biocompatibility Testing:	Confirmed safety and effectiveness (as compared to predicate device)
MRI Safety and Compatibility Testing:	Confirmed safety and effectiveness (as compared to predicate device)
Corrosion Testing:
Single stent	Equivalent simulated single stent implant corrosion susceptibility to predicate device
Overlapping stents (stent-in-stent)	Equivalent simulated stent-in-stent implant corrosion susceptibility to reference devices

Sample sizes used for the test set and data provenance:
- The document states that "Bench testing was performed... as per the design control system." It does not specify the exact sample sizes (number of units tested) for each of the bench tests listed (e.g., foreshortening, deployment force).
- Data Provenance: The bench testing was performed internally by the manufacturer, M.I.Tech Co., Ltd., based in the Republic of Korea. All data is presumably prospective as it was generated specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission relies on bench testing and comparison to predicate devices, not on a clinical test set requiring expert ground truth for interpretation of outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
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. The HANAROSTENT® Benefit™ Biliary (NNN) is a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily established by:
- Predicate device characteristics and performance: The established safety and effectiveness of the legally marketed predicate device (HANAROSTENT® Biliary (NNN), K111149).
- Engineering specifications and regulatory standards: Adherence to defined engineering specifications and relevant FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility, guidance for Nitinol devices, MRI safety).
- Bench test results: Quantitative measurements obtained from various physical and mechanical tests directly on the device.
The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical device like a stent. The device design and materials are based on established engineering principles and prior device iterations (like the predicate device), not machine learning.
How the ground truth for the training set was established:

Not applicable, as there is no training set.

Summary

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May 11, 2021

M.I.Tech Co., Ltd. % Kelly Kucharczyk Manager, Regulatory and Medical Writing Services NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K202973 Trade/Device Name: HANAROSTENT Benefit Biliary (NNN) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: April 8, 2021 Received: April 12, 2021

Dear Kelly Kucharczyk:

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 and the limitations described below. 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.

The OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

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Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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 provisions (Sections (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

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(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,

Courtney H. Lias, Ph.D. Acting Office Director 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) K202973

Device Name HANAROSTENT® Benefit™ Biliary (NNN)

Indications for Use (Describe)

The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.

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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510(k) Summary

510(k) Number	K202973
Preparation Date	May 11, 2021
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 Kim, PhDMedical 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 Device	Device Trade Name:	HANAROSTENT® Benefit™ Biliary (NNN)
	Device Classification Name:	Stents, Drains And Dilators For The Biliary Ducts
	Regulation Number:	21 CFR 876.5010
	Regulation Description:	Biliary catheter and accessories
	Device Class:	Class II
	Classification Product Code:	FGE
	Regulation Medical Specialty:	Gastroenterology/Urology
	510(k) Review Panel:	Gastroenterology/Urology
Device Description	The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designedto maintain patency of biliary obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickeltitanium alloy (Nitinol) wire. The delivery device is made of polymeric materials. The stent isloaded into the distal part of the delivery device, and expanded in the body by pulling the outersheath of the delivery device. The stent and delivery device are provided sterile and are intendedfor single use only.
Intended Use /Indications for Use	The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignantstrictures in the biliary tree.
Mechanism of Action	The stent is loaded by the delivery device. Upon deployment of the stent, it imparts an outwardradial force on the luminal surface of the biliary tract to establish patency.
Predicate Device	510(k) Number:	K111149
	Applicant:	M.I.Tech Co., Ltd.
	Trade Name:	HANAROSTENT® Biliary (NNN)
	Device Classification Name:	Stents, Drains And Dilators For The Biliary Ducts
	Regulation Number:	21 CFR 876.5010
	Regulation Description:	Biliary catheter and accessories
	Device Class:	Class II
	Classification Product Code:	FGE
	Regulation Medical Specialty:	Gastroenterology/Urology
	510(k) Review Panel:	Gastroenterology/Urology
Reference Devices	Reference Device 1:
	510(k) Number:	K163018
	Applicant:	Cook Ireland Ltd.
	Trade Name:	Zilver 635 Biliary Stent
	Device Classification Name:	Stents, Drains And Dilators For The Biliary Ducts
	Regulation Number:	21 CFR 876.5010
	Regulation Description:	Biliary catheter and accessories
	Device Class:	Class II
	Classification Product Code:	FGE
	Regulation Medical Specialty:	Gastroenterology/Urology
	510(k) Review Panel:	Gastroenterology/Urology

	Reference Device 2:
	510(k) Number:	K140630
	Applicant:	Boston Scientific
	Trade Name:	Wallflex Biliary RX Stent System
	Device Classification Name:	Stents, Drains And Dilators For The Biliary Ducts
	Regulation Number:	21 CFR 876.5010
	Regulation Description:	Biliary catheter and accessories
	Device Class:	Class II
	Classification Product Code:	FGE
	Regulation Medical Specialty:	Gastroenterology/Urology
	510(k) Review Panel:	Gastroenterology/Urology
Technological	The subject device and predicate device have substantially equivalent technological characteristics
Characteristics	with only minor differences regarding:
	• Stent shape: the subject device has straight ends; the predicate has flared ends.
	• Stent radiopaque marker quantity: the subject device has 9; the predicate device has 12.
	• Stent diameters: the subject device offers 6mm and 8mm diameter stents; the predicate device offers 8mm and 10mm diameter stents.
	• Stent lengths: the subject device offers a 110mm length stent; the predicate device does not offer a 110mm length stent.
	• Delivery device diameter: the subject delivery device diameter is 5.9Fr; the predicate delivery device diameter is 7.08Fr.
	• Stenting procedure: two subject devices can be implanted; only one predicate device is typically implanted.
	• Performance testing: The subject and predicate devices have equivalent deployment, expansion, and compression forces.
	• Corrosion testing: The subject and predicate devices have equivalent simulated single stent implant corrosion susceptibility. The subject and reference devices have equivalent simulated stent-in-stent implant corrosion susceptibility
FDA GuidanceDocuments	The following FDA guidance documents were consulted in preparing this premarket submission:• Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions, issued July 2019• 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 2016• Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol, issued October 2020• 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 the subject device as compared to the predicate device. Testing was performed as per the design control system. The following tests were conducted:• Design Verification Testing○ Foreshortening○ Crossing Profile○ Trackability○ Deployment Force○ Withdrawal (Repositioning) Force○ Expansion Force○ Stent Separation○ Deployment Accuracy○ Compression Force○ Stent Integrity○ Stent Dimensional Verification○ Delivery System Tensile Strength• Biocompatibility Testing• MRI Safety and Compatibility Testing• Corrosion Testing:○ Single stent○ Overlapping stents
Performance - Animal	No animal performance data is submitted in this 510(k).
Performance - Clinical	No clinical performance data is submitted in this 510(k).
SubstantialEquivalence	The subject device is substantially equivalent to the predicate device when evaluating intended use and technological characteristics.
Conclusion	This comparison demonstrates the subject device is substantially equivalent to the predicate device. The subject device is as safe and effective as the predicate device and will perform as intended.

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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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Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.