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 patients with malignant 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 is 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, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) are intended for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two devices: HANAROSTENT LowAx™ Colon/Rectum (NNN) and HANAROSTENT LowAx™ Duodenum/Pylorus (NNN). This notification aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain information about acceptance criteria for device performance based on a clinical study or a study proving that the device meets such criteria. Instead, it focuses on demonstrating technological equivalence and presents the results of bench testing to confirm safety and effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance derived from a clinical study, nor can I answer questions about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to clinical or AI performance studies which are not detailed in this document.

The document does provide information pertinent to physical and material performance, as outlined in the "Performance Summary" section.

Here's what can be extracted from the document regarding the performance validation performed:

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

The document describes bench testing performed to confirm safety and effectiveness compared to predicate devices, but it does not explicitly list quantitative acceptance criteria or specific reported performance values for these tests. It only lists the types of tests conducted.

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

Not applicable. The document describes bench testing, not a clinical study with human subjects.

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 document describes bench testing, not a clinical study requiring expert ground truth for interpretation.

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

Not applicable. The document describes bench testing, not a clinical study requiring adjudication of expert interpretations.

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. The document describes a medical device (stent) and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. The document describes a medical device (stent) and does not involve an algorithm with standalone performance.

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

For the bench testing, the "ground truth" would be the expected physical or mechanical properties and behaviors of the stent as per engineering specifications and relevant standards. This is inherent in the design control system and the performance tests themselves.

8. The sample size for the training set:

Not applicable. The document describes a medical device (stent) and its physical and mechanical performance testing, not a machine learning model requiring a training set.

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

Not applicable. The document describes a medical device (stent) and its physical and mechanical performance testing, not a machine learning model requiring a training set.

Summary of available information related to performance (bench testing):

The document states that "Appropriate bench testing was performed to confirm the safety and effectiveness of the proposed devices as compared to the identified predicate device." This testing was conducted "as per the design control system" and consulted "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998."

Types of Bench Tests Conducted:

Axial force
Compression force
Corrosion
Deployment force
Deployment accuracy
Dimensions
Expansion force
Repositioning force
Stent separation
Tensile strength
Trackability

Biocompatibility Assessment:

Assessed in accordance with ISO 10993-1:2003, 2012.

Conclusion from Bench Testing:
The non-clinical data (bench testing) supports the safety of the proposed devices and demonstrates that they are safe and effective and will perform as intended in the specified use conditions. It also concludes that the proposed device is substantially equivalent to the predicate devices based on these tests and technological characteristics.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.

November 2, 2018

M.I. Tech Co., Ltd. % Carol Buchert Principal Medical Research Scientist NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K180180

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: September 20, 2018 Received: September 24, 2018

Dear Carol Buchert:

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 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.

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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,

Jeffrey W. Cooper -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) K180180

Device Name

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

Indications for Use (Describe)

The HANAROSTENT LowAxTM DuodenumPylorus (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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Pre-Market Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Submitter:

Name:	M.I.Tech Co., Ltd.174 Habuk 2-gil, Jinwi-myeon,Pyeongtaek-si, Gyeonggi-do17706, Republic of Korea
Contact:	Ms. Inae Kim / ManagerPhone: +82 70-4304-7450Fax: +82 2-3473-4702

2. Device Name and Classification:

Proprietary Name:	HANAROSTENT® LowAx™ Colon/Rectum (NNN)
Common Name:	Colon/Rectum Stent
Classification Name:	Stent, Colonic, Metallic, Expandable
Classification:	21 CFR 878.3610
Product Code:	MQR
Third Party Reviewed:	No

Proprietary Name:	HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN)
Common Name:	Duodenum/Pylorus Stent
Classification Name:	Stent, Duodenal, Metallic, Expandable
Classification:	21 CFR 878.3610
Product Code:	MUM
Third Party Reviewed:	No

3. Predicate Device:

Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System, K061877 Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System, K062750

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4. Description:

The same device description applies to both the HANAROSTENT® LowAx™ Colon/Rectum (NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN).

Indications for use: 5.

The HANAROSTENT® LowAx™ 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 structures.

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

Technological Characteristics: 6.

The proposed devices are substantially equivalent to the predicate devices, the Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System, K061877 and Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System, K062750.

Both predicate devices share identical technological characteristics to each other. This is evidenced in 510(k)s K061877 and K02750. Both predicate devices cite the same predicate device within their submission: Boston Scientific Corporation's WallflexTM Enteral Colonic Stent with Anchor Lock Delivery System, K042065

Per K061877's Technological Characteristics section:

"The proposed Wallflex Enteral Colonic Stent with Anchor Lock Delivery System has the identical technological characteristics as the currently marketed Wallflex Enteral Colonic Stent with Anchor Lock Delivery System (K042065)."

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Per K062750's Technological Characteristics section:

"The proposed WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System has the identical technological (materials, construction, processing) characteristics as the predicate WallFlex Enteral Colonic Stent with Anchor Lock Delivery System and has the identical indication statement as the predicate Wallstent Enteral Endoprosthesis."

The proposed devices have the same characteristics as the predicate devices as listed below:

-Stent design
Single use -
Sterilization method -
Method of placement -
Method of deployment -
-Stent materials

The following technological differences exist between the proposed devices and the currently marketed predicate devices, the Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System and the Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System.

Stent diameter -
-Stent length
Delivery diameter -
Radiopaque markers -

Please see the table below summarizing the technological characteristics of the subject devices and predicate devices.

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Device Name	Subject Device #1HANAROSTENT®LowAxTMColon/Rectum (NNN)	Subject Device #2HANAROSTENT®LowAxTMDuodenum/Pylorus (NNN)	Predicate Device #1WallflexTM EnteralColonic Stent	Predicate Device #2WallflexTM EnteralDuodenal Stent	Comment		Yes	Yes	Yes	Yes	Identical
Applicant	M.I. Tech Co., Ltd.	M.I. Tech Co., Ltd.	Boston Scientific Corp.	Boston Scientific Corp.	N/A	Single Use
510(k) Number	TBD	TBD	K061877	K062750	N/A	Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Identical
Decision Date	TBD	TBD	09/15/2006	12/04/2006	N/A	Method of Placement	Fluoroscopic,Endoscopic	Fluoroscopic,Endoscopic	Fluoroscopic,Endoscopic	Fluoroscopic,Endoscopic	Identical
Common Name	Colon/Rectum Stent	Duodenum/PylorusStent	Colon/Rectum Stent	Duodenum/PylorusStent	Identical	Method of Deployment	Release by pullingouter sheath	Release by pullingouter sheath	Release by pullingouter sheath	Release by pullingouter sheath	Identical
Indications for Use	The palliative treatmentof colorectal stricturescaused by malignantneoplasms and torelieve large bowelobstruction prior tocolectomy in patientswith malignantstructures.	The palliative treatmentof gastroduodenalobstructions caused bymalignant neoplasms.	The palliative treatmentof colonic stricturescaused by malignantneoplasms and torelieve large bowelobstruction prior tocolectomy in patientswith malignantstructures.	The palliative treatmentof gastroduodenalobstructions caused bymalignant neoplasms.	Identical	Stent Materials	Nitinol	Nitinol	Nitinol	Nitinol	Identical
Stent Diameter	20mm body with 25mmdumbbell22mm body with 27mmdumbbell	20mm body with 25mmdumbbell22mm body with 27mmdumbbell	22mm body with 27mmflare25mm body with a30mm flare	22mm body with 27mmflare	Equivalent. Subjectdevice offers a modelthat is 2mm smaller instent diameter for thebody and dumbbell.	Radiopaque MarkerMaterials	Gold	Gold	N/A	N/A	Equivalent. Subject device has 12 gold radiopaque markers. The predicate device does not have radiopaque markers.
Stent Length	60mm70mm80mm90mm100mm110mm120mm	60mm70mm80mm90mm100mm110mm120mm	60mm90mm120mm	60mm90mm120mm	Equivalent. The lengthof subject device issubdivided within thesmallest and largestlengths of predicatedevices.	Shelf life	3 years	3 years	3 years	3 years	Identical
Delivery Diameter	3.40mm (10.2Fr)	3.40mm (10.2Fr)	3.33mm (10Fr)	3.33mm (10Fr)	Equivalent. Thediameter of our deliverysystem is 0.06mmlarger than the predicatedevice. This level iswithin a 5% toleranceof the dimension

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K180180
Page 5 of 6

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Performance Summary: 7.

Appropriate bench testing was performed to confirm the safety and effectiveness of the proposed devices as compared to the identified predicate device.

The device specific FDA guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998. Performance testing was performed as per the design control system and the following tests were conducted:

Axial force i
। Compression force
Corrosion i
Deployment force i
। Deployment accuracy
Dimensions ।
Expansion force i
Repositioning force ।
Stent separation ।
। Tensile strength
Trackability -

Biocompatibility safety was assessed in accordance with ISO 10993-1:2003, 2012.

Conclusions: 8.

The non-clinical data supports the safety of the proposed devices 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.

The non-clinical data also demonstrates that the proposed device is substantially equivalent to the predicate devices, Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System (K061877) and Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System (K062750).

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.”