HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

K183616 · M.I.Tech Co., Ltd. · MQR · Jan 10, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183616
• Device Name: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
• Applicant: M.I.Tech Co., Ltd.
• Product Code: MQR · General, Plastic Surgery
• Decision Date: Jan 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Self-expanding tubular prosthesis; maintains patency of colorectal or duodenal obstructions caused by malignant tumors. Consists of Nitinol wire stent and polymeric delivery system. Used in clinical settings (endoscopy or fluoroscopy suites) by physicians. Stent loaded into distal delivery system; introduced via 0.035-inch guidewire to target location. Radiopaque markers facilitate placement accuracy. Upon deployment, stent exerts outward radial force on luminal surface to establish patency. Delivery system removed and discarded. Single-use device.

Clinical Evidence

Bench testing only. Performance data includes axial force, compression force, corrosion, deployment force/accuracy, dimensions, expansion force, repositioning force, stent separation, tensile strength, and trackability. New bench testing provided for MR compatibility.

Technological Characteristics

Materials: Nitinol (nickel titanium alloy) wire stent, polymeric delivery system. Design: Self-expanding tubular prosthesis. Features: Radiopaque markers for visualization. Single-use. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for palliative treatment of colorectal strictures from malignant neoplasms and relief of large bowel obstruction prior to colectomy; also indicated for palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• HANAROSTENT LowAxTM Colon/Rectum (NNN) (K180180)
• HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (K180180)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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 [phone] FAX [phone]

# 5 510(k) Summary

| 510(k) Number | K183616 | Intended Use /<br>Indications for Use: | The HANAROSTENT® LowAx™ Colon/Rectum (NNN) is indicated<br>for the palliative treatment of colorectal strictures produced by<br>malignant neoplasms and to relieve large bowel obstruction prior to<br>colectomy in patients with malignant structures. | |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date: | December 21, 2018 | | The HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) is<br>indicated for the palliative treatment of pyloric or duodenal obstructions<br>caused by malignant neoplasms. | |
| Submitter: | M.I. Tech Co., Ltd.<br>174 Habuk 2-gil, Jinwi-myeon,<br>Pyeongtaek-si, Gyeonggi-do<br>17706, Republic of Korea<br>Phone: [phone]<br>Fax: [phone] | Device Description: | This self-expanding tubular prosthesis designed to maintain patency of<br>colorectal or duodenal obstructions caused by malignant tumors. It<br>consists of a self-expandable metal stent and a delivery system. The<br>self-expandable metal stent is made of nickel titanium alloy (Nitinol)<br>wire and the delivery system is made of polymeric materials. The stent<br>is loaded into the distal part of the delivery system. The<br>HANAROSTENT® LowAx™ Colon/Rectum (NNN) and<br>HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intended<br>for single use only. | |
| Primary Contact: | Inae Kim<br>Medical Affairs Team Manager<br>M.I. Tech Co., Ltd.<br>174 Habuk 2-gil, Jinwi-myeon,<br>Pyeongtaek-si, Gyeonggi-do<br>17706, Republic of Korea<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] | Predicate Device: | HANAROSTENT® LowAx™ Colon/Rectum (NNN);<br>HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN)<br>510(k) Number: K180180<br>Decision Date: 11/02/2018 | |
| Subject Device: | Trade Name:<br>Common Name:<br>Classification Regulation:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel:<br><br>Trade Name:<br>Common Name:<br>Classification Regulation:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | HANAROSTENT® LowAx™<br>Colon/Rectum (NNN)<br>Colon/Rectum Stent<br>21 CFR 878.3610<br>Esophageal Prosthesis<br>Class II<br>MQR<br>Gastroenterology/Urology<br><br>HANAROSTENT® LowAx™<br>Duodenum/Pylorus (NNN)<br>Duodenum/Pylorus Stent<br>21 CFR 878.3610<br>Esophageal Prosthesis<br>Class II<br>MUM<br>Gastroenterology/Urology | Mechanism of<br>Action: | The delivery system is supplied for either endoscopic or fluoroscopic<br>delivery. The delivery system for use with endoscopes is mostly used<br>at the department of internal treatment. The stent and delivery system<br>are inserted through the channel of endoscopes and the stent is<br>expanded and deployed at the target region. The fluoroscopic delivery<br>device is used for inserting the device at the target position during<br>fluoroscopic procedures. |
| | The stent is loaded by the delivery system and upon deployment of the<br>stent it imparts an outward radial force on the luminal surface of the<br>colon to establish patency. The stent is constrained and loaded between<br>the two sheaths. Through the use of a 0.035 inch guidewire, the delivery<br>system and stent are introduced to the intended target location.<br>Radiopaque markers allow visualizing and measuring placement<br>accuracy. After deployment of the stent the delivery system is removed<br>and discarded | | | |

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Image /page/4/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.

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Image /page/5/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and red, and it includes the company's name. Below the logo is the company's website address, www.mitech.co.kr.

| Technological<br>Characteristics: | 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 [phone] FAX [phone]

| Substantial | The subject device in this Traditional 510(k) submission is the exact |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalence: | same, identical device as predicate device K180180. There are no<br>differences between the subject device and the predicate device with<br>respect to indications and intended use. The only difference in<br>technological characteristics between the subject and predicate device<br>is that M.I. Tech is providing MR Compatibility testing with this<br>submission to support MR Conditional labeling for the subject device.<br>Therefore, the subject device and the predicate device are identical<br>devices, and support M.I. Tech's claim of substantial equivalence. |
| Conclusion: | The subject and predicate devices have the identical intended<br>use/indications for use, device description, mechanism of action,<br>technological characteristics, and performance testing.<br><br>The only difference in technological characteristics between the subject<br>and predicate device is that M.I. Tech is providing MR Compatibility<br>testing with this submission to support MR Conditional labeling for the<br>subject device.<br><br>Performance data supports the safety of the subject device and<br>demonstrates that the HANAROSTENT® LowAx™ Colon/Rectum<br>(NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus<br>(NNN) are safe and effective and will perform as intended in the<br>specified use conditions. |