HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

K201160 · M.I.Tech Co., Ltd. · ESW · Jul 23, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201160
• Device Name: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
• Applicant: M.I.Tech Co., Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Jul 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

Device Story

Self-expanding tubular prosthesis; maintains esophageal luminal patency in malignant strictures; occludes concurrent esophageal fistulas. Comprises Nitinol wire stent, gold radiopaque markers, silicone membrane (fully/partially covered), and polymeric repositioning lassos. Delivered via over-the-wire (OTW) delivery system; stent loaded in distal sheath; deployed by pulling outer sheath. Used in clinical settings by physicians. Stent exerts outward radial force on esophageal wall to establish patency. Radiopaque markers facilitate placement accuracy under imaging. Single-use device.

Clinical Evidence

No clinical performance data submitted. Bench testing only: foreshortening, expansion/compression force, guidewire passage, deployment force, placement accuracy, tensile strength, dimensions, corrosion, and MR safety/compatibility.

Technological Characteristics

Self-expanding Nitinol wire stent; gold radiopaque markers; silicone membrane; polymeric repositioning lassos. OTW delivery system. Single-use. MR safe/compatible. Bench testing per design controls.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors and concurrent esophageal fistulas requiring maintenance of esophageal luminal patency.

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

• Esophageal Stent System (K172813)

Reference Devices

• Merit Medical Systems, Inc.'s EndoMAXXTM Fully Covered Esophageal Stent (K111611)
• Boston Scientific's WallFlexTM Esophageal Stents (K091510)

Submission Summary (Full Text)

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July 23, 2021

M.I. Tech Co., Ltd % Heidi Busz Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K201160 Trade/Device Name: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: June 16, 2021 Received: June 21, 2021

Dear Heidi Busz:

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.

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

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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 (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices 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) K201160

Device Name HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (NCN)

Indications for Use (Describe)

The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|---------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the text "MIT" in a stylized blue font, with a red dot above the "I". To the right of "MIT" is the text "M.I.Tech" in a larger, bolder blue font. Below the logo is the text "www.mitech.co.kr" in a smaller font.

HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA TEL [phone] FAX [phone]

## www.mitech.co.kr

#### 5 510(k) Summary

| Preparation Date: | April 30, 2020 | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| 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] | |
| 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] | |
| Subject Devices: | Trade Name: | HANAROSTENT® Esophagus (CCC) |
| | Device: | Prosthesis, Esophageal |
| | Regulation Description: | Esophageal prosthesis |
| | Review Panel: | Gastroenterology/Urology |
| | Regulation Number: | 21 CFR 878.3610 |
| | Device Class: | Class II |
| | Product Code: | ESW |
| | Trade Name: | HANAROSTENT® Esophagus (NCN) |
| | Device: | Prosthesis, Esophageal |
| | Regulation Description: | Esophageal prosthesis |
| | Review Panel: | Gastroenterology/Urology |
| | Regulation Number: | 21 CFR 878.3610 |
| | Device Class: | Class II |
| | Product Code: | ESW |
| Intended Use /<br>Indications for Use: | The HANAROSTENT® Esophagus (CCC) and HANAROSTENT®<br>Esophagus (NCN) are intended for maintaining esophageal luminal<br>patency in esophageal strictures caused by intrinsic and/or extrinsic<br>malignant tumors, and occlusion of concurrent esophageal fistula. | |
| Device Description: | This self-expanding tubular prosthesis is designed to maintain patency in<br>esophageal strictures caused by intrinsic and/or extrinsic malignant<br>tumors, and occlusion of concurrent esophageal fistulas. It consists of a<br>self-expandable metal stent and an over the wire (OTW) delivery device.<br>The self-expandable metal stent is made of nickel titanium alloy (Nitinol)<br>wire, radiopaque markers made of gold wire, fully or partially covered<br>silicone membrane, and one repositioning lasso at each end of the stent<br>made of polymeric materials. The delivery device is made of polymeric<br>materials. The stent is loaded into the distal part of the delivery device,<br>and expanded in the body by pulling the outer sheath of the delivery<br>device. The HANAROSTENT® Esophagus (CCC) and the<br>HANAROSTENT® Esophagus (NCN) are intended for single use only. | |
| Predicate Device: | Trade Name: | Esophageal Stent System |
| | Applicant: | Micro-Tech (Nanjing) Co., Ltd. |
| | 510(k) Number: | K172813 |
| | Clearance Date: | June 21, 2018 |
| | Device: | Prosthesis, Esophageal |
| | Regulation Description: | Esophageal prosthesis |
| | Review Panel: | Gastroenterology/Urology |
| | Regulation Number: | 21 CFR 878.3610 |
| | Device Class: | Class II |
| | Product Code: | ESW |
| | Reference Devices: | Merit Medical Systems, Inc.'s EndoMAXXTM Fully Covered Esophageal<br>Stent (K111611) |
| | Boston Scientific's WallFlexTM Esophageal Stents (K091510) | |
| Mechanism of Action: | The stent is loaded by the delivery device. Upon deployment of the stent,<br>it imparts an outward radial force on the luminal surface of the esophagus<br>to establish patency. The stent is constrained and loaded between the two<br>sheaths. The delivery device and stent are introduced to the intended<br>target location through the use of a 0.035 or 0.038 inch guidewire.<br>Radiopaque markers allow visualizing and measuring placement<br>accuracy. The delivery device is removed and discarded after deployment<br>of the stent | |
| Technological<br>Characteristics: | The subject devices and predicate device have substantially equivalent<br>technological characteristics with only minor differences regarding:<br>• Packaging: The subject devices do not have a Tyvek pouch. The<br>predicate device has a Tyvek pouch.<br>• Shelf life: The subject device's shelf life is longer than the predicate<br>device's shelf life.<br>• Radiopaque marker material and quantity: The subject devices have<br>a greater number of radiopaque markers and a different material than<br>the predicate device.<br>• Stent dumbbell diameters: The subject device has a larger dumbbell<br>diameter range than the predicate device.<br>• Stent lengths: The subject devices are offered in a greater number of<br>stent lengths than the predicate device.<br>• Lasso materials and quantity: The subject devices have two lassos of<br>different materials than the predicate device.<br>• Delivery device diameter: The subject devices offers delivery devices<br>in two diameters. The predicate device offers one delivery device in<br>one diameter.<br>• Delivery device lengths: The subject delivery devices are longer than<br>the predicate delivery device.<br>• Performance test:<br>- The subject and predicate devices have equivalent expansion<br>forces.<br>- The subject and predicate devices have equivalent<br>compression forces.<br>- The subject delivery device in both 6mm (18Fr) and 8mm<br>(24Fr) diameters have lower deployment forces than the<br>predicate delivery device when deploying the<br>HANAROSTENT® Esophagus (CCC).<br>- The subject delivery device in 6mm (18Fr) diameter has lower<br>deployment force than the predicate delivery device when<br>deploying the HANAROSTENT® Esophagus (NCN). The<br>subject delivery device in 8mm (24Fr) diameter has equivalent<br>deployment force to the predicate delivery device when<br>deploying the HANAROSTENT® Esophagus (NCN) | |
| FDA Guidance<br>Documents: | The following FDA guidance documents were consulted in preparing this<br>premarket submission:<br>● Shelf Life of Medical Devices, issued April 1991<br>● Submission and Review of Sterility Information in Premarket<br>Notification (510(k)) Submissions for Devices Labeled as Sterile,<br>issued January 2016<br>● Use of International Standard ISO 10993-1, "Biological evaluation<br>of medical devices - Part 1: Evaluation and testing within a risk<br>management process", issued June 16, 2016<br>● Guidance for The Content of Premarket Notifications for Esophageal<br>and Tracheal Prostheses, issued April 28, 1998<br>● Technical Considerations for Non-Clinical Assessment of Medical<br>Devices containing Nitinol, draft issued April 2019<br>● Establishing Safety and Compatibility of Passive Implants in the<br>Magnetic Resonance (MR) Environment, issued December 2014<br>● Testing and Labeling Medical Devices for Safety in the Magnetic<br>Resonance (MR) Environment, issued August 2019<br>● Guidance for FDA, Assessment of Radiofrequency-Induced Heating<br>in the Magnetic Resonance (MR) Environment for Multi-<br>Configuration Passive Medical Devices, issued on March 22, 2016. | |
| Performance - Bench: | Bench testing was performed to confirm the safety and effectiveness of<br>the proposed subject devices as compared to the predicate devices.<br>Performance testing was performed as per the design control system. The<br>following tests were conducted:<br>● Foreshortening<br>● Expansion force<br>● Compression force<br>● Guidewire passage<br>● Deployment force<br>● Deploying accuracy<br>● Tensile strength<br>● Dimensions<br>● Corrosion<br>● MR safety and compatibility | |
| Performance - Animal | No animal performance data is submitted in this 510(k).…