HANAROSTENT Trachea/Bronchium (CCC)

K201342 · M.I.Tech Co., Ltd. · JCT · Dec 31, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201342
• Device Name: HANAROSTENT Trachea/Bronchium (CCC)
• Applicant: M.I.Tech Co., Ltd.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Dec 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

Device Story

Self-expanding tubular prosthesis; maintains patency of tracheal/bronchial obstructions caused by malignant tumors. Comprises nitinol wire stent fully covered with silicone membrane; includes repositioning lasso. Delivered via polymeric delivery device; deployed by pulling outer sheath. Used in clinical setting via bronchoscopy; physician-operated. Guidewire (0.035 inch) used for introduction; radiopaque gold markers facilitate placement visualization. Stent exerts outward radial force on luminal surface to establish patency. Single-use; sterile.

Clinical Evidence

No clinical performance data submitted. Bench testing only.

Technological Characteristics

Nitinol wire stent; fully covered silicone membrane; gold radiopaque markers. Delivery device: polymeric materials, 12Fr diameter. Self-expanding mechanism. Sterilization: EO. MR conditional. Biocompatibility per ISO 10993-1, -3, -5, -6, -10, -11, -17, -18.

Indications for Use

Indicated for adults with tracheobronchial strictures caused by malignant neoplasms.

Regulatory Classification

Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal 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

• BONASTENT® Tracheal/Bronchial (K140472)

Reference Devices

• AERO™ Tracheobronchial Stent Technology System (K082284)

Submission Summary (Full Text)

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December 31, 2020

M.I. Tech Co., Ltd. % Beryl Jeanne Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K201342

Trade/Device Name: HANAROSTENT® Trachea/Bronchium (CCC) Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: May 19, 2020 Received: May 20, 2020

Dear Beryl 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 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

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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 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 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 (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,

Brandon L. Blakely, Ph.D. Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K201342

Device Name HANAROSTENT® Trachea/Bronchium (CCC)

Indications for Use (Describe)

The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

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/0 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 stylized letters is the word "Tech" in a bold, sans-serif font. Below the logo is the website address "www.mitech.co.kr".

HEAD OFFFICE
174, HABUK2-GIL, JNW1-MECN, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL [phone] FAX [phone]

## 510(k) Summary

| Preparation Date | December 14, 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 Device | Trade Name:<br>Common Name:<br>Classification Product Code:<br>Regulation Number:<br>Classification Name:<br>Device Class:<br>Regulation Medical Specialty:<br>510(k) Review Panel | HANAROSTENT® Trachea/Bronchium (CCC)<br>Prosthesis, Tracheal, Expandable<br>JCT<br>21 CFR 878.3720<br>Tracheal Prosthesis<br>Class II<br>General & Plastic Surgery<br>Anesthesiology |
| Primary Predicate Device | EndoChoice, Inc.'s BONASTENT® Tracheal/Bronchial (K140472) | |
| Reference Predicate Device | Alveolus, Inc's AEROTM Tracheobronchial Stent Technology System (K082284) | |
| Device Description | The HANAROSTENT® Trachea/Bronchium (CCC) is a self-expanding tubular prosthesis designed to maintain patency of tracheal or/and bronchial 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 titaniumalloy (nitinol) wire that is fully covered with a silicone membrane and has one repositioning lasso at one end of the stent. 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. | |
| Intended Use/ Indications for Use | The HANAROSTENT® Trachea/Bronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms. | |
| Mechanism of Action | The stent is loaded by the delivery device. Upon deployment of the stent, it imparts an outward radial force on the luminal surface of the trachea/bronchium to establish patency. The stent is constrained and loaded between the two sheaths. The delivery device and stent are introduced to the intended target location through the use of a 0.035 inch guidewire. Radiopaque markers allow visualizing and measuring placement. | |

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Image /page/4/Picture/0 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 "MIT" is the text "M.I.Tech" in a bold, sans-serif font. The logo is blue and white.

www.mitech.co.kr

HEAD OFFFICE
174, HABUK2-GIL, JNW1-MECN, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL [phone] FAX [phone]

| Device Name | HANAROSTENT®<br>Trachea/Bronchium (CCC) | BONASTENT®<br>Tracheal/Bronchial Stent<br>System | AERO™ Tracheobronchial<br>Stent System |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | M.I.Tech Co., Ltd. | EndoChoice, Inc. | Alveolus, Inc. |
| 510(k) Number | TBD | K140472 | K082284 |
| Device<br>Classification<br>Name | Prosthesis, Tracheal, Expandable | Prosthesis, Tracheal, Expandable | Prosthesis, Tracheal, Expandable |
| Regulation<br>Number | 21 CFR 878.3720 | 21 CFR 878.3720 | 21 CFR 878.3720 |
| Regulation<br>Description | Tracheal Prosthesis | Tracheal Prosthesis | Tracheal Prosthesis |
| Device Class | Class II | Class II | Class II |
| Classification<br>Product Code | JCT | JCT | JCT |
| Regulation<br>Medical<br>Specialty | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| 510(k) Review<br>Panel | Anesthesiology | Anesthesiology | General & Plastic Surgery |
| Intended Use/<br>Indications for<br>Use | The HANAROSTENT®<br>Trachea/Bronchium (CCC) is<br>indicated for use in the<br>treatment of tracheobronchial<br>strictures caused by malignant<br>neoplasms. | The BONASTENT®<br>Tracheal/Bronchial Stent<br>Systemis indicated for the<br>treatment of tracheobronchial<br>strictures caused by malignant<br>neoplasms. | The Alveolus AERO™<br>Tracheobronchial Stent<br>Systemis indicated for use in<br>the treatment of<br>tracheobronchial strictures<br>caused by malignant<br>neoplasms. |
| Patient<br>Population | Adults | Unknown | Unknown |
| Stent Body | Nitinol | Nitinol | Nitinol |
| Stent<br>Radiopaque<br>Markers | Gold | Platinum | None |
| Stent Membrane | Fully coated silicone<br>membrane | Fully coated silicone<br>membrane | Fully coated polyurethane<br>membrane |
| Stent Lasso | One end of the stent | N/A | One end of the stent |
| Stent Diameter<br>Range | 10-20mm | 10-20mm | 10-20mm |
| Stent Length<br>Range | 20-80mm | 20-80mm | 20-80mm |
| Delivery Device<br>Diameter | 4mm<br>(12Fr) | 2.67, 3, 3.33, 4mm<br>(8, 9, 10, 12Fr) | 5.33, 7.33mm<br>(16, 22Fr) |
| Delivery Device<br>Usable Length<br>Range | 500-900mm | 500-900mm | 630-560mm |
| Method of<br>Placement | Bronchoscopy | Bronchoscopy | Bronchoscopy |
| Method of<br>Deployment | Release by pulling outer<br>sheath | Release by pulling outer<br>sheath | Release by pulling outer<br>sheath |
| Provided Sterile | Yes | Yes | No |
| Sterilization<br>Method | EO | EO | N/A. Non-sterile. |
| Single-Use<br>Only | Yes | Yes | Yes |
| Packaging | Blister<br>(Forming case+Tyvek film)<br>Inner box<br>Outerbox | Forming case<br>Tyvek Pouch<br>Inner box<br>Outer box | Forming case<br>Tyvek Pouch<br>Inner box<br>Outer box |
| Shelf Life | 3 years | 3 years | Unknown |
| MR<br>Compatibility | MR conditional | MR conditional | MR conditional |
| FDA Guidance Documents | The following FDA guidance document was consulted in preparing this premarket submission:<br><i>Guidance for The Content of Premarket Notifications for Esophageal and Tracheal<br/>Prostheses</i> , dated April 28, 1998. <i>Use of International Standard ISO 10993-1, "Biological evaluation of medical<br/>devices - Part 1: Evaluation and testing within a risk management process"</i> , issued<br>June 16, 2016. | | |
| Biocompatibility | The following biocompatibility testing was completed to determine the subject device<br>is biocompatible for its intended use:<br>Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous Reactivity (ISO 10993-10) Acute Systemic Toxicity (ISO 10993-11) Pyrogenicity (ISO 10993-11, USP <151>) Genotoxicity (ISO 10993-3, OECD Test No. 471, OECD Test No. 490) Implantation (ISO 10993-6) Chemical Characterization (ISO 10993-17, ISO 10993-18) | | |
| Performance - Bench | The following bench testing was completed to determine the subject device will<br>performas intended:<br>Deployment Force Expansion Force Compression Force Dimensions MR Safety and Compatibility Axial Force Trackability Repositioning Force Deploying Accuracy Foreshortening Corrosion Fatigue Repositioning Force Repositioning Function Tensile Strength (delivery device and lasso) | | |

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Image /page/5/Picture/0 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", followed by the text "M.I.Tech" in a larger, bolder blue font. Below the logo is the website address "www.mitech.co.kr".

HEAD OFFFICE
174, HABUK2-GIL, JNW1-MECN, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL [phone] FAX [phone]

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Image /page/6/Picture/0 description: The image shows the logo for M.I.Tech. The logo consists of the company's name in blue text, with a red dot above the "i" in "MIT". Below the logo is the company's website address, www.mitech.co.kr, in black text.

| Performance - Animal | No animal performance data is submitted in this 510(k). |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance - Clinical | No clinical performance data is submitted in this 510(k). |
| Substantial Equivalence | Subject device HANAROSTENT® Trachea/Bronchium (CCC) is substantially<br>equivalent to primary predicate device BONASTENT® Tracheal/Bronchial Stent<br>System (K140472) when evaluating intended use and technological characteristics:<br>Subject device HANAROSTENT® Trachea/Bronchium (CCC) has the<br>identical intended use as primary predicate device BONASTENT®<br>Tracheal/Bronchial Stent System. There are no differences between the<br>subject device and primary predicate device with respect to indications and<br>intended use. Subject device HANAROSTENT® Trachea/Bronchium (CCC) has minor<br>technological differences compared to predicate device BONASTENT®<br>Tracheal/Bronchial Stent Systemregarding packaging materials, stent<br>repositioning lasso, radiopaque marker materials, delivery device diameter,<br>and performance testing results. These technological characteristic differences do not raise new questions of<br>safety and effectiveness. Therefore, the subject and predicate devices are considered substantially equivalent. |
| Conclusion | M.I.Tech determined subject device HANAROSTENT® Trachea/Bronchium (CCC) is<br>substantially equivalent to the primary predicate device BONASTENT®<br>Tracheal/Bronchial Stent System when evaluating intended use and technological<br>characteristics, is biocompatible for its intended use, and will perform as intended.<br>Therefore, M.I.Tech respectfully requests marketing clearance for subject device<br>HANAROSTENT® Trachea/Bronchium (CCC). |