K Number
K201342
Device Name
HANAROSTENT Trachea/Bronchium (CCC)
Date Cleared
2020-12-31

(225 days)

Product Code
Regulation Number
878.3720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
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.
More Information

No
The device description focuses on the physical components and mechanical function of the stent and delivery system, with no mention of AI or ML. The performance studies are bench tests evaluating mechanical properties.

Yes
Explanation: The device is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms, which is a therapeutic intervention.

No

The device description clearly states its purpose is to "maintain patency of tracheal or/and bronchial obstructions caused by malignant tumors," indicating it is a treatment device, not a diagnostic one.

No

The device description explicitly states it consists of a self-expandable metal stent and a delivery device, which are physical hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "treatment of tracheobronchial strictures caused by malignant neoplasms." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
  • Device Description: The device is a "self-expanding tubular prosthesis designed to maintain patency of tracheal or/and bronchial obstructions." This is a medical device used to physically treat a condition within the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a therapeutic implant.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

JCT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Radiopaque markers allow visualizing and measuring placement.

Anatomical Site

tracheobronchial

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance - Bench: The following bench testing was completed to determine the subject device will perform as intended: 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)
Performance - Animal: No animal performance data is submitted in this 510(k).
Performance - Clinical: No clinical performance data is submitted in this 510(k).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

EndoChoice, Inc.'s BONASTENT® Tracheal/Bronchial (K140472)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Alveolus, Inc's AEROTM Tracheobronchial Stent Technology System (K082284)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.3720 Tracheal prosthesis.

(a)
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.(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.”

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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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 +82316625645 FAX +8231 662 5648

510(k) Summary

Preparation DateDecember 14, 2020
SubmitterM.I.Tech Co., Ltd.
174 Habuk 2-gil, Jinwi-myeon,
Pyeongtaek-si, Gyeonggi-do
17706, Republic of Korea
Phone: 82-31-662-5645
Fax: 82-31-662-5648
Primary ContactInae Kim
Medical Affairs Team Manager
M.I.Tech Co., Ltd.
174 Habuk 2-gil, Jinwi-myeon,
Pyeongtaek-si, Gyeonggi-do
17706, Republic of Korea
Email: inae116@mitech.co.kr
Phone: 82-70-4304-7450
Fax: 82-2-3463-4703
Subject DeviceTrade Name:
Common Name:
Classification Product Code:
Regulation Number:
Classification Name:
Device Class:
Regulation Medical Specialty:
510(k) Review PanelHANAROSTENT® Trachea/Bronchium (CCC)
Prosthesis, Tracheal, Expandable
JCT
21 CFR 878.3720
Tracheal Prosthesis
Class II
General & Plastic Surgery
Anesthesiology
Primary Predicate DeviceEndoChoice, Inc.'s BONASTENT® Tracheal/Bronchial (K140472)
Reference Predicate DeviceAlveolus, Inc's AEROTM Tracheobronchial Stent Technology System (K082284)
Device DescriptionThe 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 UseThe HANAROSTENT® Trachea/Bronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
Mechanism of ActionThe 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 +82316625645 FAX +8231 662 5648

| Device Name | HANAROSTENT®
Trachea/Bronchium (CCC) | BONASTENT®
Tracheal/Bronchial Stent
System | AERO™ Tracheobronchial
Stent System |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | M.I.Tech Co., Ltd. | EndoChoice, Inc. | Alveolus, Inc. |
| 510(k) Number | TBD | K140472 | K082284 |
| Device
Classification
Name | Prosthesis, Tracheal, Expandable | Prosthesis, Tracheal, Expandable | Prosthesis, Tracheal, Expandable |
| Regulation
Number | 21 CFR 878.3720 | 21 CFR 878.3720 | 21 CFR 878.3720 |
| Regulation
Description | Tracheal Prosthesis | Tracheal Prosthesis | Tracheal Prosthesis |
| Device Class | Class II | Class II | Class II |
| Classification
Product Code | JCT | JCT | JCT |
| Regulation
Medical
Specialty | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| 510(k) Review
Panel | Anesthesiology | Anesthesiology | General & Plastic Surgery |
| Intended Use/
Indications for
Use | The HANAROSTENT®
Trachea/Bronchium (CCC) is
indicated for use in the
treatment of tracheobronchial
strictures caused by malignant
neoplasms. | The BONASTENT®
Tracheal/Bronchial Stent
Systemis indicated for the
treatment of tracheobronchial
strictures caused by malignant
neoplasms. | The Alveolus AERO™
Tracheobronchial Stent
Systemis indicated for use in
the treatment of
tracheobronchial strictures
caused by malignant
neoplasms. |
| Patient
Population | Adults | Unknown | Unknown |
| Stent Body | Nitinol | Nitinol | Nitinol |
| Stent
Radiopaque
Markers | Gold | Platinum | None |
| Stent Membrane | Fully coated silicone
membrane | Fully coated silicone
membrane | Fully coated polyurethane
membrane |
| Stent Lasso | One end of the stent | N/A | One end of the stent |
| Stent Diameter
Range | 10-20mm | 10-20mm | 10-20mm |
| Stent Length
Range | 20-80mm | 20-80mm | 20-80mm |
| Delivery Device
Diameter | 4mm
(12Fr) | 2.67, 3, 3.33, 4mm
(8, 9, 10, 12Fr) | 5.33, 7.33mm
(16, 22Fr) |
| Delivery Device
Usable Length
Range | 500-900mm | 500-900mm | 630-560mm |
| Method of
Placement | Bronchoscopy | Bronchoscopy | Bronchoscopy |
| Method of
Deployment | Release by pulling outer
sheath | Release by pulling outer
sheath | Release by pulling outer
sheath |
| Provided Sterile | Yes | Yes | No |
| Sterilization
Method | EO | EO | N/A. Non-sterile. |
| Single-Use
Only | Yes | Yes | Yes |
| Packaging | Blister
(Forming case+Tyvek film)
Inner box
Outerbox | Forming case
Tyvek Pouch
Inner box
Outer box | Forming case
Tyvek Pouch
Inner box
Outer box |
| Shelf Life | 3 years | 3 years | Unknown |
| MR
Compatibility | MR conditional | MR conditional | MR conditional |
| FDA Guidance Documents | The following FDA guidance document was consulted in preparing this premarket submission:
Guidance for The Content of Premarket Notifications for Esophageal and Tracheal
Prostheses , dated April 28, 1998. Use of International Standard ISO 10993-1, "Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management process" , issued
June 16, 2016. | | |
| Biocompatibility | The following biocompatibility testing was completed to determine the subject device
is biocompatible for its intended use:
Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous Reactivity (ISO 10993-10) Acute Systemic Toxicity (ISO 10993-11) Pyrogenicity (ISO 10993-11, USP ) 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
performas intended:
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 +82316625645 FAX +8231 662 5648

6

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