(225 days)
The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
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.
The provided text describes a medical device, the HANAROSTENT® Trachea/Bronchium (CCC), and its 510(k) submission to the FDA. This document focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, biocompatibility, and bench testing.
The document does not contain information about acceptance criteria, the specific study that proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
Instead, the document details physical and functional attributes of the device and compares them to predicate devices to demonstrate substantial equivalence. It confirms that the device meets certain performance benchmarks through bench testing and biocompatibility standards.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance based on studies, nor can I provide details about sample sizes, expert involvement, or algorithm-specific metrics as this information is not present in the provided text.
The information that can be extracted relevant to performance and testing is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit "acceptance criteria" for clinical performance are not stated in the document, and no clinical study results are provided, a table like the one requested cannot be fully generated. The document only lists types of bench tests performed.
| Performance Metric (Type of Test) | Reported Device Performance / Evaluation | Notes |
|---|---|---|
| Biocompatibility | Determined to be biocompatible for its intended use through various tests. | 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) |
| Bench Testing | Performed 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 Function, Tensile Strength (delivery device and lasso) |
| Animal Performance | No animal performance data submitted. | |
| Clinical Performance | No clinical performance data submitted. |
2. Sample size used for the test set and the data provenance:
- The document states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)." Therefore, there is no test set of patient data described.
- The only tests mentioned are bench tests and biocompatibility tests, typically performed on a certain number of device units or material samples. The specific sample sizes for these bench and biocompatibility tests are not provided in this document.
- Data provenance is not applicable for a clinical or animal test set, as none were submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set with ground truth established by experts is mentioned.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set requiring adjudication is mentioned.
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. This is a medical device (stent), not an AI algorithm for diagnostic imaging, and therefore an MRMC study is not relevant to its type of premarket submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (stent), not an algorithm.
7. The type of ground truth used:
- For the biocompatibility and bench tests, the "ground truth" would be established by industry standards (e.g., ISO, USP) and pre-defined specifications for material properties, mechanical performance, and biological response. These are not "expert consensus, pathology, or outcomes data" in the context of clinical evaluation.
8. The sample size for the training set:
- Not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (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 Date | December 14, 2020 | |
|---|---|---|
| Submitter | M.I.Tech Co., Ltd.174 Habuk 2-gil, Jinwi-myeon,Pyeongtaek-si, Gyeonggi-do17706, Republic of KoreaPhone: 82-31-662-5645Fax: 82-31-662-5648 | |
| Primary Contact | Inae KimMedical Affairs Team ManagerM.I.Tech Co., Ltd.174 Habuk 2-gil, Jinwi-myeon,Pyeongtaek-si, Gyeonggi-do17706, Republic of KoreaEmail: inae116@mitech.co.krPhone: 82-70-4304-7450Fax: 82-2-3463-4703 | |
| Subject Device | Trade Name:Common Name:Classification Product Code:Regulation Number:Classification Name:Device Class:Regulation Medical Specialty:510(k) Review Panel | HANAROSTENT® Trachea/Bronchium (CCC)Prosthesis, Tracheal, ExpandableJCT21 CFR 878.3720Tracheal ProsthesisClass IIGeneral & Plastic SurgeryAnesthesiology |
| 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.
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 StentSystem | AERO™ TracheobronchialStent System |
|---|---|---|---|
| Applicant | M.I.Tech Co., Ltd. | EndoChoice, Inc. | Alveolus, Inc. |
| 510(k) Number | TBD | K140472 | K082284 |
| DeviceClassificationName | Prosthesis, Tracheal, Expandable | Prosthesis, Tracheal, Expandable | Prosthesis, Tracheal, Expandable |
| RegulationNumber | 21 CFR 878.3720 | 21 CFR 878.3720 | 21 CFR 878.3720 |
| RegulationDescription | Tracheal Prosthesis | Tracheal Prosthesis | Tracheal Prosthesis |
| Device Class | Class II | Class II | Class II |
| ClassificationProduct Code | JCT | JCT | JCT |
| RegulationMedicalSpecialty | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| 510(k) ReviewPanel | Anesthesiology | Anesthesiology | General & Plastic Surgery |
| Intended Use/Indications forUse | The HANAROSTENT®Trachea/Bronchium (CCC) isindicated for use in thetreatment of tracheobronchialstrictures caused by malignantneoplasms. | The BONASTENT®Tracheal/Bronchial StentSystemis indicated for thetreatment of tracheobronchialstrictures caused by malignantneoplasms. | The Alveolus AERO™Tracheobronchial StentSystemis indicated for use inthe treatment oftracheobronchial stricturescaused by malignantneoplasms. |
| PatientPopulation | Adults | Unknown | Unknown |
| Stent Body | Nitinol | Nitinol | Nitinol |
| StentRadiopaqueMarkers | Gold | Platinum | None |
| Stent Membrane | Fully coated siliconemembrane | Fully coated siliconemembrane | Fully coated polyurethanemembrane |
| Stent Lasso | One end of the stent | N/A | One end of the stent |
| Stent DiameterRange | 10-20mm | 10-20mm | 10-20mm |
| Stent LengthRange | 20-80mm | 20-80mm | 20-80mm |
| Delivery DeviceDiameter | 4mm(12Fr) | 2.67, 3, 3.33, 4mm(8, 9, 10, 12Fr) | 5.33, 7.33mm(16, 22Fr) |
| Delivery DeviceUsable LengthRange | 500-900mm | 500-900mm | 630-560mm |
| Method ofPlacement | Bronchoscopy | Bronchoscopy | Bronchoscopy |
| Method ofDeployment | Release by pulling outersheath | Release by pulling outersheath | Release by pulling outersheath |
| Provided Sterile | Yes | Yes | No |
| SterilizationMethod | EO | EO | N/A. Non-sterile. |
| Single-UseOnly | Yes | Yes | Yes |
| Packaging | Blister(Forming case+Tyvek film)Inner boxOuterbox | Forming caseTyvek PouchInner boxOuter box | Forming caseTyvek PouchInner boxOuter box |
| Shelf Life | 3 years | 3 years | Unknown |
| MRCompatibility | 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 TrachealProstheses , dated April 28, 1998. Use of International Standard ISO 10993-1, "Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a risk management process" , issuedJune 16, 2016. | ||
| Biocompatibility | The following biocompatibility testing was completed to determine the subject deviceis 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 <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 willperformas 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
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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 substantiallyequivalent to primary predicate device BONASTENT® Tracheal/Bronchial StentSystem (K140472) when evaluating intended use and technological characteristics:Subject device HANAROSTENT® Trachea/Bronchium (CCC) has theidentical intended use as primary predicate device BONASTENT®Tracheal/Bronchial Stent System. There are no differences between thesubject device and primary predicate device with respect to indications andintended use. Subject device HANAROSTENT® Trachea/Bronchium (CCC) has minortechnological differences compared to predicate device BONASTENT®Tracheal/Bronchial Stent Systemregarding packaging materials, stentrepositioning lasso, radiopaque marker materials, delivery device diameter,and performance testing results. These technological characteristic differences do not raise new questions ofsafety and effectiveness. Therefore, the subject and predicate devices are considered substantially equivalent. |
| Conclusion | M.I.Tech determined subject device HANAROSTENT® Trachea/Bronchium (CCC) issubstantially equivalent to the primary predicate device BONASTENT®Tracheal/Bronchial Stent System when evaluating intended use and technologicalcharacteristics, is biocompatible for its intended use, and will perform as intended.Therefore, M.I.Tech respectfully requests marketing clearance for subject deviceHANAROSTENT® Trachea/Bronchium (CCC). |
§ 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.”