(49 days)
Not Found
No
The summary describes a mechanical self-expanding stent and its delivery system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML for diagnosis, treatment planning, or device operation. The performance studies focus on mechanical properties and deployment accuracy.
Yes.
The device is described as a self-expanding tubular prosthesis intended for maintaining esophageal luminal patency in strictures and occluding fistulas, which are therapeutic interventions.
No
The device, a self-expanding esophageal stent, is intended for maintaining luminal patency and occluding fistulas, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a self-expanding tubular prosthesis made of metal and polymeric materials, delivered via a physical system. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain esophageal luminal patency and occlude fistulas in the esophagus. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a self-expanding metal stent and a delivery system. These are physical devices used to treat a condition within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are designed for testing samples in vitro.
Therefore, the HANAROSTENT® Esophagus TTS is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Product codes (comma separated list FDA assigned to the subject device)
ESW
Device Description
This self-expanding tubular prosthesis is designed to maintain esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a through-the scope delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and repositioning lasso made of polyester. 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 delivery system is compatible with a minimum 3.7mm working channel of a therapeutic endoscope. The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) 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 accuracy.
Anatomical Site
Esophagus
Indicated Patient Age Range
Not Found
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)
Bench testing was performed to confirm the safety and effectiveness of the proposed subject devices as compared to the predicate devices. Performance testing was performed as per the design control system. The following tests were conducted: Deployment force, Deployment accuracy, Deployment in a simulated environment, Expansion force, Compression force, Dimensions, Corrosion, Tensile strength, Foreshortening, Trackability, Repositioning force, MR safety and compatibility.
The subject and predicate devices have equivalent expansion forces. The subject and predicate devices have equivalent compression forces. The subject device's 1800mm delivery device and the predicate device's 1800mm delivery device have equivalent deployment forces. The subject device's 2300mm delivery device has greater deployment force than the predicate device's 1800mm delivery device.
No animal performance data is submitted in this 510(k).
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.
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.
Not Found
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
§ 878.3610 Esophageal prosthesis.
(a)
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.(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.”
0
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May 20, 2020
M.I. Tech Co., Ltd % Beryl St. Jeanne, MS, RAC Regulatory Consultant Namsa 400 Highway 169 South Suite 500 Minneapolis, MN 55426
Re: K200860
Trade/Device Name: HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: March 31, 2020 Received: April 1, 2020
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 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 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
1
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,
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
2
Indications for Use
510(k) Number (if known) K200860
Device Name
HANAROSTENT® Esophagus TTS (CCC); HANAROSTENT® Esophagus TTS (NCN)
Indications for Use (Describe)
The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (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) | |
---|---|
☑ 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/1 description: The image shows the logo for M.I.Tech. The logo consists of the letters "MIT" in a stylized blue font, with a red dot above the "I". To the right of the logo is the text "M.I.Tech" in a larger, bolder blue font. Below the logo is the website address "www.mitech.co.kr".
HEAD OFFICE 174, HABUK2-GIL, JINWI-MYEON, PYEONGTAEK-SI, GYEONGGI-DO, 17706, REPUBLIC OF KOREA TEL +82 31 662 5645 FAX +82 31 662 5648
6 510(k) Summary
Preparation Date | March 31, 2020 | |
---|---|---|
Submitter | M.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 Contact | Inae 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 Devices | Trade Name: | HANAROSTENT® Esophagus TTS (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 | |
Regulation Medical Specialty: | General & Plastic Surgery | |
Trade Name: | HANAROSTENT® Esophagus TTS (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 | |
Regulation Medical Specialty: | General & Plastic Surgery |
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Image /page/4/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the company name in blue letters, with a red dot above the "i" in "MIT". Below the logo is the company's website address, www.mitech.co.kr.
HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
| Intended Use /
Indications for Use | The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT®
Esophagus TTS (NCN) are intended for maintaining esophageal luminal patency
in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and
occlusion of concurrent esophageal fistulas. | Technological | The subject devices and predicate device have substantially equivalent |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | This self-expanding tubular prosthesis is designed to maintain esophageal luminal
patency in esophageal strictures caused by intrinsic and/or extrinsic malignant
tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-
expandable metal stent and a through-the scope delivery system. The self-expandable
metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers
made of gold wire, fully or partially covered silicone membrane, and repositioning
lasso made of polyester. 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 delivery system is
compatible with a minimum 3.7mm working channel of a therapeutic endoscope.
The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT®
Esophagus TTS (NCN) are intended for single use only. | Characteristics | technological characteristics with only minor differences regarding: |
| Predicate Device | Device Classification Name: Prosthesis, Esophageal
510(k) Number: K123205
Device Name: Esophageal TTS Stent
(currently commercialized as the
Niti-STM TTS Esophageal Stent)
Applicant: Taewoong Medical Co., Ltd.
Regulation Number: 21 CFR 878.3610
Classification Product Code: ESW
Decision Date: 10/09/2013
Regulation Medical Specialty: General & Plastic Surgery
510(k) Review Panel: Gastroenterology/Urology
Device Class: Class II | | Packaging: The subject devices do not have a Tyvek pouch. The predicate device has a Tyvek pouch. Radiopaque marker material and quantity: The subject devices have 12 gold radiopaque markers. The predicate device has 10 platinum-iridium radiopaque markers. Stent lengths: The subject device is offered in 60, 70, 80, 90, 100, 110, 120, 130, 140, and 150mm stent lengths. The predicate device is offered in 60, 80, 100, 120, 140, and 150mm stent lengths. Lasso materials: The subject devices use a polyester lasso material. The predicate device uses a nylon lasso material. Delivery device usable lengths: The subject devices offer an 1800mm or 2300mm delivery device. The predicate device offers an 1800mm delivery device. Performance – Bench: The subject and predicate devices have equivalent expansion forces. The subject and predicate devices have equivalent compression forces. The subject device's 1800mm delivery device and the predicate device's 1800mm delivery device have equivalent deployment forces. The subject device's 2300mm delivery device has greater deployment force than the predicate device's 1800mm delivery device. |
| 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 esophagus 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 accuracy. The delivery device is removed and discarded
after deployment of the stent. | | |
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Image /page/5/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features a stylized "MIT" with a red dot above the "I". Below the logo is the company's website address, www.mitech.co.kr.
HEAD OFFICE
174, HABUK2-GIL, JINWI-MYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA TEL +82 31 662 5645 FAX +82 31 662 5648
6
Image /page/6/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features a stylized "M" with a red dot above it. Below the logo is the website address: www.mitech.co.kr.
HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
| FDA Guidance
Documents | The following FDA guidance documents were consulted in preparing this
premarket submission:
Shelf Life of Medical Devices, issued April 1991 Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 2016 Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June 2012 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 Guidance for The Content of Premarket Notifications for Esophageal and Tracheal Prostheses, issued April 28, 1998 Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol, draft issued April 2019 Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 2014 Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, issued August 2019 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance - Bench | Bench testing was performed to confirm the safety and effectiveness of the
proposed subject devices as compared to the predicate devices. Performance
testing was performed as per the design control system. The following tests were
conducted:
Deployment force Deployment accuracy Deployment in a simulated environment Expansion force Compression force Dimensions Corrosion Tensile strength Foreshortening Trackability Repositioning force MR safety and compatibility |
| Performance - Animal | No animal performance data is submitted in this 510(k). |
| Performance - Clinical | No clinical performance data is submitted in this 510(k). |
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Image /page/7/Picture/1 description: The image shows the logo for M.I.Tech, a company with a website at www.mitech.co.kr. The logo features the company name in a stylized font, with the letters "MIT" connected and a red dot above the "I". The website address is printed in a smaller font below the logo.
HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
| Substantial
Equivalence | The subject devices are substantially equivalent to the predicate device when
evaluating intended use and technological characteristics. The subject devices have the identical intended use as the predicate device. There are no differences between the subject device and predicate device with respect to intended use. The subject devices have different indications for use than the predicate device. The subject devices are additionally indicated for occlusion of concurrent esophageal fistulas. The subject devices and predicate device are substantially equivalent with only minor technological differences. These differences do not raise new questions of safety and effectiveness. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | This comparison demonstrates the subject devices are substantially equivalent to the predicate device. The subject devices are as safe and effective as the predicate device and will perform as intended. Therefore, M.I. Tech respectfully requests market clearance for the subject devices. |