(49 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the stent and delivery system, with no mention of AI or ML.
Yes.
This device is designed to maintain luminal patency in esophageal strictures and occlude fistulas, which are therapeutic interventions.
No
The device is a stent intended for maintaining esophageal luminal patency and occluding fistulas, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of a self-expandable metal stent and a delivery device, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HANAROSTENT® Esophagus Asymmetric (CCC) is a physical device (a stent) that is implanted into the esophagus to maintain patency and occlude fistulas. It directly interacts with the body's anatomy.
- Intended Use: The intended use describes a therapeutic intervention (maintaining luminal patency and occluding fistulas) within the body, not an analysis of a specimen outside the body.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
Product codes
ESW
Device Description
This self-expanding tubular prosthesis is designed to maintain 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 delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire with fully covered silicone membrane, and 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 HANAROSTENT® Esophagus Asymmetric (CCC) is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal
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
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:
• Foreshortening
• Expansion force
• Compression force
• Guidewire passage
• Deployment force
• Deploying accuracy
• Dimensions
No animal and clinical performance data is submitted in this 510(k).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2021
M.I.Tech Co., Ltd. % Heidi Busz Regulatory Consultant Namsa 00 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K213251
Trade/Device Name: HANAROSTENT Esophagus Asymmetric (CCC) Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: Class II Product Code: ESW Dated: October 15, 2021 Received: October 19, 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K213251
Device Name HANAROSTENT® Esophagus Asymmetric (CCC)
Indications for Use (Describe)
The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
| 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 is blue and features the company name in a stylized font. 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
5 510(k) Summary
| Preparation Date: | September 29, 2021 | |
|---|---|---|
| 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: | Sunyoung Jo | |
| Regulatory Affairs 1 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: 82-70-4304-7429 | ||
| Fax: 82-70-8282-5642 | ||
| Subject Devices: | Trade Name: | HANAROSTENT® Esophagus |
| Asymmetric (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 | |
| Intended Use / | ||
| Indications for Use: | The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for | |
| maintaining esophageal luminal patency in esophageal strictures caused | ||
| by intrinsic and/or extrinsic malignant tumors, and occlusion of | ||
| concurrent esophageal fistula. |
4
Image /page/4/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features the company name in a stylized font. Below the logo is the company's website address, www.mitech.co.kr.
| Device Description: | This self-expanding tubular prosthesis is designed to maintain 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 delivery device. The self-expandable
metal stent is made of nickel titanium alloy (Nitinol) wire with fully
covered silicone membrane, and 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 HANAROSTENT® Esophagus Asymmetric (CCC) is
intended for single use only. | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | Trade Name:
Applicant:
510(k) Number:
Clearance Date:
Device:
Regulation Description:
Review Panel:
Regulation Number:
Device Class:
Product Code:
Regulation Medical Specialty: | HANAROSTENT® Esophagus (CCC)
M.I.Tech Co., Ltd.
K201160
July 23, 2021
Prosthesis, Esophageal
Esophageal prosthesis
Gastroenterology/Urology
21 CFR 878.3610
Class II
ESW
General & Plastic Surgery |
| Reference Devices: | Boston Scientific's WallFlex™ Esophageal Stents (K091510) | |
| | Boston Scientific's Ultraflex ™ Esophageal Stents (K955347) | |
| Comparison to the
Predicate: | Both the subject and predicate devices are designed to maintain patency
in esophageal strictures caused by intrinsic and/or extrinsic malignant
tumors, and occlusion of concurrent esophageal fistulas.
The subject device and the predicate device have the same material,
manufacturing process, sterilization method, and operation method, but
have different stent diameters, dumbbell diameters and lengths. | |
5
Image /page/5/Picture/0 description: The image shows the logo for M.I.Tech. The logo is blue and has a red dot above the "M". Below the logo is the website address www.mitech.co.kr.
| Technological
Characteristics: | The intended use of the subject device, HANAROSTENT® Esophagus
Asymmetric (CCC), is identical to the predicate device,
HANAROSTENT® Esophagus (CCC).
The subject device is identical to the delivery device of predicate device
in working length, outer diameter, method of placement, and guidewire
compatibility.
The subject device has same stent materials as the predicate device and
is similar in terms of performance. The subject device is similar to the
reference device, Boston Scientific's WallFlex™ Esophageal Stents
(K091510) and Ultraflex ™ Esophageal Stents (K955347), in terms of
stent diameter, dumbbell diameter and length. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Guidance
Documents: | The following FDA guidance documents were consulted in preparing this
premarket submission:
• Guidance for The Special 510(k) Program, issued September 13,
2019
• 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
• 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
• Use of International Standard ISO 14971, " Medical devices –
Application of risk management to medical devices", issued
December, 2019 |
6
Image /page/6/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features the company's name in a stylized font. Below the logo is the company's website address, www.mitech.co.kr.
HEAD OFFICE HEAD OFK2-GE, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
TEL +82 31 662 5645 FAX +82 31 662 5648
| Performance
Testing: | 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:
• Foreshortening
• Expansion force
• Compression force
• Guidewire passage
• Deployment force
• Deploying accuracy
• Dimensions
No animal and clinical performance data is submitted in this 510(k). |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | The subject devices are substantially equivalent to the predicate devices
when evaluating intended use and technological characteristics.
• The subject device has exact same intended use/indications for use
as the predicate.
• 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. |