(49 days)
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.
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.
The provided document is a 510(k) summary for the HANAROSTENT® Esophagus Asymmetric (CCC), a device intended for maintaining esophageal luminal patency in esophageal strictures and occlusion of concurrent esophageal fistula. This type of device approval (510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA).
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing performed to demonstrate that the new device is substantially equivalent to existing, legally marketed devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) device are generally established by comparison to a predicate device and relevant industry standards. For this device, the "acceptance criteria" are implied by the performance tests conducted, with the underlying assumption that the device's performance in these tests is comparable to or acceptable relative to the predicate device. The document does not explicitly state numerical acceptance criteria, but rather lists the types of tests performed to demonstrate substantial equivalence.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Foreshortening | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Expansion force | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Compression force | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Guidewire passage | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Deployment force | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Deploying accuracy | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Dimensions | Confirmed safety and effectiveness as compared to predicate devices via bench testing. |
| Biocompatibility | Evaluated as per ISO 10993-1. |
| Sterility | Evaluated as per relevant guidance. |
| Shelf Life | Evaluated as per relevant guidance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No animal and clinical performance data is submitted in this 510(k)." The testing performed was "Bench testing." The sample sizes for each specific bench test (e.g., number of stents tested for foreshortening) are not specified in the provided text.
- Sample Size for Test Set: Not specified for individual bench tests.
- Data Provenance: The bench testing was performed by M.I.Tech Co., Ltd., which is based in the Republic of Korea. The testing is described as "performance testing was performed as per the design control system," suggesting it was conducted under controlled, in-house laboratory conditions (retrospective in the sense that the data already existed at the time of submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. For a 510(k) reliant on bench testing and substantial equivalence, there isn't a "ground truth" established by external medical experts in the same way there would be for a diagnostic AI study. The "ground truth" for the performance tests would be the established engineering specifications and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving interpretation by multiple human readers, not for bench testing of medical devices. The "adjudication" for bench test results would be based on comparison to engineering specifications and predicate device data.
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
There was no MRMC comparative effectiveness study done. This study is for a physical medical device (esophageal stent), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This study is for a physical medical device (esophageal stent), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on the engineering specifications and performance characteristics derived from bench testing, as compared to the predicate device and relevant standards. It is not based on expert consensus, pathology, or outcomes data. The goal is to demonstrate that the new device performs comparably to the predicate device in key functional aspects.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of a 510(k) submission for a physical medical device like an esophageal stent. Training sets are relevant for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated above.
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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
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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
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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® EsophagusAsymmetric (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 formaintaining esophageal luminal patency in esophageal strictures causedby intrinsic and/or extrinsic malignant tumors, and occlusion ofconcurrent esophageal fistula. |
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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 inesophageal strictures caused by intrinsic and/or extrinsic malignanttumors, and occlusion of concurrent esophageal fistulas. It consists of aself-expandable metal stent and a delivery device. The self-expandablemetal stent is made of nickel titanium alloy (Nitinol) wire with fullycovered silicone membrane, and the delivery device is made of polymericmaterials. 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) isintended 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.K201160July 23, 2021Prosthesis, EsophagealEsophageal prosthesisGastroenterology/Urology21 CFR 878.3610Class IIESWGeneral & Plastic Surgery |
| Reference Devices: | Boston Scientific's WallFlex™ Esophageal Stents (K091510) | |
| Boston Scientific's Ultraflex ™ Esophageal Stents (K955347) | ||
| Comparison to thePredicate: | Both the subject and predicate devices are designed to maintain patencyin esophageal strictures caused by intrinsic and/or extrinsic malignanttumors, and occlusion of concurrent esophageal fistulas.The subject device and the predicate device have the same material,manufacturing process, sterilization method, and operation method, buthave different stent diameters, dumbbell diameters and lengths. |
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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.
| TechnologicalCharacteristics: | The intended use of the subject device, HANAROSTENT® EsophagusAsymmetric (CCC), is identical to the predicate device,HANAROSTENT® Esophagus (CCC).The subject device is identical to the delivery device of predicate devicein working length, outer diameter, method of placement, and guidewirecompatibility.The subject device has same stent materials as the predicate device andis similar in terms of performance. The subject device is similar to thereference device, Boston Scientific's WallFlex™ Esophageal Stents(K091510) and Ultraflex ™ Esophageal Stents (K955347), in terms ofstent diameter, dumbbell diameter and length. |
|---|---|
| FDA GuidanceDocuments: | The following FDA guidance documents were consulted in preparing thispremarket 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 PremarketNotification (510(k)) Submissions for Devices Labeled as Sterile,issued January 2016• Use of International Standard ISO 10993-1, "Biological evaluationof medical devices - Part 1: Evaluation and testing within a riskmanagement process", issued June 16, 2016• Guidance for The Content of Premarket Notifications for Esophagealand Tracheal Prostheses, issued April 28, 1998• Technical Considerations for Non-Clinical Assessment of MedicalDevices containing Nitinol, draft issued April 2019• Use of International Standard ISO 14971, " Medical devices –Application of risk management to medical devices", issuedDecember, 2019 |
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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
| PerformanceTesting: | Bench testing was performed to confirm the safety and effectiveness ofthe proposed subject devices as compared to the predicate devices.Performance testing was performed as per the design control system. Thefollowing tests were conducted:• Foreshortening• Expansion force• Compression force• Guidewire passage• Deployment force• Deploying accuracy• DimensionsNo animal and clinical performance data is submitted in this 510(k). |
|---|---|
| SubstantialEquivalence: | The subject devices are substantially equivalent to the predicate deviceswhen evaluating intended use and technological characteristics.• The subject device has exact same intended use/indications for useas the predicate.• The subject devices and predicate device are substantially equivalentwith only minor technological differences.• These differences do not raise new questions of safety andeffectiveness. |
| Conclusion: | This comparison demonstrates the subject devices are substantiallyequivalent to the predicate device. The subject devices are as safe andeffective as the predicate device and will perform as intended. Therefore,M.I. Tech respectfully requests market clearance for the subject devices. |
§ 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.”