← Product Code [ESW](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW) · K093537 # HANAROSTENT ESOPHAGUS (CCC) (K093537) _M.I.Tech Co., Ltd. · ESW · Jun 4, 2010 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/ESW/K093537 ## Device Facts - **Applicant:** M.I.Tech Co., Ltd. - **Product Code:** [ESW](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW.md) - **Decision Date:** Jun 4, 2010 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.3610 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use HANAROSTENT® Esophagus (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. ## Device Story HANAROSTENT® Esophagus (CCC) is a self-expanding, tubular, polygon mesh prosthesis; constructed from Nitinol wire with a silicone membrane coating. Designed to maintain esophageal luminal patency in patients with malignant strictures or esophageal fistulas. Features larger banded flanges at both ends to prevent migration and tumor in-growth. Device is deployed via a delivery system; intended for use by clinicians in a medical setting. Stent provides mechanical support to the esophageal wall; prevents occlusion by tumors or fistulas. Benefits include improved patient ability to swallow and reduced risk of stent migration. ## Clinical Evidence Bench testing only. Testing included expansion force, compression force, and corrosion resistance in simulated gastric fluid (>18 days). ## Technological Characteristics Self-expanding tubular prosthesis; Nitinol wire (hook and cross structure); silicone membrane coating; symmetrical shape with banded flanges; diameters 18/22mm; lengths 80/170mm; delivery diameter 6mm. ## Regulatory 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. ## Special Controls The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.” ## Predicate Devices - Choostent™ covered Esophageal Stent ([K072094](/device/K072094.md)) - UltraflexTM Esophageal NG Stent System ([K032930](/device/K032930.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K093537 pg 1 of 3 ## 510(K) SUMMARY JUN - 4 2010 [as required by 807.92(c)] 2010. April.23 A.510k Number: B. Applicant: Company name: PATS CORP Contact Person: Brandon Choi Address: 49 Candlewood Way, Buena Park, CA 90621, USA Phone: 714-523-1592 Fax: 714-523-1592 C. Proprietary and Established Names: M. I. Tech Co., Ltd Address: 241-3 Habuk-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do 451-864 KOREA D. Regulatory Information - Classification Name: prosthesis, esophageal - Common / Usual Name: esophageal stent - Proprietary Name: HANAROSTENT® Esophagus (CCC) - Classification / Product Code: Class II / ESW (21 CFR 878.3610) E. Indication for use HANAROSTENT® Esophagus (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. F. Description of the Device:. HANAROSTENT® Esophagus (CCC) is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of esophageal strictures caused by malionant tumors. The stent is made of Nitinol wire (hook and cross wire structure) and a silicon membrane designed in such a way as to prevent migration and tumor in-growth. The stent is symmetrical in shape, with the diameter of both ends of the stent extending beyond the diameter of the stent body (larger banded flanges). This band design has become standard practice and aids in preventing stent migration. G. Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory testing indicate that the new device is as safe and effective as the predicate devices. {1}------------------------------------------------ ## K093537 | Product name
Feature | HANAROSTENT®
Esophagus (CCC) | Choostent™ covered
Esophageal Stent | UltraflexTM Esophageal
NG Stent System | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | | K072094 | K032930 | | Intended Use | HANAROSTENT®
Esophagus (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. | The CHOOSTENT™
covered esophageal
stent is intended for
maintaining esophageal
luminal patency in
esophageal strictures
caused by intrinsic and
or extrinsic malignant
tumors only and
occlusion of concurrent
esophageal fistula. | The UltraflexTM
Esophageal NG Stent
System is intended for
maintaining esophageal
luminal patency in
esophageal strictures
caused by intrinsic and/or
extrinsic malignant
tumors and, for occlusion
of concurrent esophageal
fistula (for covered stents
only). | | Protheses
configuration | Fully coated | Fully coated | Same | | Coating material | Silicon | Silicone | Silicone | | Stent diameter
(mm) | Diameter : 18 / 22mm | 18mm | Diameter : 23mm | | Stent length
(mm) | Length : 80 / 170mm | 80-170 | Length : 100 / 120mm | | Delivery
diameter | Diameter : 6mm | Diameter : 6mm | | | Expansion Force | 0.94/0.79 lbs | 0.83 | | | Compression
force | 1.88 lbs | 2lbs | | | Corrosion (in
simulated gastric
fluid) | > 18days | >18days | | ## H. Conclusion () . The HANAROSTENT® Esophagus (CCC) has substantial equivalent intended use as the-market cleared K072094, K032930 and has substantial equivalent technological and performance characteristics. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of M. I. Tech Co., Ltd. that the HANAROSTENT® Esophagus (CCC) is as safe and {2}------------------------------------------------ K093537 p3 of 3 effective as the predicate devices, it has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns. Consequently, it is clear that it substantially equivalent to the predicate devices. (・・ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized representation of three wavy lines, which are likely meant to symbolize the department's mission of promoting health and well-being. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002 M.I. Tech Co., Ltd. c/o Brandon Choi. General Manager PATS CORP 49 Candlewood Way BUENA PARK CA 90621 . JUN - 4 2010- · Re: K093537 Trade/Device Name: HANAROSTENT® Esophagus (CCC) Regulation Number: 21 CFR \$878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: April 27, 2010 Received: May 6, 2010 Dear Mr. Choi: 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. 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 {4}------------------------------------------------ Page 2 - adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation.control.provisions.(Sections: 531-542-of-the-Act); 21-CFR 1000-1050. - If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K093537 Device Name: HANAROSTENT® Esophagus (CCC) Indications For Use: HANAROSTENT® Esophagus (CCC) is intended for maintaining esophageal luminal patency inesophageal strictures caused by intrinsic and/or extrinsic malignant turnors, and occlusion of concurrent esophageal fistula. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/ESW/K093537](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/ESW/K093537) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com