HANAROSTENT ESOPHAGUS (CCC) by M.I. TECH CO., LTD.

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 Description

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.

AI/ML Overview

Based on the provided text, the device in question, HANAROSTENT® Esophagus (CCC), is a medical device, specifically an esophageal stent, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "device performance" in the context of AI models (e.g., accuracy, sensitivity, specificity) and human reader studies (MRMC) does not directly apply here.

The document describes a 510(k) submission for substantial equivalence to predicate devices, focusing on physical and mechanical properties, as well as intended use.

However, I can extract information related to the device's technical specifications and compare them to predicate devices, which serves as the basis for its "acceptance" by the FDA as substantially equivalent.

Here's an interpretation based on the provided text, framed to align as closely as possible with your request, even though it's a medical device rather than an AI system:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are generally demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing intended use, technological characteristics, and performance data to ensure no new safety or effectiveness concerns are raised.

In this case, the reported "device performance" is a comparison of key physical and mechanical properties to predicate devices. The "acceptance criteria" are implied to be that these characteristics are similar enough to not introduce new risks.

Characteristic	Acceptance Criterion (Predicate Device: Choostent™ covered Esophageal Stent / Ultraflex™ Esophageal NG Stent System)	Reported HANAROSTENT® Esophagus (CCC) Performance
Intended Use	Maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.	Matches Predicate (stated as "substantial equivalent intended use")
Prostheses configuration	Fully coated	Fully coated
Coating material	Silicone	Silicon
Stent diameter (mm)	18mm / 23mm	18 / 22mm (Within acceptable range or minor difference not raising new concerns)
Stent length (mm)	80-170mm / 100 / 120mm	80 / 170mm (Within acceptable range)
Delivery diameter	6mm	6mm
Expansion Force (lbs)	0.83 lbs	0.94/0.79 lbs (Comparable)
Compression force (lbs)	2 lbs	1.88 lbs (Comparable)
Corrosion (in simulated gastric fluid)	>18 days	> 18 days (Matches Predicate)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states "The results of bench and test laboratory testing indicate that the new device is as safe and effective as the predicate devices." and mentions "analyzing both bench as well as laboratory testing to applicable standards".

Sample size for test set: Not explicitly stated. The testing appears to be on the physical device itself (material, mechanical properties, etc.), not a clinical "test set" of patients.
Data provenance: Not explicitly stated. It's bench and laboratory testing, likely conducted by the manufacturer, M. I. Tech Co., Ltd. (Korea), given their address is provided.
Retrospective or prospective: Not applicable as it's bench/lab testing, not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involves bench and laboratory testing of a physical medical device's properties, not the evaluation of a diagnostic or predictive algorithm. There isn't a "ground truth" to be established by medical experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no adjudication method in the context of physical property testing for substantial equivalence.

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 physical medical device (esophageal stent), not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench and laboratory testing, the "ground truth" would be established by validated scientific methods and accepted engineering standards for measuring physical and mechanical properties (e.g., using calibrated instruments to measure force, diameter, corrosion resistance). It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for a traditional medical device like this.

Summary

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K093537
pg 1 of 3

510(K) SUMMARY

JUN - 4 2010

[as required by 807.92(c)]

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

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.

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K093537

Product nameFeature	HANAROSTENT®Esophagus (CCC)	Choostent™ coveredEsophageal Stent	UltraflexTM EsophagealNG Stent System
510(k) No.		K072094	K032930
Intended Use	HANAROSTENT®Esophagus (CCC) isintended formaintaining esophagealluminal patency inesophageal stricturescaused by intrinsicand/or extrinsicmalignant tumors, andocclusion of concurrentesophageal fistula.	The CHOOSTENT™covered esophagealstent is intended formaintaining esophagealluminal patency inesophageal stricturescaused by intrinsic andor extrinsic malignanttumors only andocclusion of concurrentesophageal fistula.	The UltraflexTMEsophageal NG StentSystem is intended formaintaining esophagealluminal patency inesophageal stricturescaused by intrinsic and/orextrinsic malignanttumors and, for occlusionof concurrent esophagealfistula (for covered stentsonly).
Prothesesconfiguration	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
Deliverydiameter	Diameter : 6mm	Diameter : 6mm
Expansion Force	0.94/0.79 lbs	0.83
Compressionforce	1.88 lbs	2lbs
Corrosion (insimulated gastricfluid)	> 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

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K093537
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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.

(・・

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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

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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

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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

Regulation Number and Section

§ 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.”