The ARIX Hand System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Device Description

The ARIX Hand System is designed to fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures. The ARIX Hand System consists of the ARIX Hand System Plate and the ARIX Hand System Screw. The ARIX Hand System Plate is made of Pure Titanium (ASTM F67) and the ARIX Hand System Screw is made of the Titanium Alloy (ASTM F136). This device performance is not adversely affected by aging or storage conditions since this device is to be sterilized at the hospital before use and also to be single use.

AI/ML Overview

The provided text describes the ARIX Hand System, a device for internal fixation of hand and wrist bones, and its 510(k) submission for substantial equivalence to a predicate device. The submission primarily focuses on comparing the ARIX Hand System to the Profyle System, K062498, based on materials, design, intended use, and mechanical properties.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for the ARIX Hand System itself. Instead, it states that "the ARIX Hand System has the similar device characteristics as the predicate device" and that "Only the technical specifications - bending stiffness, tensile strength, driving torque, torsion and pullout - are slightly different." The study performed for the ARIX Hand System involved comparing its mechanical performance to the predicate device. The implicit acceptance criterion is that the ARIX Hand System's performance for these tests should be comparable to or better than the predicate device to establish substantial equivalence. However, specific numerical thresholds for "acceptance" are not provided for either the predicate or the new device, nor are the reported performance values for each.

Test Parameter	Acceptance Criteria (Implicitly: Comparable to Predicate)	Reported Device Performance (ARIX Hand System)
Plate Bending Strength (ASTM F382)	Should be similar to predicate device (Profyle System)	Not explicitly reported numerically
Plate Tensile Strength	Should be similar to predicate device (Profyle System)	Not explicitly reported numerically
Screw Driving Torque (ASTM F543)	Should be similar to predicate device (Profyle System)	Not explicitly reported numerically
Screw Torsion (ASTM F543)	Should be similar to predicate device (Profyle System)	Not explicitly reported numerically
Screw Axial Pullout Strength (ASTM F543)	Should be similar to predicate device (Profyle System)	Not explicitly reported numerically

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the mechanical tests. The data provenance is not explicitly stated in terms of country of origin of the data or if it was retrospective or prospective. It describes laboratory mechanical tests (e.g., Bending Strength, Tensile Strength, Driving Torque, Torsion, Axial Pullout Strength) which are typically conducted in a controlled environment, not on patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable in this context. The "test set" consists of mechanical tests on the device components (plates and screws), not on clinical data requiring expert human review to establish ground truth.

4. Adjudication Method for the Test Set

This question is not applicable as the "test set" involves objective mechanical property measurements, not subjective evaluations that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes mechanical bench tests to demonstrate substantial equivalence, not a clinical study involving human readers or cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical implant (bone plate and screw system), not an algorithm or software. Therefore, human-in-the-loop or standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on objective mechanical performance metrics obtained from standardized tests (e.g., ASTM F382, ASTM F543). The comparison is made against the mechanical properties of a legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a training set. The evaluation focuses on its mechanical properties.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As stated above, the device is not an AI/ML algorithm requiring a training set.

Summary

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2 Kolon Science V Guro-Dong, Guro-Gu, Seoul, 152-05 Tel : +82 2 850 3500 / Fax : +82 2 850 3535

510(k) Summary

K131566 page 1 of 2

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c),

Date: May 28, 2013

Company and Correspondent making the submission:

	Company
Name	Jeil Medical Corporation
Address	#702, Kolon science valley 2nd811, Guro-Dong, Guro-GuSeoul, Republic of Korea 152-050
PhoneFaxContact	+82 2 850-3524+82 2 850-3525Jieun Kim

NOV 04 2013

2. Device:

Proprietary Name - ARIX Hand System Common Name - Bone plate & screw Classification Name - Single/multiple component metallic bone fixation appliances and accessories

3. Predicate Device:

Profyle System, K062498, Howmedica Osteonics Corp.

4. Classifications Names & Citations:

Orthopedic HRS, 21CFR888.3030

5. Description:

6. Indication for use:

The ARIX Hand System is intended for use in internal fixation of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

1. Review:
  The ARIX Hand System has the similar device characteristics as the predicate device, the Profyle System, K062498, Howmedica Osteonics Corp .; intended use, materials, design and use concept,

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K131566 page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for JEIL MEDICAL corporation. The logo consists of a stylized graphic to the left of the text. The text is in all caps and is stacked, with "MEDICAL" on top of "corporation."

#702, Kolon Science Valle Guro-Dong, Guro-Gu, Seoul, 152-050 Tel : +82 2 850 3500 / Fax : +82 2 850 3535

sterilization, etc. Only the technical specifications -bending stiffness, tensile strength, driving torque, torsion and pullout - are slightly different.

The following tests were performed with the predicate device: ·Plates

Bending Strength test per ASTM F382 •
- Tensile Strength test
-·Screw
- Driving torque test ASTM F543 -
- י Torsion test ASTM F543
- Axial Pullout Strength per ASTM F543 -

Based on the comparison of intended use and technical features, the ARIX Hand System is substantially equivalent to the predicate devices.

8. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation concludes that the ARIX Hand System are substantially equivalent to predicate devices as described herein.

1. Jeil Medical Corporation will update and include in this summary any other information deemed reasonably necessary by the FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 4, 2013

Jeil Medical Corporation Mr. Ji-Eun Kim Regulatory Affairs Manager Number 702, Kolon Science Valley 2nd 811 Guro-Dong, Guro-Gu Seoul-City 152-050 Republic of Korea South Korea

Re: K131566

Trade/Device Name: ARIX Hand System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: October 16, 2013 Received: October 17, 2013 、

Dear Mr. Kim:

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.

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Page 2 - Mr. Ji-Eun Kim

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 (reporting of medical device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Image /page/3/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The letters "I" and "K" are designed with geometric patterns and lines, giving them a unique and artistic appearance. The rest of the letters are in a more standard, bold font, which contrasts with the stylized letters. The overall effect is a visually interesting and modern take on a name.

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#702, Kolon Science V: Guro-Dong, Guro-Gu, Seoul, 152-05 Tel : +82 2 850 3500 / Fax : +82 2 850 3535

Indications for Use

510(k) Number (if known): K131566

Device Name: ARIX Hand System

Indications for Use:

Prescription Use メ (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)

Page 1 of 1

Elizabeth L. Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.