(89 days)
No
The summary describes a system of bone plates and screws for fracture fixation, made of standard titanium alloys. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties and compliance with material standards.
Yes
The device is intended for the treatment of fractures and osteotomies, which is a therapeutic purpose.
No
The device is described as an implantable system for treating fractures and osteotomies, and its components include plates and screws, which are interventional rather than diagnostic tools. It also mentions "Non-Clinical Test was conducted to verify that the subject device met all design specifications," further indicating it performs a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of physical components like plates, screws, and surgical instruments made of titanium alloy.
Based on the provided information, the ARIX Elbow System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for treating fractures and osteotomies of specific bones in the elbow (proximal radius, ulnar olecranon, and distal humerus). This is a therapeutic and surgical purpose, not a diagnostic one.
- Device Description: The device consists of plates, screws, and surgical instruments. These are all physical implants and tools used in surgery, not reagents, instruments, or software intended for examining specimens from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to diagnose diseases or other conditions. The ARIX Elbow System is a surgical implant system used to fix bones.
N/A
Intended Use / Indications for Use
The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humerus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The ARIX Elbow System is consist of proximal radius plate, ulna olecranon plate, distal humerus plate and bone screw.
The ARIX Elbow System is made of Unalloyed Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
The plates vary essentially through different type and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments such as drill bits, drill sleeve and sleeve handle, driver, depth gauge, bender, handle, driver shafts and depth gauge.
The ARIX Elbow System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal radius, ulnar olecranon, distal humerus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary:
Non-Clinical Test was conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards:
- ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws
- ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The results of this testing indicate that the ARIX Elbow System is equivalent to predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K090053, K103332, K112560, K063049
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K170705, K170313, K171285, K172008
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
September 15, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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.
Jeil Medical Corporation Sejin Ryu RA Specialist 702,703,704,705,706,804,805,807,812,815-ho 55 Digital-ro 34-gil, Guro-gu Seoul, 08378 Korea
Re: K201656
Trade/Device Name: ARIX Elbow 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. HWC Dated: June 10, 2020 Received: June 18, 2020
Dear Sejin Ryu:
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
1
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 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 (QS) 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 medical devices and radiation-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,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
ARIX Elbow System
Indications for Use (Describe)
The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humenus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (7/17)
Page 1 of 1
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510(k) Summary
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
August 13, 2020
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Jeil Medical Corporation . Name of Sponsor: Address: 702·703·704·705·706·804·805·807·812·815-ho,55 -Digital-ro34-gil, Guro-gu, Seoul, 08378, Korea
- Contact Name: Sejin Ryu / RA Specialist
- Telephone No.: +82 2 850 3583 -
- Fax No.: +82 2 850 3536
- -Email Address: rsj@jeilmed.co.kr
- Registration Number: 3004049923
- . Name of Manufacturer: Same as Sponsor . Address: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| • | Trade Name; | ARIX Elbow System |
|---|---|---|
| • | Common Name; | Plate, Fixation, Bone (Primary) |
| Screw, Fixation, Bone | ||
| • | Classification Name; | Single/multiple component metallic bone fixation |
| appliances and accessories | ||
| • | Classification Panel; | Orthopedic |
| • | Classification regulation; | 21 CFR 888.3030 (Primary), |
| 21 CFR 888.3040 | ||
| • | Product code; | HRS (Primary), |
| HWC | ||
| • | Device Class: | II |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate device within this submission are shown as follow;
| Primary Predicate | K090053 – APTUS 2.0 Radial Head System
Medartis AG |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional Predicates | K103332 – APTUS Ulna Plates
Medartis AG
K112560 – APTUS Distal Humerus System
Medartis AG
K063049 – Synthes Modular Mini Fragment LCP System
Synthes (USA) |
| Reference Device | K170705 – ARIX Wrist System, Jeil Medical Corporation
K170313 – ARIX Ankle Distal Tibia System, Jeil Medical Corporation
K171285 – ARIX Diaphysis System, Jeil Medical Corporation
K172008 – ARIX Humerus System, Jeil Medical Corporation |
There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components.
5. Description of the Device [21 CFR 807.92(a)(4)]
The ARIX Elbow System is consist of proximal radius plate, ulna olecranon plate, distal humerus plate and bone screw.
The ARIX Elbow System is made of Unalloyed Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
The plates vary essentially through different type and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments such as drill bits, drill sleeve and sleeve handle, driver, depth gauge, bender, handle, driver shafts and depth gauge.
The ARIX Elbow System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
5
6. Indication for use [21 CFR 807.92(a)(5)]
The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humerus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
Bone Plate: Based on a technical feature comparison, the subject device was found to be similar to predicated devices with regard to design and materials. The subject plates also have locking feature, similar to the design used in the predicate device. (K090053, K103332, K112560)
Bone Screw: They share similar head, neck, and thread designs as the screws that are previously cleared under the predicate devices. (K063049, K170705)
Non-Clinical Test Summary:
Non-Clinical Test was conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards:
- ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws
- ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
The results of this testing indicate that the ARIX Elbow System is equivalent to predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K090053, K103332, K112560 and K063049), the ARIX Elbow System presented in this submission has the same:
- Indication for Use
- Technological characteristics
- Operating principle ●
- Design features
- . Performance
- Biocompatibility ●
- Materials
- Method of sterilization
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9. Conclusion [21 CFR 807.92(b)(3)]
In all respects, the ARIX Elbow System is the equivalent of currently marketed devices. This device is made of the same materials and has similar dimensions and characteristics. This device is manufactured from titanium that is used generally in this kind of bone plate/screw system. This device, ARIX Elbow, is substantially equivalent in design, material, and function to the predicate device.