(89 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is intended for internal fixation of bones in the hand and wrist (e.g., for fractures, fusions, osteotomies) rather than providing therapy.
No
The ARIX Hand System is described as a device for internal fixation of bones in the hand and wrist. Its purpose is to treat conditions like fractures and joint fusions, not to diagnose them.
No
The device description explicitly states that the ARIX Hand System consists of a plate and screws made of titanium, which are hardware components. The performance studies also describe bench tests on these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ARIX Hand System Function: The ARIX Hand System is a surgical implant used for internal fixation of bones in the hand and wrist. It is a physical device implanted into the body to provide structural support and stability.
- Intended Use: The intended use clearly states it's for "internal fixation of the hand and wrist" in surgical procedures. This is a therapeutic and structural function, not a diagnostic test performed on a sample outside the body.
The description of the device, its materials, and the performance studies (bench tests on mechanical properties) all align with a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The ARIX Hand System is intended for use in internal fixation of thand 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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)
Bench tests were conducted to verify that the proposed device met all design specifications.
- Plate
- ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates
- Screw
- ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws
The following tests were performed with the predicate device:
- ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws
- Plate
- Tensile strength test
- Bending strength test per ASTM F382
- Screw
- Driving torque test per ASTM F543
- Axial pull-out test per ASTM F543
- Torsion test per ASTM F543
The results of this testing indicate that the ARIX Hand System is equivalent to predicate device.
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.
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Jeil Medical Corporation Seungyong Lee RA Specialist Seoul, 152-728 KOREA
Re: K161746 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, HWC Dated: August 23, 2016 Received: August 25, 2016
Dear Seungyong Lee:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3535.
K161746 page 1 0f 1
Indication for Use
510(k) Number (if known): K161746
Device Name: ARIX Hand System
Indication for Use:
The ARIX Hand System is intended for use in internal fixation of thand 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.
Prescription Use _ X (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)
3
Image /page/3/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The phone number is +82 2 850 3533 and the fax number is +82 2 850 3535.
510(k) Summary
K161746 page 1 of 3
[As required by 21 CRF 807.92]
1. Date Prepared [21 CRF 807.92(a)(a)]
20. June 2016
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | Jeil Medical Corporation |
|---|---|
| - Address: | 702-703-704-705-706-804-805-807-812-ho,55 Digital-ro34-gil, Guro-gu, Seoul, 08378, Korea |
| • Contact Name: | Seungyong Lee / RA Specialist |
|---|---|
| - Telephone No.: | +82 2 850 3533 |
| - Fax No.: | +82 2 850 3525 |
- Email Address : leesy@jeilmed.co.kr -
3004049923 . Registration Number: Name of Manufacturer: Same as Sponsor ●
- -Address: Same as Sponsor
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
| • | Trade Name: | ARIX Hand System |
|---|---|---|
| • | Common Name: | Bone plate & screw |
| • | Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories | ||
| • | appliances and accessories | |
| • | Classification Panel: | Orthopedic |
| • | Classification Regulation: | 21 CFR 888.3030 |
| • | Product Code: | HRS, HWC |
| • | Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow;
| • 510(k) Number: | K131566 |
|---|---|
| • Applicant: | Jeil Medical Corporation |
| • Common Name: | Bone plate & screw |
| • Device Name: | ARIX Hand System |
Orthopedic Bone plate & screw
There are no significant differences between the Additional models and the predicate devices (K131566) that would adversely affect the use of the product.
4
Image /page/4/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The phone number is +82 2 850 3533 and the fax number is +82 2 850 3535.
Description of the Device [21 CFR 807.92(a)(4)] 5.
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.
Intended Use [21 CFR 807.92(a)(5)] 6.
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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
ARIX Hand System. Orthopedic: With same thickness and titanium grade. But, the plate and screw changed some dimensions have increased to enhance the strength under the predicate devices (K131566)
Non-Clinical Test Summary:
Bench tests were conducted to verify that the proposed device met all design specifications.
- . Plate
- ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates
- . Screw
- ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws i
The following tests were performed with the predicate device:
- Plate .
- Tensile strength test -
- Bending strength test per ASTM F382 i
- . Screw
- Driving torque test per ASTM F543 i
- Axial pull-out test per ASTM F543
- Torsion test per ASTM F543
The results of this testing indicate that the ARIX Hand System is equivalent to predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
5
Image /page/5/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is listed as 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3535.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, raw material, and use concept and employ the same anodization and sterilization method. The differences are in shape and dimensions; however; the performance test data provided in this submission proves the subject device is substantially equivalent to the predicate.
Conclusion [21 CFR 807.92(b)(3)] 9.
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 ARIX Hand System Bone Plate & Screw is safe and effective and substantially equivalent to the predicate device as described herein.