(158 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "internal fixation" system intended for use in procedures like replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures, all of which are medical interventions aimed at treating or alleviating conditions.
No
The device is described as a system for internal fixation of hand and wrist bones, used in surgical procedures like fracture treatment and joint fusions. This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description explicitly states that the ARIX Hand System consists of a plate and screws made of titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "internal fixation of the bones of hand and wrist." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device consists of plates and screws made of titanium. These are implants used to stabilize bones, not reagents or instruments used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The ARIX Hand System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS
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
bones of hand and wrist
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)
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, 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
- 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.
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
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 2nd |
| 811, Guro-Dong, Guro-Gu | |
| Seoul, Republic of Korea 152-050 | |
| Phone | |
| Fax | |
| Contact | +82 2 850-3524 |
| +82 2 850-3525 | |
| Jieun 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:
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.
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.
-
- 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,
- Review:
1
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.
-
- Jeil Medical Corporation will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
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.
3
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
4
#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:
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.
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