(137 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is intended for stabilization and fixation of chest wall fractures to promote fusion, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a system for "stabilization and fixation of fractures" and "sternal reconstructive surgical procedures," which are treatment functionalities, not diagnostic ones.
No
The device description explicitly states it is a rigid fixation system consisting of plates and screws made of titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ARIX Sternal System is for the "stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details plates and screws made of titanium alloy, designed for surgical implantation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not interact with such specimens.
The ARIX Sternal System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ARIX Sternal System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.
Product codes
HRS, HWC
Device Description
The ARIX Sternal System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Sternal 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-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 lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 2.4, 2.7mm. And both are provided with lengths from 8 mm to 20 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternum
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
Bench tests were 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 F382, Standard Specification and Test Method for Metallic Bone Plates; ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws. The following tests were performed with the predicate device: Plate (4-Point Bending Test, 4-Point Fatigue Test), Screw (Driving Torque Test, Torsion Test, Axial Pull-out Test). The results of this testing indicate that the ARIX Sternal System is equivalent to predicate device. No clinical studies were considered necessary and performed.
Key Metrics
Not Found
Predicate Device(s)
K110574, K111908, K121302, K161896
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 20, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
Jeil Medical Corporation Ahhyeon Woo RA Specialist 702.703.704.705.706.804.805.807.812.815-ho.55 Digital-ro 34-gil, Guro-gu Seoul, 08378 KR
Re: K181806
Trade/Device Name: ARIX Sternal 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: October 25, 2018 Received: October 25, 2018
Dear Ahhyeon Woo:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K181806 |
| Device Name | ARIX Sternal System |
| Indications for Use (Describe) | The ARIX Sternal System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
702-703-704-705-7 Digital-ro 34-ail. Guro-au. Seoul. 08378. Korea Tel : +82 2 850 3533 / Fax : +82 2 850 3536
510(k) Summary
[As required by 21 CRF 807.92]
K181806 Page 1
1. Date Prepared [21 CRF 807.92(a)(a)]
4th July 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Sponsor: Jeil Medical Corporation . Address: 702·703·704·705·706·804·805·807·812·815-ho,55 -Digital-ro34-gil, Guro-gu, Seoul, 08378, Korea
- Contact Name: Ahhyeon Woo / RA Specialist ●
- Telephone No. : +82 2 850 3533 -
- -Fax No. : +82 2 850 3536
- Email Address : uah0606@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 Sternal System
- Bone Plate and Bone Screw ● Common Name:
- . Classification Name: Plate, Fixation, Bone / Screw, Fixation, Bone
- Classification Description: Single/multiple component metallic bone fixation . appliances and accessories
- Classification Panel: Orthopedic .
- . Classification Regulation: 21 CFR 888.3030
- Product Code: HRS, HWC .
- . Device Class: ll
4
702-703-704-705-7 07-812-815-ho 55 Digital-ro 34-ail Guro-au Seoul 08378 Korea Tel : +82 2 850 3533 / Fax : +82 2 850 3536
K181806 Page 2
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 | K110574-SternaLock Blu Biomet Microfixation Sternal Closure System
Biomet Microfixation |
|-----------------------|--------------------------------------------------------------------------------------------|
| Additional Predicates | K111908-Biomet Microfixation Sternal Closure System
Biomet Microfixation |
| | K121302-Biomet Microfixation Sternal Closure System
Biomet Microfixation |
| | K161896-Biomet Microfixation Sternal Closure System
Biomet Microfixation |
There are no significant differences between the subject device and the predicate devices (K110574, K111908, K121302, K161896) 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 Sternal System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes.
The ARIX Sternal 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-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 lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 2.4, 2.7mm. And both are provided with lengths from 8 mm to 20 mm.
6. Indication for use [21 CFR 807.92(a)(5)]
The ARIX Sternal System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
ARIX Sternal System, Bone Plate:
Based on a technical feature comparison, the subject device was found to be similar to all predicate device with regard to design and materials. The subject plates also have a variable locking feature, similar to the design used in the predicate device (K110574).
ARIX Sternal System, Bone Screw:
They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate device (K110574).
Non-Clinical Test Summary:
Bench tests were conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards:
5
Image /page/5/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic to the left of the text. The graphic consists of a curved orange line with three colored circles above it in gray, green, and blue. To the right of the graphic, the text "JEIL" is written in orange, and the text "MEDICAL CORPORATION" is written in gray.
702·703·704·705·706·804·805·807·812·815-ho. 55, Digital-ro 34-gil, Guro-qu, Seoul, 08378, Korea Tel : +82 2 850 3533 / Fax : +82 2 850 3536
- ASTM F382. Standard Specification and Test Method for Metallic Bone Plates .
- . ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws
The following tests were performed with the predicate device:
K181806 Page 3
- Plate
- 4-Point Bending Test
- 4-Point Fatigue Test
- Screw .
- Driving Torque Test
- Torsion Test
- Axial Pull-out Test
The results of this testing indicate that the ARIX Sternal System is equivalent to predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.
When compared to the predicate device (K110574), the ARIX Sternal System presented in this submission has the same:
- Indication for Use
- Technological characteristics ●
- Operating principle ●
- Design features
- . Performance
- . Biocompatibility
- Materials
- Method of sterilization ●
Conclusion [21 CFR 807.92(b)(3)] 9.
In all respects, the ARIX Sternal System is the equivalent of currently marketed devices. This device is made of same materials and has similar dimensions and characteristics. The ARIX Sternal System is manufactured from the unalloyed titanium and titanium alloy that is used generally in this kind of bone plate and bone screw system. Based on the information submitted, ARIX Sternal System is substantially equivalent to the currently marketed predicate device.