(30 days)
No
The device description focuses solely on physical components (plates and screws) and their materials and intended use for fixation. There is no mention of software, algorithms, or any capabilities that would suggest AI/ML is involved.
No
This device is identified as plates and screws used for fixation and stabilization of fractures, which are considered restorative rather than therapeutic.
No
The device description clearly states its purpose is for fixation and stabilization of fractures, and it is comprised of plates and screws. There is no mention of it performing any diagnostic function.
No
The device description explicitly states it is comprised of plates and screws made of titanium, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Optimus Neuro System is comprised of plates and screws made of titanium. These are physical implants used to fix and stabilize bone fractures during surgery.
- Intended Use: The intended use is for "selective trauma of the cranial surgery and reconstructive procedure," which involves directly interacting with the patient's anatomy during a surgical procedure.
The device is a surgical implant, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.
Product codes
GWO, GXR, HBW
Device Description
The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.
Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial skeleton
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 tests:
There are a number of differences between the unmodified devices and the modified devices as presented in this submission, however, the differences were evaluated through design control, risk analysis and verification & validation activities, and test results demonstrated that the differences do not raise a question of safety and effectiveness.
The following tests were performed on the subject device and the predicate devices.
- 4 Point Bending Test
- Packaging Process Validation Test
The test results of the subject device were overall higher than the predicate devices supporting that the subject device is substantially equivalent to the predicate devices. Validation of sterilization parameters and biocompatibility of the submission device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K141911
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
January 2, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osteonic Co., Ltd % Jung Hyeon Park Official Correspondent BT Solutions, Inc. 904, Eonju-ro 68-gil 5, Gangnam-gu Seoul, 06210 Kr
Re: K183352
Device Name: Optimus Neuro System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: November 29, 2018 Received: December 3, 2018
Dear Jung Hyeon Park:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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,
Image /page/1/Figure/7 description: The image shows a digitally signed document by John Marler. The signature includes the date 2019.01.02 and a timestamp of 21:09:44 -05'00'. The document is addressed to Carlos L. Peña, who holds a PhD and MS degree and serves as the Director of the Division of Neurological and Physical Medicine Devices, within the Office of Device Evaluation and the Center for Devices and Radiological Health.
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K183352
Device Name
Optimus Neuro System
Indications for Use (Describe)
Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Date: November 16, 2018
1. Applicant / Submitter:
Osteonic Co., Ltd. 1206ho, 38, Digital-ro 29-gil Guro-gu, Seoul, Korea, (Postcode 08381) Tel :+82-2-6902-8411Fax : +82-2-6902-8401
2. Submission Correspondent
Do Hvun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210, Republic of Korea Fax: +82-2-539-9140 Tel: +82-2-538-9140 Email: smanager@btsolutions.co.kr
3. Device:
- · Proprietary Name OPTIMUS NEURO SYSTEM
- · Common Name Neuro Plating System
- · Classification Name Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener
4. Predicate Device:
- 트 Primary Predicate Device: K141911-OPTIMUS NEURO SYSTEM by Osteonic Co., Ltd.
5. Product Code & Regulation Number:
- " Primary GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250. 21CFR8882.5360)
6. Device Description:
The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.
Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient
4
7. Indication for use:
Optimus NEURO System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
8. Non-clinical tests:
There are a number of differences between the unmodified devices and the modified devices as presented in this submission, however, the differences were evaluated through design control, risk analysis and verification & validation activities, and test results demonstrated that the differences do not raise a question of safety and effectiveness.
The following tests were performed on the subject device and the predicate devices.
- 4 Point Bending Test
- י Packaging Process Validation Test
The test results of the subject device were overall higher than the predicate devices supporting that the subject device is substantially equivalent to the predicate devices. Validation of sterilization parameters and biocompatibility of the submission device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K141911
9. Substantial Equivalence:
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 manufacturing processes including anodization and sterilization method. The differences are in shape and dimensions; however; the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.
5
| | Subject Device | Unmodified (Predicate)
Device | Equivalence |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Manufacturer | OSTEONIC Co., Ltd. | OSTEONIC Co., Ltd. | - |
| Device Name | OPTIMUS NEURO
SYSTEM | OPTIMUS NEURO
SYSTEM | - |
| 510(K) # | - | K141911 | - |
| Class | 2 | 2 | Equivalent |
| Product Code | GWO, GXR, HBW | GWO, GXR, HBW | Equivalent |
| Intended Use | Optimus NEURO System is
intended for use in selective
trauma of the cranial
skeleton, cranial surgery
and reconstructive
procedure. | Optimus NEURO System
is intended for use in
selective trauma of the
cranial skeleton, cranial
surgery and reconstructive
procedure. | Equivalent |
| Material
(Chemical
composition) | •Plate- Pure Titanium
ASTM F67
•Screw- Titanium Alloy
ASTM F136 | •Plate- Pure Titanium
ASTM F67
•Screw- Titanium Alloy
ASTM F136 | Equivalent |
| Surface
Treatment | • Plate: Anodizing
• Screw: Anodizing | • Plate: Anodizing
• Screw: Anodizing | Equivalent |
| Shape and
Dimension | D-Y Shape, Y-Shape, Burr
hole Plate and mesh with
various length and
thickness (0.3 to 0.6mm). | Straight, angle, Y-shape,
X-shape, burr hole, square,
matrix and mesh with
various lengths and
thickness
Plate has various length
and thickness (0.1 to
0.6mm). The screws range
in diameters of 0.8 to
1.8mm and lengths from
3.0 to 6.0mm | Plates were found to be safe
and effective through standard
strength testing methods. |
| Single Use | YES | YES | Equivalent |
| Sterile | Non sterile, steam
sterilization before use | Non sterile, steam
sterilization before use | Equivalent |
10. Conclusions:
Based on documentation supplied with this submission, conclusions drawn from design control, risk analysis and verification & validation activities demonstrate that the subject devices are substantially equivalent to the predicate device.