(210 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of plates and screws, with no mention of AI or ML capabilities.
No.
The device functions as an orthopedic fixation system to stabilize fractures and aid in reconstructive procedures of the cranial skeleton, not as a device that delivers therapeutic treatment or modifies the physiological state.
No
The device description indicates it is comprised of plates and screws used for fixation and stabilization of fractures, and the intended use is for surgical procedures to the cranial skeleton. It is a physical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is comprised of plates and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is comprised of "plates and screws" made of titanium. These are physical implants used to fix and stabilize bone fractures.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The Optimus Neuro System is a surgical implant used for bone fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
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, GRX, 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 3 colors (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, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag.
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
| Test | Result | Conclusion |
|---|---|---|
| Sterilization Validation Test | Sterility assurance level(106) for the recommended steam sterilization parameters is met. | The recommended sterilization parameters for the user are valid. |
| Mechanical Test | Worst case test articles have passed the pre-set criteria. | The subject devices have been validated in mechanical characteristics. |
| Cleaning Process Validation Test | The subject devices showed low bioburden level and met criteria of 2.15 EU/device for endotoxin. | The cleaning process at the manufacturing sites has been validated. |
| Packaging Validation Test | Final packaging of the subject device has passed the testing for its complete sealing. | The subject device will be well protected until use in its packaging. |
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2015
OSTEONIC Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Ave. Suite 110 Fullerton, California 92831
Re: K141911
Trade/Device Name: OPTIMUS NEURO SYSTEM Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GRX, HBW Dated: January 5. 2015 Received: January 8, 2015
Dear Ms. Chung,
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 Part 801); medical device reporting (reporting of medical device
1
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 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 remarket 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 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 yours,
Carlos L. Pena -SFD/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141911
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (K141911)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 02/08/2015
1. 510K Applicant
OSTEONIC Co., Ltd.
505-3Ho, Digital-ro 29-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-6082-8885 Fax: +82-2-6326-7001
2. US Agent/ Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: OPTIMUS NEURO SYSTEM
- Classification Name: Neuro Plating System
- · Classification regulation: 21CFR§882.5320
- 21CFR § 882.5250 21CFR §882.5360 • Product Code: GWO, GRX, HBW
4. Predicate Device:
- · Neuro plating system (K121624) by Biomet Microfixation
- LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812) by Jeil Medical Corporation
- · Frontier Devices Neuro Closure System (K100205) by Frontier Devices
5. 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 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in
4
lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag.
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.
6. Indications for use:
Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
7. Comparison to the Cleared Device
The subject device is similar to the predicate devices in terms of indications, materials, and design. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. There might be slight differences in dimensions and shapes between the subject device and each predicate device; however, the test results of non-clinical testing including mechanical testing provided in this submission proves substantial equivalence to the predicate devices.
8. Performance Data
| Test | Result | Conclusion |
|---|---|---|
| Sterilization Validation Test | Sterility assurance level(106) | |
| for the recommended steam | ||
| sterilization parameters is | ||
| met. | The recommended sterilization | |
| parameters for the user are | ||
| valid. | ||
| Mechanical Test | Worst case test articles have | |
| passed the pre-set criteria. | The subject devices have been | |
| validated in mechanical | ||
| characteristics. | ||
| Cleaning Process Validation | ||
| Test | The subject devices showed low | |
| bioburden level and met | ||
| criteria of 2.15 EU/device for | ||
| endotoxin. | The cleaning process at the | |
| manufacturing sites has been | ||
| validated. | ||
| Packaging Validation Test | Final packaging of the subject | |
| device has passed the testing for | ||
| its complete sealing. | The subject device will be well | |
| protected until use in its | ||
| packaging. |
The following bench tests have been performed on the subject device and passed the pre-set criteria.
9. Conclusion
Based on the non-clinical testing data and the information provided in the submission, we have concluded that our devices are substantially equivalent to the predicate devices in the market. No new questions of safety and effectiveness have been raised.