(254 days)
Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:
- Fractures
- Osteotomies
- Reconstructive procedures
- Revision procedures where other treatments or devices have failed.
The system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold).
The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use.
The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set).
The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.
This document is a 510(k) premarket notification for a medical device called the "Optimus CMF System," which consists of implantable bone plates and bone screws for maxillofacial and mandible surgery. As such, it primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the way an AI/ML device would.
Therefore, the requested information elements related to AI/ML device studies (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission. This document describes a physical medical implant, not a diagnostic or interpretative AI/ML system.
However, I can extract information related to the device's performance testing as a substitute for "acceptance criteria and reported performance" in the context of this device type.
1. A table of acceptance criteria and the reported device performance
The document describes non-clinical tests performed to evaluate the performance of the Optimus CMF System compared to predicate devices. The "acceptance criteria" here implicitly refer to demonstrating comparable or superior mechanical strength to legally marketed predicate devices, thereby establishing substantial equivalence.
| Acceptance Criteria Category (Implicit) | Specific Test Type | Performance Metric Evaluated | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | 4 Point Bending Test (ASTM F382-14) | Yield strength, bending structural stiffness, bending strength | "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." |
| Torsional Strength Test (ASTM F543-13) | Torsional strength | "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." | |
| Pullout Force Test (ASTM F543-13) | Pullout force | "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." | |
| Biocompatibility | Biocompatibility Testing | Compatibility with biological systems | "Validation of sterilization parameters and biocompatibility of the submission device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K140037." |
| Sterilization | Sterilization Validation | Efficacy of sterilization process | "Validation of sterilization parameters and biocompatibility of the submission device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K140037." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the number of samples (plates/screws) used for each mechanical test. Standard ASTM testing methods usually specify a minimum number of samples, but this information is not detailed in this summary.
- Data Provenance: The tests were performed to support a submission by Osteonic Co., Ltd. (located in Seoul, Korea) to the FDA in the USA. The specific location where the testing was physically conducted is not mentioned. These are prospective engineering tests performed on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as this is a non-AI physical device. Ground truth, in the context of these mechanical tests, is established by measurement instruments according to standardized ASTM protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is a non-AI physical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is a non-AI physical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a non-AI physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical tests consists of objective measurements (e.g., force, displacement) obtained from standardized engineering tests (ASTM F382-14, ASTM F543-13) using calibrated equipment. For biocompatibility and sterilization, the ground truth is established by adherence to recognized standards and validated reports, often involving laboratory analyses.
8. The sample size for the training set
Not applicable, as this is a non-AI physical device and does not involve a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a non-AI physical device and does not involve a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Osteonic Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt, Ste 417 Irvine, California 92620
Re: K160363
Trade/Device Name: Optimus CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: September 15, 2016 Received: September 20, 2016
Dear Priscilla 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
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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 devicerelated 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 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 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160363
Device Name Optimus CMF System
Indications for Use (Describe)
Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:
-
Fractures
-
Osteotomies
-
Reconstructive procedures
-
Revision procedures where other treatments or devices have failed.
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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K160363
510(k) Summary
Date: Oct 20, 2016
1. Applicant / Submitter:
Osteonic Co., Ltd. 1206ho, 38, Digital-ro 29-gil Guro-gu, Seoul, Korea, (Postcode 08381) Tel :+82-2-6902-8411 Fax : +82-2-6902-8401
2. Submission Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt, Ste 417 Irvine CA 92620 Tel: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device:
- Proprietary Name OPTIMUS CMF SYSTEM
- Common Name Dental Bone Plate & Screw System
- Classification Name Bone Plate
4. Predicate Device:
- Primary Predicate Device: K140037-OPTIMUS CMF SYSTEM by Osteonic Co., Ltd.
- Reference Predicate Device: K112457-LeForte System Bone Plate & Screw by Jeil Medical Corporation
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5. Product Code & Regulation Number:
- Primary JEY (21CFR 872.4760)
- Secondary DZL
6. Device Description:
The system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold).
The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use.
The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set).
The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.
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7. Indication for use:
Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:
-
- Fractures
-
- Osteotomies
-
- Reconstructive procedures
-
- Revision procedures where other treatments or devices have failed.
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 in accordance with ASTM F382-14 to evaluate strength (yield strength, bending structural stiffness, and bending strength)
- Torsional strength test and pullout force test in accordance with ASTM F 543 13 to evaluate strength
The test results of the subject device were overall higher than the predicatedevices 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 K140037.
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.
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| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| 510K Number | K160363 | K140037 | K112457 |
| Product Code | JEY, DZL | JEY, DZL | JEY, DZL |
| Manufacturer | OSTEONIC Co., Ltd. | Jeil Medical Corporation | |
| Indications forUse | Optimus CMF System is implantable bone plates andbone screws for maxillofacial and mandible surgeryprocedures including:1. Factures2. Osteotomies3. Reconstructive procedures4. Revision procedures where other treatments or deviceshave failed. | This device is intended foruse in selective trauma ofthe mid-face,reconstruction proceduresand selective orthognathicsurgery of the maxilla andchin. | |
| Materials | Unalloyed Titanium and Titanium alloy | Unalloyed Titanium andTitanium alloy | |
| Shape | • PlateLeforte I,Segmentalleforte I,Buttress,Tand Straight types withvarious lengths. | • PlateStraight,Y,D-Y,X,L,Z,Square,Matrix,Orbital,Chinand Reconstruction typeswith various lengths. | • PlateL, T, Mesh, Straight, Y, H,Curved, Square, Quad, X,Calvarium, Hexagon,Double Y, RC, Z, I,Compression, Chin, Rigidstraight, BSSO, AngledReconstruction, MG,Orbital Mesh, A, AngledLocking, Prebending L,Curved Locking, Straightreconstruction Locking,Straight BSSO Locking,Angled ReconstructionLocking, MultiReconstruction Locking,Straight Locking |
| • ScrewPre-drilling screw,Self-drilling screw,IMF screw | • ScrewPre-drilling screw,Self-drilling screw,IMF screw | • ScrewCommon screw-Micro,Common screw-Mid,Common screw-Mini | |
| Common screw-Maxi,Auto screw-Micro, Autoscrew-Mid, Auto screw-Mini, Mini Locking Autoscrew, Maxi Locking Autoscrew, Mini LockingCommon screw, MaxiLocking common screw | |||
| Dimensions | • PlateThe plate thickness sizesrange from 0.6 to 1.5mm.Length:21.5 | • PlateThe plate thickness sizesrange from 0.4 to 2.6mm.Length: 11.6 | • PlatePlate length 5.2 |
| SurfaceTreatment | Anodizing | Plate: AnodizingScrew: N/A | |
| Anodizing Color | • PlateSilver, blue, green and gold• ScrewLight blue, silver and gold | • PlateSilver, blue, green andgold• ScrewLight blue, silver, purple,blue, gold and green | • PlateLight blue, silver and gold• ScrewN/A |
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| Sterilization | Non-sterile products | Non sterile |
|---|---|---|
| Usage | Single use only | Single use |
| Packaging | 1EA/bag | 1EA/bag |
Conclusions: 10.
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.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.