(445 days)
No
The device description and performance studies focus on the mechanical properties and materials of the fixation system components (plates, screws, meshes). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is composed of plates, screws, and meshes used for fixation in cranial reconstructive procedures, directly addressing a medical condition (trauma, surgery) by providing structural support.
No
The device description indicates that the MCI - Neuro Fixation System is composed of plates, screws, and meshes used for cranial surgery and reconstructive procedures. It is an implantable system used for fixation, not for diagnosing conditions.
No
The device description explicitly states it is composed of physical components like plates, screws, and meshes made from titanium, which are hardware.
Based on the provided information, the MCI - Neuro Fixation System is not an In Vitro Diagnostic (IVD) device.
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 intervention on the body, not a test performed on samples taken from the body.
- Device Description: The device is composed of plates, screws, and meshes made of titanium. These are physical implants used to fix bone.
- Function: The device's function is to provide structural support and fixation to the cranial skeleton. This is a mechanical function within the body.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a physiological state, health, or disease.
In summary, the MCI - Neuro Fixation System is a surgical implant used for cranial bone fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
Product codes (comma separated list FDA assigned to the subject device)
GWO, GXR, HBW
Device Description
The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.
MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.
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
qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.
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)
- Metallographic Test (ASTM F67-13): The material complied with the specifications set forth in the applied standard.
- Metallographic Test (ASTM F136-13): The material complied with the specifications set forth in the applied standard.
- Cyclic polarization tests (ASTM F2129-19 a): The devices have high resistance to initiation and to the propagation of localized corrosion.
- Cycle Bend Testing of Metallic Bone Plates (ASTM F382-17 Annex A.1):
- Structural Stiffness (Ele) of a bone plate: 0.003 Nm² for both subject and reference devices.
- Bending Stiffness (K) of a bone plate: Reference device plate was 70.4 N/mm and subject device plate was 75.7 N/mm.
- Bending Strength (R) of a bone plate: 0.04 Nm for both subject and reference devices.
- Proof Load (P): Reference device plate was 16.08 N and subject device plate was 15.74 N.
- Key Results: The subject device worst case plate proved to be slightly stiffer and mechanically resistant than the reference device K944565 and, therefore, can be considered equivalents for the performance standpoint.
- Screw Torsion yield Test (ASTM F543-17 Annex A.1):
- Minimum Torsional Strength: 0.2 Nm for Screw type 1.5. Both the subject device and reference device K944565 met this requirement.
- Maximum Torque: Reference device screws presented 0.28 Nm, while subject screws presented 0.29 Nm. Both tested screws accomplish the standard requirements and therefore can be considered equivalents.
- Pull out testing (ASTM F543-17 Annex A.3):
- Maximum force: Reference device screw 46.71 N, subject device screw 45.54 N.
- Key Results: A maximum force variation of less than 2.5% was observed between reference and subject device and therefore they were considered equivalent.
- Driving torque testing (ASTM F543-17 Annex A.2):
- Subject device: insertion torque 0.05 Nm, removal torque 0.02 Nm.
- Reference device: insertion torque 0.09 Nm, removal torque 0.03 Nm.
- Key Results: For both cases, subject and reference, the insertion and removal torque are below than the Torsional Yield Strength. The behavior of the subject and reference device can be deemed equivalent.
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.
K141911 - OPTIMUS NEURO SYSTEM
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.
K971297, K161821, K141452, K121624, K182758, K944565
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
§ 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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 21, 2022
MCI Medical Concept Innovation Inc. % Graziela Brum Regulatory Affairs Specialist Passarini Regulatory Affairs/ PR Servicos Regulatorios Administrativos Ltda ME Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096-570 Brazil
Re: K212391
Trade/Device Name: MCI-Neuro Fixation System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: September 20, 2022 Received: September 21, 2022
Dear Graziela Brum:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212391
Device Name MCI - Neuro Fixation System
Indications for Use (Describe)
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| ADMINISTRATIVE INFORMATION | ||
|---|---|---|
| Sponsor/Manufacturer Name | MCI Medical Concept Innovation Inc. | |
| 4592 North Hiatus Road | ||
| Sunrise, Florida, USA 33351 | ||
| Telephone +01 (954) 306-2521 | ||
| Contact Person and Preparer | Graziela Brum and Ana Carolina Carvalho | |
| Regulatory Affairs Specialist | ||
| Passarini Regulatory Affairs | ||
| PR Serviços Regulatórios Administrativos Ltda | ||
| E-Mail: graziela@passarini.com.br | ||
| Telephone +55 (16) 3421-8488 | ||
| Date Prepared | 20/September/2022 | |
| DEVICE NAME AND CLASSIFICATION | ||
| Trade/ Proprietary Name | ||
| Common Name | MCI - Neuro Fixation System | |
| Plate, Cranioplasty, Preformed, Alterable; Cover, Bur | ||
| Hole; Fastener, Plate, Cranioplasty | ||
| Classification Regulation | 21 CFR 882.5320 | |
| Product Code | GWO, GXR, HBW | |
| Classification Panel | ||
| Reviewing Branch | Neurology | |
| Neurology | ||
| PREDICATE DEVICE INFORMATION | ||
| Predicate Device | K141911 - OPTIMUS NEURO SYSTEM | |
| SUBJECT DEVICE | PREDICATE DEVICE | |
| Device Name | MCI - Neuro Fixation System | Neuro Plating System |
| 510(K) # | K212391 | K141911 |
| Manufacturer | MCI Medical Concept Innovation Inc. | OPTIMUS NEURO SYSTEM |
| Indications for | ||
| use | MCI - Neuro Fixation System is | |
| indicated 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. | ||
| Class | 2 | 2 |
| Product Code | GWO, GRX, HBW | GWO, GRX, HBW |
| Material | ||
| (Chemical | ||
| composition) | •Plate- Pure Titanium ASTM F67 | |
| (Anodized) | ||
| •Screw- Titanium Alloy ASTM F136 | ||
| (Anodized) | •Plate- Pure Titanium ASTM F67 (Anodized) | |
| •Screw- Titanium Alloy ASTM F136 | ||
| (Anodized) | ||
| Device types | ||
| and | ||
| Dimension | Straight, Square, Rectangular, Y-shape, | |
| X-shape, Z -shape, clover, triangular, | ||
| mesh, burr hole with | ||
| various lengths and thickness (03 to | ||
| 06.mm). The screws range in 1.5 mm diameter to 1.7 mm and in lengths from | 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. |
Reference Devices
K971297 - CENTRE-DRIVE DRILL-FREE SCREW K161821- Stryker Universal Mesh K141452 - Leforte Neuro System Bone Plate and Screw K121624 - Biomet Microfixation Neuro Plating System K182758 - MCI -CMF System K944565- KLS-MARTIN Micro Osteosynthesis System (1.5mm)
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INDICATIONS FOR USE
MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery, and reconstructive procedure.
DEVICE DESCRIPTION
The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.
MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.
Comparison of Technological Characteristics with the Predicate Device
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| 3.0mm to 6.0 mm. | ||
|---|---|---|
| Single Use | Yes | Yes |
| Sterilization | Nonsterile, steam | |
| sterilization before use | Nonsterile, steam | |
| sterilization before use |
The subject device is substantially equivalent in indications and design principles to the following predicate device: K141911 - OPTIMUS NEURO SYSTEM
Any difference in the technological characteristics do not raise new issues of safety or efficacy.
Performance Data
| Test | Test Method Summary | Results |
|---|---|---|
| Metallographic | ||
| Test | Applied Standard ASTM F67-13. | |
| Perform metallography on implant | ||
| through an Olympus BX41M-LED | ||
| microscope, with Kroll attack - | ||
| immersion. | The material complied with the | |
| specifications set forth in the applied | ||
| standard. | ||
| Metallographic | ||
| Test | Applied Standard ASTM F136 -13. | |
| Perform metallography on implant | ||
| through an Olympus BX41M-LED | ||
| microscope, with Kroll attack - | ||
| immersion. | The material complied with the | |
| specifications set forth in the applied | ||
| standard. | ||
| Cyclic | ||
| polarization | ||
| tests | Applied Standard ASTM F2129-19 a. | |
| A scan rate of 1,0 mV /s was used | ||
| increasing from the corrosion | ||
| potential, after 1 h of open-circuit or | ||
| a potential variation less than 3 mV | ||
| in 60 seconds. The scan was reversed | ||
| to cathodic direction at 800 mVECS | ||
| or when the current density reaches | ||
| two orders of magnitude greater | ||
| than the passivation threshold. | The devices have high resistance to | |
| initiation and to the propagation of | ||
| localized corrosion. | ||
| Cycle Bend | ||
| Testing of | ||
| Metallic Bone | ||
| Plates | Applied Standard ASTM F382-17 Annex | |
| A.1. |
Testing machine: Universal Testing
Machine.
The test was performed in ambient
conditions (ambient air at room
temperature.
OBJECTIVE: To determine the following
four-point bending properties (static) of
metallic bone plate: | The Structural Stiffness (Ele) of a bone
plate, is the bone plate normalized
effective bending stiffness. The test
reports showed a Structural Stiffness of
0.003 Nm² for the subject and
reference devices.
The Bending Stiffness (K) of a bone
plate, is the maximum slope of the
linear elastic portion of the load versus
load-point displacement curve. The
test reports show that the reference
device plate Bending Stiffness was 70.4 |
| | - Structural Stiffness
- Stiffness
- Bending Strength
- Proof Load | N/mm and to the subject device plate
75.7 N/mm. |
| | | The Bending Strength (R) of a bone
plate, is the bending moment
necessary to produce a 0.2 % offset
displacement in the bone plate when
tested as the standard prescription.
The test reports showed a Bending
Strength of 0.04 Nm for the subject
and reference devices. |
| | | The proof load (P) is the applied load at
the intersection point of line. BC with
the load versus load-point
displacement curve. The test reports
show a reference device plate Proof
Load of
16.08 N and to the subject device plate
of 15.74 N. |
| | | The above results allow the conclusion
that the subject device worst case plate
proved to be slightly stiffer and
mechanically resistant than the
reference device K944565 and
therefore, can be considered
equivalents for the performance
standpoint. |
| Screw Torsion
yield Test | Applied Standard ASTM F543-17 Annex
A.1. | The table A5.5 of the standard ASTM
F543-17 - Standard Specification and
Test Methods for Metallic Medical Bone
Screws establish that the Screw type 1.5
should presents minimum Torsional
Strength of 0.2 Nm. The worst case of
the device in question and the reference
device K944565 met the requirement of
the applied standard. |
| | Testing machine: Torsion Equipment.
The test was performed in ambient
conditions (ambient air at room
temperature. | |
| | OBJECTIVE: To determine the following
torsional properties of bone screw:
Torsional Yield Strength
Maximum Torque | The Torsion test reports show the
reference device screws presented a
maximum torque 0.28 Nm, while the
subject screws presented a maximum
torque of 0.29 Nm. Both tested screws
(subject and reference device)
accomplish the standard requirements
and therefore can be considered
equivalents. |
| | According to the ASTM F543-17
Standard, the specimen needs to be
placed in the holding device so that five
threads, below the head of the screw,
are exposed outside the holding device.
The screws that were evaluated do not
attend this condition because they are
too small. So, the "Breaking Angle" | |
| | | |
| | request is not applicable in this case. | |
| Pull out testing | Applied Standard ASTM F543-17 Annex A.3.
OBJECTIVE: Determine axial pullout strength of bone screw | The test reports show for the reference device screw a maximum force of 46.71 N, and for the subject device screw of 45.54 N. A maximum force variation of less than 2.5% was observed between reference and subject device and therefore they were considered equivalent. |
| Driving torque testing | Applied Standard ASTM F543-17 Annex A.2.
OBJECTIVE: To determine the driving torque of bone screw
Testing machine: Torsion Equipment.
The test was performed in ambient conditions (ambient air at room temperature. | The driving torque testing shows for the subject device an insertion torque of 0.05 Nm and a removal torque of 0.02 Nm. The reference device has presented an insertion and removal torque of 0.09 Nm and 0.03 Nm, respectively. For both cases, subject and reference, the insertion and removal torque are below than the Torsional Yield Strength. Therefore, considering the overall results of mechanical performance, the behavior of the subject and reference device can be deemed equivalent. |
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7
Biocompatibility of the subject devices are supported by the reference device K182758.
No clinical data were included in this submission.
The subject devices are provided non-sterile and have no expiration date defined.
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject devices have equivalent features and performance and, therefore, are substantially equivalent to the identified predicate device.