(120 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biomechanical testing of a spinal plate and screw system, with no mention of AI or ML.
Yes.
The device is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions, addressing conditions like degenerative disc disease, trauma, tumors, and deformity. This purpose directly aligns with the definition of a therapeutic device, as it is designed to treat or alleviate a medical condition.
No
The device, Mecta-C plate system, is an implantable plate and screw system intended for temporary stabilization of the anterior spine during cervical spine fusions. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the Mecta-C Cervical Plate consists of physical components made of Ti6AI4V ELI, including plates and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Mecta-C plate system is a surgical implant intended for the temporary stabilization of the anterior spine during fusion. It is a physical device implanted in the body, not used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing. The performance studies focus on biomechanical properties, which are relevant to surgical implants, not IVDs.
Therefore, the Mecta-C plate system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mecta-C plate system is intended for anterior Interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) psuedarthrosis, and/or 6) failed previous fusion. This device system is intended for anterior cervical intervertebral body fusions only.
Product codes
KWQ, KWO
Device Description
The Mecta-C Cervical Plate consists of single and multilevel plates up to four levels used to stabilize the cervical spine in order to promote fusion. The cervical plates are offered with lengths between 20 and 92mm and are made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136). The plate is fixed on the vertebral body either by means of fixed angle or variable angle screws. Screws are available in 4mm and 4.5mm diameters with a length between 12mm and 22mm. The screws consist of an inner locking screw and the outer main screw shaft and are available with a self-tapping or a self-drilling tip. The main screw shaft is made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136) and the locking screw is made of Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The cervical plates and screws are available both in sterile and unsterile packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to T1
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)
The Mecta-C Cervical Plate biomechanical tests are defined according to the Guidance for Industry and FDA Staff - Spinal System 510(k)s, issued on May 3, 2004. The quidance suqqests performing static and dynamic compression tests as well as static torsion tests. Tests were performed on a two level construct as suggested in the ASTM F1717 standard. In addition to the recommended tests, screw push-out tests were performed in order to prove the substantial equivalence of the screw plate interface. The biomechanical test results of the Mecta-C Cervical Plate constructs were compared with results of the predicate devices and were determined not to be worst case. The Mecta-C Cervical Plate was tested using the worst-case device for each of the following tests: Static Compression yield strength - ASTM F1717, Static Compression Stiffness - ASTM F1717, Dynamic Compression - ASTM F1717, Static Torsion yield torque - ASTM F1717, Static Torsion Stiffness - ASTM F1717, Screw plate interface strength: Push-out.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000742, K001794, K974706, K050451, K081038
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a stylized letter "M" formed by two triangles, followed by the text "edacta" in a sans-serif font. Below the word "edacta" is a horizontal line, and below that is the word "International" followed by a plus sign.
JUN 1 2 2014
510(k) Summary
Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: February 5, 2014
DEVICE INFORMATION
Trade/Proprietary Name: Mecta-C Cervical Plate Common Name: Anterior Cervical Plate Classification Name: appliance, fixation, spinal intervertebral body 21 CFR 888.3060 Class II Product Code(s): KWQ
Predicate Devices: )
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K000742 | CSLP | Synthes | 3/29/2000 |
| K001794 | Anterior Cervical Plate | EBI | 7/12/2000 |
| K974706 | ABC Plate | Aesculap | 3/13/1998 |
| K050451 | Vectra | Synthes | 3/24/2005 |
| K081038 | Atlantis | Medtronic | 8/15/2008 |
1
Product Description
The Mecta-C Cervical Plate consists of single and multilevel plates up to four levels used to stabilize the cervical spine in order to promote fusion. The cervical plates are offered with lengths between 20 and 92mm and are made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136). The plate is fixed on the vertebral body either by means of fixed angle or variable angle screws. Screws are available in 4mm and 4.5mm diameters with a length between 12mm and 22mm. The screws consist of an inner locking screw and the outer main screw shaft and are available with a self-tapping or a self-drilling tip. The main screw shaft is made of Ti6AI4V ELI (ISO 5832-3/ASTM F 136) and the locking screw is made of Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The cervical plates and screws are available both in sterile and unsterile packaging.
Indications for Use
The Mecta-C plate system is intended for anterior Interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) psuedarthrosis, and/or 6) failed previous fusion. This device system is intended for anterior cervical intervertebral body fusions only.
Comparison to Predicate Devices
The indications for use, design features and materials of the Mecta-C Cervical Plate are substantially equivalent to those of the predicate devices. The substantial equivalence of the Mecta-C Cervical Plate implants are supported by the performance testing. materials information, and data analysis provided within this Premarket Notification.
Performance Testing
The Mecta-C Cervical Plate biomechanical tests are defined according to the Guidance for Industry and FDA Staff - Spinal System 510(k)s, issued on May 3, 2004. The quidance suqqests performing static and dynamic compression tests as well as static torsion tests. Tests were performed on a two level construct as suggested in the ASTM F1717 standard. In addition to the recommended tests, screw push-out tests were performed in order to prove the substantial equivalence of the screw plate interface. The biomechanical test results of the Mecta-C Cervical Plate constructs were compared with results of the predicate devices and were determined not to be worst case. The Mecta-C Cervical Plate was tested using the worst-case device for each of the following tests:
Static Compression vield strength - ASTM F1717
2
Static Compression Stiffness - ASTM F1717 Dynamic Compression - ASTM F1717 Static Torsion yield torque - ASTM F1717 Static Torsion Stiffness - ASTM F1717 Screw plate interface strength: Push-out
Conclusion:
Based on the above information, the Mecta-C Cervical Plate can be considered as substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2014
Medacta International SA % Mr. Adam Gross Medacta USA 1556 West Caroll Avenue Chicago, Illinois 60607
Re: K140361
Trade/Device Name: Mecta-C Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: May 14, 2014 Received: May 15, 2014
Dear Mr. Gross:
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-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.
4
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/ReportalProblem/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Explration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140361
Device Name Mecta-C Cervical Plate
Indications for Use (Describe)
The Mecta-C plate system is intended for anterior Interbody scrow/plate fixation from C2 to T1.
The system is indicated for use in the temporary spine during the development of cervical spine fusions in patients with: 1) degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including frectures), 3) lumors, 4) defined as kyphosis, lordosis, or scoliosis, a 5) paudarthrosis, and/or of failed previous fusion. This device system is intended for anterior cervical intervetebral body fusions only.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
1 1 1 135 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FOR FOR FOR FOR USE ONLY 11 11 11 11 13 1 1 1850 - 1 1 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
FORM FDA 3881 (1/14)
Page 1 of 2
PSC Published Berniers (TDU 441 6743
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