(225 days)
Not Found
No
The summary describes a physical intervertebral body fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
This device is an intervertebral body fusion device used for anterior cervical interbody fusion procedures to treat cervical disc disease and promote bone fusion after surgical correction. It is designed to alleviate neck pain and restore function, which aligns with the definition of a therapeutic device.
No
This device is an intervertebral body fusion device, intended for surgical implantation to facilitate fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is a physical implant made of PEEK, titanium, and tantalum markers, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "anterior cervical interbody fusion procedures" and is a physical implant ("intervertebral body fusion device"). This is a surgical device used in the body.
- Device Description: The description details the physical components of the device (PEEK body, titanium coating, tantalum markers) and its function as a "fusion device intended for stabilization and to promote bone fusion." This is consistent with a surgical implant.
- No mention of in vitro testing: The text does not describe any testing of samples (like blood, urine, tissue) outside of the body to diagnose a condition or monitor a treatment.
- Performance Studies: The performance studies focus on mechanical testing of the implant itself (compression, shear, torsion, wear) and its ability to withstand in vivo loading. This is typical for a surgical implant, not an IVD.
- Radiological Assessment: While radiological assessment is mentioned, it's for assessing the position and orientation of the implant after surgery, not for diagnosing a condition using an in vitro test.
In summary, the Mecta-C device is a surgical implant designed to be placed within the body to facilitate bone fusion. This is fundamentally different from an In Vitro Diagnostic device, which is used to perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.
The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Mecta-C TiPEEK Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C TiPEEK intervertebral body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C TiPEEK intervertebral body fusion device consists of a PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body with a commercially pure titanium (CPTi, ASTM F 1580) coating and tantalum markers (ISO 13782 / ASTM F 560). The markers are placed in the implant on each end of the TiPEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent TiPEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C2-T1
Indicated Patient Age Range
skeletally mature patients.
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)
Performance testing was conducted in accordance with FDA Guidance - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device as well as in accordance with FDA Guidance - Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. Additional wear analysis for particulates was conducted and it was determined that Mecta-C TiPEEK passed all requirements.
Mecta-C TiPEEK was tested for wear analysis using the worst-case component size and option/design for each of the following standards: Test Methods for Intervertebral Body Fusion Devices - ASTM F2077 Standard Practice for Characterization of Particles - ASTM F1877
The following mechanical tests were performed on the K112862 predicate device: Static Axial Compression - ASTM F2077 Dynamic Axial Compression - ASTM F2077 Static Compression/Shear - ASTM F2077 Dynamic Compression/Shear - ASTM F2077 Static Torsion - ASTM F2077 Dynamic Torsion - ASTM F2077 Subsidence - ASTM F2267
Enzymatic digestion validation on titanium particulate testing was performed on the K133192 predicate device according to: Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants - ASTM F1580
A review of the mechanical data indicates that the performance of the Mecta-C TiPEEK is substantially equivalent to the predicate devices and is capable of withstanding expected in vivo loading without failure.
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.
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.
Not Found
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a graphic representation of a human figure, with three profiles layered on top of each other to create a sense of depth and dimension.
May 7, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medacta International Mr. Michael G. Loiterman Director of Regulatory, Quality and Compliance 1556 W. Carroll Avenue Chicago, Illinois 60607
Re: K142744 Trade/Device Name: Mecta-C TiPEEK Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 3, 2015 Received: April 6, 2015
Dear Mr. Loiterman,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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 on last page. |
| -- | ---------------------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number (if known) | K142744 |
|---|---|
| Page 1 of 2 | |
| Device Name | Mecta-C TiPEEK |
Indications for Use (Describe)
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.
The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment with the device.
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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in blue font, with two blue triangles to the left of the word. Below the word is a yellow line, and below that is the word "International" in a smaller font. To the right of the word "International" is a red square with a white cross in the center.
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: Michael G. Loiterman Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (312) 548-9971 Fax: (312) 546-6881 Email: mloiterman@medacta.us.com
April 28, 2015 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: Mecta-C TiPEEK Classification Name: Intervertebral Body Fusion Device, Cervical 21 CFR 888.3080 Class II Device Product Code(s): ODP
Primary Predicate Device:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K112862 | Mecta-C | Medacta International | 12/19/2011 |
Additional Predicate Device:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K133192 | MectaLIF TiPEEK | Medacta International | 1/30/2014 |
5
Product Description
The Mecta-C TiPEEK Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C TiPEEK intervertebral body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C TiPEEK intervertebral body fusion device consists of a PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body with a commercially pure titanium (CPTi, ASTM F 1580) coating and tantalum markers (ISO 13782 / ASTM F 560). The markers are placed in the implant on each end of the TiPEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent TiPEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.
Purpose
The purpose this submission is to add a CPTi coating as well as add an alternative PEEK material.
Indications for Use
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.
The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.
Comparison to Predicate Devices
The indications for use, design features and materials of the Mecta-C TiPEEK are substantially equivalent to those of the predicate devices. The substantial equivalence of the Mecta-C TIPEEK implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.
6
Performance Testing
Performance testing was conducted in accordance with FDA Guidance - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device as well as in accordance with FDA Guidance - Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. Additional wear analysis for particulates was conducted and it was determined that Mecta-C TiPEEK passed all requirements.
Mecta-C TiPEEK was tested for wear analysis using the worst-case component size and option/design for each of the following standards: Test Methods for Intervertebral Body Fusion Devices - ASTM F2077 Standard Practice for Characterization of Particles - ASTM F1877
The following mechanical tests were performed on the K112862 predicate device: Static Axial Compression - ASTM F2077 Dynamic Axial Compression - ASTM F2077 Static Compression/Shear - ASTM F2077 Dynamic Compression/Shear - ASTM F2077 Static Torsion - ASTM F2077 Dynamic Torsion - ASTM F2077 Subsidence - ASTM F2267
Enzymatic digestion validation on titanium particulate testing was performed on the K133192 predicate device according to: Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants - ASTM F1580
A review of the mechanical data indicates that the performance of the Mecta-C TiPEEK is substantially equivalent to the predicate devices and is capable of withstanding expected in vivo loading without failure.
Conclusion:
Based on the above information, the Mecta-C TiPEEK can be considered as substantially equivalent to its predicate devices.