(21 days)
Not Found
No
The device description focuses on the material composition, physical design, and mechanical properties of an intervertebral body fusion device. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML. The performance studies listed are standard mechanical and material tests for implants.
Yes
The device is used to treat cervical disc disease by facilitating interbody fusion and stabilization of the spine to alleviate neck pain.
No.
This device is an intervertebral body fusion device intended for surgical implantation to promote bone fusion during spinal correction, not for diagnosis.
No
The device is an intervertebral body fusion device, which is a physical implant made of PEEK and titanium. The description details the material composition, physical characteristics, and mechanical testing of the device, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior cervical interbody fusion procedures" and is an "intervertebral body fusion device." This describes a surgical implant used in vivo (within the body) to facilitate bone fusion.
- Device Description: The description details the physical characteristics of the implant (PEEK body, titanium markers, coating, geometry) and its function in providing support and promoting fusion between vertebrae. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such analysis. IVDs are designed for diagnostic purposes.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in sketally 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 with titanium markers and the Mecta-C TiPEEK with titanium markers are intervertebral body 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 and the Mecta-C TiPEEK intervertebral body fusion devices are indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1.
The Mecta-C with titanium markers are intervertebral body fusion devices manufactured with an implant grade polyetheretherketone (PEEK) body and titanium markers. The Mecta-C TiPEEK with titanium markers are intervertebral body fusion devices manufactured with a PEEK body, commercially pure titanium (CPTi) coating, and titanium markers' material is changing from tantalum to titanium to reduce artefact during imaging scans.
The titanium marker's spikes are also being modified to reduce the conical edge from 90° to 50°. The purpose of the conical edge change is to create a sharper tip design which allows for better penetration of the titanium pin and a more uniform contact between the PEEK cage and vertebral body.
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)
As the subject devices are a line extension to previously cleared devices, verification activities, as identified through risk analysis, were previously conducted on the worst-case implants to written protocols with pre-defined acceptance criteria. Engineering rationales determined that the proposed implants did not represent a new worst-case for mechanical testing.
The following performance tests were conducted on the predicate devices and reviewed as part of the Mecta-C (K112862) and the Mecta-C TiPEEK (K142744) submissions:
- shear testing;
- tension testing;
- shear and bonding fatigue;
- coating characterization;
- abrasion resistance;
- mechanical testing;
- subsidence testing;
- wear testing; and
- implant imaging properties artefacts reduction.
Pyrogenicity
- Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
- Medacta does not intend to label the subject devices as non-pyrogenic or pyrogen free.
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
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2017
Medacta International SA % Elizabeth Rose, MST, RAC (US) Manager, Medical Devices Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K172587
Trade/Device Name: Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 25, 2017 Received: August 28, 2017
Dear Ms. Rose:
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
1
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 (DICE) 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 (DICE) 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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Indications for Use (Describe)
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in sketally 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
3.0 510(k) Summary
I. Submitter
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: Stefano Baj, Regulatory Affairs Manager, Medacta International SA Date Prepared: August 25, 2017
II. Device
| Device Proprietary Name: | Mecta-C with titanium markers and Mecta-C TiPEEK
with titanium markers |
|--------------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification Name: | Intervertebral Body Fusion Device, Cervical |
| Primary Product Code: | ODP |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
IV. Device Description
The purpose of this submission is to add the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers to Medacta's Mecta-C product offering. The Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are intervertebral body 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 and the Mecta-C TiPEEK intervertebral body fusion devices are indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1.
The Mecta-C with titanium markers are intervertebral body fusion devices manufactured with an implant grade polyetheretherketone (PEEK) body and titanium markers. The Mecta-C
4
TiPEEK with titanium markers are intervertebral body fusion devices manufactured with a PEEK body, commercially pure titanium (CPTi) coating, and titanium markers' material is changing from tantalum to titanium to reduce artefact during imaging scans.
The titanium marker's spikes are also being modified to reduce the conical edge from 90° to 50°. The purpose of the conical edge change is to create a sharper tip design which allows for better penetration of the titanium pin and a more uniform contact between the PEEK cage and vertebral body.
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.
V. 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.
VI. Comparison of Technological Characteristics
The Mecta-C with titanium markers, the Mecta-C TiPEEK with titanium markers, and the predicate devices share the following characteristics:
- cage and coating materials of construction;
- cage design: ●
- sterility:
- diameter:
- shelf life; and
- packaging.
5
The Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are technologically different from the predicate devices as the markers' material of construction has changed and the conical edge has been reduced to 50°.
The Mecta-C with titanium markers are manufactured using PEEK Implant Grade Polyetheretherketone (ASTM F2026-16 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and titanium (ISO 5832-3:1996 Implants for Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy). The Mecta-C TiPEEK with titanium markers are manufactured using PEEK Implant Grade Polyetheretherketone (ASTM F2026-16) and titanium (ISO 5832-3:1996) with a commercially pure titanium (ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants) coating.
These materials have a long history of use in implantable orthopedic devices and material information has been provided in previous Medacta 510(k) submissions for the Mecta-C (K112862) and Mecta-C TiPEEK (K142744).
Due to the extensive history of use in currently marketed medical devices, as well as identical manufacturing processes between the subject and predicate devices the Mecta-C (K112862) and the Mecta-C TiPEEK (K142744), additional biocompatibility testing was deemed unnecessary for the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers.
A comparison of the subject and predicate devices is provided in the table below.
| Parameters | Mecta-C with titanium markers
and Mecta-C TiPEEK with
titanium markers | Mecta-C PEEK and
Mecta-C TiPEEK
(K112862 and K142744) |
|-----------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------|
| Height | 4 mm - 9 mm | 4 mm - 9 mm |
| Lordosis | 5° and 7° | 5° and 7° |
| Width | 14 mm, 16 mm, and 18 mm | 14 mm, 16 mm, and 18 mm |
| Depth | 12 mm, 14 mm, and 15 mm | 12 mm, 14 mm, and 15 mm |
| Material of
Construction | Cage: PEEK and PEEK w/CPTi
coating
Markers: titanium | Cage: PEEK and PEEK w/CPTi
coating
Markers: tantalum |
| Conical Edge | 50° | 90° |
| Device Usage | Single Use | Single Use |
Technological comparison
6
| Parameters | Mecta-C with titanium markers
and Mecta-C TiPEEK with
titanium markers | Mecta-C PEEK and
Mecta-C TiPEEK
(K112862 and K142744) |
|------------|------------------------------------------------------------------------------|-------------------------------------------------------------|
| Sterility | Gamma Radiation | Gamma Radiation |
| Shelf Life | 5 Years | 5 Years |
| Packaging | Individual packaging | Individual packaging |
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. As seen above, the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are identical to the predicate devices in terms of materials of construction (except markers material), design, diameter, sterility, and packaging. Performance data provided within this submission supports that the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are substantially equivalent to the identified predicate devices.
VII. Performance Data
As the subject devices are a line extension to previously cleared devices, verification activities, as identified through risk analysis, were previously conducted on the worst-case implants to written protocols with pre-defined acceptance criteria. Engineering rationales determined that the proposed implants did not represent a new worst-case for mechanical testing.
The following performance tests were conducted on the predicate devices and reviewed as part of the Mecta-C (K112862) and the Mecta-C TiPEEK (K142744) submissions:
- shear testing;
- tension testing; ●
- shear and bonding fatigue; ●
- coating characterization; ●
- abrasion resistance;
- mechanical testing;
- subsidence testing;
- wear testing; and
- implant imaging properties artefacts reduction. ●
Pyrogenicity
- Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
7
- Medacta does not intend to label the subject devices as non-pyrogenic or pyrogen free. .
VIII. Conclusion
Based on the above information, the Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers can be considered substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The Mecta-C with titanium markers and the Mecta-C TiPEEK with titanium markers are as safe and effective as the predicate devices, Mecta-C (K112862) and Mecta-C TiPEEK (K142744).