(29 days)
No
The device description and performance studies focus on the mechanical properties and materials of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to treat degenerative disc disease and related conditions by providing interbody fusion and stabilization of the spine, which directly addresses a medical condition in patients.
No
The and Device Description sections clearly state that the MectaLIF Anterior Stand Alone system is an "anterior interbody fusion device" intended for surgical intervention in patients with degenerative disc disease. It is a physical implant designed for treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components made of PEEK, titanium, and tantalum, including spacers, plates, and screws. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The MectaLIF Anterior Stand Alone system is an implantable device used for spinal fusion. It is a physical structure (spacers, plates, screws) inserted into the body during surgery.
- Intended Use: The intended use is to provide structural support and promote fusion in the spine for patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgical implant, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The MectaLIF Anterior Stand Alone devices are stand-alone anterior interbody fusion devices indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand Alone is intended to be used with the provided bone screws and requires no additional supplementary fixation.
MectaLIF Anterior Stand Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026). The spacers are provided uncoated or coated with a commercially pure titanium (CPTi, ASTM F1580) coating. Both uncoated and coated spacers contain tantalum markers (ISO 13782/ASTM F560), and include bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F136), and a plate made of Titanium: Ti6A14V ELI (ISO 5832-3/ASTM F136).
The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
The patients should be skeletally mature.
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 MectaLIF Anterior Stand Alone devices were tested per ASTM F2077-11, ASTM F2267-04 (reapproved 2011), ASTM F1877-05 (reapproved 2010), and ISO 17853:2011 using the worst-case device for each of the following tests:
-
- Static Axial Compression
-
- Dynamic Axial Compression
-
- Static Compression-Shear
-
- Dynamic Compression-Shear
-
- Static Torsion
-
- Dynamic Torsion
-
- Subsidence
-
- Expulsion
The subject devices do not represent a new worst case when compared to the previously cleared devices (K160605 and K124034).
The data and information provided in K160605 and K124034 support the conclusion that the MectaLIF Anterior Stand Alone devices are safe and effective in stand-alone applications and conform to applicable standards and FDA guidance.
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.
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/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
Medacta International SA % Roshana Ahmed Sr. Manager, Regulatory Affairs Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K170455
Trade/Device Name: MectaLIF Anterior Stand Alone Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: February 15, 2017 Received: February 15, 2017
Dear Ms. Ahmed:
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
1
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.
Lori A. Wiggins -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)
K170455
Device Name MectaLIF Anterior Stand Alone
Indications for Use (Describe)
The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the interior of the spacer component of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
| 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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C)
3
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 Date Prepared: February 07, 2017
II. Device
| Device Proprietary Name: | MectaLIF Anterior Stand Alone |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumba |
| Regulation Number: | 21 CFR 888.3080 |
| Product Code: | OVD |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate:
-
. MectaLIF Anterior Stand-Alone, K160605, Medacta International SA
Reference Device: -
MectaLIF Anterior, K124034, Medacta International SA .
IV. Device Description
The MectaLIF Anterior Stand Alone devices are stand-alone anterior interbody fusion devices indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand Alone is intended to be used with the provided bone screws and requires no additional supplementary fixation.
4
MectaLIF Anterior Stand Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026). The spacers are provided uncoated or coated with a commercially pure titanium (CPTi, ASTM F1580) coating. Both uncoated and coated spacers contain tantalum markers (ISO 13782/ASTM F560), and include bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F136), and a plate made of Titanium: Ti6A14V ELI (ISO 5832-3/ASTM F136).
The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.
The MectaLIF Anterior plates and bone screws were cleared under K124034 and K160605.
V. Indications for Use
The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
VI. Comparison of Technological Characteristics
The MectaLIF Anterior Stand Alone and the predicate device share the following characteristics:
- Design
- Materials of construction ●
- Packaging
- Sterilization method ●
The MectaLIF Anterior Stand Alone is technologically different from the predicate device as follows:
- New footprints added to the range of sizes available for the cages ●
- Lordosis angle in 20 degrees added to the available cages ●
5
| Parameters | MectaLIF Anterior Stand Alone
(Subject Device) | MectaLIF Anterior Stand-Alone
K160605
(Predicate Device) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Design/Types | Stand-alone anterior interbody
fusion device to be used with bone
screws | Identical |
| Materials of
Construction | Cage: PEEK
Coating (for coated cages): CPTi
Marker: Tantalum | Identical |
| Cage Footprints
(Width x Length
x Height) | From 31 x 24 x 10 to 31 x 24 x 18
From 35 x 27 x 10 to 35 x 27 x 18
From 30 x 35 x 10 to 30 x 35 x 18
From 30 x 40 x 10 to 30 x 40 x 18 | Min Size: 31 x 24 x 10
Max Size: 35 x 27 x 18 |
| Lordosis | 5°, 10°, 15°, 20° | 5°, 10°, 15° |
| Compatibility
with implant
system | MectaLIF Anterior
Stand-Alone system | Identical |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent contact | Identical |
| Sterilization | Gamma | Identical |
| Packaging | Individual packaging | Identical |
A comparison of the subject and predicate devices is provided in the table below.
Discussion
As seen above, the differences between the subject and predicate devices are the new footprints added to the range of sizes available for the cages and the lordosis angle in 20 degrees added to the available cages. These technological differences do not raise new questions of safety or effectiveness and a comparison evaluation shows there are no new risks associated with the subject device design.
VII. Performance Data
The MectaLIF Anterior Stand Alone devices were tested per ASTM F2077-11, ASTM F2267-04 (reapproved 2011), ASTM F1877-05 (reapproved 2010), and ISO 17853:2011 using the worst-case device for each of the following tests:
-
- Static Axial Compression
-
- Dynamic Axial Compression
-
- Static Compression-Shear
6
-
- Dynamic Compression-Shear
-
- Static Torsion
-
- Dynamic Torsion
-
- Subsidence
-
- Expulsion
The subject devices do not represent a new worst case when compared to the previously cleared devices (K160605 and K124034).
The data and information provided in K160605 and K124034 support the conclusion that the MectaLIF Anterior Stand Alone devices are safe and effective in stand-alone applications and conform to applicable standards and FDA guidance.
VIII. Conclusion
The information provided above supports that the subject MectaLIF Anterior Stand Alone devices are as safe and effective as the predicate device. The addition of new sizes and lordosis angle do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the MectaLIF Anterior Stand Alone is substantially equivalent to the predicate device.
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