(60 days)
Not Found
No
The device description and performance studies focus on the mechanical and biological properties of an interbody fusion device, with no mention of AI or ML.
Yes
The device is an anterior interbody fusion device used to treat degenerative disc disease, which is a therapeutic intervention.
No
Explanation: The device is an interbody fusion device intended for treatment of degenerative disc disease, not for diagnosing it.
No
The device description clearly states it is an interbody fusion device made of physical materials (Ti6A14V ELI, PEEK, Ti-PEEK) and includes mechanical and biological performance testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MectaLIF Anterior is an anterior interbody fusion device. Its purpose is to facilitate the fusion of vertebrae in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The device description details the components of the implant (plates and spacers) and their materials. These are surgical implants, not reagents or instruments used to examine specimens from the human body.
- Performance Studies: The performance studies described are focused on the mechanical and biological properties of the device (static and dynamic testing, bacterial endotoxin testing). These are tests to ensure the safety and efficacy of the implant itself, not tests to diagnose a condition.
- Key Metrics: The document explicitly states "Not Applicable (Performance testing was mechanical and biological, not diagnostic)" for key metrics like sensitivity, specificity, PPV, and NPV, which are typical metrics for diagnostic devices.
In summary, the MectaLIF Anterior is a surgical implant used for spinal fusion, which is a treatment, not a diagnostic procedure.
N/A
Intended Use / Indications for Use
The MectaLF Anterior is an anterior interbody fusion device 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 System 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. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The MectaLIF Anterior Simple devices are interbody fusion devices which require supplementary fixation such as pedicle screws and rods or a lumbar anterior plate system. The design incorporates the benefits of a modular anterior plate and a radiolucent interbody spacer; the plate is secured to the disc spacer via an interlocking mechanism.
The plates, manufactured from Ti6A14V ELI (ISO 5832-3 and ASTM F136), are provided sterile and are offered in five (5) heights (10 - 18 mm). The spacers, cleared under K124034, K160605, and K170455, are manufactured from PEEK and Ti-PEEK.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
L2 to S1 (Spine)
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 plates 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; and expulsion.
In addition, the Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination.
Worst-case analysis was conducted on the MectaLIF Anterior plate family. It was determined that the MectaLIF Anterior Simple does not introduce new worst-case plate when compared to the previously cleared plates (K124034); therefore, additional verification testing is not required.
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
March 9, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K200048
Trade/Device Name: MectaLIF Anterior Simple Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 6, 2020 Received: January 9, 2020
Dear Mr. Lussier:
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.
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
1
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 mediation-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.
for
Brent L. Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MectaLIF Anterior Simple
Indications for Use (Describe)
The MectaLF Anterior is an anterior interbody fusion device 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 System 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. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
2.0 510(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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director, Quality and Regulatory, Medacta USA Date Prepared: January 6, 2020 Date Revised: February 24, 2020
II. Device
| Device Proprietary Name: | MectaLIF Anterior Simple |
|---|---|
| Common or Usual Name: | Anterior Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device With Bone Graft, |
| Lumbar | |
| Primary Product Code: | MAX |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
-
. Primary Predicate: MectaLIF Anterior, K124034, Medacta International SA
The following are additional predicate devices: -
MectaLIF Anterior Stand Alone, K160605, Medacta International SA
-
. MectaLIF Anterior Stand Alone, K170455, Medacta International SA
IV. Device Description
The MectaLIF Anterior Simple devices are interbody fusion devices which require supplementary fixation such as pedicle screws and rods or a lumbar anterior plate system. The design incorporates the benefits of a modular anterior plate and a radiolucent interbody spacer; the plate is secured to the disc spacer via an interlocking mechanism.
The plates, manufactured from Ti6A14V ELI (ISO 5832-3 and ASTM F136), are provided sterile and are offered in five (5) heights (10 - 18 mm).
4
The spacers, cleared under K124034, K160605, and K170455, are manufactured from PEEK and Ti-PEEK.
V. Indications for Use
The MectaLIF Anterior 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 System 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. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
VI. Comparison of Technological Characteristics
The MectaLIF Anterior Simple and the predicate device share the following characteristics:
- size; ●
- materials of construction;
- biocompatibility; ●
- device usage: ●
- sterilization method; ●
- shelf life; and
- packaging.
The MectaLIF Anterior Simple and the predicate devices are technologically different as the subject devices are not stand-alone products; therefore, they are not provided with bone screws and supplementary fixation is required.
Performance Data VII.
The MectaLIF Anterior plates 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:
5
- static compression-shear; ●
- dynamic compression-shear;
- static torsion;
- dynamic torsion;
- . subsidence; and
- expulsion.
In addition, the Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination.
Worst-case analysis was conducted on the MectaLIF Anterior plate family. It was determined that the MectaLIF Anterior Simple does not introduce new worst-case plate when compared to the previously cleared plates (K124034); therefore, additional verification testing is not required.
VIII. Conclusion
The information provided above supports that the MectaLIF Anterior Simple plates are substantially equivalent to the identified predicate device.