(346 days)
No
The summary describes a physical intervertebral body fusion device and its materials, with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is described as an intervertebral body fusion device used to treat degenerative disc disease and restore spinal column height, which are therapeutic functions.
No
The device description clearly states it is an implant designed to replace a degenerative disc and restore spinal column height, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an implantable medical device made of physical materials (PEEK, tantalum, titanium) and is used in a surgical procedure. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The device is a physical implant made of PEEK, tantalum, and titanium, designed to be surgically placed in the spine. This is not the typical description of an IVD device which would involve reagents, test strips, or analytical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is a medical device intended for surgical implantation to treat degenerative disc disease.
N/A
Intended Use / Indications for Use
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
MectaLIF Transforaminal TiPEEK lumbar intervertebral body fusion device is characterized by different sizes of implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). They are provided sterile and used to replace a degenerative disc in order to restore the height of the spinal column structure.
MectaLIF Transforaminal TiPEEK is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.
MectaLIF Transforaminal TiPEEK consists of a PEEK (ASTM F2026) body, tantalum (ISO 13782 / ASTM F560) markers and a titanium (Ti6A14V ISO 5832-3 / ASTM F136) gear that acts as an instrument interface. The implant surface is coated with commercially pure titanium (CPT) ASTM F1580).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels L2 - S1
Indicated Patient Age Range
Patients must 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)
Non-Clinical Studies:
- CHARACTERIZATION TESTING
- Wear Test according to IL 07.09.237 rev.7 and Test Reports 970.1970715.30.1385 and 970.190829.70.1272.
- PYROGENICITY:
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted.
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.
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February 12, 2021
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K200551
Trade/Device Name: MectaLIF Transforaminal TiPEEK Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 13, 2021 Received: January 14, 2021
Dear Chris 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.
1
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 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 medical devices and radiation-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.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200551
Device Name MectaLIF Transforaminal TiPEEK
Indications for Use (Describe)
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
| 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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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 Bai, Regulatory and Compliance Director. Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: March 2, 2020 Date Revised: January 13, 2021
II. Device
| Device Proprietary Name: | MectaLIF Transforaminal TiPEEK |
|---|---|
| Common or Usual Name: | 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:
-
A MectaLIF Extension, K131671, Medacta Interational SA
In addition, the following reference devices are cited within the submission: -
A MectaLIF TiPEEK, K133192, Medacta International SA
-
MectaLIF Posterior Extension, K181970, Medacta International SA A
Device Description IV.
MectaLIF Transforaminal TiPEEK lumbar intervertebral body fusion device is characterized by different sizes of implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). They are provided sterile and used to replace a degenerative disc in order to restore the height of the spinal column structure.
4
MectaLIF Transforaminal TiPEEK is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.
MectaLIF Transforaminal TiPEEK consists of a PEEK (ASTM F2026) body, tantalum (ISO 13782 / ASTM F560) markers and a titanium (Ti6A14V ISO 5832-3 / ASTM F136) gear that acts as an instrument interface. The implant surface is coated with commercially pure titanium (CPT) ASTM F1580).
V. Indications for Use
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
VI. Comparison of Technological Characteristics
The MectaLIF Transforaminal TiPEEK and the predicate MectaLIF Extension (K131671) share the following characteristics:
- shape:
- sizes: ●
- biocompatibility;
- device usage:
- sterility: ●
- shelf life: and ●
- packaging.
The MectaLIF Transforaminal TiPEEK differs from the predicate device, MectaLIF Extension (K131671), with regards to the material only.
Discussion
Medacta International SA has not made any change to the intended use, shape, sizes, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
The different material of the MectaLIF Transforaminal TiPEEK with respect to the predicate devices, does not compromise device safety and performance since the only material difference is the presence of TiPEEK coating on the subject devices respect to the predicate. Subject device TiPEEK coating is exactly the same coating used in the reference devices, MectaLIF TiPEEK, cleared within K133192.
The comparison of technological characteristics and performance data provided within this submission. shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the MectaLIF Transforaminal TiPEEK implants to the identified predicate devices.
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VII. Performance Data
Based on the risk analysis, testing activities were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- CHARACTERIZATION TESTING
- o Wear Test according to IL 07.09.237 rev.7 and Test Reports 970.1970715.30.1385 and 970.190829.70.1272.
- . PYROGENICITY:
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted.
Conclusion VIII.
The information provided above supports that the MectaLIF Transforaminal TiPEEK are as safe and effective as the predicate devices. Therefore, it is concluded that the MectaLIF Transforaminal TiPEEK are substantially equivalent to the predicate device.