(110 days)
No
The summary describes a patient-specific 3D printed implant based on radiographic studies, but there is no mention of AI or ML being used in the design or manufacturing process. The focus is on the material, function, and mechanical testing of the device.
Yes
The device is clearly indicated for intervertebral body fusion procedures to treat degenerative disc disease, which is a therapeutic intervention.
No
Explanation: The device is an intervertebral body fusion cage, which is an implant used for treatment (fusion procedures), not for diagnosing medical conditions. It is used in conjunction with radiographic studies, but the device itself does not perform diagnostic functions.
No
The device description explicitly states it is a 3D printed TLIF cage made from titanium alloy, which is a physical implant and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The UNiD Patient specific 3D printed TLIF cage is an implantable medical device designed to be surgically inserted into the spine to aid in fusion. Its function is mechanical support and stabilization, not the analysis of biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The description focuses on the physical characteristics, materials, and mechanical function of the implant.
- Performance Studies: The performance studies described are non-clinical mechanical and biocompatibility tests, which are typical for implantable devices, not IVDs.
Therefore, the UNiD Patient specific 3D printed TLIF cage falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
MEDICREA INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implant with specific heights, length and lordosis angle to the patient. It is intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach. The MEDICREA INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function:
The UNiD Patient specific 3D printed TLIF cage was developed as an implant:
- To provide immobilization and stabilization of posterior spinal segments
- to augment the development of a solid spinal fusion
- to provide stability to ease fusion
- to be mechanically resistant to allow the fusion of the operated level
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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)
Non-clinical Test Summary:
Biocompatibility Testing
The UNiD Patient specific 3D printed TLIF cage are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
The UNiD Patient specific 3D printed TLIF cage did not introduce a new worst-case device. The previously identified worst-case device was evaluated following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".
The following tests were conducted: Static Compression-shear, Dynamic Compression, Dynamic Compression-shear and Subsidence test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 8, 2019
Medicrea International S.A. Mr. David Ryan Chief Operating Officer 5389 route de Strasbourg Vancia Rillieux-La-Pape 69140 France
Re: K190092
Trade/Device Name: UNiD Patient specific 3D printed TLIF cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 3, 2019 Received: May 6, 2019
Dear Mr. Ryan:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190092
Device Name UNiD Patient specific 3D printed TLIF cage
Indications for Use (Describe)
UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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)
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510(k) SUMMARY MEDICREA INTERNATIONAL's UNiD Patient specific 3D printed TLIF cage
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the UNiD Patient Specific 3D printed TLIF cage:
Date Prepared: January, 14, 2019
-
- Submitter:
MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
- Submitter:
Contact Person:
David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
-
- Trade name: UNiD Patient specific 3D printed TLIF cage
Regulatory Identification/ Classification
Intervertebral Body Fusion Device with Bone Graft, lumbar Regulation Number: 21CFR 888.3080 Product Code: MAX Class II
-
- Predicate or legally marketed devices which are substantially equivalent:
Primary predicate device:
- IMPIX 3D printed cage, (MEDICREA INTERNATIONAL, K163595) .
Additional Predicate:
- . UNiD Patient specific 3D printed cage (MEDICREA INTERNATIONAL, K173782)
4. Description of the device:
MEDICREA® INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implant with specific heights, length and lordosis angle to the patient. It is intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function:
The UNiD Patient specific 3D printed TLIF cage was developed as an implant:
- To provide immobilization and stabilization of posterior spinal segments ●
- to augment the development of a solid spinal fusion
- to provide stability to ease fusion ●
- to be mechanically resistant to allow the fusion of the operated level
5. Indication for Use
UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history
4
and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
6. Substantial equivalence claimed to predicate devices
The UNiD Patient specific 3D printed TLIF cage are technologically similar to the already cleared IMPIX 3D printed cages (K163595) in terms of intended use, material used, mechanical safety and performances.
The table below compares the features and characteristics of the submitted UNiD Patient specific 3D printed TLIF cage to their predicate devices.
| Device | MEDICREA
INTERNATIONAL
UNiD Patient
specific 3D printed
TLIF cage | PREDICATE
MEDICREA
INTERNATIONAL
IMPIX 3D Printed cage | ADDITIONAL
PREDICATE
UNiD Patient specific
3D printed cage |
|---------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 510(k) number | To be determined | K163595 | K173782 |
| Intended use | | | |
| Lumbar | Yes | Yes | Yes |
| Components | | | |
| Shape | Rectangular
anatomical shape | Rectangular anatomical
shape | Rectangular anatomical
shape |
| Dimensions | Lenghts: 15 to 40mm
Heights: 6 to 20mm
Width: 8 to 12mm
Lordosis angle: 0 to
22° | Lenghts: 15 to 40mm
Heights: 6 to 20mm
Width: 8 to 12mm
Lordosis angle: 0 to 22° | Lenghts: 15 to 40mm
Heights: 6 to 20mm
Width: 8 to 12mm
Lordosis angle: 0 to 22° |
| Cage | Titanium Alloy (Ti-
6Al-4V) according to
the ASTM F3001 | Titanium Alloy (Ti-6Al-
4V) according to the
ASTM F3001 | Titanium Alloy (Ti-6Al-
4V) according to the
ASTM F3001 |
| | Provided Sterile or
non sterile - Single
use only | Provided Sterile - Single
use only | Provided Sterile or non
sterile - Single use only |
Non-clinical Test Summary: 7.
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The UNiD Patient specific 3D printed TLIF cage are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
The UNiD Patient specific 3D printed TLIF cage did not introduce a new worst-case device. The previously identified worst-case device was evaluated following the protocols outlined in ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and in the ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression".
The following tests were conducted: Static Compression-shear, Dynamic Compression, Dynamic Compression-shear and Subsidence test
5
8. Conclusions
UNiD Patient Specific 3D printed TLIF cages are substantially equivalent to legally marketed predicate devices.