(266 days)
No
The summary describes a patient-matched implant based on radiographic studies, but there is no mention of AI or ML being used in the design or manufacturing process. The customization appears to be based on patient anatomy derived from imaging, not through an AI/ML algorithm.
Yes
Explanation: The device is an intervertebral cage designed for spinal fusion procedures to treat degenerative disc disease, which is a therapeutic intervention aimed at restoring function and alleviating pain.
No
The device, MEDICREA® INTERNATIONAL UNiD® IB3D ALIF, is an implant for spinal fusion procedures, providing stabilization and aiding fusion. It is a treatment device, not a diagnostic one. The mention of "radiographic studies" refers to the pre-existing diagnosis of the patient by other means, not diagnosis performed by this specific device.
No
The device description explicitly states it is an implant manufactured from titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures in skeletally mature patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is an implantable cage made of titanium alloy, designed to be inserted between vertebrae. This is a medical device used for treatment, not for diagnosing a condition.
- Function: The listed functions are related to providing immobilization, stabilization, and mechanical resistance to aid in spinal fusion. These are all therapeutic functions.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for diagnosis. The "radiographic studies" mentioned are used to confirm the patient's condition before the device is used for treatment.
In summary, the MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions.
The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient.
MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L2-S1
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)
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The UNiD® IB3D ALIF are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
Finite Element Analysis (FEA) was conducted and it was determined that no new worst-case implant was created. Therefore additional testing per ASTM F2077 "Standard Test Methods for Intervertebral of Intervertebral Body Fusion Device under Static Axial Compression" was not 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.
IB3D ALIF, (MEDICREA® INTERNATIONAL, K191134)
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.
UNiD® Patient matched PLIF cage, (MEDICREA® INTERNATIONAL, K182158), UNiD® Patient Specific 3D printed cage (MEDICREA® INTERNATIONAL. K173782), IMPIX® 3D printed cages (MEDICREA® INTERNATIONAL, K163595)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2020
Medicrea International S.A. David Ryan Chief Operating Officer 5389, route de Strasbourg Rillieux-la-Pape, 69140 France
Re: K200316
Trade/Device Name: UNiD® IB3D ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 30, 2020 Received: October 2, 2020
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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200316
Device Name
UNiD® IB3D ALIF
MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative 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® IB3D ALIF
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the UNiD® IB3D ALIF:
Date Prepared: February 3, 2020
-
- Submitter:
MEDIČREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88
- Submitter:
Contact Person: David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
-
- Trade name: UNiD® IB3D ALIF
Requlatory Identification/ Classification
FDA classification name: Intervertebral Body Fusion Device with Bone Graft, lumbar Regulation Number : 21CFR 888.3080 Product Code: MAX Class II
3. Predicate or legally marketed devices which are substantially equivalent:
Primary predicate device:
- IB3D ALIF, (MEDICREA® INTERNATIONAL, K191134) .
Reference Devices:
- o UNiD® Patient matched PLIF cage, (MEDICREA® INTERNATIONAL, K182158)
- UNiD® Patient Specific 3D printed cage (MEDICREA® INTERNATIONAL. K173782) ●
- IMPIX® 3D printed cages (MEDICREA® INTERNATIONAL, K163595) ●
Those three devices have not been subject to a design-related recall.
4. Description of the device:
The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions.
The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient.
MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function:
4
The UNiD® IB3D ALIF 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
MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal 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 or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. UNiD® IB3D ALIF device 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® IB3D ALIF are technologically similar to the already cleared MEDICREA® INTERNATIONAL IB3D ALIF in terms of intended use, material used, mechanical safety and performances.
The table below compares the features and characteristics of the submitted UNiD® IB3D ALIF to its predicate device.
| Device | MEDICREA® INTERNATIONAL
UNID® IB3D ALIF | MEDICREA®
INTERNATIONAL
IB3D ALIF |
|---------------|--------------------------------------------|-----------------------------------------|
| 510(k) number | K200316 | K191134 |
| Intended use | | |
| | Lumbar | Yes |
| Approach | Anterior | Anterior |
| Material | | |
| | Raw material | Titanium Ti6Al4V ELI |
| Sterilization | | |
| | Sterilization | Provided sterile or non-sterile |
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7. Non-clinical Test Summary:
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The UNiD® IB3D ALIF are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
Finite Element Analysis (FEA) was conducted and it was determined that no new worst-case implant was created. Therefore additional testing per ASTM F2077 "Standard Test Methods for Intervertebral of Intervertebral Body Fusion Device under Static Axial Compression" was not conducted.
8. Conclusions
UNiD® IB3D ALIF devices are substantially equivalent to legally marketed predicate device