(184 days)
Not Found
No
The document describes a standard spinal fusion device and its intended use, materials, and performance testing (FEA and expulsion). There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description or performance studies.
Yes
This device is an implantable medical device used in spinal fusion procedures to treat degenerative disc disease, which falls under the definition of a therapeutic device.
No
The device is an intervertebral cage intended for spinal fusion procedures, used to treat degenerative disc disease by providing structural support between vertebrae. It is a therapeutic implant, not a diagnostic tool.
No
The device description clearly states it is a physical implant manufactured from titanium alloy, 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 taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The MEDICREA® INTERNATIONAL IB3D ALIF device is an implantable medical device designed for spinal fusion procedures. It is surgically inserted into the body to stabilize the spine.
- No Mention of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens outside of the body.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MEDICREA® INTERNATIONAL IB3D ALIF device is 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. 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
MAX
Device Description
MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-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.
The purpose of this submission is to introduce IB3D ALIF.
MATERIALS: 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
Spinal fusion procedures, 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)
Non-clinical Test Summary:
Biocompatibility Testing
The IB3D ALIF devices are made from the same materials as the predicates and the manufacturing processes are the same as a predicate.
Mechanical testing
Finite Element Analysis (FEA) was conducted and it was determined that no new worse-case implant was created. Therefore additional testing per ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression" was not conducted. However, expulsion testing was conducted to evaluate new endplate configurations.
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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October 30, 2019
Medicrea International S.A. David Ryan Chief Operating Officer 5389 route de Strasbourg - Vancia Rillieux-la-Pape 69140 France
Re: K191134
Trade/Device Name: IB3D ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 1, 2019 Received: October 3, 2019
Dear David 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices 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) K191134
Device Name IB3D ALIF
Indications for Use (Describe)
MEDICREA® INTERNATIONAL IB3D ALIF device is 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. 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 IB3D ALIF
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the IB3D ALIF:
Date Prepared: April, 25, 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 +33 (0)4 72 01 87 87
-
- Trade name: IB3D ALIF
Regulatory Identification/ Classification
FDA classification name: Intervertebral Body Fusion Device with Bone Graft, lumbar Requlation Number : 21CFR 888.3080 Product Code: MAX Class II
3. Predicate or legally marketed devices which are substantially equivalent:
Primary predicate device:
- Cellular Titanium ALIF, (EIT, K172888) .
Additional Predicates:
- Anterior Spine Truss System (STS) Interbody Fusion Device, (4WEB, K170851) ●
- . IMPIX 3D print (MEDICREA INTERNATIONAL, K163595)
Those three devices have not been subject to a design-related recall.
4. Description of the device:
MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-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.
The purpose of this submission is to introduce IB3D ALIF.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
4
Function:
The 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 IB3D ALIF device is 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. 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.
6. Substantial equivalence claimed to predicate devices
The IB3D ALIF are technologically similar to the already cleared EIT Cellular Titanium® ALIF (K172888), 4WEB Anterior Spine Truss System (STS) Interbody Fusion Device (K170851) and MEDICREA INTERNATIONAL IMPIX 3D print (K163595) in terms of intended use, material used, mechanical safety and performances.
The table below compares the features and characteristics of the submitted IB3D ALIF to their predicate devices.
| Device | MEDICREA
INTERNATIONAL
ALIF IB3D | EIT
Cellular
Titanium® ALIF | 4WEB
Anterior Spine
Truss System (STS)
Interbody Fusion
Device | MEDICREA
INTERNATIONAL
IMPIX 3D print |
|------------------|----------------------------------------|-----------------------------------|----------------------------------------------------------------------------|---------------------------------------------|
| 510(k)
number | K191134 | K172888 | K170851 | K163595 |
| Intended use | | | | |
| Lumbar | Yes | Yes | Yes | Yes |
| Approach | Anterior | Anterior | Anterior | Posterior |
| Material | | | | |
| Raw material | Titanium
Ti6Al4V ELI | Titanium
Ti6Al4V ELI | PET &
Pure titanium
(T40) conforming
to ASTM F67. | Titanium
Ti6Al4V ELI |
| Sterilization | Provided sterile | Provided
sterile | Provided sterile | Provided sterile |
7. Non-clinical Test Summary:
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
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The IB3D ALIF devices are made from the same materials as the predicates and the manufacturing processes are the same as a predicate.
Mechanical testing
Finite Element Analysis (FEA) was conducted and it was determined that no new worse-case implant was created. Therefore additional testing per ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression" was not conducted. However, expulsion testing was conducted to evaluate new endplate configurations.
8. Conclusions
IB3D ALIF devices are substantially equivalent to legally marketed predicate devices