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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "IB3D ALIF," an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial with defined acceptance criteria and human reader studies (MRMC studies).

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, and other specifics typically found in studies proving a device meets such criteria (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, training set details).

The requested information is not available in the provided text because this is a 510(k) submission for a physical implant (an intervertebral body fusion device), not a software or AI-driven diagnostic device.

Here's an explanation of why the requested information is absent and what is typically provided in a 510(k) for a physical device:

Acceptance Criteria and Device Performance (Table): Not applicable in the context of AI software. For this device, "performance" relates to mechanical strength, biocompatibility, and intended function as an intervertebral body fusion device, which are tested against standards like ASTM F2077 and F2267. The document states "no new worse-case implant was created" by FEA, and expulsion testing was conducted, but specific pass/fail criteria or detailed results are not explicitly listed in this summary.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (for test set), Training Set Details: These questions are specifically relevant to the evaluation of AI or imaging diagnostic software. The IB3D ALIF is a physical implant. Its evaluation for 510(k) clearance primarily involves:
- Mechanical Testing: Such as finite element analysis (FEA) and expulsion testing to ensure the device can withstand forces and maintain placement.
- Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
- Materials Comparability: Demonstrating the materials are the same as previously cleared predicate devices.
- Indications for Use Comparability: Showing the device is intended for the same patient population and conditions as predicate devices.
- Sterilization Validation: Ensuring the device can be sterilized effectively.

In summary, the provided document relates to a physical medical device (an implant) and not an AI or software-based diagnostic tool. As such, the concept of "acceptance criteria" and "studies" as understood for AI/software in the prompt are not relevant to this 510(k) submission.

Summary

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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

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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)

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

1. Submitter:
  MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR

Contact Person: David RYAN MEDICREA INTERNATIONAL 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR +33 (0)4 72 01 87 87

1. 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:

The purpose of this submission is to introduce IB3D ALIF.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

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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

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	MEDICREAINTERNATIONALALIF IB3D	EITCellularTitanium® ALIF	4WEBAnterior SpineTruss System (STS)Interbody FusionDevice	MEDICREAINTERNATIONALIMPIX 3D print
510(k)number	K191134	K172888	K170851	K163595
Intended use
Lumbar	Yes	Yes	Yes	Yes
Approach	Anterior	Anterior	Anterior	Posterior
Material
Raw material	TitaniumTi6Al4V ELI	TitaniumTi6Al4V ELI	PET &Pure titanium(T40) conformingto ASTM F67.	TitaniumTi6Al4V ELI
Sterilization	Provided sterile	Providedsterile	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

Regulation Number and Section

§ 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.