The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion

Device Description

The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has shape which restores the intervertebral height and lordosis. The device contains two slots to receive bone graft to promote the fusion process between the endplates. The device has to be used with bone graft.

The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136. The screws are made from Ti-6AI-4V ELI per ASTM F136 and are anodized in different colors, according to their length, Idvs® ALIF ZP 3DTi cages are positioned using a set of surqical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

AI/ML Overview

This document is a 510(k) summary for the Idys® ALIF ZP 3DTi intervertebral body fusion device. It details product information and demonstrates substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for device performance in detecting or diagnosing a condition. Therefore, the requested information (acceptance criteria, study details, expert involvement, and ground truth characteristics) related to diagnostic performance cannot be extracted from this text.

The document focuses on the mechanical and biocompatibility performance of the device and its substantial equivalence to a previously cleared predicate device due to minor modifications (change in screw design and addition of cage sizes).

Here's what can be extracted regarding the performance data provided for the device itself:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Test/Area	Performance Reported
Biocompatibility	ISO 10993-5 (in vitro cytotoxicity) & -11 (systemic toxicity)	Successfully performed (confirmatory testing), no new testing required as no change in manufacturing methods or patient-contacting materials.
Sterility	ISO 11737	Successfully completed (repeated sterilization validation).
Cleaning	Cleaning validation	Acceptable limits of residues shown.
Mechanical Performance	ASTM F2077 (for cages)	No new testing required for cages as additional cage sizes do not create new worst-case scenarios.
Mechanical Performance	ASTM F543 (for screws)	Tested to demonstrate and support substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. These tests are laboratory-based mechanical and biocompatibility evaluations, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to mechanical and biocompatibility testing, not expert-adjudicated clinical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI medical device or a reader study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented performance data, which are based on established ISO and ASTM standards for materials and mechanical testing.

8. The sample size for the training set: Not applicable. This is not a study involving machine learning or AI models with training data.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Changes:

The document describes a Special 510(k) notice for the Idys® ALIF ZP 3DTi device.

Original Device: Idys® ALIF ZP 3DTi (K192168)
Modifications:
- Change in the screw's design.
- Addition of new cage sizes (with identical design and shape as previously cleared cages).
Purpose of Testing: To demonstrate that these modifications do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

Summary

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May 29, 2020

CLARIANCE SAS % Janice M. Hogan, J.D. Regulatory Counsel Hogan Lovells US LLP 1735 Market Street. Suite 2300 Philadelphia, Pennsylvania 19103

Re: K200920

Trade/Device Name: Idys® ALIF ZP 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: May 19, 2020 Received: May 19, 2020

Dear Ms. Hogan:

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.

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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 L. Showalter, Ph.D. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page

510(k) Number (if known) K200920

Device Name

ldvs® ALIF ZP 3DTi Indications for Use (Describe)

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion

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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FORM FDA 3881 (8/14)

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510(k) SUMMARY CLARIANCE's Idys® ALIF ZP 3DTi Intervertebral body fusion device with bone graft

Submitter's Name, Address, Telephone number, Contact person and Date prepared

CLARIANCE SAS 18 rue Robespierre 62217 Beaurains, France

Phone: + 33 (0)3 21 16 12 15 Facsimile: + 33 (0)3 21 15 50 73

Contact Person: Fadwa Bahr, Quality and Regulatory Affairs Manager

Date Prepared: April 6, 2020

Name of Device:

ldys® ALIF ZP 3DTi

Common or Usual Name:

Lumbar Intervertebral Body Fusion Device with Bone Graft

Classification Name:

Class II, 21 CFR §888.3080 - Intervertebral body fusion device, MAX

Predicate Devices

ldys® ALIF ZP 3DTi, CLARIANCE SAS (K192168): primary predicate

Idys® ALIF System, CLARIANCE SAS (K172083): additional predicate (materials and instruments)

SYNFIX® Evolution Secured Spacer System (K150673): cage size reference device

Purpose of the Special 510(k) notice

The Idys® ALIF ZP 3DTi device is a modification of the 510(k) cleared Idys® ALIF ZP 3DTi predicate (K192168). The modification consists of a change in the screw's design as compared to the previously cleared Idys® ALIF ZP 3DTi predicate (K192168) and the addition of cage sizes. The cages have identical design and shape as those already cleared under (K192168) for the Idys® ALIF ZP 3DTi predicate device.

Device Description

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promote the fusion process between the endplates. The device has to be used with bone graft.

Intended Use/Indications for Use

The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic origin back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

Performance Data

Biocompatibility

As there have been no changes to the manufacturing methods or patient contacting materials, no new biocompatibility testing was required to establish equivalence. Confirmatory testing per ISO 10993-5 and -11 had been performed.

Sterility and Cleaning

Repeated sterilization validation per ISO 11737 and ISO 11137 has been successfully completed. Cleaning validation has shown acceptable limits of residues.

Mechanical Testing

As the additional cage's sizes do note create a new worst case reqarding mechanical performance, no new mechanical testing according to ASTM F2077 and ASTM was required to establish equivalence to the Idys® ALIF ZP 3DTi predicate device (K192168).

The screws were tested according to ASTM F543 to demonstrate and to support the decision of substantial equivalence with the primary predicate.

Conclusions

The Idys® ALIF ZP 3DTi is as safe and effective as the cleared Idys® ALIF ZP 3DTi predicate device (K192168).The Idys® ALIF ZP 3DTi has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Idys® ALIF ZP 3DTi and its predicate

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device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys® ALIF ZP 3DTi is as safe and effective as its predicate. Thus, the Idys® ALIF ZP 3DTi is substantially equivalent.

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.