The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys@-C ZP 3DTi device must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

Device Description

The Idys® C ZP 3DTi is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade Titanium alloy and must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no additional supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Idys®-C ZP 3DTi), which is a premarket notification to the FDA. It declares substantial equivalence to existing devices rather than proving performance against specific acceptance criteria in a study. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.

The document primarily focuses on establishing substantial equivalence through:

Indications for Use: Demonstrating similar intended uses to predicate devices.
Technological Characteristics: Showing similar design and materials.
Performance Data (Mechanical Testing, Biocompatibility, Sterility/Cleaning): Proving that the device meets established standards for safety and function, aligning with predicate devices.

Here's a breakdown of what is available concerning performance and testing, and where the requested information is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance in the manner typically found in a clinical study. Instead, it refers to compliance with established standards and comparison to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: No changes to manufacturing/materials	Confirmatory testing per ISO 10993-5 and ISO 10993-11 had been performed.
Sterility: Success against standards	Sterilization validation per ISO 11137 successfully completed.
Cleaning: Acceptable residue limits	Cleaning validation per ISO 19227 showed acceptable limits of residues.
Mechanical Strength: Substantial equivalence to Idys™ C	Mechanical testing per ASTM F2077 and ASTM F2267 demonstrated substantial equivalence. This included static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion, and static torsion testing.

This section does not provide specific numerical metrics or thresholds for "acceptance criteria" and "reported device performance," but rather states that the device met the requirements implied by the testing standards and showed equivalence to predicates.

Study Information (Based on Available Text)

Sample size used for the test set and the data provenance: Not applicable/Not provided. The document describes mechanical and validation testing, not a clinical study with a "test set" of patients or data in the usual sense. The testing is for the physical device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is relevant for diagnostic or AI-driven devices, which is not the case for this intervertebral fusion device.
Adjudication method for the test set: Not applicable/Not provided.
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 device is an implantable medical device, not an AI-driven diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is compliance with engineering standards (e.g., ASTM, ISO) and comparison to the mechanical properties of an established predicate device. There is no biological or diagnostic "ground truth" in the clinical sense.
The sample size for the training set: Not applicable/Not provided. This refers to a machine learning context, which is not relevant here.
How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided document is a 510(k) submission for an intervertebral body fusion device, focusing on substantial equivalence to predicate devices through technical and performance testing rather than clinical study results demonstrating efficacy against specific acceptance criteria for a diagnostic or AI-based device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 12, 2021

CLARIANCE, SAS % Janice Hogan, J.D. Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K212562

Trade/Device Name: Idys®-C ZP 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: August 13, 2021 Received: August 13, 2021

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.

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

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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 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,

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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Indications for Use

510(k) Number (if known) K212562

Device Name Idys® C ZP 3DTi

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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K212562

510(k) SUMMARY

CLARIANCE's Idys® C ZP 3DTi

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CLARIANCE, SAS 18 rue Robespierre F-62217 Beaurains, France Phone: +33 (0)3 21 16 12 15 Facsimile: +33 (0)3 21 15 50 73 Contact Person: Mélody La Porte, Regulatory Affairs Specialist Date Prepared: October 6, 2021

Name of Device and Name/Address of Sponsor

CLARIANCE, Idys® C ZP 3DTi

Common or Usual Name

Intervertebral Fusion Device with Integrated Fixation, Cervical

Classification Name

Class II, 21 CFR § 888.3080 - Intervertebral Fusion Device, OVE

Predicate Devices

Primary: Idys™-C. CLARIANCE SAS (K130853): (Instruments mechanical performances, device mechanical performances, packaging and sterilization)

Additional: Vault-C Standalone Cervical Interbody Fusion System, Spinal USA, Inc. (K132029)

Additional: Idvs®-ALIF ZP 3DTi, CLARIANCE SAS (K200920) (screws, manufacturing, cleaning and raw materials)

Intended Use / Indications for Use

The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The ldys® C ZP 3DTi device must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.

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Device Description

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 ISO 10993-11 had been performed.

Sterility and Cleaning

Sterilization validation per ISO 11137 has been successfully completed. Cleaning validation per ISO 19227 has shown acceptable limits of residues.

Mechanical Testinq

Mechanical testing according to ASTM F2077 and ASTM F2267 were used to support substantial equivalence to Idys™ C (K130853). Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, all of which demonstrated the substantial equivalence of the system to legally marketed devices.

Substantial Equivalence

The Idys® C ZP 3DTi is substantially equivalent to the Idys™-C (K130853) and Vault-C Standalone Cervical Interbody Fusion System (K132029). The Idys® C ZP 3DTi has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Idys® C ZP 3DTi and its predicate devices do not raise any new questions of safety or effectiveness. In addition, performance data demonstrate that the Idys® C ZP 3DTi is as safe and effective as its predicate devices. Thus, the Idys® C 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.