(60 days)
Not Found
No
The description focuses on the material, design, and mechanical properties of a physical implant for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for addressing symptoms of cervical disc disease (radiculopathy and/or myelopathy due to herniated disc and/or osteophyte formation) by promoting interbody fusion and restoring intervertebral height and lordosis. It is used to directly treat a medical condition in patients.
No
The device is described as an intervertebral body fusion device used in surgical procedures to restore intervertebral height and promote fusion, not to diagnose a condition.
No
The device description explicitly states it is manufactured from medical grade Titanium alloy and is a physical implantable device (cervical intervertebral body fusion device) used with bone screws and bone graft. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for cervical interbody fusion. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a physical implant made of titanium alloy, designed to be placed between vertebrae and filled with bone graft. This is a medical device used in surgery, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing of the implant's structural integrity and equivalence to other surgical implants, not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Idys®-C ZP 3DTi device does not fit this description.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
OVE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-C3 disc to the C7-T1 disc (cervical spine)
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)
Biocompatibility: 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 Testing: 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.
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.
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.
Not Found
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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K212562
Device Name Idys® C ZP 3DTi
Indications for Use (Describe)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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.
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.