(371 days)
No
The summary describes a physical interbody fusion device and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an interbody fusion device intended for stabilization and to promote bone fusion in patients with degenerative disc disease, which qualifies it as a therapeutic device.
No
This device is an interbody fusion system designed for the treatment of degenerative disc disease by promoting bone fusion and stabilization, not for diagnosing medical conditions.
No
The device description clearly states it is an interbody fusion device made of titanium alloy and PEEK, intended for surgical implantation. It also mentions associated surgical instruments. This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (an interbody fusion device) intended for use within the human body to stabilize the spine and promote bone fusion. It is a physical device implanted during surgery, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for treating degenerative disc disease in the lumbosacral spine through surgical implantation.
Therefore, the Idys® ALIF 3DTi System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Idys® ALIF 3DTi (Anterior Lumbar Integrated Fusion) System is 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 back pain of discogenic origin 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 level. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF System should be used with the integrated fixation screws provided.
The Idys® ALIF 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.
Product codes
OVD
Device Description
The Idys® ALIF 3DTi consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.
The Idys® ALIF 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion process between the endplates.
The device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft.
The Idys® ALIF 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with bone graft. The insert for fixation of the plate is made of ASTM F2026 compliant polyetheretherketone (PEEK). The screws and plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF 3DTi cages are positioned using a set of surgical 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
lumbosacral spine (L2-S1)
Indicated Patient Age Range
skeletally mature
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
Bench mechanical testing according to ASTM F2077 and ASTM F2267 were used to support the decision of substantial equivalence with Idys® ALIF cages and Idys® ALIF ZP 3DTi predicate devices (K172083 and K192168, respectively). Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing (titanium particles), all of which demonstrated the substantial equivalence of the system to legally marketed devices.
Based on the clinical performance as documented in the pivotal clinical study, the Idys® ALIF 3DTi has a safety and effectiveness profile that is similar to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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April 12, 2021
Clariance % Janice Hogan, Esq. Partner Hogan Lovells US LLP 1735 Market Street. Suite 2300 Philadelphia, Pennsylvania 19103
Re: K200919
Trade/Device Name: Idys® ALIF 3DTi Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 16, 2021 Received: February 16, 2021
Dear Janice 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.
1
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,
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director 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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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)
K200919
Device Name Idys® ALIF 3DTi
Indications for Use
The Idys® ALIF 3DTi (Anterior Lumbar Integrated Fusion) System is 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 back pain of discogenic origin 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 level. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF System should be used with the integrated fixation screws provided.
The Idys® ALIF 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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K200919 510(k) SUMMARY CLARIANCE's Idys® ALIF 3DTi
Submitter's Name, Address, Telephone number, Contact person and Date prepared
CLARIANCE 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: Fadwa Bahr, Quality and Regulatory Affairs Manager
Date Prepared: February 16, 2021
Name of Device
Idys® ALIF 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, OVD
Predicate Devices
Idvs® ALIF. CLARIANCE SAS (K172083): primary predicate ldys® ALIF ZP 3DTi, CLARIANCE SAS (K192168): reference device
Device Description
The Idvs® ALIF 3DTi consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.
The Idys® ALIF 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion process between the endplates.
The device has to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft.
The Idys® ALIF 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with bone graft. The insert for fixation of the plate is made of ASTM F2026 compliant polyetheretherketone (PEEK). The screws and
4
plates are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idvs® ALIF 3DTi cages are positioned using a set of surgical 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.
Intended Use/Indications for Use
The Idvs® ALIF 3DTi (Anterior Lumbar Integrated Fusion) System is 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 back pain of discogenic origin 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 level. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF System should be used with the integrated fixation screws provided.
The Idys® ALIF 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.
Substantial Equivalence
The Idys® ALIF 3DTi and the predicate Idys® ALIF (K172083) are designed for use as lumbar intervertebral body fusion devices Both devices are available with equivalent range and configurations to accommodate patient anatomy.
The Idys® ALIF 3DTi and the Idys® ALIF (K172083) feature a similar outer shape and design. The design features two slots to allow the incorporation of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. Each of the superior and inferior surfaces of the Idys® ALIF 3DTi and the Idys® ALIF (K172083) have teeth to grip the surface of the vertebral endplates and help to resist expulsion.
The primary difference between the cleared Idys® ALIF (K172083) and the subject device is the change of the raw material and the manufacturing process of the cage. Idvs® ALIF 3DTi caqe are made of ASTM F3001 titanium alloy components and ASTM F136 Ti-6AI-4V ELI, while the predicate cage (K172083) is made of F2026 compliant polyetheretherketone (PEEK). Moreover, the Idys® ALIF 3DTi has a porous structure that integrates to the bone while the predicate Idys® ALIF cages use teeth. Idys® ALIF 3DTi has the same insert of its predicate device, made of F2026 compliant polyetheretherketone (PEEK), in order to attach to the plate.
Performance Data
Biocompatibility
The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1.
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
Bench mechanical testing according to ASTM F2077 and ASTM F2267 were used to support the decision of substantial equivalence with Idys® ALIF cages and Idys® ALIF ZP 3DTi
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predicate devices (K172083 and K192168, respectively). Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing, and wear testing (titanium particles), all of which demonstrated the substantial equivalence of the system to legally marketed devices.
Based on the clinical performance as documented in the pivotal clinical study, the Idys® ALIF 3DTi has a safety and effectiveness profile that is similar to the predicate device.
Conclusions
The Idys® ALIF 3DTi is as safe and effective as the Idys® ALIF (K172083) and Idys® ALIF ZP 3DTi (K192168). The Idys® ALIF 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 3DTi and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys® ALIF 3DTi is as safe and effective as its predicates. Thus, the Idys® ALIF 3DTi is substantially equivalent.