(27 days)
Not Found
No
The 510(k) summary describes a physical medical device (an interbody fusion system) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components.
Yes.
Explanation: The device is intended for use in patients with degenerative disc disease who have undergone non-operative treatment and is designed to promote bone fusion and stabilization in the lumbar spine, which are therapeutic actions.
No
The device is an interbody fusion system intended for surgical implantation to promote bone fusion in patients with degenerative disc disease, not for diagnosing conditions.
No
The device is a physical implant made of PEEK and titanium, intended for surgical insertion into the spine. The description details its material composition, design features, and mechanical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation in the lumbosacral spine to promote bone fusion in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (interbody fusion device) made of PEEK and titanium, designed to restore spinal height and facilitate fusion. It is a medical device used in vivo (within the body) during surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac 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 levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Idys™ ALIF TiVac 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 TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft.
The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench mechanical testing according to ASTM F2077 and ASTM F2267 was used to support the decision of substantial equivalence compared to the Idys™ ALIF predicate device (K172083). 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 (PEEK and titanium particles). The results of these studies were determined to be substantially equivalent to legally marketed devices.
Mechanical bench testing of the pure titanium coating was performed according to the FDA's guidance, Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. Specifically, the following tests were performed: static tensile strength testing according to ASTM F1147, static shear strength according to ASTM F1044, shear fatigue strength according to ASTM F1160, abrasion resistance according to ASTM F1978- 99, and coating porosity/thickness per ASTM F1854 with satisfactory results.
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
June 6, 2019
Image /page/0/Picture/1 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
CLARIANCE SAS
% Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K191263
Trade/Device Name: Idys™ ALIF TiVac Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: May 10, 2019 Received: May 10, 2019
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K191263
Device Name
ldys™ ALIF TiVac Indications for Use (Describe)
The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac 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 levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys™ ALIF TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.
| 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)
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K191263 510(k) SUMMARY CLARIANCE's Idys™ ALIF TiVac Intervertebral Fusion Device With Integrated Fixation, Lumbar
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: Willy VIVANZ, Chief Technology Officer
Date Prepared: May 28, 2019
Name of Device
ldys™ ALIF TiVac
Common or Usual Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Classification Name
Class II, 21 CFR §888.3080 - Intervertebral body fusion device, OVD
Predicate Devices
Idys™ ALIF, CLARIANCE SAS (K172083): primary predicate
ldys™ TLIF TiVac, CLARIANCE SAS (K183259): additional predicate
Purpose of the Special 510(k) notice
The Idys™ ALIF TiVac is a modification to the 510(k) cleared Idys™ ALIF predicate (K172083). The modification consists of the addition of plasma-sprayed, pure titanium coating compliant with ASTM F1580 on the superior and inferior surface of the device. The same coating has been previously cleared in K183259. The cages have similar design, shape and dimensions as those already cleared under K172083 for the Idys™ ALIF predicate device.
4
Device Description
The Idys™ ALIF TiVac 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 TiVac System is designed for use as a lumbar intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (INVIBIO PEEK OPTIMA LT1) coated with titanium on its superior and inferior surfaces and is to be used with autograft.
The device has a shape which restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The superior and inferior surfaces of the implant coated with titanium are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting back out. The Idys™ ALIF TiVac System is a standalone system intended to be used with plate and four bone screws, autogenous bone graft and requires no additional supplementary fixation. The Idys™ ALIF TiVac System cages are made of ASTM F2026 compliant polyetheretherketone (PEEK) coated with compliant ASTM F1580 titanium and, markers made of Tantalum according to ASTM F560, the plate and screws are made of ASTM F136 titanium alloy. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages, plates and screws are provided sterile and are for single use only.
Indications for Use
The Idys™ ALIF (Anterior Lumbar Interbody Fusion) TiVac 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 spondvlolisthesis 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 TiVac System should be used with the integrated fixation screws provided. The Idys™ ALIF TiVac System is intended to be used with autograft.
Substantial Equivalence
The Idys™ ALIF TiVac and the predicate Idys™ ALIF (K172083) are designed for use as lumbar intervertebral body fusion devices are available with equivalent range and configurations to accommodate patient anatomy.
The Idys™ ALIF TiVac and the Idys™ ALIF (K172083) feature a similar outer shape and design. The design features two slots to allow the incorporation of bone graft which is essential for promoting the fusion process. The superior and inferior surfaces of the Idys™ ALIF TiVac and the Idys™ ALIF (K172083) have teeth to grip the surface of the vertebral endplates and help to resist expulsion.
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The primary difference between the cleared Idys™ ALIF (K172083) and the subject device is the addition of the plasma-sprayed titanium coating on the superior and the inferior surface of the Idys™ ALIF TiVac cages. However, the same coating has been cleared in CLARIANCE Idys™ TLIF TiVac (K183259).
Verification and Validation steps performed following the addition of the titanium coating demonstrate that the modification does not raise any new issues of safety or effectiveness compared to the cleared Idys™ ALIF (K172083).
Performance Data
Biocompatibility
The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1.
Mechanical Testing
Bench mechanical testing according to ASTM F2077 and ASTM F2267 was used to support the decision of substantial equivalence compared to the Idys™ ALIF predicate device (K172083). 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 (PEEK and titanium particles). The results of these studies were determined to be substantially equivalent to legally marketed devices.
Mechanical bench testing of the pure titanium coating was performed according to the FDA's guidance, Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. Specifically, the following tests were performed: static tensile strength testing according to ASTM F1147, static shear strength according to ASTM F1044, shear fatigue strength according to ASTM F1160, abrasion resistance according to ASTM F1978- 99, and coating porosity/thickness per ASTM F1854 with satisfactory results.
Conclusions
The Idvs™ ALIF TiVac is as safe and effective as the Idvs™ ALIF (K172083). The Idvs™ 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 TiVac and its predicate device do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Idys™ ALIF TiVac is as safe and effective as its predicate. Thus, the Idys™ ALIF TiVac is substantially equivalent.