(30 days)
No
The device description focuses on the material, manufacturing process (additive manufacturing), and physical design of the interbody device. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The performance studies are based on mechanical testing and finite element analysis, not data-driven performance metrics typically associated with AI/ML.
Yes
The device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) to alleviate discogenic back pain, which is a therapeutic purpose.
No
This device is an intervertebral body fusion device used for surgical implantation, not for diagnosing medical conditions.
No
The device description clearly states that the device is a range of titanium intervertebral body spacers, which are physical implants. It also mentions dedicated surgical instruments. This indicates a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Lumbar Interbody Device" for "intervertebral body fusion procedures." This is a surgical implant used in the body, not a device used to test samples outside the body.
- Device Description: The description details a "range of titanium intervertebral body spacers" and mentions surgical instruments. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Use in a laboratory setting
Therefore, the JULIET® Ti LL Lumbar Interbody Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, implanted via a lateral approach, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The Juliet® Ti LL spinal implants are additively manufactured and present both solid and porous structures. the The subject implants Juliet® Ti LL will extend the previously cleared Juliet® Ti (PO, OL & TL) range of implants (K153621) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM) and will join the previously cleared Juliet® LL range of implants (K161888; K141135) which presents similar design features and addresses the same surgical approach and utilize the same instrumentation designed purposely. The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
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
The following non-clinical tests were conducted on the predicate devices: Static and dynamic axial compression, static and dynamic shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267. A Finite Element Analysis has been submitted to support substantial equivalence. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. No additional testing has been performed for the Spineart Juliet® Ti LL spinal implants.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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January 3, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
SPINEART Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 PLAN LES OUATES GENEVA SWITZERLAND
Re: K173702
Trade/Device Name: Juliet® Ti LL Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 1, 2017 Received: December 4, 2017
Dear Mr. Pennesi:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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, Katherine D. Kavlock -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name Juliet® Ti LL
Indications for Use (Describe)
JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
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
Special 510k Juliet® Ti LL
| 510k | SPECIAL |
|---|---|
| Basis for submission | Extension of the range of Juliet® Ti devices |
| Submitted by | SPINEART |
| 3 Chemin du Pré Fleuri | |
| 1228 PLAN LES OUATES | |
| GENEVA SWITZERLAND | |
| Contacts | Franck PENNESI Chief Technical Officer |
| Phone : +41 22 570 1200 Fax : +41 22 594 8306 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | January 03, 2018 |
| Common Name | Intervertebral body fusion device |
| Trade Name | Juliet® Ti LL |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed | Primary predicate: Juliet® Ti (K153621) manufactured by Spineart |
| predicate devices | Additional predicates: Juliet® LL (K161888, K141135) manufactured by Spineart |
| Indications for use | JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body |
| fusion procedures in skeletally mature patients with degenerative disc disease | |
| (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic | |
| back pain with degeneration of the disc confirmed by patient history and | |
| radiographic studies. These DDD patients may also have up to Grade 1 | |
| spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants | |
| are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody | |
| Device is to be used with supplemental fixation. Patients should have at least | |
| six (6) months of non-operative treatment prior to treatment with an | |
| intervertebral cage. | |
| Spineart Juliet® Ti LL spinal implants consist of a range of titanium | |
| Description of the | |
| device | intervertebral body spacers, implanted via a lateral approach, with various sizes |
| and footprints so as to adapt different patient's conditions. The Juliet® Ti LL | |
| spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM | |
| F136. The Juliet® Ti LL spinal implants are additively manufactured and present | |
| both solid and porous structures. | |
| the The subject implants Juliet® Ti LL will extend the previously cleared Juliet® Ti | |
| (PO, OL & TL) range of implants (K153621) which presents similar design | |
| features and the same manufacturing technology, i.e. additive manufacturing | |
| (SLM) and will join the previously cleared Juliet® LL range of implants (K161888; | |
| K141135) which presents similar design features and addresses the same | |
| surgical approach and utilize the same instrumentation designed purposely. | |
| The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and | |
| supplied with dedicated surgical instruments (reusable - provided non-sterile). | |
| The Juliet® Ti LL spinal implants are manufactured using the same | |
| manufacturing technology, i.e. additive manufacturing (SLM) as predicate | |
| device Juliet® Ti (PO, OL & TL). The characterization of the chemical, physical | |
| and mechanical properties of the material was performed in accordance with | |
| ASTM F3001 and ASTM E8/E8M. The porous structure featured on titanium | |
| alloy implants additively manufactured was validated based on the FDA's | |
| Guidance for industry on the testing of metallic plasma sprayed coatings on | |
| Technological | orthopedic implants to support reconsideration of postmarket surveillance |
| characteristics | requirements. |
| compared to the | The Juliet® Ti LL spinal implants present a similar design feature and range of |
| predicate devices | devices as the previously cleared Juliet® LL spinal implants. Both Juliet® Ti LL and |
| Juliet® LL are designed for a lateral approach. | |
| The following non-clinical tests were conducted on the predicate devices: Static | |
| and dynamic axial compression, static and dynamic shear compression | |
| according to ASTM F2077 and subsidence testing according to ASTM F2267. A | |
| Finite Element Analysis has been submitted to support substantial equivalence. | |
| Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity | |
| testing to achieve the Endotoxin limit of 20 EU / device. | |
| Discussion of Testing | No additional testing has been performed for the Spineart Juliet® Ti LL spinal |
| implants. | |
| Conclusion | Based on the design features, technological characteristics, feature |
| comparisons, and indications for use, Juliet® Ti LL has demonstrated substantial | |
| equivalence to the identified predicate devices. |
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