(214 days)
JULIET®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). This device is to be used with autogenous bone graft. JULIET®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
The JULIET®LL Titanium Lateral Lumbar cages are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®LL intervertebral body fusion spacer comes in various sizes and footprints in order to fulfill surgeons' needs and accommodate different patient anatomies. The JULIET®LL system is made of Titanium Ti 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3.
The provided text describes a medical device, the JULIET® LL Lateral Lumbar Cage, and its FDA 510(k) summary for substantial equivalence. It does not describe acceptance criteria and a study proving device performance in the context of an AI/algorithm-based diagnostic or assistive device.
Therefore, I cannot provide the requested information, particularly items 1-9, as they pertain to the evaluation of an AI-powered device's diagnostic performance, which is not detailed in this document. The document focuses on the mechanical and material performance of an orthopedic implant.
Here's why each point cannot be addressed with the given text:
- A table of acceptance criteria and the reported device performance: The document discusses non-clinical tests like "Static axial compression, Static shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267," and states that the device "performs as safely and effectively as its predicate devices." However, it does not provide specific quantitative acceptance criteria or detailed numerical results from these tests in a table format that would be relevant for an AI system's performance.
- Sample sized used for the test set and the data provenance: Not applicable. This refers to an AI test set, not mechanical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to an AI test set's ground truth, not mechanical testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to establishing ground truth for an AI test set.
- 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 describes an AI study, not an orthopedic implant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes an AI study.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to clinical outcomes or imaging interpretations for an AI, not mechanical properties of an implant. The document mentions "degenerative disc disease (DDD) ... confirmed by patient history and radiographic studies" for the indications for use, but this is not ground truth for a diagnostic AI's performance evaluation.
- The sample size for the training set: Not applicable. This refers to an AI training set.
- How the ground truth for the training set was established: Not applicable. This refers to an AI training set.
The document is a 510(k) summary for a physical medical implant, demonstrating substantial equivalence to predicate devices based on mechanical testing and material compatibility, not the performance of an AI or diagnostic algorithm.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of four stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2014
SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 route de pré-bois CP1813 1215 Geneva Switzerland
Re: K141135
Trade/Device Name: JULIET® LL Lateral Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 5, 2014 Received: November 6, 2014
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Franck Pennesi
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
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 |
Indications for Use
510(k) Number (if known)
Device Name
JULIET® LL Lateral Lumbar Cage
Indications for Use (Describe)
JULIET® 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). This device is to be used with autogenous bone graft. JULIET® 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
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
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Traditional 510k JULIET® LL Titanium Lateral Lumbar Cage
510(k) SUMMARY
| Submitted by | SPINEARTInternational Center Cointrin20 route de pré-boisCP18131215 GENEVA 15SWITZERLAND |
|---|---|
| Contacts | Franck PENNESI Director of Industry & QualityPhone : +41 22 799 40 25 Fax : +41 22 799 40 26Mail : fpennesi@spineart.comRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr |
| Date Prepared | November 26th 2014 |
| Common Name | Intervertebral body fusion device |
| Trade Name | JULIET® LL Lateral Lumbar Cage |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 21CFR 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketedpredicate devices | Primary predicate device: Juliet® (K133557) manufactured by SpineartAdditional predicates include: Dynamik® (K081888) manufactured bySpineart; Nuvasive Coroent Titanium System (K120918) manufacturedby Nuvasive; Lanx Fusion System – Lateral (K103666) manufactured byLanx; Endoskeleton TO (K102067) manufactured by Titan Spine andLucent (K071724) manufactured by Spinal Elements. |
| Indications for use | JULIET®LL Lumbar Interbody Device is indicated for intervertebral bodyfusion procedures in skeletally mature patients with degenerative discdisease (DDD) at one or two contiguous levels from L2-S1. DDD isdefined as discogenic back pain with degeneration of the disc confirmedby patient history and radiographic studies. These DDD patients mayalso have up to Grade 1 spondylolisthesis or retrolisthesis at theinvolved level(s). This device is to be used with autogenous bone graft.JULIET®LL Lumbar Interbody Device is to be used with supplementalfixation. Patients should have at least six (6) months of non-operativetreatment prior to treatment with an intervertebral cage |
| Description of the device | The JULIET®LL Titanium Lateral Lumbar cages are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®LL intervertebral body fusion spacer comes in various sizes and footprints in order to fulfill surgeons' needs and accommodate different patient anatomies. The JULIET®LL system is made of Titanium Ti 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. |
| Technological Characteristics | The JULIET® LL Titanium Lateral Lumbar cages are available in eight lengths (from 25 to 60 mm) and six heights (from 8 to 16 mm). The JULIET® LL Titanium Lateral Lumbar cages are available in three widths and two lordosis (17mm lordosis 0°; 21mm lordosis 6° and 25mm lordosis 6°). The JULIET® LL range of lumbar implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non sterile). |
| Discussion of Testing | The following non-clinical tests were conducted on JULIET®LL Titanium Lateral Lumbar cages: Static axial compression, Static shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267. A Finite Element Analysis was submitted to support substantial equivalence. The non-clinical performance testing demonstrates that JULIET®LL Titanium Lateral Lumber cage is substantially equivalent to predicate devices. |
| Conclusion | The JULIET® LL Titanium Lateral Lumbar cage is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The results demonstrate that JULIET®LL performs as safely and effectively as its predicate devices. |
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§ 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.