(52 days)
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
The JULIET®OL Transforaminal 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®OL system is made of PEEK Optima LT1 conforming to ASTM F2026 with Tantalum markers conforming ASTM F560. The line extension of Juliet® OL device consists in an additional size (height 07 mm) and a lordotic profile in order to better fulfill surgeons' needs and accommodate different patient anatomies and in a design change of the 08 mm height implant with bi-convex profile.
The provided documents describe a traditional 510(k) submission for a medical device, the JULIET® OL Transforaminal Lumbar Cage, which is an intervertebral body fusion device.
Crucially, this type of submission for devices like this typically relies on demonstrating substantial equivalence to a predicate device based on material, design, mechanical properties, and function rather than extensive clinical efficacy studies with specific performance metrics such as sensitivity, specificity, or reader improvement.
Therefore, most of the requested information (like sample sizes for test sets, expert qualifications, HRMR studies, standalone performance, training set details, and specific ground truth methods for clinical endpoints) is not applicable to this type of device and submission. The "study" here refers to non-clinical bench testing.
Here's the breakdown of what can be extracted or inferred from the provided text:
Acceptance Criteria and Device Performance for JULIET® OL Transforaminal Lumbar Cage
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Substantial Equivalence to Predicate Devices | |
| Static axial compression | Performance comparable to predicate devices (K081888, K101720, K121760, K120368, K090816) | JULIET®OL performs as safely and effectively as its predicate devices. |
| Static shear compression | Performance comparable to predicate devices (K081888, K101720, K121760, K120368, K090816) | JULIET®OL performs as safely and effectively as its predicate devices. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a mechanical device, and the "test set" refers to bench testing of the device itself, not clinical data from patients. The document describes "non-clinical tests" (mechanical testing) rather than a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The "ground truth" for this device's performance is established through engineering and biomechanical standards (ASTM F2077) and comparison to predicate device performance, not by expert interpretation of clinical data in the context of this 510(k) submission.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. 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 is not an AI/software device. It's a physical implant for spinal fusion.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/software algorithm.
7. The type of ground truth used
- Engineering and Biomechanical Standards: The ground truth for this device's safety and effectiveness relies on adherence to established ASTM standards (specifically ASTM F2077 for static axial and shear compression) and the comparative mechanical performance against legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" refers to non-clinical bench testing conducted on the JULIET® OL Transforaminal Lumbar Cage.
- Test Performed: Static axial compression and Static shear compression.
- Standards Adhered To: ASTM F2077.
- Methodology: The device's mechanical performance under these conditions was tested and compared to the performance of several legally marketed predicate devices:
- Conclusion: The tests demonstrated that the JULIET® OL Transforaminal Lumbar Cage "performs as safely and effectively as its predicate devices." This substantial equivalence in mechanical properties, along with similar intended use, materials, and design, forms the basis for its clearance. No clinical trials or human subject data was presented in this 510(k) summary for establishing efficacy.
{0}------------------------------------------------
Traditional 510k JULIET® OL Transforaminal Lumbar Cage
sing of the online of the finalismes of the finalismes and online of the finalismes and the comments of the comments of the comments of the comments of the comments of the co
APR 1 8 2014
510(k) SUMMARY
| SPINEART | |
|---|---|
| International Center Cointrin | |
| Submitted by | 20 route de pré-bois |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Franck PENNESI Director of Industry & Quality | |
| Phone : +41 22 799 40 25 Fax : +41 22 799 40 26 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) | |
| idrubaix@nordnet.fr | |
| Date Prepared | April 14th 2014 |
| Common Name | Intervertebral body fusion device |
| Trade Name | JULIET® OL Transforaminal Lumbar Cage |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| JULIET® lumbar cages (K081888 and K101720) manufactured by | |
| Legally marketed | Spineart; Capstone (K121760, K120368) manufactured by Medtronic; |
| predicate devices | AVS PL PEEK AVS Plus -UniLIF (K090816) manufactured by StrykerSpine |
| 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 | |
| Indications for use | 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 |
{1}------------------------------------------------
:
.
| Description of the device | The JULIET®OL Transforaminal 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®OL system is made of PEEK Optima LT1 conforming to ASTM F2026 with Tantalum markers conforming ASTM F560. The line extension of Juliet® OL device consists in an additional size (height 07 mm) and a lordotic profile in order to better fulfill surgeons' needs and accommodate different patient anatomies and in a design change of the 08 mm height implant with bi-convex profile. |
|---|---|
| Technological Characteristics | The JULIET®OL Transforaminal Lumbar cages are available in two lengths (28 and 32 mm), five heights (from 7 to 14 mm) and three lordosis (0, 9º and 12º). The JULIET®OL Transforaminal Lumbar cages 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®OL: Static axial compression, Static shear compression according to ASTM F2077. Results demonstrate that JULIET®OL performs as safely and effectively as its predicate devices. |
| Conclusion | The JULIET® OL 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. Non clinical performance testing demonstrate that JULIET® OL is as safe, as effective, and performs as safely and effectively as its predicate devices. |
.
:
. .
:
and the comments of the comments of
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G69 Silver Spring, MI) 20993-0002
April 18, 2014
Spincart Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 route de pré-bois. CP1813 1215 Geneva 15. SWITZERLAND
K140474 Re: Re:
Trade/Device Name: Juliet® OL Transforaminal Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 24, 2014 Received: February 25, 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 eommers 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). and Cosmetier for rely rely rely the device, subject to the general controls provisions of the Act. The r ou may : nerely provisions of the Act include requirements for annual registration, listing of General on on 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 cither class II (Special Controls) or class III (PMA). it your device is elassified to the major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA may found in the Gode of Peerients 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 complics with other requirements of the Act that I DA has made a determination that your federal agencies. You must comply or any I ederal statures and regularly, but not limited to: registration and listing (21 CFR with an the Fee I requirement (1): medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{3}------------------------------------------------
Page 2 - Mr. Franck Pennesi
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
| Food and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017 |
|---|---|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known)K140474 | |
| Device NameJUIIETROL Transforuminal Lumbar Cage | |
| ." " " " | |
| Indications for Use (Describe)JULIET & Lumbur Interbody Device is intervertebral body fusion procedures in skeletally inature patientswith degeneralive disc discase (DDD) at one or two contiguous levels from 12-S15/DDD is defined as discogenie backpain with degeneration of the dise confirmed by patient history and radiographic studies. These DDD patients may alsohave up to Grade I spondylolisthesis or retrolisthesis at the involved level (s); This device is to be used with autogenousbone graft. JULIETY & Lumbard to be used with supplemental lixation. Patients should have at least six(6) months of non-operative treatment prior to treatment with an intervertebral cage | |
| ﻬﺎ ﻓﻬﻮ | |
| Type of Use (Salect one or both, as applicable) | |
| 2 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| oncurrence of Center for Devices and Radiological Health (CDRH) (Signalure) | |
| Anton E. Dmitriev, | |
| 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 lime for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaffofda.hhs.gov | |
| *An agency may not conduct or sponsor. and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." |
.
.
.
.
·
the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the stat
.
§ 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.