(28 days)
Not Found
No
The document describes a physical interbody fusion device and its mechanical testing, with no mention of AI or ML technology.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and is designed to aid in spinal fusion, which is a therapeutic intervention.
No
Explanation: The device description clearly states it is an "Interbody Device" used for fusion procedures in patients with degenerative disc disease. Its purpose is therapeutic (fusion), not diagnostic (identifying or characterizing a condition).
No
The device description explicitly states that the device is a physical implant made of PEEK and tantalum, which are hardware components. It is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- JULIET® OL Lumbar Interbody Device Function: The description clearly states that the JULIET® OL Lumbar Interbody Device is an implantable device used in surgical procedures to facilitate intervertebral body fusion in the lumbar spine. It is a physical device placed within the body.
- Intended Use: The intended use is for surgical treatment of degenerative disc disease, not for analyzing biological samples.
- Device Description: The device is described as a solid-machined piece made of PEEK, designed to be implanted.
- Input: While radiographic studies are used to assess the patient's condition and the placement of the device, the device itself does not process or analyze these images to provide a diagnosis.
The JULIET® OL Lumbar Interbody Device is a surgical implant used in the treatment of a specific medical condition, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 I 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
JULIET® range of products consists of lumbar Interbody cages available in various models to adapt to anatomical variations and surgical techniques. JULIET® OL cages are dedicated to transforaminal approach and are manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F0560 are used to visualize the position of the implant in the disc space. JULIET® OL Lumbar Interbody Devices are supplied either sterile or non sterile with a complete set of surgical instruments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing includes static axial compression performed according to ASTM F2077-03 and subsidence testing performed according to ASTM F2267-04. Results demonstrate that additional components perform as safely and effectively as their predicate devices.
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
510(k) SUMMARY
.JUL 1 6 2010
As required by section 807.92
| SPINEART | |
|---|---|
| Submitter | International Center Cointrin 20 route de pré-bois CP1813 |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Contacts | Franck PENNESI Director of Industry & Quality |
| Phone : +41 22 799 40 25 | |
| Fax : +41 22 799 40 26 | |
| Mail : fpennesi@spineart.ch | |
| Regulatory contact: Dr Isabelle DRUBAIX | |
| (Idée Consulting) idrubaix@nordnet.fr | |
| Preparation date | June 16, 2010 |
| Trade Name | JULIET® OL Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | MAX |
| CFR section | 21 CFR 888.3080 |
| Device panel | Orthopedic |
| Legally marketed predicate | DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE (K081888) |
| devices | manufactured by SPINEART. |
| SPECIAL 510k | JULIET OL - Extension of range of products |
| Description | JULIET® range of products consists of lumbar Interbody cages |
| available in various models to adapt to anatomical variations and | |
| surgical techniques. JULIET® OL cages are dedicated to | |
| transforaminal approach and are manufactured as single solid- | |
| machined piece made of PEEK conforming ASTM F2026. Markers | |
| made of tantalum conforming to ASTM F0560 are used to visualize | |
| the position of the implant in the disc space. | |
| JULIET® OL Lumbar Interbody Devices are supplied either sterile or | |
| non sterile with a complete set of surgical instruments. |
1
| Intended Use | 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 I 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. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | JULIET® OL Lumbar Interbody Device conforms to Class II Special
Controls Guidance Document: Intervertebral Body Fusion Device-
Document issued on: June 12, 2007.
Mechanical testing includes static axial compression performed
according to ASTM F2077-03 and subsidence testing performed
according to ASTM F2267-04. Results demonstrate that additional
components perform as safely and effectively as their predicate
devices. |
| Substantial equivalence | JULIET® OL Lumbar Interbody Device is substantially equivalent to
its predicate devices in terms of intended use, material, design,
mechanical properties and function. Non clinical performance
testing according to special control demonstrate that additional
components are as safe, as effective, and performs as safely and
effectively as their predicate devices. |
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and the comments of the comments of
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Revised July 16, 2010
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
· Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 16 2010
SPINEART
% Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de pre-bois, CP1813 1215 Geneva 15 Switzerland
Re: K101720
Trade/Device Name: JULIET® OL Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 16, 2010 Received: June 18, 2010
・・
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.
ff 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.
3
Page 2 - Mr. Franck Pennesi
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,
Carlan boyelum
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K101720
Device Name: JULIET® OL Lumbar Interbody Device
Indications For Use:
JULIET® OL 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 spondylolistesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. JULIET® OL 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KID1720 510(k) Number_
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