(60 days)
No
The summary describes a physical implantable device (interbody fusion device) and its mechanical testing, with no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is a lumbar interbody fusion device used to facilitate fusion in patients with degenerative disc disease, which is a therapeutic purpose.
No
This device is an intervertebral body fusion device, used for treatment (fusion procedures) rather than diagnosis.
No
The device description explicitly states it is a physical implant made of PEEK and Tantalum, intended for surgical implantation.
Based on the provided information, the JULIET® Lumbar Interbody Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- JULIET® Device Description: The description clearly states that the JULIET® Lumbar Interbody Device is a physical implant made of PEEK and Tantalum, designed to be placed between vertebrae during spinal fusion surgery.
- Intended Use: The intended use is for intervertebral body fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The JULIET® Lumbar Interbody Device is a surgical implant, not a diagnostic device.
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 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
Product codes
MAX
Device Description
The JULIET® PO are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®PO is made of PEEK Optima LT-1 conforming to ASTM F2026 with Tantalum markers conforming to ASTM F560.
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)
The following non-clinical tests were conducted on JULIET®PO: Static axial compression, Static shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267. Results demonstrate that JULIET®PO performs as safely and effectively as its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dynamik (Juliet® PO) Lumbar Interbody Fusion Cage (K081888), Juliet®OL Lumbar Interbody Fusion Cage by (K140474), Lucent® Intervertebral Body Fusion Device (K071724), Capstone® Lumbar Interbody Fusion Cage (K120368)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2014
Spineart Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de Pré-Bois - CP 1813 1215 Geneva - SWITZERLAND
Re: K142277
Trade/Device Name: JULIET® PO Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2014 Received: August 15, 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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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/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 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.
Ronald#Alean -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®PO
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)
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
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Traditional 510k
Juliet® PO
Image /page/3/Picture/2 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the text. The "a" in "spineart" is a different color than the rest of the text.
510(k) SUMMARY
| SPINEART | |
|---|---|
| Submitted by | International Center Cointrin |
| 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Contacts | Franck PENNESI Director of Industry & Quality |
| Phone : +41 22 5701246 Fax : +41 22 799 40 26 | |
| e-mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) | |
| e-mail : idrubaix@nordnet.fr | |
| Date Prepared | October 10th, 2014 |
| Common Name | Intervertebral body fusion device |
| Trade Name | JULIET® PO |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate device: Dynamik (Juliet® PO) Lumbar Interbody |
| Fusion Cage (K081888) by Spineart®; | |
| Additional predicates include: Juliet®OL Lumbar Interbody Fusion | |
| Cage by (K140474)Spineart®; Lucent® Intervertebral Body Fusion | |
| Device (K071724) by Spinal Elements®; Capstone® Lumbar | |
| Interbody Fusion Cage (K120368) by Medtronic® | |
| 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 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 | |
| Purpose of this submission | Line extension to the previously cleared system (Dynamik/Juliet® PO) |
| Lumbar Interbody Fusion Cage (K081888) | |
| Description of the | |
| device | The JULIET® PO are rectangle-shaped intervertebral body fusion |
| devices with a central cavity that can be filled with bone graft | |
| (autograft) to facilitate fusion. The JULIET®PO is made of PEEK | |
| Optima LT-1 conforming to ASTM F2026 with Tantalum markers | |
| conforming to ASTM F560. | |
| Technological | |
| Characteristics | The JULIET® PO are 22mm long devices available in four heights |
| (from 8 to 14 mm) and two lordosis (9° and 12°). The JULIET®PO 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®PO: Static |
| axial compression, Static shear compression according to ASTM | |
| F2077 and subsidence testing according to ASTM F2267. Results | |
| demonstrate that JULIET®PO performs as safely and effectively as its | |
| predicate devices. | |
| Conclusion | The JULIET® PO 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 demonstrates that JULIET®PO is substantially equivalent to | |
| predicate devices. |
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