(237 days)
Not Found
No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The product is a posterior osteosynthesis system intended for spinal fusion, which is a therapeutic intervention.
No
The device, ELLIPSE posterior osteosynthesis system, is an implant used for immobilization and stabilization of spinal segments, not for diagnosis.
No
The device description explicitly lists hardware components such as pedicular screws, spondylolistesis screws, longitudinal rods, transverse connector rods, connectors, and nuts, all made of TA6V4ELI. It also mentions surgical instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine in patients with specific conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a spinal fixation system (screws, rods, connectors, etc.) made of a specific material. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance study mentioned is mechanical testing, which is relevant for the structural integrity of an implant, not for diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ELLIPSE posterior osteosynthesis system does not fit this description.
N/A
Intended Use / Indications for Use
ELLIPSE Lumbar posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
ELLIPSE posterior osteosynthesis system is intended to use in the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed after the development of a solld fusion mass.
When use as a pedicle screw fixation system, ELLIPSE is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1- S1): degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Product codes
MNI, MNH, KWP
Device Description
ELLIPSE posterior osteosynthesis system includes pedicular screws, spondylolistesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ELLIPSE posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ELLIPSE components are supplied either sterile or not sterile and 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
thoracic, lumbar, and sacral spine, L5-S1 vertebra, non cervical spine, fifth lumbar - first sacral (L5-S1) vertebral joint, lumbar and sacral spine, thoracic, lumbar, and sacral spine (T1-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 was conducted per ASTM 1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYNERGY (K011437), XIA Spinal system (numerous 510k including K013823)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
$\qquad K08//165$
DEC 1 7 2008
.
.
510(k) Summary of Safety and EFFECTIVENESS
As required by section 807.92(c)
| Submitter | SPINEART
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 |
| Trade Name | ELLIPSE Lumbar posterior osteosynthesis system |
| Common Name | Pedicle screw spinal system |
| Classification Name | Pedicle screw spinal system |
| Device classification | 21 CFR 888.3070 |
| Product code | MNI, MNH, KWP |
| Legally marketed
predicate devices | SYNERGY (K011437) and XIA Spinal system (numerous
510k including K013823) |
| Description | ELLIPSE posterior osteosynthesis system includes |
| | pedicular screws, spondylolistesis screws longitudinal |
| | rods and transverse connector rods, connector and nut. |
| | All components of ELLIPSE posterior osteosynthesis |
| | system are made of TA6V4ELI conforming to ISO 5832.3 |
| | and ASTM F 136. |
| | ELLIPSE components are supplied either sterile or not |
| | sterile and with a complete set of surgical instruments. |
| Intended Use | ELLIPSE Lumbar posterior osteosynthesis system is |
| | intended to provide immobilization and stabilization of
spinal segments in skeletally mature patients as an |
| | adjunct to fusion in the treatment of the following acute |
| | and chronic instabilities or deformities of the thoracic, |
| | lumbar, and sacral spine: severe spondylolisthesis |
| | (grades 3 and 4) of the L5-S1 vertebra; degenerative |
| | spondylolisthesis with objective evidence of neurologic |
| | impairment; fracture; dislocation; scoliosis; kyphosis; |
| | spinal tumor; and failed previous fusion |
| | (pseudarthrosis). |
| | |
| Performance data | ELLIPSE Lumbar posterior osteosynthesis system |
| | conforms to special control established for Pedicle screw |
| | spinal system and to « Spinal System 510(k)s - |
| | Guidance for Industry and FDA Staff Document » issued |
| | on: May 3, 2004.
Mechanical testing was conducted per ASTM 1717 |
| Substantial
equivalence | ELLIPSE Lumbar posterior osteosynthesis system is |
| | substantially equivalent to its predicate devices in terms |
| | of intended use, material, design, mechanical properties
according to ASTM 1717 and function. |
Revised December 16, 2008
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spineart % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 Route de Pre-Bois CP1813 Geneva, Switzerland 1215
DEC 1 7 2008
Re: K081165
Trade/Device Name: ELLIPSE posterior osteosynthesis system Regulation Number: 21 CFR 888.2070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWP Dated: December 8, 2008 Received: December 10, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. Franck Pennesi
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
K081165 510(k) Number (if known): _ Device Name: ELLIPSE posterior osteosynthesis system Indications for Use:
ELLIPSE posterior osteosynthesis system is intended to use in the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed after the development of a solld fusion mass.
When use as a pedicle screw fixation system, ELLIPSE is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1- S1): degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
| Prescription Use | ✓ | Over-The-Counter Use |
|---|---|---|
| Part 21 CFR 801 Subpart AND/OR | (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of General Restorative,
and Neurological Devices
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| 510(k) Number | K081166 |
|---|---|
| --------------- | --------- |