(112 days)
ROMEO 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).
The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of Extension of the length range of pre-bent Rod Ø5.4mm (35, 45 and 55 mm) Extension of the length range of straight Rod Ø5.4mm (55 mm) Extension of the length range of transverse Connectors (20, 30 and 40 mm) Addition of iliac Connectors (Length 15, 20, 30, 40, 50 and 60 mm) Addition of axial Rod Connector, Parallel Rod Connector, Addition of Percutaneous pre-bent and straight titanium Rod Ø5.4 (Length 30 to 200 mm) These components are supplied either sterile or not sterile
The provided document is a 510(k) summary for a medical device called the ROMEO posterior osteosynthesis system. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing of the additional components. It does not describe a study about the performance of an AI/ML powered device, nor does it contain acceptance criteria or reported performance metrics typically associated with such devices.
Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI-powered device.
The "Performance data" section refers to:
- Acceptance Criteria/Standards: Conformity 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.
- Study: Mechanical testing including static axial compression, static torsion, and dynamic axial compression tests have been performed according to ASTM F1717-09.
- Reported Device Performance: "Results demonstrate that additional components perform as safely and effectively as their predicate devices."
This is, however, for the physical components of the spinal system, not for an AI/ML powered device.
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AUG 1 1 2011
510(k) SUMMARY
ﺮ
As required by section 807.92
| Submitter | SPINEARTInternational Center Cointrin 20 route de pré-bois CP18131215 GENEVA 15SWITZERLAND |
|---|---|
| Contacts | Franck PENNESI Director of Industry & QualityPhone : +41 22 799 40 25Fax : +41 22 799 40 26Mail : fpennesi@spineart.chRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr |
| Trade Name | ROMEO posterior osteosynthesis system |
| SPECIAL 510k | Modification to ROMEO posterior osteosynthesis system(Extension of range of products) |
| CFR section | 888.3070 |
| Classification Name | Pedicle screw spinal system |
| Class | II |
| Product Code | MNI orthosis, spinal pedicle fixation |
| Subsequent product codes | MNH orthosis, spondylolisthesis spinal fixationKWP Spinal interlaminal fixation orthosis |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | ELLIPSE posterior osteosynthesis system (K081165) andROMEO posterior osteosynthesis system (K093170 and K101678) manufactured by SPINEART |
| Description | The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of Extension of the length range of pre-bent Rod Ø5.4mm (35, 45 and 55 mm) Extension of the length range of straight Rod Ø5.4mm (55 mm) Extension of the length range of transverse Connectors (20, 30 and 40 mm) Addition of iliac Connectors (Length 15, 20, 30, 40, 50 and 60 mm) Addition of axial Rod Connector, Parallel Rod Connector, Addition of Percutaneous pre-bent and straight titanium Rod Ø5.4 (Length 30 to 200 mm) These components are supplied either sterile or not sterile |
| Intended Use | ROMEO posterior osteosynthesis system is intended toprovide immobilization and stabilization of spinal segmentsin skeletally mature patients as an adjunct to fusion in thetreatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar, and sacral spine: severespondylolisthesis (grades 3 and 4) of the L5-S1 vertebra;degenerative spondylolisthesis with objective evidence ofneurologic impairment; fracture; dislocation; scoliosis;kyphosis; spinal tumor; and failed previous fusion(pseudarthrosis). |
| Performance data | ROMEO posterior osteosynthesis additional componentsconforms to special control established for Pedicle screwspinal system and to « Spinal System 510(k)s - Guidancefor Industry and FDA Staff Document » issued on: May 3,2004.Mechanical testing including static axial compression, statictorsion and dynamic axial compression tests have beenperformed according to ASTM F1717-09. Resultsdemonstrate that additional components perform as safelyand effectively as their predicate devices. |
| Substantial equivalence | ROMEO posterior osteosynthesis system additionalcomponents are substantially equivalent to their predicatedevice in terms of intended use, material, design,mechanical properties and function.Non clinical performance testing according to special controldemonstrate that additional components are as safe, aseffective, and performs as safely and effectively as theirpredicate devices. |
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Preparation date, April 12, 2011
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Spineart % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 Route de Pre-Bois, CP 1813 1215 Geneva, Switzerland
AUG 1 1 2011
Re: K111127
Trade/Device Name: ROMEO Posterior Osteosynthesis System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: July 18, 2011 Received: July 20, 2011
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 usc 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.
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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm] 1 5809.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,
Mark N. Mello
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K111127 510(k) Number (if known): _ Device Name: ROMEO posterior osteosynthesis system Indications for Use:
ROMEO 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; spinal tumor; and failed previous fusion (pseudarthrosis).
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign (/)
(Diylsion Sign-O!) Difision of Surgit si, Orthopedic, and Restorative Devices
KIII27 510(k) Number_
§ 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.