(28 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).
ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments
The provided text describes a medical device, the "ROMEO posterior osteosynthesis system," and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria, device performance metrics, or any associated study data (sample sizes, ground truth establishment, expert qualifications, etc.).
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The output will reflect this lack of information for each requested point.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states "ROMEO 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." This refers to general regulatory controls and guidance, not specific quantified performance acceptance criteria for this particular device. | Not provided in the document. The document asserts "ROMEO posterior osteosynthesis system is substantially equivalent to its predicate device in terms of intended use, material, design, mechanical properties and function," implying performance similar to the predicate, but no specific performance metrics are reported. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical or performance study with a test set that would involve sample sizes or data provenance. The clearance is based on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving ground truth establishment by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication for a test set.
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. The document is for a physical medical device (osteosynthesis system) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document is for a physical medical device and does not describe an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a study that utilized ground truth.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm or a study with a training phase.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or its ground truth establishment.
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K043110 Page \frac{1}{2}
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
| NOV - 4 | 2009 |
|---|---|
| --------- | ------ |
| Submitter | SPINEARTInternational Center Cointrin 20 route de pré-boisCP18131215 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 (IdéeConsulting) idrubaix@nordnet.fr |
| Trade Name | ROMEO posterior osteosynthesis system |
| SPECIAL 510k | Modification to ELLIPSE posterior osteosynthesissystem |
| 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 |
| CFR section | 888.3070 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | ELLIPSE posterior osteosynthesis system(K081165) manufactured by SPINEART |
| Description | ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut.All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136.ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments |
| Intended Use | ROMEO posterior osteosynthesis system is intendedto provide immobilization and stabilization of spinalsegments in skeletally mature patients as anadjunct to fusion in the treatment of the followingacute and chronic instabilities or deformities of thethoracic, lumbar, and sacral spine: severespondylolisthesis (grades 3 and 4) of the L5-S1vertebra; degenerative spondylolisthesis withobjective evidence of neurologic impairment;fracture; dislocation; scoliosis; kyphosis; spinaltumor; and failed previous fusion (pseudarthrosis). |
| Performance data | ROMEO posterior osteosynthesis system conformsto special control established for Pedicle screwspinal system and to « Spinal System 510(k)s -Guidance for Industry and FDA Staff Document »issued on: May 3, 2004. |
| Substantialequivalence | ROMEO posterior osteosynthesis system issubstantially equivalent to its predicate device interms of intended use, material, design, mechanicalproperties and function. |
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Preparation date, September 30, 2009
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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 image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 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 15 Switzerland
NOV - 4 2009
Re: K093170
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: October 5, 2009 Received: October 7, 2009
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 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
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Page 2 - Mr. Franck Pennesi
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/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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. I
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/cdrh/industry/support/index.html.
Sincerely vours.
Neil R.P. Gyle
Mark N. Melkerson 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
K-093190 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 AND/OR D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
83
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OF NEEDED) ·
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Surgical. Orthopedic, and Restorative Devices |
| 510(k) Number | K093170 |
|---|---|
| --------------- | --------- |
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§ 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.