(43 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 provided text 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 through mechanical testing, rather than clinical performance based on diagnostic accuracy. Therefore, many of the requested categories related to diagnostic studies and expert-driven ground truth are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to special control established for Pedicle screw spinal system. | Additional components conform to special control established for Pedicle screw spinal system. |
| Conforms to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on: May 3, 2004. | Additional components conform to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on: May 3, 2004. |
| Performs as safely and effectively as their predicate devices based on mechanical testing (static axial compression, static torsion, dynamic axial compression) conducted according to ASTM F1717-09. | Results of mechanical testing (static axial compression, static torsion, dynamic axial compression tests performed according to ASTM F1717-09) demonstrate that additional components perform as safely and effectively as their predicate devices. |
| Substantially equivalent to predicate device in terms of intended use, material, design, mechanical properties, and function. | ROMEO posterior osteosynthesis system additional components are substantially equivalent to their predicate device in terms of intended use, material, design, mechanical properties and function. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This study involves mechanical testing of device components, not a test set of patient data.
- Data Provenance: Not applicable. The data comes from mechanical test reports on the device components, not from patient populations or countries of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in this context refers to engineering specifications and performance standards (ASTM F1717-09, FDA guidance), not expert interpretation of diagnostic images or patient outcomes.
4. Adjudication method for the test set
- Not applicable. There was no need for adjudication as the study did not involve interpretation of test results by multiple human readers.
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. This is not an AI-assisted diagnostic device; it is a spinal implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithmic device. The "standalone" performance refers to the mechanical integrity of the device components themselves.
7. The type of ground truth used
- The ground truth in this submission is the mechanical performance standards defined by ASTM F1717-09 and the FDA's "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document." The device effectively measures up against these established engineering and regulatory benchmarks.
8. The sample size for the training set
- Not applicable. There is no training set of data for this type of device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
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510(k) SUMMARY
As required by section 807.92
JUL 2 8 2010
| 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) manufactured by SPINEART |
| Description | The modifications to ROMEO posterior osteosynthesis system (K081165 & K093170) manufactured by SPINEART consist of addition of 4.0 and 8.0 mm in diameter polyaxial screws made of titanium alloy, addition of Cobalt Chrome alloy rods, and extension of length range for other screw diameter and rods. |
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| 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. |
Revised July 16, 2010
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the wings and body. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 8 2010
Spineart % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de pre-bois CP1813 1215 Geneva 15, Switzerland
Re: K101678
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 19, 2010 Received: July 20, 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.
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/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,
Валал Омеша
Mark N. Me 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
1161678
K101678 510(k) Number (if known): Device Name: ROMEO posterior osteosynthesis system Indications for Use:
JUL 2 8 2010
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-Ci Division of Surgical, Orthopedic, Restorative Devices
510(k) Number.
N/A