(36 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).
When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO® posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Romeo® posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCrMo rods, and cross connectors. The Romeo® Polyaxial Screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. The modification to Romeo® posterior osteosynthesis system consists of the addition of a polyaxial pedicle screw 5 mm in diameter and 25 mm in length.
The provided document is a 510(k) summary for the SPINEART Romeo® posterior osteosynthesis system. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proof of meeting acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria and a study proving their fulfillment is largely not present in this document in the way it would be for a software-as-a-medical-device (SaMD) or a novel device requiring extensive performance testing against defined metrics.
However, I can extract the relevant information and explain why certain aspects of your request cannot be fully answered from this specific regulatory submission.
Explanation of Device and Regulatory Context:
The Romeo® posterior osteosynthesis system is a pedicle screw spinal system. The 510(k) submission (K140948) is for a modification to an existing, legally marketed device (Romeo® posterior osteosynthesis system, K101678, and Ellipse posterior osteosynthesis system, K081165). The modification specifically involves the addition of a polyaxial pedicle screw with a 5 mm diameter and 25 mm length.
For this type of modification, the focus of the regulatory review is on demonstrating that the new component (the added screw) does not introduce new questions of safety or effectiveness and remains substantially equivalent to the predicate devices. This is primarily done through material, design, and mechanical property comparisons, often supported by bench testing (mechanical and material characterization). Clinical studies are typically not required unless the modification significantly alters the fundamental scientific technology or poses new clinical risks.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like one would see for a diagnostic device or an AI algorithm. Instead, the "acceptance criteria" for this type of device modification would relate to its physical and mechanical properties being comparable to, or exceeding, those of the predicate devices and relevant industry standards.
| Acceptance Criteria (Implied from Regulatory Context) | Reported Device Performance (from K140948 Summary) |
|---|---|
| Material Conformance | Romeo® pedicle screws are made of Titanium Ta6V Eli grade conforming to ASTM F136. |
| Mechanical Performance | The submission states: "Verification Activity and Validation Activity demonstrate that the added polyaxial pedicle screw is as safe, as effective, and performs at least as safely and effectively as its predicates polyaxial pedicle screws (K081165 & K101678)." It also notes conformance to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document” issued on May 3, 2004. Note: Specific quantitative mechanical test results (e.g., fatigue strength, torsional strength) are not provided in this summary, but would have been part of the full 510(k) submission. The conclusion implies these tests were performed and met equivalence to the predicate. |
| Design, Function & Intended Use | "The extended range of Romeo® posterior osteosynthesis system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function." |
| Biocompatibility | Implied by the use of ASTM F136 compliant Titanium which is a well-established biocompatible material for implants. |
| Sterilization | Delivered either sterile (gamma sterilization) or not sterile. (Demonstrates acceptable sterilization methods are applied). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable in the context of this device and submission. There was no "test set" of patient data in the sense of clinical images or outcomes for an AI/diagnostic device. The testing mentioned refers to mechanical and material testing of the physical screw.
- Data Provenance: Not applicable. The "data" pertains to engineering and material specifications, and mechanical test results, not clinical data from patients.
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):
- Number of Experts & Qualifications: Not applicable. Ground truth, in the context of diagnostic performance (e.g., for AI), is not relevant here. The "ground truth" for a mechanical implant relates to engineering specifications and performance standards. Engineers, material scientists, and biomechanical experts would be involved in designing and testing such a device, but not in establishing "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. There was no diagnostic "test set" requiring adjudication.
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:
- MRMC Study: No. This is a spinal implant, not an AI-assisted diagnostic device. Therefore, no MRMC study was performed, and there is no "effect size of human readers improving with AI."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this device's performance is based on established mechanical testing standards (e.g., those referenced in the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document") and material specifications (e.g., ASTM F136 for Titanium Ta6V Eli grade). The conclusion states that "Verification Activity and Validation Activity" demonstrate performance, indicating these engineering benchmarks were met.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that uses a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.
Summary regarding the Study:
The "study" referenced in the document is the set of Verification Activity and Validation Activity which would typically encompass:
- Material Characterization: Ensuring the Titanium alloy meets ASTM F136.
- Mechanical Bench Testing: Such as static and fatigue testing of the screw, screw-rod assembly, and potentially the construct, compared against the predicate devices and relevant ASTM/ISO standards. This includes evaluating parameters like pull-out strength, bending stiffness, torsional strength, and fatigue life.
- Biocompatibility Assessment: Primarily by demonstrating the material's compliance with established standards for implantable materials.
- Sterilization Validation: If provided sterile, ensuring the gamma sterilization process is effective for the device.
The conclusion of the 510(k) states that these activities successfully demonstrated that the added polyaxial pedicle screw is "as safe, as effective, and performs at least as safely and effectively as its predicates polyaxial pedicle screws." This means the testing showed equivalence to the previously cleared devices, satisfying the regulatory requirement for this specific type of modification.
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K140948
Page 1 of 2
510(k) SUMMARY
MAY 2 0 2014
| SPINEART | |
|---|---|
| Submitted by | International Center Cointrin |
| 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Franck PENNESI Director of Industry & Quality | |
| Phone : +41 22 799 40 25 Fax : +41 22 799 40 26 | |
| Contacts | Mail : fpennesi@spineart.com |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) | |
| idrubaix@nordnet.fr | |
| Date Prepared | April 9th 2014 |
| Common Name | Pedicle screw spinal system |
| Trade Name | Romeo® posterior osteosynthesis system |
| Classification Name | Pedicle screw spinal system |
| Class | II |
| Product Code | MNH, MNI |
| CFR section | 888.3070 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Ellipse posterior osteosynthesis system (K081165) and Romeo® posterior osteosynthesis system (K101678) |
| Indications for use | Romeo® posterior osteosynthesis system is intended to provideimmobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of thethoracic, lumbar, and sacral spine: severe spondylolisthesis (grades3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis withobjective evidence of neurologic impairment; fracture; dislocation;scoliosis; kyphosis; spinal tumor; and failed previous fusion(pseudarthrosis).When used as a posterior, non-cervical, non-pedicle screw fixationsystem, Romeo® posterior osteosynthesis system is intended forthe following indications: degenerative disc disease (DDD) (definedas back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies); spondylolisthesis;trauma (i.e., fracture or dislocation); spinal stenosis; curvatures(i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis;and failed previous fusion. |
| Description of the device | The Romeo® posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCrMo rods, and cross connectors. The Romeo® Polyaxial Screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. The modification to Romeo® posterior osteosynthesis system consists of the addition of a polyaxial pedicle screw 5 mm in diameter and 25 mm in length. |
| TechnologicalCharacteristics | Romeo® pedicle screws are made of Titanium Ta6V Eli grade conforming to ASTM F136. Romeo® pedicle screws are delivered either sterile (gamma sterilization) or not sterile and supplied with dedicated surgical instruments (reusable – provided non sterile). |
| Discussion of Testing | 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. No additional testing has been performed for the added polyaxial pedicle screw. |
| Conclusion | The extended range of Romeo® posterior osteosynthesis system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. Verification Activity and Validation Activity demonstrate that the added polyaxial pedicle screw is as safe, as effective, and performs at least as safely and effectively as its predicates polyaxial pedicle screws (K081165 & K101678). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
Spineart Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de pré-bois. CP 1813 1215 Geneva 15 SWITZERLAND
Re: K140948
· 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: MNH, MNI Dated: April 22, 2014 Received: April 25, 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
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device-related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/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/McdicalDevices/Safetv/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -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 SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K140948 |
|---|---|
| Device Name | ROMEO® posterior osteosynthesis system |
| Indications for Use (Describe) | 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 1.5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor, and failed previous fusion (pseudarthrosis).When used as a posterior, non-cervical, non-pedicle screw, fixation system, ROMEO posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion |
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) | James P. Bertram-S |
| 2014.05.19 14:42:28 -04'00' |
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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.