(76 days)
No
The device description and performance studies focus on mechanical properties and surgical components, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for treating various instabilities or deformities, which aligns with the definition of a therapeutic device that aims to treat or alleviate a disease or condition.
No
The device is described as an osteosynthesis system intended to provide immobilization of spinal segments as an adjunct to fusion for treating various spinal conditions; it is a surgical implant designed for treatment, not diagnosis.
No
The device description explicitly states it comprises physical components like screws, rods, and connectors, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for providing immobilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The device description details physical components like screws, rods, and connectors, which are also consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is clearly intended for implantation within the body.
N/A
Intended Use / Indications for Use
The ROMEO® 2 Posterior Osteosynthesis System is intended to provide immobilization 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: degenerative disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the ROMEO® 2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO® 2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP
Device Description
The ROMEO 2 Posterior Osteosynthesis System comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors available in several sizes and models to accommodate different patient anatomies. ROMEO implantable components are single-use device provided sterile (gamma radiation) and supplied with dedicated 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
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
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)
The following non-clinical tests were conducted to demonstrate that the open Illiac Connector is substantially equivalent to its predicate device: Axial Rotation (rotation around the rod) and Axial Push Down (slipping along the rod) tests per ASTM F1798. Results demonstrate comparable mechanical properties to the predicate devices. It has been demonstrated that the ROMEO®2 Screw Line Extension range does not introduce new worst-case design and remains substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K081165, K093170, K093936, K101678, K111127, K112108, K130267, K140948, K151695
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2017
Spineart Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates Geneva. Switzerland
Re: K172101
Trade/Device Name: ROMEO® 2 Posterior Osteosynthesis System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: July 10, 2017 Received: July 12, 2017
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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 SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172101
Device Name
ROMEO® 2 Posterior Osteosynthesis System
Indications for Use (Describe)
The ROMEO® 2 Posterior Osteosynthesis System is intended to provide immobilization 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: degenerative disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the ROMEO® 2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO® 2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
2 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)
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510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | The purpose of this submission is to make modifications to the indications for use, to add |
| additional sizes and a new connector design to the ROMEO® 2 Posterior Osteosynthesis | |
| System cleared under K081165, K093170, K093936, K101678, K111127, K112108, K130267, | |
| K140948 and K151695 | |
| Submitted by | SPINEART |
| 3 Chemin du Pré Fleuri | |
| 1228 PLAN LES OUATES | |
| GENEVA SWITZERLAND | |
| Contacts | Franck PENNESI Chief Technical Officer |
| Phone : +41 22 570 1200 Fax : +41 22 594 8306 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | Revised September 8, 2017 |
| Common Name | Pedicle screw spinal system |
| Trade Name | ROMEO® 2 Posterior Osteosynthesis System |
| Classification Name | Thoracolumbosacral Pedicle Screw System |
| Class | II |
| Product Code | NKB, KWP |
| CFR section | 888.3070 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary predicate: ROMEO (Ellipse) Posterior Osteosynthesis System (K081165) manufactured by Spineart |
| Additional predicates: ROMEO Posterior Osteosynthesis System (K093170, K093936, K101678, K111127, K112108, K130267, K140948, K151695) manufactured by Spineart, | |
| Reform Pedicle Screw System (K143248) manufactured by Precision Spine, Inc and Xia (K142381) / Xia - Mantis (K133188) manufactured by Stryker Spine | |
| Indications for use | The ROMEO®2 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: degenerative disc disease; spondylolisthesis; fracture; | |
| dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion | |
| (pseudarthrosis).When used for posterior non-cervical pedicle screw fixation in pediatric | |
| patients, the ROMEO®2 Posterior Osteosynthesis System is indicated as an adjunct to | |
| fusion to treat adolescent idiopathic scoliosis. The ROMEO®2 Posterior Osteosynthesis | |
| System is intended to be used with autograft and/or allograft. Pediatric pedicle screw | |
| fixation is limited to a posterior approach |
4
| Description of the device | The ROMEO 2 Posterior Osteosynthesis System comprises polyaxial screws, monoaxial
screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods,
and various connectors available in several sizes and models to accommodate different
patient anatomies. ROMEO implantable components are single-use device provided sterile
(gamma radiation) and supplied with dedicated surgical instruments. |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics compared
to the predicate devices | The line extension to the ROMEO®2 Posterior Osteosynthesis System include additional
lengths of polyaxial Screws, additional lengths and diameters of spondylolisthesis
screws and addition of a new design of open Iliac Connector.
As was established in this submission through a side by side comparison, previously
cleared and added components included in the ROMEO Posterior Osteosynthesis
System are substantially equivalent and have the same technological characteristics
to predicate devices in areas including indications for use, function, material composition,
design, range of sizes and mechanical performance. |
| Discussion of Testing | The following non-clinical tests were conducted to demonstrate that the open Illiac
Connector is substantially equivalent to its predicate device: Axial Rotation (rotation
around the rod) and Axial Push Down (slipping along the rod) tests per ASTM F1798.
Results demonstrate comparable mechanical properties to the predicate devices.
It has been demonstrated that the ROMEO®2 Screw Line Extension range does not
introduce new worst-case design and remains substantially equivalent to the predicate
devices. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons,
indications for use, and non-clinical performance testing, the ROMEO 2 Posterior
Osteosynthesis System has demonstrated substantial equivalence to the identified
predicate devices. |