(76 days)
Not Found
No
The device description focuses on mechanical components and their function, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for use as an adjunct to fusion in the lumbar spine to achieve stabilization in patients with various spinal conditions, indicating it is used for treatment and rehabilitation.
No
The device is described as a "posterior, non-pedicle supplemental fixation device" and a "Spinous Process Fixation device" intended for "achieving stabilization as an adjunction to fusion." Its function is mechanical stabilization, not diagnosis.
No
The device description clearly states it is a physical implantable device made of titanium components (plates, cylinder, spikes) and includes dedicated surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The ROMEO®2 PAD is a physical implantable device designed to provide mechanical stabilization to the spine. It is surgically implanted and does not involve testing biological samples.
- Intended Use: The intended use clearly states it's a "posterior, non-pedicle supplemental fixation device" used as an "adjunct to fusion" in the lumbar spine. This describes a surgical implant for structural support, not a diagnostic test.
Therefore, the ROMEO®2 PAD falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization as an adjunction to fusion in patients with degenerative disc disease - 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) and /or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended for standalone use.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
The ROMEO®2 PAD is a Spinous Process Fixation device consisting of two titanium plates linked by a titanium cylinder that is used to perform immobilization of spinous processes of adjacent vertebras and thus provide supplemental stabilization of spinal segments to facilitate fusion. The device is locked and secure automatically at the same time. The plates include spikes on their opposing faces to provide attachment to bone. The mobile plate can translate along the titanium cylinder and includes some features that insure continuous locking at any position. The locking anti-back-out system maintains the plates in the desired position and pressed firmly against the spinous processes. The ROMEO®2 PAD is available in a range of sizes to fit the anatomical needs of a variety of patients. Components are provided pre-assembled and delivered sterile (gamma sterilization) with dedicated surgical instruments (reusable – provided non sterile).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L1-S1)
Indicated Patient Age Range
Not Found
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)
Discussion of Testing
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.
K102195, K112592, K130438, K071877, K092536, K073278, K131238, K032037
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.
Not Found
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The profiles are stacked slightly on top of each other, creating a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 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: K141508
Trade/Device Name: ROMEO® 2 PAD Posterior Axial Device Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: June 5, 2014 Received: June 6, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/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 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 yours.
Ronaldf�@Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141508
Device Name
ROMEO®2 PAD Posterior Axial Device
Indications for Use (Describe)
The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization as an adjunction to fusion in patients with degenerative disc disease - 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) and /or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended for standalone use.
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Traditional 510k ROMEO®2 PAD Posterior Axial Device
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510(k) SUMMARY
| Submitted by | SPINEART
International Center Cointrin
20 route de pré-bois
CP1813
1215 GENEVA 15
SWITZERLAND |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality
Phone : +41 22 799 40 25 Fax : +41 22 799 40 26
Mail : fpennesi@spineart.com
Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)
idrubaix@nordnet.fr |
| Date Prepared | August 18th 2014 |
| Common Name | Spinous Process Plate |
| Trade Name | ROMEO®2 PAD Posterior Axial Device |
| Classification Name | Spinal interlaminal fixation orthosis |
| Class | II |
| Product Code | PEK |
| CFR section | 888.3050 |
| Device panel | Orthopedic |
| Legally marketed
predicate devices | SP-Fix® by Globus Medical (K102195); Axle® System by X-Spine
(K112592, K130438); Spinous Process Fusion Plate by Lanx
(K071877, K092536); Affix® spinous Process Plate by NuVasive
(K073278, K131238) and Spire® Spinous Process Plate by Medtronic
(K032037). |
| Indications for use | The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle
supplemental fixation device, intended for use as an adjunct to fusion
at a single level in the lumbar spine (L1-S1). It is intended for
attachment to the spinous processes for the purpose of achieving
stabilization as an adjunction to fusion in patients with degenerative
disc disease - 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) and
/or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended
for standalone use. |
4
| Description of the device | The ROMEO®2 PAD is a Spinous Process Fixation device consisting of
two titanium plates linked by a titanium cylinder that is used to |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | perform immobilization of spinous processes of adjacent vertebras
and thus provide supplemental stabilization of spinal segments to
facilitate fusion. The device is locked and secure automatically at the
same time. |
| Technological
Characteristics | The plates include spikes on their opposing faces to provide
attachment to bone. The mobile plate can translate along the
titanium cylinder and includes some features that insure continuous
locking at any position. The locking anti-back-out system
maintains the plates in the desired position and pressed firmly
against the spinous processes. The ROMEO®2 PAD is available in a
range of sizes to fit the anatomical needs of a variety of patients.
Components are provided pre-assembled and delivered sterile
(gamma sterilization) with dedicated surgical instruments (reusable –
provided non sterile).
As was established in this submission, the subject ROMEO®2 PAD is
substantially equivalent to other predicate devices cleared by the FDA
for commercial distribution in the United States. The subject device
was shown to be substantially equivalent and have equivalent
technological characteristics to its predicate devices through
comparison in areas including design, labeling/intended use, material
composition, mechanical performance and function. |
| | Discussion of Testing |