(43 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation device and does not mention any AI or ML components or functions.
Yes
The device is described as a "spinal fixation device to provide support and stabilization of the cervical vertebrae" and is indicated for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumors, which are all treated medical conditions.
No
The device description clearly states its function as a "spinal fixation device to provide support and stabilization of the cervical vertebrae," which is a treatment, not a diagnostic, function. The intended use also lists various conditions for which the device is used for fixation, further indicating its therapeutic purpose.
No
The device description clearly states it consists of physical components (plates and screws made of titanium and cobalt chrome) and functions as a spinal fixation device, which is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for anterior screw fixation to the cervical spine for various spinal conditions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a spinal fixation device consisting of plates and screws. These are implants designed to provide structural support to the spine.
- Function: The function is to provide support and stabilization of the cervical vertebrae. This is a mechanical function within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis), and deformity (defined as scoliosis, kyphosis or lordosis).
Product codes
KWQ
Device Description
The Pyrenees Cervical Plate System consists of plates and screws made of titanium alloy (Ti-6Al-4V per ASTM F1472 and Ti-6Al-4V ELI per F136) and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs and the screws are fixed or variable. The subject 510(k) adds screws with a cobalt chrome component (per ASTM F1537) to the system. The Pyrenees system components are provided non-sterile.
Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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 predicate and subject Pyrenees implants were tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717. An engineering analysis determined that the modifications to the screws did not represent a new worst case.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2015
K2M, Incorporated Ms. Nancv Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175
Re: K152281
Trade/Device Name: Pyrenees Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 25, 2015 Received: August 26, 2015
Dear Ms. Giezen:
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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152281
Device Name Pyrenees Cervical Plate System
Indications for Use (Describe)
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis), and deformity (defined as scoliosis, kyphosis or lordosis).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY Pyrenees Cervical Plate System
Submitter
K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 571-9192000 Date Prepared: 09/23/2015
Classification
Pyrenees Cervical Plate System Trade Name: Common Name: Spinal Fixation System Regulatory Class: Class II
Classification Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code KWQ)
Predicate Device(s)
Primary Predicate: K2M Pyrenees Cervical Plate System (K092474) Additional Predicates: K2M Pyrenees Cervical Plate System (K063544)
Device Description
The Pyrenees Cervical Plate System consists of plates and screws made of titanium alloy (Ti-6Al-4V per ASTM F1472 and Ti-6Al-4V ELI per F136) and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs and the screws are fixed or variable. The subject 510(k) adds screws with a cobalt chrome component (per ASTM F1537) to the system. The Pyrenees system components are provided non-sterile.
Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.
Intended Use
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
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Technological Comparison to Predicate(s)
The Pyrenees Cervical Plate System was compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.
Non-clinical Performance Evaluation
The predicate and subject Pyrenees implants were tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717. An engineering analysis determined that the modifications to the screws did not represent a new worst case.
Conclusion
There are no significant differences between the Pyrenees Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.