(117 days)
No
The summary describes a mechanical spinal fixation system and its performance in mechanical testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is intended for anterior screw fixation to the cervical spine for various medical conditions like degenerative disc disease, trauma, and tumors, and functions as an adjunct to fusion for immobilization of spinal segments. These uses clearly indicate a therapeutic purpose.
No
The device is a spinal fixation system intended to provide immobilization as an adjunct to fusion, not to diagnose medical conditions.
No
The device description explicitly states it consists of cervical screws and plates, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "anterior screw fixation to the cervical spine (C2-C7)" 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 system which consists of cervical screws and plates." These are physical implants used to stabilize the spine.
- Function: The function is to "provide immobilization of cervical segments of the spine" as an adjunct to fusion. This is a mechanical function within the body.
IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Pyrenees and K2M Cervical Plate Systems are surgical implants used in vivo (within the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Pyrenees and 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), 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 is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.
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
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 Pyrenees Cervical Plate System was mechanically tested and compared to the predicate systems and other currently marketed systems. The Pyrenees system performed equally to or better than these systems in static torsion, dynamic compression, and static tension testing per ASTM F1717. The design features and sizing of the components were also compared and the Pyrenees Cervical Plate System found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063544, K971883, K000536, K051665
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.
0
AUG 1 7 2011
510(k) Summary for the
Pyrenees Cervical Plate System, Translational Plate
This safety and effectiveness summary for the System is provided as required per Section 513(i(i(i) of the Food, Drug and Cosmetic Ast.
| 1. Submitter :
K2M, Inc.
751 Miller Drive SE,
Suite F1
Leesburg, VA 20175
Date Prepared: April 21, 2011 | Contact Person :
Nancy Giezen
K2M, Inc.
751 Miller Drive SE
Leesburg, VA 20175
Telephone: 703-777-315 |
| ---------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------- |
|---|
| 2. Tradename: | Pyrenees Cervical Plate System 510(k), Translational Plate |
|---|---|
| Common Name: | Spinal Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (888.3060) |
| Product Code: | KWQ |
| Device Class: | II |
3. Predicate or legally marketed devices which are substantially equivalent :
- Pyrenees Cervical Plate System ( K2M, Inc. ) K063544 .
- . Cervical Spine Locking Plate (Synthes) K971883, K000536
- . Vectra-T (Synthes) K051665
4. Description of the device :
The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.
5. Intended Use:
The Pyrenees and 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), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scollosis, kyphosis or lordosis).
6. Comparison of the technological characteristics of the device to predicate and legally marketed
devices :
The Pyrenees Cervical Plate System was mechanically tested and compared to the predicate systems and other currently marketed systems. The Pyrenees system performed equally to or better than these systems in static torsion, dynamic compression, and static tension testing per ASTM F1717. The design features and sizing of the components were also compared and the Pyrenees Cervical Plate System found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems.
There are no significant differences between the Pyrenes Cervical Plate Systems currently being marketed. It is substantially equivalent to these other devices in design, function, material and intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175
AUG 17 2011
Re: K111135
Trade/Device Name: Pyrenees Cervical Plate System, Translational Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 19, 2011 Received: July 20, 2011
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
2
Page 2 - Ms. Nancy Giezen
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/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 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
Mark N. Mellema
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KITI 113 S
Indications for Use
510(k) Number: Pending
Device Name: Pyrenees Cervical Plate System, Translational Plates
Indications for Use:
The Pyrenees and 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), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
Prescription Use X (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 C
(Division Sign-() Division of Surgical, Orthopedic, and Restorative ﺗﺤﺘﺎﺭ ﻴﻨﺎ ﻋ
510(k) Number_ KIIII 35