(102 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of AI or ML.
Yes
The Tempus™ Cervical Plate System is intended for spinal fixation to treat various medical conditions like degenerative disc disease, trauma, and spinal stenosis, directly aiming to alleviate symptoms and improve the patient's condition.
No
The device description indicates that the Tempus™ Cervical Plate System is composed of screws and plates used for anterior cervical fixation. Its intended use is to treat various spinal conditions by physically stabilizing the cervical spine through fusion procedures. There is no mention of the device being used to identify or determine the nature of a disease or condition, which is the primary function of a diagnostic device.
No
The device description explicitly states that the system consists of screws and plates manufactured from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Tempus™ Cervical Plate System is a surgical implant consisting of plates and screws made of titanium alloy. It is designed to be surgically implanted into the cervical spine for fixation.
- Intended Use: The intended use is for anterior cervical fixation for various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical implant used for structural support and fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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 (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1)
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 Tempus™ Cervical Plate System has been tested in static axial compression bending, static torsion, and dynamic axial compression bending in accordance with ASTM F1717-11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The results of this nonclinical testing show that the updated Tempus™ Cervical Plate System is mechanically equivalent to the previously cleared Tempus™ Cervical Plate System.
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.
Tempus™ Cervical Plate System (K120515)
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
§ 888.3060 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
| Submitter's Name: | NeuroStructure, LLC |
|---|---|
| Submitter's Address: | 16 Technology Dr Ste 132 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800-352-6103 |
| Contact Name: | John Stephani |
| Date Summary was | |
| Prepared: | 10-May-13 |
| Trade or Proprietary Name: | Tempus™ Cervical Plate System |
| Common or Usual Name: | Spinal intervertebral body fixation orthosis |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Tempus™ Cervical Plate System (K120515) |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Tempus™ Cervical Plate System consists of screws and plates. Screws are available in a variety of diameter-length combinations. Plates are available in a variety of lengths to accommodate fusion procedures from one to five levels of the cervical spine. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Tempus™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate.
INDICATIONS FOR USE
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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 (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The indication for use for the updated Tempus™ Cervical Plate System is identical to that of the predicate, Tempus™ Cervical Plate System (K120515).
TECHNICAL CHARACTERISTICS
The plates and screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks.
Tempus™ Cervical Plate System Confidential
AUG 23 2013
1
The updated Tempus™ Plates are similar to the previously cleared devices.
PERFORMANCE DATA
The Tempus™ Cervical Plate System has been tested in static axial compression bending, static torsion, and dynamic axial compression bending in accordance with ASTM F1717-11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The results of this nonclinical testing show that the updated Tempus™ Cervical Plate System is mechanically equivalent to the previously cleared Tempus™ Cervical Plate System.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Tempus™ Cervical Plate System is substantially equivalent to the predicate device.
Tempus™ Cervical Plate System Confidential
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2013
NeuroStructures, LLC % Ms. Meredith May Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado springs, Colorado 80918
Re: K131374
Trade/Device Name: Tempus™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 31, 2013 Received: June 4, 2013
Dear Ms. May:
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
3
Page 2 - Ms. Meredith May
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/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 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,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Device Name: Tempus™ Cervical Plate System
The Tempus™ Cervical Plate System is intended for anterior cervical fixation (C2-TI) 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 (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use X Over-The-Counter Use Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Tempus™ Cervical Plate System Confidential
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