(49 days)
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No
The summary describes a mechanical implant system and its mechanical testing, with no mention of AI or ML.
Yes
The device is described as providing "temporary stabilization during the development of cervical spinal fusion" for various medical conditions, indicating its role in treating diseases or injuries.
No
Explanation: The device is an implantable medical device (plate and screws) used for stabilization during spinal fusion, not for diagnosing conditions.
No
The device description explicitly states that the system consists of screws and plates made from Titanium alloy, 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 clearly states that the device is for "anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The device is described as consisting of "screws and plates" made from "Titanium alloy." These are physical implants.
- 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.
The Curiteva Anterior Cervical Plate System is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Curiteva Anterior Cervical Plate System is interior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine (C2-T1)
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Curiteva Anterior Cervical Plate System was mechanically tested in the following test modes: static and dynamic compression bend per ASTM F1717, static torsion per ASTM F1717, and axial screw pushout.
The results of this non-clinical testing show that the strength and performance of the Curiteva Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2018
Curiteva, LLC Mr. Eric Linder Chief Operating Officer 25127 Will McComb Drive, Suite 100 Tanner, Alabama 35671
Re: K181562
Trade/Device Name: Curiteva Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 13, 2018 Received: June 14, 2018
Dear Mr. Linder:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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Indications for Use
510(k) Number (if known) K181562
Device Name
Curiteva Anterior Cervical Plate System
Indications for Use (Describe)
The Curiteva Anterior Cervical Plate System is interior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
A. Submitter Information
| Submitter: | Curiteva, LLC
25127 Will McComb Drive, Suite 100
Tanner, AL 35671
Phone: (256) 213-1057
Fax: (256) 213-1058 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eric Linder
regulatory@curiteva.com |
| Date Prepared: | August 2, 2018 |
B. Device Information
| Trade Name: | Curiteva Anterior Cervical Plate System |
|---|---|
| Common Name: | Anterior Cervical Plate System |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Device Classification: | Class II (per 21 CFR 888.3060) |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |
| Predicate Device(s): | Primary: Synthes Anterior CSLP System - K030866 |
| Additional: DeGen Medical Hyper-C Anterior Cervical Plate | |
| System -- K150759 |
C. Device Description
The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
D. Indications for Use
The Curiteva Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient
4
history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
E. Technological Characteristics
As was established in this submission, the subject Curiteva Anterior Cervical Plate System 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 to have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
F. Performance Data
The Curiteva Anterior Cervical Plate System was mechanically tested in the following test modes: static and dynamic compression bend per ASTM F1717, static torsion per ASTM F1717, and axial screw pushout.
The results of this non-clinical testing show that the strength and performance of the Curiteva Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
G. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Curiteva Anterior Cervical Plate System has been shown to be substantially equivalent to legally marketed predicate devices.