(59 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the immobilization of the cervical spine to treat various spinal conditions, such as degenerative disc disease, trauma, and tumor, which are therapeutic medical purposes.
No
The device is an anterior cervical plate system intended for surgical fusion of the cervical spine. While its indications are based on conditions often diagnosed radiographically, the device itself is a surgical implant designed for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of physical components (plates, bone screws) made from Ti-6Al-4V ELI, which are hardware implants.
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 a surgical implant system for stabilizing the cervical spine during fusion procedures. It is used in vivo (within the body) to provide structural support.
- Device Description: The description details physical components like plates, screws, and instruments made of titanium. These are surgical implants and tools, not reagents, kits, or instruments used to analyze biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The PreView-III™ Anterior Cervical Plate System is intended for the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). PreView-III™ Anterior Cervical Plate System is intended for use under the following indications degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture), tumor, deformity (i.e., kyphosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The PreView III™ Anterior Cervical Plate System is composed of the following components:
- Plates with preassembled locking rings
- Bone screws
These components can be assembled by associated instruments to provide immobilization of the cervical spine. All components made from Ti-6Al-4V ELI (ASTM F-136).
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
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 following mechanical performance tests were conducted per ASTM F1717:
- Static Compression Bending
- Static Torsion
- Dynamic Compression Bending
The results demonstrated that the subject device has substantially equivalent mechanical performance to predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
February 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".
Nexus Spine, LLC % Ms. Christine Scifert Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K223627
Trade/Device Name: PreView-III™ 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: December 1, 2022 Received: December 5, 2022
Dear Ms. Scifert:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K223627
Device Name PreView-III™ Anterior Cervical Plate System
Indications for Use (Describe)
The PreView-III™ Anterior Cervical Plate System is intended for the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). PreView-III™ Anterior Cervical Plate System is intended for use under the following indications degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture), tumor, deformity (i.e., kyphosis, and scoliosis), spinal stenosis, pseudoarthrosis, and 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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3
510(k) Summary
PreView-III™ Anterior Cervical Plate System January 31, 2023
| Company: | Nexus Spine, LLC
2825 East Cottonwood Parkway Suite 330
Salt Lake City, UT 84121 |
|--------------------|----------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert
Partner, MRC Global
Phone: (901) 831-8053
Email: christine.scifert@AskMRCGlobal.com |
| Trade Name: | PreView-III™ Anterior Cervical Plate System |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Panel: | Orthopedic |
| Product Code: | KWQ |
| Primary Predicate: | K062371 PreView Anterior Cervical Plate System, Alphaspine, Inc |
Device Description:
The PreView III™ Anterior Cervical Plate System is composed of the following components:
- Plates with preassembled locking rings
- . Bone screws
These components can be assembled by associated instruments to provide immobilization of the cervical spine. All components made from Ti-6Al-4V ELI (ASTM F-136).
Indications for Use:
The PreView III™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). The PreView III™ Anterior
4
Cervical Plate System is intended for use under the following indications degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture), tumor, deformity (i.e., kyphosis, lordosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.
Substantial Equivalence:
The subject components are substantially equivalent to the following predicate device:
- PreView Anterior Cervical Plate System, Alphaspine, Inc (K062371)
The subject components are substantially equivalent to the primary predicate device listed above in terms of intended use, materials of construction, principles of operation, and general design.
Performance Testing:
The following mechanical performance tests were conducted per ASTM F1717:
- . Static Compression Bending
- Static Torsion
- Dynamic Compression Bending
The results demonstrated that the subject device has substantially equivalent mechanical performance to predicate device.
Conclusion:
The data presented in this submission demonstrates that the subject PreView III™ Anterior Cervical Plate System is substantially equivalent to the predicate, Alphaspine, Inc, PreView Anterior Cervical Plate System (K062371).