(253 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the temporary stabilization of the anterior spine as an adjunct to fusion for a variety of medical conditions such as degenerative disc disease, trauma, and tumors, which are therapeutic purposes.
No
The device is an implantable plate intended for stabilization of the cervical spine, not for diagnosing medical conditions. Its intended use is for anterior screw fixation as an adjunct to fusion, not for diagnostic purposes.
No
The device description explicitly states it is a titanium alloy plate and bone screws, which are physical hardware components, not software.
Based on the provided information, 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 description clearly states that the Quantum Anterior Cervical Plate is a titanium alloy plate intended for anterior screw fixation to the cervical spine. It is a physical implant used in surgery.
- Intended Use: The intended use describes the surgical application of the device for stabilizing the spine during fusion.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze biological samples or perform any kind of diagnostic test.
Therefore, the Quantum Anterior Cervical Plate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical fusion in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis.
Product codes
KWQ
Device Description
The Quantum Anterior Cervical Plate is a titanium alloy plate, conforming to ASTM F3001, intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selfdrilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (08 mm - 110 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm. and 4.75 mm) and a variety of lengths (10 mm - 20 mm). Screws are made from titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
Indicated Patient Age Range
skeletally mature patients
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)
No FDA performance standards have been established for the Quantum Anterior Cervical Plate. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- · Static and dynamic compression (per ASTM F1717)
- · Static torsion (per ASTM F1717)
The results of these tests, as well as engineering analysis of device characteristics, indicate that the Quantum Anterior Cervical Plate is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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.
October 22, 2021
Analaura Villarreal-Berain Extremity Project Engineer 4590 Lockhill Selma San Antonio, Texas 78249
Re: K210424
Trade/Device Name: Quantum Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 9, 2021 Received: February 11, 2021
Dear Analaura Villarreal-Berain:
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
801and Part 809); 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, 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
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Indications for Use
510(k) Number (if known)
Device Name
Quantum Anterior Cervical Plate
K210424
Indications for Use (Describe)
The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical fusion in patients with:
·degenerative disc disease (as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors.
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
- · failed previous fusion,
- · spinal stenosis.
Type of Use (Select one or both, as applicable)
| ☑ Transaction Notified in STR-MAL Software Platform | □ Case File Created in STR-MAL Software Platform |
|---|---|
| --------------------------------------------------------------------------------------------------------------- | -------------------------------------------------- |
|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
DATE PREPARED
February 9, 2021
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Analaura Villarreal-Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: (210) 545-3713 ext. 109 Email: analauravillarreal@nvisionbiomed.com
PROPRIETARY NAME OF SUBJECT DEVICE
Quantum Anterior Cervical Plate
COMMON NAME
Anterior Cervical Plate
DEVICE CLASSIFICATION
Spinal intervertebral body fixation orthosis (21 CFR 888.3060, Product Code KWQ, Class II)
PREMARKET REVIEW
ODE/DOD/ASDB Orthopedic Panel
INDICATIONS FOR USE
The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
· spondylolisthesis.
- · trauma (i.e. fractures or dislocations),
- tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis.
4
- · failed previous fusion,
- spinal stenosis.
DEVICE DESCRIPTION
The Quantum Anterior Cervical Plate is a titanium alloy plate, conforming to ASTM F3001, intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selfdrilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (08 mm - 110 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm. and 4.75 mm) and a variety of lengths (10 mm - 20 mm). Screws are made from titanium alloy per ASTM F136.
PREDICATE DEVICE IDENTIFICATION
The Quantum Anterior Cervical Plate is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|---------------------------------------------------------------------|----------------------|
| K161524 | Tangis Anterior Cervical Plate / Nvision Biomedical
Technologies | ✓ |
| K151553 | Anterior Cervical Plate System / Osteomed Implantes, LTDA | |
| K031276 | ACLP System / Synthes Spine | |
The following reference devices are also cited in this submission:
- Nvision Biomedical's Multi-Drive Interference Screw System (K200428) ●
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Quantum Anterior Cervical Plate. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- · Static and dynamic compression (per ASTM F1717)
- · Static torsion (per ASTM F1717)
The results of these tests, as well as engineering analysis of device characteristics, indicate that the Quantum Anterior Cervical Plate is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the Quantum Anterior Cervical Plate is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K161524, K151553 and K031276. The subject device also has
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the same intended use, as well as similar technological characteristics (variable and fixed screws, screw locking features) as these predicates. The Indications for Use are equivalent and any minor differences in wording choices are insignificant. These technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the testing performed, including static compression, dynamic compression, static torsion as well as engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Quantum Anterior Cervical Plate are assessed to be substantially equivalent to the predicate devices.