(28 days)
No
The summary describes a mechanical anterior cervical plating system and its associated instruments. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on mechanical properties and substantial equivalence to predicate devices.
Yes
The device is intended for anterior screw fixation of the cervical spine for various indications like degenerative disc disease, trauma, tumors, and deformity, which are therapeutic purposes. It is an implantable system designed to treat conditions rather than diagnose them.
No
The device is an anterior cervical plating system designed for surgical fixation of the cervical spine, not for diagnosing medical conditions. Its function is to treat various spinal pathologies through physical implantation, not to provide diagnostic information.
No
The device description explicitly states it consists of "a variety of implant components including screws and plates, as well as associated manual general surgical instruments." This indicates it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "anterior screw fixation of the cervical spine C2-C7". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments." These are physical implants and surgical tools used during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform such tests.
The information provided describes a surgical implant system used for spinal fusion, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NuVasive ACP System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3. The NuVasive ACP System was initially cleared in K191500. In K191500, static torsion results were included for the predicate NuVasive ACP System. The tested construct varied slightly in design from the cleared device. After clearance, confirmatory ASTM F1717 mechanical testing was completed on the cleared design, which revealed lower results in static torsion. The purpose of this submission is to present the lower static torsion test values of the subject NuVasive ACP System, which remain greater than Helix Mini ACP System (K073275), the cited predicate for static torsion, in K191500. Additionally, minor design changes and a labeling update to the system are presented. The design changes are minor updates to the system since clearance in K191500. Select changes have been implemented via the add to file process. Additional design updates are also being presented, which will be implemented pending review of the subject submission.
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)
Nonclinical testing was performed to demonstrate that the subject NuVasive ACP System is substantially equivalent to other predicate devices. The following testing was performed:
- o Static torsion, static compression bending, and dynamic compression bending testing per ASTM F1717
In addition to the testing above, Finite Elemental Analysis and engineering rationales were used to establish that the minor design updates introduced did not create a new worst case.
The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.
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.
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
Mav 20, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
NuVasive, Incorporated Ivanna Lopez Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K201078
Trade/Device Name: NuVasive® ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 21, 2020 Received: April 22, 2020
Dear Ivanna Lopez:
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,
for
Colin O'Neill, M.B.E. Acting 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)
K201078
Device Name NuVasive® ACP System
Indications for Use (Describe)
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
| 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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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left, with the top portion in purple and the bottom portion in gray. To the right of the leaf shape is the word "NUVASIVE" in gray, with a trademark symbol next to it. The logo is clean and modern, with a focus on the company name.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
A. Submitted by:
Ms. Ivanna Lopez Specialist. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (858) 909-3302
Date Prepared: May 19, 2020
B. Device Name
| Trade or Proprietary Name: | NuVasive® ACP System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject NuVasive ACP System is substantially equivalent to the following devices:
Primary Predicate
D. Device Description
The NuVasive ACP System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3. The NuVasive ACP System was initially cleared in K191500. In K191500, static torsion results were included for the predicate NuVasive ACP System. The tested construct varied slightly in design from the cleared device. After clearance, confirmatory ASTM F1717 mechanical testing was completed on the cleared design, which revealed lower results in static torsion. The purpose of this submission is to present the lower static torsion test values of the subject NuVasive ACP System, which remain greater than Helix Mini ACP System (K073275), the cited predicate for static torsion, in K191500. Additionally, minor design changes and a labeling update to the system are presented. The design changes are minor updates to the system since clearance in K191500. Select changes have been implemented via the add to file process. Additional design updates are
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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is purple on the top and gray on the bottom. The logo is simple and modern.
also being presented, which will be implemented pending review of the subject submission.
E. Indications for Use
The NuVasive ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
F. Technological Characteristics
As was established in this submission, the subject NuVasive ACP 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 have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject NuVasive ACP System is substantially equivalent to other predicate devices. The following testing was performed:
- o Static torsion, static compression bending, and dynamic compression bending testing per ASTM F1717
In addition to the testing above, Finite Elemental Analysis and engineering rationales were used to establish that the minor design updates introduced did not create a new worst case.
The results of these studies show that the subject NuVasive ACP System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive ACP System has been shown to be substantially equivalent to legally marketed predicate devices.