(29 days)
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.
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, and lower static torsion test values were presented in K201078. The purpose of this submission is to introduce design changes to the ACP Self-Drilling Screws. Select changes implemented via the add to file process as well as additional design updates are also presented in this submission.
Here's an analysis of the provided FDA 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: NuVasive® ACP System (Anterior Cervical Plating System)
The provided document describes a spinal intervertebral body fixation orthosis and the review for its 510(k) premarket notification. This type of device is a physical implant, not an AI/ML-based diagnostic or assistive device. Therefore, the questions related to AI/ML performance metrics, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this submission.
The "acceptance criteria" for such a device are primarily based on demonstrating substantial equivalence to a predicate device through non-clinical performance data (e.g., mechanical testing).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by regulation and predicate comparison) | Reported Device Performance |
|---|---|
| Meet or exceed performance of predicate device (mechanical strength, specifically static torsion). | "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" |
| Conform to relevant ASTM standards (e.g., ASTM F1717 for static torsion). | "Static torsion testing per ASTM F1717" |
| Biocompatibility of materials. | "The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3." |
| Maintain the same technological characteristics as predicate. | "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." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as "sample size" in the context of clinical studies. The testing performed is non-clinical (mechanical testing). The document does not specify the number of implants or test specimens used for the static torsion testing.
- Data Provenance: The data is generated from laboratory mechanical testing. The country of origin and whether it's retrospective or prospective are not applicable as it's not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. Ground truth, in the context of clinical interpretation by experts, is not relevant for this type of mechanical device submission. The "ground truth" for mechanical performance is established by standardized testing methods and material specifications (e.g., ASTM F1717 for static torsion, ASTM F136 for material).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods are used for expert consensus on clinical data. For mechanical testing, the results are quantitative and objective, typically requiring no adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. This device is a physical implant, not an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by objective, standardized mechanical testing results (e.g., torque at failure, deformation under load) compared against predetermined criteria derived from predicate device performance and relevant ASTM standards.
8. The sample size for the training set
- This is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable. This is a physical device, not an AI/ML algorithm.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical performance study focused on mechanical testing.
- Purpose: To demonstrate that the NuVasive® ACP System is substantially equivalent to predicate devices, particularly regarding its mechanical performance and material composition.
- Key Test: Static torsion testing per ASTM F1717.
- Material Testing: The device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, ensuring material properties meet established standards.
- Results/Conclusion: "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." This statement confirms that the device's mechanical performance, specifically in static torsion, was found to be acceptable and comparable or superior to the legally marketed predicate devices, thereby establishing substantial equivalence.
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December 3, 2020
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NuVasive, Incorporated Ms. Jessica LeBlanc Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K203253
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: November 2, 2020 Received: November 4, 2020
Dear Ms. LeBlanc:
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
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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)
K203253
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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K203253 - Page 1 of 2
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510(k) Premarket Notification NuVasive® ACP System
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. Jessica LeBlanc Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (951) 816-0973
Date Prepared: November 2, 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
-
K201078 NuVasive® ACP System 0
Additional Predicates -
K191500 NuVasive ACP System ●
-
K073275 - NuVasive Helix Mini ACP System
Device Description D.
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, and lower static torsion test values were presented in K201078. The purpose of this submission is to introduce design changes to the ACP Self-Drilling Screws. Select changes implemented via the add to file process as well as additional design updates are also presented in this submission.
E. Indications for Use
The NuVasive ACP System is intended for anterior screw fixation to 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
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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.
G. Performance Data
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 testing per ASTM F1717
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.
§ 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.