(55 days)
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherketone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136, and tantalum conforming to ASTM F560. The implants are available in a variety of sizes to accommodate anatomical conditions. The CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplemental fixation.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the NuVasive® CoRoent® Small Interlock™ System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the "device meets acceptance criteria" in terms of an AI/ML algorithm's performance.
Therefore, the specific information requested in the prompt regarding acceptance criteria, performance metrics, test set, ground truth, expert adjudication, MRMC studies, and training set details are not applicable to this document. The document describes a physical intervertebral body fusion device, not a software or AI-based diagnostic/screening tool.
Here's a breakdown of why each point is not relevant based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. This device is a physical implant. The "performance data" mentioned (Section G) refers to a clinical study demonstrating safety and effectiveness for a physical device, not an algorithm's performance metrics like sensitivity, specificity, or AUC.
- Sample sized used for the test set and the data provenance: Not applicable. The "clinical study" mentioned is to support the expanded indication for a physical implant, not to test an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, refers to expert-labeled data. Here, the "ground truth" for the device's efficacy would be clinical outcomes in patients.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving disagreements among human labelers of data for AI model training or testing.
- 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: Not applicable. MRMC studies are used to assess the impact of AI tools on human interpretation of medical images. This device is an implant, not an AI tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, ground truth relates to clinical outcomes and safety profiles. The document mentions "clinical data" and "safety and effectiveness profile" but doesn't detail the specific type of ground truth beyond that.
- The sample size for the training set: Not applicable. There is no AI model or training set described.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document is for a physical medical implant (intervertebral body fusion device), not a software or AI-powered device. Therefore, the questions related to AI/ML model acceptance criteria, performance studies, and ground truth establishment are not addressed in this document.
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November 13, 2019
NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K192582
Trade/Device Name: NuVasive® CoRoent® Small Interlock™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 18, 2019 Received: September 19, 2019
Dear Jessica 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
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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 medical devices and radiation-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 Ronald P. Jean, Ph.D. Director (Acting) 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) K192582
Device Name
NuVasive® CoRoent® Small Interlock™ System
Indications for Use (Describe)
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate 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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Image /page/3/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in capital letters to the right of the leaf. The leaf is divided into two sections, with the top section colored in purple and the bottom section in gray.
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:
Jessica LeBlanc Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3302
Date Prepared: September 18, 2019
510(k) Number: K192582
B. Device Name
| Trade or Proprietary Name: | NuVasive ® CoRoent ® Small Interlock ™ System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVE |
Predicate Devices C.
The subject CoRoent Small Interlock System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K142299) serves as the primary predicate device, the NuVasive CoRoent Small Interbody System (K163491) and the Centinel Spine STALIF C and STALIF C-Ti (K150053) serve as additional predicates, and NuVasive Archon Anterior Cervical Plate System (K131025) serves as a reference predicate.
D. Device Description
The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherketone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136, and tantalum conforming to ASTM F560. The implants are available in a variety of sizes to accommodate anatomical conditions. The CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplemental fixation.
The purpose of this 510(k) is to modify the indications for use to include the treatment of multilevel cervical disc degeneration with the subject device without supplemental fixation.
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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. 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 is split into two colors, with the top half being purple and the bottom half being gray.
E. Indications for Use
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
F. Technological Characteristics
As was established in this submission, the subject CoRoent Small Interlock 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 as its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
G. Performance Data
The purpose of this 510(k) is to modify the indications for the subject CoRoent Small Interlock System for multilevel use without supplemental fixation. A retrospective clinical study of patients with cervical disc degeneration treated with the subject device was performed. Based on the clinical data, it was determined that the CoRoent Small Interlock System used in the treatment of multilevel cervical disc degeneration has a safety and effectiveness profile similar to the predicate device. Additionally, a clinical literature analysis of multilevel anterior cervical discectomy and fusion (ACDF) procedures was performed to support the use of the subject device in the treatment of cervical disc degeneration.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Small Interlock System has been shown to be substantially equivalent to legally marketed predicate devices.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.