(75 days)
When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Republic Spine Restore Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine Restore cervical interbody fusion device, which is intended to be implanted as a single device via an anterior approach.
The provided text is a 510(k) premarket notification for a medical device (Republic Spine Restore Cervical Interbody Fusion System). It does not contain information related to an AI/ML-based medical device study, acceptance criteria, or performance data for such a study.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets these criteria based on the input provided. The document describes mechanical testing for an implantable device, not a study evaluating an AI system's performance.
To answer your request, I would need a document detailing the clinical performance study of an AI-powered medical device, including information on its acceptance criteria, study design, expert involvement, and ground truth establishment.
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June 19, 2019
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Republic Spine, LLC James Doulgeris Director of Business Development and Quality Systems 2424 N. Federal Hwy Boca Raton, Florida 33431
Re: K190889
Trade/Device Name: Republic Spine Restore Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 29, 2019 Received: April 24, 2019
Dear James Doulgeris:
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 Melissa Hall 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) K190889
Device Name
Republic Spine Restore Cervical Interbody Fusion System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
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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510(k) Summary
| Date | June 18th, 2019 |
|---|---|
| Sponsor | Republic Spine, LLC2424 N. Federal Hwy Suite 257Boca Raton, FL 33421 |
| Phone | 561-362-8094 |
| Contact Person | James Doulgeris |
| Proposed ProprietaryTrade Name | Republic Spine Restore Cervical Interbody Fusion System |
| Regulatory Class | Class II |
| Common Name: | Intervertebral fusion device with bone graft, cervical |
| Classification Name | 21 CFR 888.3080 Spinal Intervertebral Body Fusion Device |
| Product Code | ODP |
| Purpose of Submission | The purpose of this submission is to gain clearance for the Republic Spine RestoreCervical Interbody Fusion System |
| Device Description | The Republic Spine Restore Cervical Interbody Fusion System will be offered invarious device configurations based on surgical approach and patient anatomy, andconsist of a Republic Spine Restore cervical interbody fusion device, which isintended to be implanted as a single device via an anterior approach. |
| Indications for Use | When used as a cervical intervertebral body fusion device, the Republic SpineCervical Interbody Fusion System is indicated for intervertebral body fusion inskeletally mature patients with degenerative disc disease (DDD) of the cervicalspine with accompanying radicular symptoms at one disc level from the C2-C3 discto the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the discconfirmed by history and radiographic studies. The device system is designed foruse with supplemental fixation and with autograft to facilitate fusion. Patientsshould have at least six (6) weeks of non-operative treatment prior to treatmentwith an intervertebral cage. |
| Materials | The Republic Spine Restore Cervical Interbody Fusion System implant componentsare made of titanium alloy (Ti-6AL-4 ELI) per ASTM F136 or polyether ether ketone(Evonik Vestakeep®) that conforms to ASTM F2026. Additionally, the PEEK devicescontain tantalum markers (per ASTM F560) to assist the surgeon with properplacement of the device. The additional implant offering being proposed has similartechnological characteristics and identical indications as the currently clearedpredicates |
| Primary Predicate | Eminent Spine Copperhead (K090064) |
| Additional Predicate(s) | Zavation IBF (K181246)Choice Spine (K183397) |
| Reference Device(s) | Republic Spine (K150283) |
| SubstantialEquivalenceConclusion | The basis of substantial equivalence of the subject device(s) and predicate device(s)is established on the following:The subject device and the predicate devices have the following similarities:Both systems have the same indications for use. The intended patientpopulation and intended use are the same. Both systems operate using the same fundamental scientific technology. Both systems incorporate the same basic implant design. Both systems use the same methods of sterilization. Both systems use the same operational principles for the surgicalimplantation of the interbody cages. Both systems are manufactured from the same materials. The subject device and the predicate devices have the following differences: Minor dimensional differences in height, width and depth. |
| PerformanceData | Mechanical Testing:The subject PEEK device is considered worst case and therefore, was utilizedduring design verification mechanical bench tests to address the designdifferences between the subject device(s) and the predicate device(s). A reducedsample size of titanium cages was tested alongside the PEEK cages to verify thatthey performed equivalent to or greater than the PEEK interbody cages. ASTM F2267 - Static Subsidence Purpose: to verify that the interbody cage will not subside when underaverage daily living forces for both materials. ASTM 2077 – Static/Dynamic Compression & Static/Dynamic Torsion Purpose: to verify that the interbody cage would not fail when underaverage daily living forces for both materials. Expulsion Testing Purpose: to verify that the interbody cage would not dislodge underaverage daily living forces for both materials. Conclusions The results of the testing demonstrate that both the subject PEEK and Tidevices are substantially equivalent to the predicate. |
| Conclusions | Evaluation of the risks and performance data based on the differences betweenthe subject device(s) and predicate(s) does not raise any new issues or concernsrelated to safety or effectiveness. It is concluded that the subject device(s), is assafe and effective as the predicate device(s) for its intended use and issubstantially equivalent to the legally marketed predicate device(s). |
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§ 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.