(75 days)
No
The 510(k) summary describes a physical implantable device (cervical interbody fusion system) and its mechanical testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets typically associated with AI/ML technologies.
Yes
The device is a cervical intervertebral body fusion device used to treat degenerative disc disease and facilitate fusion, which aims to alleviate symptoms and restore function, hence qualifying it as therapeutic.
No
Explanation: This device is an intervertebral body fusion device used for treatment, not diagnosis. It is implanted to facilitate fusion in patients with degenerative disc disease.
No
The device description explicitly states it consists of a "Republic Spine Restore cervical interbody fusion device, which is intended to be implanted as a single device via an anterior approach." This describes a physical implantable medical device, not software. The performance studies also focus on mechanical testing of physical devices (PEEK and titanium cages).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in vivo (within the body) to facilitate the fusion of vertebrae.
- Device Description: The device is described as an interbody fusion device intended to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-C3 disc to the C7-T1 disc
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)
Mechanical Testing:
The subject PEEK device is considered worst case and therefore, was utilized during design verification mechanical bench tests to address the design differences between the subject device(s) and the predicate device(s). A reduced sample size of titanium cages was tested alongside the PEEK cages to verify that they 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 under average 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 under average daily living forces for both materials.
Expulsion Testing
Purpose: to verify that the interbody cage would not dislodge under average daily living forces for both materials.
Conclusions:
The results of the testing demonstrate that both the subject PEEK and Ti devices are substantially equivalent to the predicate.
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.
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
§ 888.3080 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.
0
June 19, 2019
Image /page/0/Picture/1 description: The image shows 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.
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
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 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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date | June 18th, 2019 |
|---|---|
| Sponsor | Republic Spine, LLC |
| 2424 N. Federal Hwy Suite 257 | |
| Boca Raton, FL 33421 | |
| Phone | 561-362-8094 |
| Contact Person | James Doulgeris |
| Proposed Proprietary | |
| Trade 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 Restore |
| Cervical Interbody Fusion System | |
| Device Description | 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. | |
| Indications for Use | When used as a cervical intervertebral body fusion device, the Republic Spine |
| 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. | |
| Materials | The Republic Spine Restore Cervical Interbody Fusion System implant components |
| are 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 devices | |
| contain tantalum markers (per ASTM F560) to assist the surgeon with proper | |
| placement of the device. The additional implant offering being proposed has similar | |
| technological characteristics and identical indications as the currently cleared | |
| predicates | |
| Primary Predicate | Eminent Spine Copperhead (K090064) |
| Additional Predicate(s) | Zavation IBF (K181246) |
| Choice Spine (K183397) | |
| Reference Device(s) | Republic Spine (K150283) |
| Substantial | |
| Equivalence | |
| Conclusion | 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 patient | |
| population 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 surgical | |
| implantation 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. | |
| Performance | |
| Data | Mechanical Testing: |
| The subject PEEK device is considered worst case and therefore, was utilized | |
| during design verification mechanical bench tests to address the design | |
| differences between the subject device(s) and the predicate device(s). A reduced | |
| sample size of titanium cages was tested alongside the PEEK cages to verify that | |
| they 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 under | |
| average 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 under | |
| average daily living forces for both materials. Expulsion Testing Purpose: to verify that the interbody cage would not dislodge under | |
| average daily living forces for both materials. Conclusions The results of the testing demonstrate that both the subject PEEK and Ti | |
| devices are substantially equivalent to the predicate. | |
| Conclusions | Evaluation of the risks and performance data based on the differences between |
| the subject device(s) and predicate(s) does not raise any new issues or concerns | |
| related to safety or effectiveness. It is concluded that the subject device(s), is as | |
| safe and effective as the predicate device(s) for its intended use and is | |
| substantially equivalent to the legally marketed predicate device(s). |
4