(90 days)
The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The InterPlate™ C consists of plates, bone screws and screw covers in a variety of sizes. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size. The InterPlate™ C components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
The provided document is a 510(k) summary for a medical device called InterPlate™ C. It details the device's classification, description, intended use, and substantial equivalence to previously cleared devices. However, this type of document, a 510(k) summary for a Class II medical device, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a specific clinical study with detailed acceptance criteria and performance metrics against those criteria. It does not contain information about:
- Acceptance criteria and reported device performance in a table. The document asserts substantial equivalence, meaning it matches the predicate device’s performance characteristics, but doesn't specify new, quantifiable acceptance criteria or new study results for those criteria.
- Sample sizes for a test set or data provenance. Because it relies on substantial equivalence and mechanical testing, specific patient-based test set details are not included.
- Number of experts or their qualifications for ground truth. This typically pertains to studies involving human interpretation or diagnosis, which isn't the primary focus of this submission.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study. This is relevant for imaging or diagnostic AI devices, not for a spinal implant.
- Standalone (algorithm only) performance. Not applicable to a physical implant.
- Type of ground truth used for a clinical study.
- Sample size for a training set or how ground truth for a training set was established. These are concepts relevant to AI/ML device development, not a spinal implant and its 510(k) submission.
What the document does provide in relation to product performance and evidence is:
- Substantial Equivalence Statement: The primary "proof" is the statement that the InterPlate™ C is "substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, material of manufacture and mechanical performance." This implies that the device meets the same performance expectations as its predicate based on these factors.
- Mechanical Performance: The document explicitly mentions "mechanical performance" as a basis for substantial equivalence. While it doesn't quantify specific acceptance criteria or results here, it means that the device was likely subjected to various mechanical tests (e.g., fatigue, static strength, subsidence) to demonstrate that it performs as safely and effectively as the predicate device mechanically. The specific details of these tests and their criteria would be in the full 510(k) submission, not typically in the public summary.
- Material: Manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, indicating compliance with recognized material standards.
- Intended Use & Indications: These are detailed, showing the specific clinical context for which the device is approved. The device is for intervertebral body fusion in the cervical spine (C3 to T1) for certain conditions, with specific warnings.
In summary, for this specific K092070 submission:
The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than establishing new, detailed performance metrics for this specific device in a clinical study as might be done for novel AI or diagnostic technologies. The FDA determined that the device is substantially equivalent, allowing it to be marketed.
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8. 510(k) Summary
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| Sponsor: | RSB Spine, LLC3030 Superior Ave., Suite 703Cleveland, OH 44114Phone: 216.241.2804Fax: 216.241.2820 | OCT - 6 2009 | |
|---|---|---|---|
| Contact Person: | James M. Moran, D. Eng.Vice President of Engineering and Chief Technical Officer | ||
| Proposed Trade Name: | InterPlate™ C | ||
| Device Classification | Class II | ||
| Classification Name: | Appliance, fixation, spinal intervertebral body | ||
| Regulation: | 888.3060 | ||
| Device Product Code: | KWQ | ||
| Device Description: | The InterPlate™ C consists of plates, bone screws and screw covers in avariety of sizes. Various plate sizes are available to accommodate individualpatient anatomy and graft material size. Screw covers are individuallymatched to the plate size. The InterPlate™ C components are manufacturedfrom titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. | ||
| Intended Use: | The InterPlate™ C is indicated for intervertebral body fusion of the spine inskeletally mature patients. The device system is designed for use withautograft to facilitate fusion. One device is used per intervertebral space. Itis intended for use at one level in the cervical spine, from C3 to T1, for thetreatment of cervical disc disease (defined as neck pain of discogenic originwith degeneration of the disc confirmed by history and radiographicstudies). The cervical device is to be used in patients who have had sixweeks of non-operative treatment.In addition, the InterPlate™ C is intended for anterior screw fixation of thecervical spine. These implants have been designed to provide stabilizationas an adjunct to cervical fusion. Indications for the use of this implantsystem include degenerative disc disease (defined as neck pain ofdiscogenic origin with the degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fractures ordislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis orscoliosis), tumor, pseudarthrosis or failed previous fusion.WARNING: The InterPlate™ C is not intended for screw attachment orfixation to the posterior elements (pedicles) of the cervical, thoracic orlumbar spine. | ||
| SubstantialEquivalence: | Documentation was provided which demonstrated the InterPlate™ C to besubstantially equivalent to previously cleared devices. The substantialequivalence is based upon equivalence in intended use, indications,anatomic sites, material of manufacture and mechanical performance. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
RSB Spine, LLC % Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026
OCT - 6 2009
Re: K092070
Trade/Device Name: Interplate™ C Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO, ODP Dated: July 7, 2009 Received: July 8, 2009
Dear Dr. Warden:
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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Karen E. Warden, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M Millam
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Indications for Use Statement
510(k) Number:_| | 09 20 70
Device Name: InterPlate™ C
Indications for Use:
The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use X
AND/OR
Over-the-Counter Use
(21 CFR 807 Subpart C)
(21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K092070 510(k) Number .
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§ 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.