(77 days)
The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.
The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) summary and FDA clearance letter for the InterPlate™ VBR System, focusing on demonstrating substantial equivalence to previously cleared devices rather than providing specific performance study results.
Therefore, I cannot populate the table or answer the questions as the required information is not present in the given text.
The document primarily states: "Documentation was provided which demonstrated the InterPlate™ VBR System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the device was cleared based on its similarity to existing devices, not on a new performance study with explicit acceptance criteria.
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Tab IV 510(k) Summary
| Sponsor: | RSB Spine, LLC3030 Superior Ave., Suite 703Cleveland, OH 44114 | APR 19 2007 |
|---|---|---|
| Contact Person: | James M. Moran, D. Eng.Vice President of Engineering and Chief Technical Officer | |
| Proprietary TradeName: | InterPlate™ VBR System | |
| Classification Name | 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| Device ProductCode: | MQP | |
| Device Description: | The InterPlate™ VBR consists of plates, bone screws and screw covers. Variousplate sizes are available to accommodate individual patient anatomy and graftmaterial size. Screw covers are individually matched to the plate size. | |
| Intended Use: | The InterPlate™ VBR device is indicated for the replacement of a complete orpartial vertebrectomy, when used with a bone graft material to facilitate fusion. Itis designed to restore biomechanical integrity of the thoracic and lumbar spine,from T1 to L5, which has been damaged due to a collapsed or unstable vertebralbody resulting from a tumor or traumatic injury. | |
| Materials: | The InterPlate™ VBR System components are manufactured from Ti-6Al-4Vtitanium alloy (ASTM F136). | |
| SubstantialEquivalence: | Documentation was provided which demonstrated the InterPlate™ VBR Systemto be substantially equivalent to previously cleared devices. The substantialequivalence is based upon equivalence in intended use, indications, anatomicsites, performance and material of manufacture. |
- September 19.
|
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RSB Spine, LLC % Mr. James Moran Vice President, Engineering 2530 Superior Avenue, Suite 703 Cleveland, Ohio 44114
APR 1 9 2007
K070316 Trade/Device Name: InterPlate™ VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: January 29, 2007 Received: February 1, 2007
Dear Mr. Moran:
Re:
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 such 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); 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 - Mr. James Moran
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Darban Buell
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Tab II Indications for Use
KS70316 510(k) Number:
Device Name: InterPlate TM Vertebral Body Replacement (VBR) System
Indications for Use:
The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
1 81
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arslane Mneimneh
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K070316
Page 16
§ 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.