(91 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 lumber 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 device is intended to be used with a supplemental internal fixation system.
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 is a 510(k) summary for the InterPlate™ VBR System, a spinal intervertebral body fixation orthosis. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating the device meets quantitative acceptance criteria based on performance.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in the provided text, as this is typically found in performance studies used for original device approvals or efficacy claims.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Device Performance
Not available. The document does not provide a table of acceptance criteria and reported device performance metrics in terms of clinical or technical outcomes. The substantial equivalence claim is based on equivalence in "intended use, indications, anatomic sites, performance and material of manufacture" compared to predicate devices, but no specific performance data or criteria are listed.
Study Details
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Sample size used for the test set and the data provenance:
- Not available. The document does not describe a performance study with a test set. The 510(k) process for this device relies on demonstrating substantial equivalence to predicates, not on a new clinical or technical performance study with a specific test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. Since no performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or corresponding adjudication method is discussed.
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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:
- No. This is a medical implant (spinal fixation system), not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. No ground truth is established for a performance study in this document. The "ground truth" for the 510(k) process is typically the established safety and effectiveness of the predicate devices.
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The sample size for the training set:
- Not applicable/Not available. No training set is mentioned as this is not an AI/ML device that requires training.
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How the ground truth for the training set was established:
- Not applicable/Not available. As above, no training set is discussed.
Summary of Device Information Available in the Text:
- Device Name: InterPlate™ VBR System
- Intended Use: Replacement of a complete or partial vertebrectomy, used with a bone graft to facilitate fusion. Designed to restore biomechanical integrity of the thoracic and lumbar spine (T1 to L5) following damage from tumor or traumatic injury. Intended for use with a supplemental internal fixation system.
- Materials: Ti-6Al-4V titanium alloy (ASTM F136).
- Substantial Equivalence Claim: Based on equivalence in intended use, indications, anatomic sites, performance, and material of manufacture to predicate devices including:
- MC+ Partial VBR (LDR Spine USA)
- SynFix™ - LR (Synthes USA)
- Stalif™ TT (Surgicraft, LTD)
- Telescopic Plate Spacer (Interpore Cross International)
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AUG 1 8 2006
510(k) Summary
| Sponsor: | RSB Spine, LLC3030 Superior Ave., Suite 703Cleveland, OH 44114 |
|---|---|
| ContactPerson: | James M. Moran, D. Eng.Vice President of Engineering and Chief Technical Officer |
| ProprietaryTrade Name: | InterPlate™ VBR System |
| ClassificationName | 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Device ProductCode: | MQP |
| DeviceDescription: | 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 to facilitate fusion. It isdesigned to restore biomechanical integrity of the thoracic and lumber spine, fromT1 to L5, which has been damaged due to a collapsed or unstable vertebral bodyresulting from a tumor or traumatic injury. The InterPlate™ VBR device isintended to be used with a supplemental internal fixation system. |
| Materials: | The InterPlate™ VBR System components are manufactured from Ti-6Al-4Vtitanium alloy (ASTM F136). |
| SubstantialEquivalence: | Documentation was provided which demonstrated the InterPlate™ VBRSystem to be substantially equivalent to previously cleared devices includingthe MC+ Partial VBR (LDR Spine USA), the SynFix™ - LR (Synthes USA),the Stalif™ TT (Surgicraft, LTD) and the Telescopic Plate Spacer (InterporeCross International). The substantial equivalence is based upon equivalence inintended use, indications, anatomic sites, performance and material ofmanufacture. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a caduceus-like symbol with three parallel lines representing the branches of government, and a stylized eagle with its wings spread, symbolizing protection and service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
RSB Spine, LLC % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, Ohio 44026
Re: K061401
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: MQP Dated: July 26, 2006 Received: July 31, 2006
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 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 - Karen E. Warden, Ph.D.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buck MD
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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Indications for Use
510(k) Number: K061 401
Device Name: InterPlate ™ 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. The InterPlate™ VBR device is intended to be used with a supplemental internal fixation system.
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Vreeland
vision of General, nes and Neurological Devices
510(k) Number K061401
§ 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.