(83 days)
The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.
The Phenix™ VBR is a rectangular implant with an open center comprised of titanium, (Ti-6Al-4V). The Phenix™ VBR's superior and inferior ends have ridges to interface with the vertebral endplates to resist rotation and migration. The implant is available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. The Titanium allows for radiographic visualization.
This document is a 510(k) premarket notification for the Phenix™ Vertebral Body Replacement (VBR) device. It is a submission to the FDA for market clearance, not a study demonstrating device performance against acceptance criteria in the manner of a clinical trial or AI algorithm validation. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative measurement sense, nor does it report specific device performance metrics against such criteria in the provided text. The "Performance Data" section merely states: "Testing was completed to characterize the device." This implies mechanical or material property tests, but no results or acceptance criteria for those tests are detailed in this document.
Therefore, a table cannot be constructed from the provided information.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided because the document is a 510(k) premarket notification, not a clinical study report validating performance against specific acceptance criteria for software or an AI device. The "test set" in this context would likely refer to the physical Phenix™ VBR devices subjected to mechanical testing. The provenance of such physical tests (e.g., in a lab, specific conditions) is not detailed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI or diagnostic device requiring expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical spinal implant, not a diagnostic imaging device or an AI assistant for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical spinal implant, not an algorithm.
7. Type of Ground Truth Used
Not applicable in the typical sense for medical device performance (e.g., pathology for diagnostic accuracy). The "ground truth" for a physical implant would be its adherence to design specifications, material properties, and mechanical performance under various loads, which would be assessed through engineering tests, not a "ground truth" established by experts.
8. Sample Size for the Training Set
Not applicable. This is a physical spinal implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical spinal implant, not a machine learning model.
Summary of Device Information from the 510(k) Application:
- Device Name: Phenix™ Vertebral Body Replacement (VBR)
- Company: Spinal Devices, LLC
- Classification: Class II
- Product Code: MQP, 888.3060 (Spinal intervertebral body fixation orthosis)
- Device Description: Rectangular implant with an open center, made of titanium (Ti-6Al-4V). Features ridges on superior and inferior ends for vertebral endplate interface. Available in various sizes, flat and lordotic angles. Radiographically visible.
- Intended Use: For use in the thoracic spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies resected due to tumor or trauma (fracture). Designed to restore mechanical integrity of the spinal column. Intended for use with supplemental spinal fixation systems labeled for thoracic spine use. Can be packed with bone graft (autograft bone mentioned in the "Indications for Use Statement").
- Predicate Device: Substantial equivalence was determined based on the same indications for use, intended use, design, and performance to a predicate device (not named in the provided text).
- Performance Data: "Testing was completed to characterize the device." (No specific results or acceptance criteria are detailed in this extract).
- FDA Clearance Date: October 15, 2007 (K072029)
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Phenix™ Vertebral Body Replacement 510(k) Application
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| Company:Company NameStreet addressCity, State Zip CodeTelephone | Spinal Devices, LLC1155 Allgood Road, Suite 6Marietta, GA 30062770-874-0935 | UC |
|---|---|---|
| Company Contact: | Tim Lusby | |
| Common Name | Spinal vertebral body replacement device | |
| Trade Name: | Phenix™ VBR | |
| Classification: | Class II | |
| Product Code; | MQP, 888.3060 | |
| Device Description: | The Phenix™ VBR is a rectangular implant with anopen center comprised of titanium, (Ti-6Al-4V). ThePhenix™ VBR's superior and inferior ends haveridges to interface with the vertebral endplates toresist rotation and migration. The implant is availablein a range of sizes, as well as flat and lordotic angledimplants to accommodate variations in patient'sanatomy. The Titanium allows for radiographicvisualization. | |
| Intended Use: | The Phenix™ VBR is a vertebral body replacementdevice intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstablevertebral body resected or excised (i.e., partial or totalvertebrectomy) due to tumor or trauma (i.e., fracture).The Phenix™ VBR is designed to restore themechanical integrity of the anterior, middle andposterior spinal column even in the absence of fusionfor a prolonged period. The Phenix™ VBR is intendedfor use with supplemental spinal fixation systems thathave been labeled for use in the thoracic spine. Theinterior of the Phenix™ VBR may be packed with bonegraft. | |
| Predicate Device: | Based on the same indications for use, intended use,design and performance to the predicate device,substantial equivalence was determined. | |
| Performance Data: | Testing was completed to characterize the device. |
16072029
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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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, official design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
New Business Development, LLC % Mr. Tim Lusby General Manager, Member 1155 Allgood Road, Suite 6 Marietta, Georgia 30062
OCT 1 5 2007
K072029 Trade/Device Name: Phenix Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 31, 2007 Received: September 4, 2007
Dear Mr. Lusby:
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. Tim Lusby
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchur
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indication for Use Statement
510(k) Number (if known): K072029
Device Name: Phenix™ Vertebral Body Replacement
Indications for Use:
The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in moshanisal intogray of the prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems which are labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with autograft bone.
Prescription Use X Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara BuchR
- Restorative, and Neurological Devices
510(k) Number: K072029
§ 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.