(73 days)
The VertiFlex™ PEEK VBR is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaqed, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex™ PEEK VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. The interior of the VertiFlex™ PEEK VBR may be packed with bone graft.
The VertiFlex™ Octane™ PEEK Vertebral Body Replacement, or PEEK VBR, is an implant composed of pure Poly(Etheretherketone), or PEEK, intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). The implant is available in a range of sizes, and is intended to achieve anterior decompression of the spinal cord and neural structures, and to restore vertebral height. In so doing, the device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column. The device is hollow to permit packing with bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The device may be implanted by either conventional surgical methods, or via minimally-invasive techniques, using manual instrumentation provided by VertiFlex™, Inc., specifically for use with the subject device. The device is offered non-sterile.
The provided text describes a 510(k) premarket notification for a medical device, the VertiFlex™ Octane™ PEEK Vertebral Body Replacement. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy and safety through extensive clinical trials for de novo approval. As such, the study described is not a typical clinical trial assessing device performance against specific, pre-defined acceptance criteria for a new therapy, but rather non-clinical tests to show equivalence in performance to existing devices.
Here's an analysis of the provided text based on your request:
Acceptance Criteria and Study to Prove Device Meets Them
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance | The device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column. This is fundamental to its function as a vertebral body replacement. | "Tests conducted in accordance with such recognized standards as ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance." This implies the device meets or exceeds the mechanical properties expected of such implants. |
| Material Equivalence | The device is composed of pure Poly(Etheretherketone), or PEEK. The acceptance criterion is that this material choice (and its physical properties) is substantially equivalent to predicate devices. | "Testing and comparisons of design characteristics and features have established that the subject VertiFlex™ PEEK VBR is substantially equivalent in design, materials of composition, indications, performance, and other features, to other vertebral body replacement devices commercially available in the U.S." This indicates the material (PEEK) and its performance are equivalent to predicate devices. |
| Mechanical Performance (e.g., strength, fatigue, subsidence) | The device must be of "sufficient strength to provide column support even in the absence of fusion for prolonged periods." This implies specific mechanical performance requirements (e.g., compressive strength, fatigue life) that are typically assessed by standards like ASTM F2077. | "Non-clinical tests, including those conducted in accordance with such recognized standards as ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance." ASTM F2077 specifically covers mechanical testing for intervertebral body fusion devices, addressing aspects like static compression, dynamic compression, and expulsion resistance. |
| Dimensions and Sizing | The device should be available in a range of sizes to achieve anterior decompression and restore vertebral height, comparable to predicate devices. | "The implant is available in a range of sizes..." This design characteristic, along with comparison to predicate devices, implies the sizing is appropriate and equivalent. Comparison studies would verify this. |
| Biocompatibility | As an implant, the PEEK material must be biocompatible and substantially equivalent to predicate devices using similar materials. | While not explicitly stated as an "acceptance criterion" in the provided text, biocompatibility is an inherent requirement for any implant. The statement "substantially equivalent in... materials of composition" implies that PEEK's biocompatibility has been established and is equivalent to the PEEK used in predicate devices. |
Study Description:
The study conducted was a non-clinical comparative testing program designed to demonstrate "substantial equivalence" of the VertiFlex™ Octane™ PEEK Vertebral Body Replacement device to several legally marketed predicate devices.
- Type of Study: Non-clinical (benchtop)
- Purpose: To establish substantial equivalence in design, materials, indications, and performance to predicate devices (Interpore Cross PEEK CAS, Quantum Orthopedics Crystal™ and Lucent™, Signus Medizintechnik Curved Tetris™, Stryker Spine AVSTM PL Spacer, Synthes Vertebral Spacer).
- Methodology: The study included tests conducted in accordance with recognized standards, specifically ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices. This standard outlines various mechanical tests such as static and dynamic compression, expulsion resistance, and subsidence, appropriate for assessing the structural integrity and performance of vertebral body replacement devices.
- Outcome: The study concluded that the VertiFlex™ Octane™ PEEK Vertebral Body Replacement device is substantially equivalent to the identified predicate devices in terms of performance.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The provided text does not specify the sample size used for the non-clinical tests. ASTM F2077-03 would provide guidance on the number of samples required for each specific test (e.g., number of constructs for static compression, fatigue testing).
- Data Provenance: The data provenance is laboratory-generated data from non-clinical (benchtop) testing. It is not patient or human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable to this type of submission. The "ground truth" in this context is established by recognized international standards (like ASTM F2077-03) for mechanical testing. Expert consensus would be involved in interpreting the results relative to these standards and the predicate devices, but the text does not detail an "expert panel" for establishing clinical ground truth for a diagnostic device.
- For mechanical testing, the "experts" would be the engineers and technicians performing the tests and interpreting the data against material and mechanical engineering principles, as well as the requirements of the ASTM standard.
4. Adjudication Method for the Test Set
- This question is not applicable to a non-clinical, benchtop study for substantial equivalence based on mechanical properties. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human expert assessment of images/data to establish a clinical ground truth.
5. 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
- This question is not applicable. The device is a physical implant (Vertebral Body Replacement), not an AI-based diagnostic tool or software. Therefore, an MRMC study related to human readers and AI assistance is entirely outside the scope of this submission.
- No clinical testing was conducted or required for this 510(k) submission ("No clinical testing was conducted to support this submission").
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. The device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this non-clinical study is based on established engineering principles and recognized industry standards (specifically ASTM F2077-03) for the mechanical performance of vertebral body fusion devices. The performance of the predicate devices also serves as a benchmark for comparison.
8. The sample size for the training set
- This question is not applicable. This is a non-clinical study for a physical device, not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for a physical implant.
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510(k) SUMMARY 5.0
In accordance with Title 21 Code of Federal Regulations (21 CFR), Part 807, and in particular, §807.92, the following 510(k) summary is provided for the VertiFlex™ Octane™ PEEK Vertebral Body Replacement device:
5.1 Submitted By:
APR - 6 2007
VertiFlex™, Incorporated 1954 Kellogg Avenue, Suite 100 Carlsbad, California 92008
Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance
Date Prepared: December 22, 2006
5.2 Device Name
| Trade or Proprietary Name: | VertiFlexTM OctaneTM PEEK VertebralBody Replacement |
|---|---|
| Common or Usual Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Classification Regulation: | 21 CFR, §888.3060 |
| Product Code: | MQP |
5.3 Predicate Devices
The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate devices:
Interpore Cross PEEK CAS (K050861) Quantum Orthopedics Crystal™ and Lucent™ (K062004) Signus Medizintechnik Curved Tetris™ (K041888) Stryker Spine AVSTM PL Spacer (K062132) Synthes Vertebral Spacer (K011037)
5.4 Device Description
The VertiFlex™ Octane™ PEEK Vertebral Body Replacement, or PEEK VBR, is an implant composed of pure Poly(Etheretherketone), or PEEK, intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). The implant is available in a range of sizes, and is intended to achieve anterior decompression of the spinal cord and neural structures, and to restore vertebral height. In so doing, the device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column. The device is hollow to permit packing with bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The device may be implanted by either conventional surgical methods, or via minimally-invasive techniques, using manual instrumentation provided by VertiFlex™, Inc., specifically for use with the subject device. The device is offered non-sterile.
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ર્સ્ડ Intended Use
The subject device is indicated for use as follows:
The VertiFlex™ PEEK VBR is indicated for use in the thoracolumbar spine (T1 to L.5) for partial or total replacement of a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex™ PEEK VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The interior of the VertiFlex™ PEEK VBR may be packed with bone graft.
5.6 Comparison to Predicate Devices
Testing and comparisons of design characteristics and features have established that the subject VertiFlex™ PEEK VBR is substantially equivalent in design, materials of composition, indications, performance, and other features, to other vertebral body replacement devices commercially available in the U.S.
5.7 Summary of Non-Clinical Tests
Non-clinical tests, including those conducted in accordance with such recognized standards as ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices, have demonstrated the substantial equivalence of the subject device to commerciallyavailable predicate devices in terms of performance.
5.8 Summary of Clinical Tests
No clinical testing was conducted to support this submission.
5.9 Conclusions
The results of all testing and comparison demonstrated the substantial equivalence of the subject device to the identified predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 6 2007
Vertiflex, Incorporated % Mr. Steve Reitzler Vice President, Regulatory and Quality Assurance 1954 Kellogg Avenue, Suite 100 Carlsbad, California 92008
Re: K070218
Trade/Device Name: VertiFlex™ Octane™ PEEK Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: March 20, 2007 Received: March 22, 2007
Dear Mr. Reitzler:
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. Steve Reitzler
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 Buchner
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 (if known): K070218
Device Name: Vertiflex Octane PEEK Vertebral Body Replacement
The VertiFlex™ PEEK VBR is indicated for Indications For Use: use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaqed, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex™ PEEK VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. The interior of the VertiFlex™ PEEK VBR may be packed with bone graft.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K070218 |
|---|---|
| --------------- | --------- |
§ 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.