(84 days)
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.
The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting of a variety of shapes and sizes of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A 1- 4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.
This document is a 510(k) summary for a medical device called the Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information, specifically addressing the acceptance criteria and study aspects you've requested.
It's important to note that this document is a 510(k) summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical trial data or performance metrics in the same way a PMA (Premarket Approval) application would for novel, high-risk devices. The "study" here refers to mechanical testing for equivalence, not a clinical study on human subjects.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K922543, K010632) for intended use and safety/functionality. | "Mechanical testing was performed on the PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the ZPLATE-ATL™ Anterior Fixation System and the BUTTERFLY™ PLATE Fixation System." |
| Meeting relevant ASTM/ISO standards for materials. | "The implant components are made of titanium alloy (Ti-6Al-4V) described by ASTM Standard F136 or ISO 5832-3." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of number of physical components tested, but implies sufficient samples were used for mechanical testing to establish equivalence. This is not a clinical "test set" in the traditional sense of patient data.
- Data Provenance: The origin of the mechanical testing data (e.g., specific lab, country) is not specified. Given Medtronic's location in Memphis, TN, it's likely U.S.-based or from a reputable international testing facility. This would be considered "prospective" testing as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this type of submission. Ground truth established by medical experts (e.g., radiologists) is relevant for diagnostic devices or AI algorithms interpreting medical images. For a spinal fixation system, "ground truth" for mechanical performance is established by engineering standards and comparative testing to predicate devices, typically assessed by engineers and regulatory bodies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 (two readers agree, third resolves discrepancy) are used for clinical studies involving human interpretation (e.g., image reading). Mechanical testing relies on objective measurements against defined criteria.
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 is not applicable. This device is a passive implantable medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be the established performance characteristics and safety profiles of the predicate devices based on their own clearances and recognized engineering standards (e.g., ASTM/ISO). The new device's performance is compared to these benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This is not applicable. This device is a physical implant, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as it applies to machine learning algorithms.
Summary of the "Study" mentioned:
The study referred to in this 510(k) summary is mechanical testing.
- Objective: To demonstrate that the PYRAMID™ ANTERIOR PLATE Fixation System is "substantially equivalent" in terms of functionality and safety to the predicate devices (ZPLATE-ATL™ Anterior Fixation System and BUTTERFLY™ PLATE Fixation System).
- Methodology: Mechanical tests were performed. While specifics of the tests (e.g., fatigue testing, static testing, torsional testing) are not detailed in this summary, they would typically involve applying forces and stresses to the device and comparing its performance (e.g., strength, durability, screw pull-out resistance, plate bending strength) against those of the predicate devices.
- Proof of Meeting Acceptance Criteria: The statement "Mechanical testing was performed... which determined it to be substantially equivalent..." serves as the proof that the device meets the (implied) acceptance criteria of performance comparable to the cleared predicate devices. This equivalence demonstrates that it is as safe and effective as the devices already on the market.
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JAN 2 9 2002 1
KO13665 11 € 2
Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System 510(k) Summary
| Submitter: | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132 |
|---|---|
| Contact Person: | Richard Treharne |
| Trade Name: | PYRAMID™ ANTERIOR PLATE Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II |
| Predicate Device(s): | The PYRAMID™ ANTERIOR PLATE Fixation System is substantially |
| equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation | |
| System, which was cleared on May 19, 1993 and the BUTTERFLY™ PLATE | |
| Fixation System (K010632) which was cleared on May 31, 2001. | |
| Device Description: | The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental |
| fixation construct consisting of a variety of shapes and sizes of plates, and | |
| screws, as well as ancillary products and instrument sets. The PYRAMID™ | |
| ANTERIOR PLATE Fixation System implant components can be locked into a | |
| variety of configurations, with each construct being tailor-made for the | |
| individual case. The implant components are made of titanium alloy (Ti-6A 1- | |
| 4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and | |
| titanium implant components must not be used together in a construct. | |
| Intended Use: | The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation |
| System is indicated for use as an anteriorly placed supplemental fixation | |
| device for the lumbosacral level below the bifurcation of the vascularstructures. | |
| When properly used, this system will help provide temporary stabilization until | |
| a solid spinal fusion develops. Specific indications include: 1) Degenerative | |
| disc disease (as defined by back pain of discogenic origin with degeneration of | |
| the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) | |
| Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) | |
| Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) | |
| Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, | |
| lordosis, and/or kyphosis) associated with deficient posterior elements such as | |
| that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) |
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KO13665 Of
Neuromuscular deformity (i.e., scoliosis, and / or kyphosis) associated with pelvic obliquity.
Functionality & Safety Testing: Mechanical testing was performed on the PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the ZPLATE-ATL™ Anterior Fixation System and the BUTTERFLY™ PLATE Fixation System.
. . . . . . . . . . . . . . . . . .
The PYRAMID™ ANTERIOR PLATE Fixation System is substantially Conclusion: equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation System (SE 5/19/93) and to the Medtronic Sofamor Danek BONE GRAFT WASHER (K994122 SE 12/06/99).
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JAN 2 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
K013665 Re:
Trade Name: PYRAMID™ Anterior Plate Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: November 4, 2001 Received: November 6, 2001
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above w d we have determined the device is substantially equivalent (for the indications for use stated in and we have decemined and dered in interstate commerce prior to May 28, 1976, the enactment date aft the Medical Device Amendments, or to devices that have been reclassified in accordance with the or and the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the provisions of the Pouchal Pood, Drovisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I levice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning may round in the Federal Register. Please note: this response to your premarket notification your do ho me not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Richard Treharne
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely, yours,
Mark N. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K013665
Device Name: PYRAMID™ ANTERIOR PLATE Fixation System
Indications for Use:
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Useper 21 CFR 801.109)(Optional 1-2-96) | X | OR | Over-the-counter Use | __________ |
|---|---|---|---|---|
| -------------------------------------------------------------- | --- | ---- | ---------------------- | ------------ |
for Mark N Milkerur
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorativeand Neurological Devices | |
| 510(k) Number | K013665 |
Concurrence of CDRH, Office of Evaluation (ODE)
Pres (Per (Op
§ 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.