(76 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.
The VERTEX™ Reconstruction System is fabricated from medical grade titanium or titanium allov. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.
The purpose of this submission was to add components to the system including a threaded rod, lateral connectors and modified screws.
The provided text is a 510(k) summary for the VERTEX™ Reconstruction System, a spinal interlaminal fixation orthosis. It describes the device, its indications for use, and a statement of substantial equivalence to a previously cleared predicate device.
However, this document does not contain information regarding specific acceptance criteria, comprehensive study data, sample sizes, expert qualifications, or ground truth methodologies that would be used to prove the device meets performance criteria in the way a diagnostic or AI-driven device would typically present.
The 510(k) process for a device like the VERTEX™ Reconstruction System (an implantable hardware device) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves:
- Materials testing: Ensuring the materials meet biocompatibility and mechanical strength standards.
- Mechanical testing: Demonstrating that the system components (rods, hooks, screws, connectors) can withstand the expected physiological loads and conditions without failure.
- Design comparison: Showing that the design features and intended use are similar to the predicate.
Given this context, I cannot fill out the requested table and answer many of your specific questions because the information is not present in the provided 510(k) summary. These details are more commonly found for AI/diagnostic software submissions.
Here's what I can provide based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: (Implied, but not explicitly stated with metrics in this document) | Documentation has been provided which demonstrates the subject VERTEX™ Reconstruction System components are substantially equivalent to VERTEX™ Reconstruction System components previously cleared in K003780 (SE 9/28/01). This implies that the device successfully met the same (or substantially similar) design, material, and mechanical performance requirements as the predicate device. Specific performance metrics (e.g., fatigue strength, pull-out force) are not detailed here. |
| Biocompatibility: (Implied, but not explicitly stated with metrics in this document) | Fabricated from medical grade titanium or titanium alloy. Use of Shape Memory Alloy (Nitinol - NiTi) retaining ring - stated as compatible with titanium or titanium alloy implants only. This implies biocompatibility was addressed through material selection and testing comparable to the predicate. |
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. This document focuses on substantial equivalence based on design and pre-clinical testing, not clinical studies with "test sets" of data as typically defined for AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in this context would likely refer to engineering standards and material specifications, verified by engineers and materials scientists during device development and testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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: Not applicable. This is a hardware implant, not an AI or diagnostic device that involves "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a hardware device like this, the "ground truth" would generally be established by:
* Engineering standards: Adherence to recognized ASTM, ISO, or other industry standards for medical implants.
* Biocompatibility standards: Confirmation that materials meet established safety profiles for implantation.
* Performance specifications: Mechanical testing results that meet predetermined thresholds for strength, durability, and fatigue.
* Predicate device's established performance: The primary "ground truth" for this 510(k) is that the new components perform as well as or similarly to the predicate device (K003780).
8. The sample size for the training set: Not applicable/Not provided. This is a hardware device; "training sets" are not typically used in its development or evaluation in the same way as for AI.
9. How the ground truth for the training set was established: Not applicable/Not provided.
{0}------------------------------------------------
DEC 2 1 2004
VERTEXTM Reconstruction System 510(k) Summary October 2004
| I. | Company: | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133 |
|---|---|---|
| Contact: | Richard W. Treharne, Ph.D.Senior Vice President, Regulatory Affairs | |
| II. | Product Name: | VERTEX™ Reconstruction System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis | |
| Regulation Number: | 888.3050 | |
| Code: | KWP |
III. Description:
The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.
The VERTEX™ Reconstruction System is fabricated from medical grade titanium or titanium allov. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.
The purpose of this submission was to add components to the system including a threaded rod, lateral connectors and modified screws.
IV Indications
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous
{1}------------------------------------------------
fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
V. Substantial Equivalence:
Documentation has been provided which demonstrates that the subject VERTEX™ Reconstruction System components are substantially equivalent to VERTEX™ Reconstruction System components previously cleared in K003780 (SE 9/28/01).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2004
Mr. Richard Treharne, Ph.D. Senior Vice President Regulatory Affairs Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
Re: K042789/S1
Trade/Device Name: VERTEXTM Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: November 17, 2004 Received: November 24, 2004
Dear Dr. Treharne:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Richard W. Treharne, 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
{4}------------------------------------------------
Page 1 of October 2004
510(k) Number (if known): _K642789
VERTEX™ Reconstruction System Device Name:
Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEX™ Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restarative, and Neurological Datanto
510(k) Number_Ko42745
0000000
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.