(70 days)
No
The device description and intended use focus on the physical components and surgical application of a spinal reconstruction system. There is no mention of AI or ML in the text, and the purpose of the submission is specifically to update labeling for MRI safety information.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities and conditions of the craniocervical junction, cervical spine, and thoracic spine, which aligns with the definition of a therapeutic device designed to treat medical conditions.
No
The VERTEX® Reconstruction System is a posterior implant system (plates, rods, hooks, screws, etc.) used to provide immobilization and restore integrity of spinal segments as an adjunct to fusion or for temporary support in patients with specific spinal conditions. Its purpose is to physically stabilize the spine, not to identify or analyze medical conditions.
No
The device description explicitly states it is a posterior system consisting of various physical components like plates, rods, hooks, and screws, fabricated from medical-grade materials. The submission's purpose is to update labeling for MRI safety information related to these physical implants.
Based on the provided information, the VERTEX® Reconstruction System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- VERTEX® Reconstruction System Function: The description clearly states that the VERTEX® Reconstruction System is a system of implants (plates, rods, screws, etc.) intended for surgical implantation to provide immobilization and stability to the spine. It is a physical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use describes surgical procedures and conditions of the spine, not laboratory testing.
- Device Description: The description focuses on the materials and components of the implantable device.
- Performance Studies: The performance studies described relate to MR-safety of the implanted device, not the accuracy or performance of a diagnostic test.
Therefore, the VERTEX® Reconstruction System falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VERTEX® Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative diseaseof the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use
Product codes
NKG, KWP
Device Description
The VERTEX® Reconstruction System is a posterior system which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. Conditions of the cervical spine, such as degenerative disc disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX® Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX® Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX® Reconstruction System are fabricated from medical grades of commercially pure titanium (ASTM F67-13), titanium alloy (ASTM F136-13), and cobalt chromium (ASTM F1537-11). The VERTEX® Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi (ASTM F2063-12).
The sole purpose for this submission is to update the labeling for the VERTEX® Reconstruction System to include MRI safety information while also providing MRI technologists with a method of concluding whether an MRI scan can be performed and specific instructions on how to perform the scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7), thoracic spine from T1-T3, occipitocervical and upper thoracic spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical Testing:
Due to the high degree of complexity in the allowable device configuration, a comprehensive computer simulation study was undertaken to identify the expected worst-case configuration. The computational study involved evaluating simple models (rods, screws, hooks) and adding additional components to create a more complex model. The computer simulations showed that heating generally decreased with increasing complexity of the Vertex constructs. Once the worst-case configurations were identified, these constructs were physically tested in reoal MR scanners (both 1.5 and 3 T) to measure the actual heating observed during scanning.
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject VERTEX® Reconstruction System was evaluated for MR-safety in accordance with the following standards:
- ASTM F2052:2014 "Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment"
- ASTM F2213:2006 (2011) – "Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment"
- ASTM F2119:2007 (2013) – "Standard test method for evaluation of MR image artifacts from passive implants"
- ASTM F2182:2002a, 2011, 2011a - "Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K003780, K022015, K042498, K052402, K052376, K071942, K123906
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Victoria Scheitlin Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
October 28, 2015
Re: K152338
Trade/Device Name: VERTEX® Reconstruction System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: August 18, 2015 Received: August 19, 2015
Dear Ms. Scheitlin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
Page 2 - Ms. Victoria Scheitlin
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K152338
Device Name VERTEX® Reconstruction System
Indications for Use (Describe)
The VERTEX® Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative diseaseof the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY MEDTRONIC Sofamor Danek MRI Update for VERTEX® Reconstruction System October 2015
Fax: (901) 346-9738
October 22, 2015
| I. | Company: | Medtronic Sofamor Danek USA, Inc. |
|---|---|---|
| 1800 Pyramid Place | ||
| Memphis, Tennessee 38132 | ||
| (800) 876-3133 | ||
| Contact: | Victoria Scheitlin | |
| Regulatory Affairs Specialist | ||
| Telephone: (901) 344-0706 |
Date Prepared:
II. Device:
| Name of Device: |
|---|
| Classification Name: |
Class: Product Code: Classification Name: Class: Product Code:
VERTEX® Reconstruction System Orthosis, Cervical Pedicle Screw Spinal Fixation (Unclassified) Pre-Amendment NKG Appliance, Fixation, Spinal (21 CFR§ 888.3050) ll KWP
lll. Predicate Devices:
Primary Predicate – VERTEX® Reconstruction System K143471 (S.E. 02/06/2015)
- Reference Device VERTEX® Reconstruction ● System K003780 ( S.E. 09/28/2001)
- Reference Device - VERTEX® Reconstruction System K022015 ( S.E. 07/18/2002)
- . Reference Device - VERTEX® Reconstruction System K042498 ( S.E. 10/07/2004)
- . Reference Device - VERTEX® Reconstruction System K052402 ( S.E. 09/23/2005)
- . Reference Device - VERTEX® Reconstruction System K052376 ( S.E. 01/05/2006)
- Reference Device - VERTEX® Reconstruction System K071942 ( S.E. 12/11/2007)
- . Reference Device - VERTEX® Reconstruction System K123906 (S.E. 04/01/2013)
The predicate has not been subject to a design related recall. Seven reference devices were used in this submission.
4
IV. Description:
The VERTEX® Reconstruction System is a posterior system which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. Conditions of the cervical spine, such as degenerative disc disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX® Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX® Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX® Reconstruction System are fabricated from medical grades of commercially pure titanium (ASTM F67-13), titanium alloy (ASTM F136-13), and cobalt chromium (ASTM F1537-11). The VERTEX® Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi (ASTM F2063-12).
The sole purpose for this submission is to update the labeling for the VERTEX® Reconstruction System to include MRI safety information while also providing MRI technologists with a method of concluding whether an MRI scan can be performed and specific instructions on how to perform the scan.
V. Indications for Use:
The VERTEX® Reconstruction System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
5
VI. Comparison of Technological Characteristics with the Predicate Devices:
The design/specifications of the subject device are not being addressed. No changes have occurred for the device and the subject device is considered substantially equivalent to the previously cleared 510(k) submission:
-
- The following submission contains identical indications for use as the subject device:
- i. Primary Predicate VERTEX® Reconstruction System K143471 (S.E. 02/06/2015)
-
- The following submissions contain the appropriate mechanical testing for the VERTEX® Reconstruction System:
- I. VERTEX® Reconstruction System K003780 ( S.E. 09/28/2001)
- II. VERTEX® Reconstruction System K022015 ( S.E. 07/18/2002)
- III. VERTEX® Reconstruction System K042498 ( S.E. 10/07/2004)
- IV. VERTEX® Reconstruction System K052402( S.E. 09/23/2005)
- V. VERTEX® Reconstruction System K052376 ( S.E. 01/05/2006)
- VI. VERTEX® Reconstruction System K071942 ( S.E. 12/11/2007)
- VII. VERTEX® Reconstruction System K123906 (S.E. 04/01/2013)
VII. Performance Data:
The following performance data were provided in support of substantial equivalence.
The subject VERTEX® Reconstruction System implants are permanent implants and will be classified as permanent , >30 day body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject implants are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards:
- ASTM F136-13: Standard Specification for Wrought Ti-6Al-4V ELI Alloy for Surgical Implant
- ASTM F67-13: Standard Specification for Unalloyed Titanium, for Surgical Implant Applications
- ASTM F1537-11: Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants
- ASTM F2063-12: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
VIII. Mechanical Testing
Due to the high degree of complexity in the allowable device configuration, a comprehensive computer simulation study was undertaken to identify the expected worst-case configuration. The computational study involved evaluating simple models (rods, screws, hooks) and adding additional components to create a more complex model. The computer simulations showed that heating generally decreased with increasing complexity of the Vertex constructs. Once the worst-case configurations were identified, these
6
constructs were physically tested in real MR scanners (both 1.5 and 3 T) to measure the actual heating observed during scanning.
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject VERTEX® Reconstruction System was evaluated for MR-safety in accordance with the following standards:
- ASTM F2052:2014 "Standard test method for measurement of . magnetically induced displacement force on passive implants in the magnetic resonance environment"
- . ASTM F2213:2006 (2011) – "Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment"
- . ASTM F2119:2007 (2013) – "Standard test method for evaluation of MR image artifacts from passive implants"
- ASTM F2182:2002a, 2011, 2011a - "Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging"
The VERTEX® Reconstruction System has been labeled in accordance with ASTM F2503-13 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment".
IX. Conclusion:
The subject VERTEX® Reconstruction System was evaluated for MR-safety and compatibility. Additional testing was not performed on the VERTEX® Reconstruction System as no changes to the actual product are occurring. Therefore as no changes have occurred the subject device is considered substantially equivalent to the previously cleared 510(k) submission:
-
- The following submission contains identical indications for use as the subject device:
- i. Primary Predicate – VERTEX® Reconstruction System K143471 (S.E. 02/06/2015)
-
- The following submissions contain the appropriate mechanical testing for the VERTEX® Reconstruction System:
- i. VERTEX® Reconstruction System K003780 ( S.E. 09/28/2001)
- ii. VERTEX® Reconstruction System K022015 ( S.E. 07/18/2002)
- iii. VERTEX® Reconstruction System K042498 ( S.E. 10/07/2004)
- iv. VERTEX® Reconstruction System K052402( S.E. 09/23/2005)
- v. VERTEX® Reconstruction System K052376 ( S.E. 01/05/2006)
- vi. VERTEX® Reconstruction System K071942 ( S.E. 12/11/2007)
- vii. VERTEX® Reconstruction System K123906 (S.E. 04/01/2013)
The VERTEX® Reconstruction System was determined to be MR-conditional.