(29 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is designed to replace damaged or unstable vertebral bodies caused by various conditions like tumors, trauma, or osteomyelitis, which is a therapeutic intervention.
No.
This device is a vertebral body replacement device intended for surgical correction and stabilization of the spine, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of titanium alloy, intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a mechanical implant made of titanium alloy, designed for surgical insertion and expansion. This aligns with a surgical device, not a device used for in vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is a surgical implant used for structural support and stabilization of the spine.
N/A
Intended Use / Indications for Use
Cervical and Thoracolumbar
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients.
When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectorny System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine. the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collabsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratoshere™ Expandable Corpectorny centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous bone graft as an adjunct to fusion. When used in the thoracic and lumbar spine, the 72 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectory System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Thoracolumbar
The T2 Stratosphere™ Expandable Corpectory System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine.
The T2 Stratosphere™ Expandable Corpectory System is intended for use with autograft or allograft, as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes
MQP, PLR
Device Description
The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements.
The T2 STRATOSPHERE™ Expandable Corpectomy may be used in the thoracolumbar and cervical spine. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. Only the 13mm devices are cleared for both cervical and thoracolumbar region of the spine.
The device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral, oblique, or posterior approach using a minimally invasive technique or implanted through a lateral, oblique, posterior, or anterior approach through a traditional open technique.
The T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation cleared for use in the cervical and thoracolumbar spine. The device is not intended to be used as a stand-alone implant.
The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy (TI6A14V) in accordance with ASTM F136 Standard Specification for Wrought Titanium- Aluminium-4 Vanadium ELI Alloy for Surgical Implant Applications. The centerpieces are available in multiple diameters and heights. The system also features modular end caps which are available in various angles and geometries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine (TI-L5), cervical spine (C2-C7)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
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)
Biocompatibility: The subject, T2 STRATOSPHERE™ Expandable Corpectomy System Implants are permanent implants(>30days) and will be classified as body contacting devices according to 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 within risk management process." The subject implants are manufactured from identical materials as the predicate devices (K181328, S.E. 08/19/2018 and K173125, S.E. 12/20/2017) in accordance with the following standards: ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications. The manufacturing processes performed on the subject implants are standard industry practices and are identical to the predicates 1 and 2.
Mechanical Testing: The subject implants are the same as the predicate implants in terms of material, sizes and intended use. Mechanical testing for the predicate implants were tested in accordance with the following standards: ASTM F2077, Test Methods For Intervertebral Body Fusion Devices ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices Staff. Therefore, non-clinical mechanical testing was not performed on the Subject sterile implants. Detailed Mechanical Testing information is provided in the Predicate 2 (K173125, S.E 12/20/2017) submission. The subject devices do not introduce a new worst case, hence Medtronic believes that testing conducted on the predicate implants satisfies testing requirements for the subject devices. The subject devices do not introduce a new worst case scenario and are substantially equivalent to the predicate devices.
Pyrogenicity: The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed, and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2019
Medtronic Sofamor Danek, USA Inc. Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K183510
Trade/Device Name: T2 STRATOSPHERE™ Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: December 13, 2018 Received: December 18, 2018
Dear Ms. Hamilton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183510
Device Name
T2 Stratosphere™ Expandable Corpectomy System
Indications for Use (Describe)
Cervical and Thoracolumbar
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients.
When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectorny System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine. the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collabsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratoshere™ Expandable Corpectorny centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous bone graft as an adjunct to fusion. When used in the thoracic and lumbar spine, the 72 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectory System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183510
Device Name
T2 Stratosphere™ Expandable Corpectomy System
Indications for Use (Describe)
Thoracolumbar
The T2 Stratosphere™ Expandable Corpectory System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine.
The T2 Stratosphere™ Expandable Corpectory System is intended for use with autograft or allograft, as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
4
510(k) SUMMARY
MEDTRONIC T2 STRATOSPHERE™ Expandable Corpectomy System
December 2018
| Submitter: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Elizabeth Hamilton
Regulatory Affairs Specialist
Direct Telephone: (901) 399-3395 |
| Date Prepared | December 13, 2018 |
| Name of Device | T2 STRATOSPHERE™ Expandable Corpectomy System |
| Common Name | Spinal Vertebral Body Replacement Device |
| Classification Name | Spinal Intervertebral Body Fixation Orthosis: 21 CFR 888.3060 |
| Classification | Class II |
| Product Codes | MQP, PLR |
| Predicate Devices | There are three (3) Predicates:
Primary Predicate 1 - T2 Stratosphere™ Expandable Corpectomy System
(K181328, S.E. 09/19/2018)
Predicate 2 - T2 Stratosphere™ Expandable Corpectomy System (K173125,
S.E. 12/20/2017)
Predicate 3 -T2 XVBR™ System (K071033. S.E. 08/14/2007) |
| Description of
Devices | The T2 STRATOSPHERE™ Expandable Corpectomy System is an
adjustable vertebral body replacement device and features a self-adjusting end
cap which provides continuous angulation between 0-8° in any direction to
accommodate the patient's anatomical requirements.
The T2 STRATOSPHERE™ Expandable Corpectomy may be used in the
thoracolumbar and cervical spine. The T2 STRATOSPHERE™ Expandable
Corpectomy devices for use in the cervical spine are restricted to 13mm |
| | diameter centerpieces. Only the 13mm devices are cleared for both cervical
and thoracolumbar region of the spine. |
| | The device is inserted between two vertebral bodies in the thoracolumbar or
cervical spine and is expanded to aid in the surgical correction and
stabilization of the spine. The device may be implanted through a lateral,
oblique, or posterior approach using a minimally invasive technique or
implanted through a lateral, oblique, posterior, or anterior approach through
a traditional open technique. |
| | The T2 STRATOSPHERE™ Expandable Corpectomy System is intended to
be used with supplemental fixation cleared for use in the cervical and
thoracolumbar spine. The device is not intended to be used as a stand-alone
implant. |
| | The T2 STRATOSPHERE™ Expandable Corpectomy System is made
of titanium alloy (TI6A14V) in accordance with ASTM F136
Standard Specification for Wrought Titanium- Aluminium-4 Vanadium ELI
Alloy for Surgical Implant Applications. The centerpieces are available
in multiple diameters and heights. The system also features modular end
caps which are available in various angles and geometries. |
| Indications for Use | TL Indications |
| | The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral
body replacement system intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor, or
trauma (i.e.; fracture). The T2 STRATOSPHERE™ Expandable Centerpiece
may be used with or without optional modular end caps which accommodate
individual anatomic requirements. The device is to be used with supplemental
fixation cleared for use in the thoracolumbar spine.
T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use
with autograft or allograft, as an adjunct to fusion. The T2 STRATOSPHERE™
Expandable Corpectomy System is also intended to restore the integrity of the
spinal column even in the absence of fusion for a limited time in patients with
advanced stage tumors involving the thoracolumbar spine in whom life
expectancy is of insufficient duration to permit achievement of fusion, with bone
graft used at surgeon's discretion. |
| | Cervical Indications |
| | The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral
body replacement system intended for use in the thoracolumbar spine (T1-L5)
and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable
Corpectomy System is intended for use in skeletally mature patients. |
| | When used in the cervical spine, the T2 STRATOSPHERE® Expandable
System is used to replace a collapsed, damaged, or unstable vertebral body
caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction
following corpectomy performed to achieve decompression of the spinal cord
and neural tissues in cervical degenerative disorders. When used in the cervical
spine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not be
used with optional modular end caps. When used in the cervical spine at one or
two levels, the T2 STRATOSPHERE™ Expandable Corpectomy System is
intended to be used with supplemental fixation for use in the cervical spine.
When used at more than two levels, supplemental fixation should include
posterior fixation cleared for use in the cervical spine.
When used in the thoracolumbar spine, the T2 STRATOSPHERE® Expandable
System is used to replace a collapsed, damaged, or unstable vertebral body due
to tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable
Corpectomy System may be used with or without optional modular end caps
which accommodate individual anatomic requirements. The device is to be used
with supplemental fixation cleared for use in the thoracolumbar spine.
When used in the cervical spine, the T2 STRATOSPHERE™ Expandable
Corpectomy System is intended for use with autograft or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft as an adjunct to
fusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™
Expandable Corpectomy System is intended for use with autograft or allograft
as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy
System is also intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time in patients with advanced stage tumors
involving the cervical and/or thoracolumbar spine in whom life expectancy is of
insufficient duration to permit achievement of fusion, with bone graft used at the
surgeon's discretion. |
| Comparison of
Technological
Characteristics with
the Predicate
Devices | T2 STRATOSPHERE™ Expandable Corpectomy System Implants
The subject T2 STRATOSPHERE™ Expandable Corpectomy System Implants
have identical: indications for use, intended use, material (Titanium Alloy Per
ASTM F136), levels of attachment, fundamental scientific technology and
similar design as the T2 STRATOSPHERE™ Expandable Corpectomy devices
previously cleared by the FDA in K181328, S.E. 09/19/2018 and K173125, S.E.
12/20/2017. The subject devices are identical to the predicates cleared within
the T2 STRATOSPHERE™ Expandable Corpectomy system in terms of
material, intended use, level of attachment, size range, material and
fundamental scientific technology. The subject devices are very similar in
design to the predicate devices and the only technological difference between
the subject and predicate T2 Stratosphere™ Expandable Corpectomy System
implants is the subject T2 STRATOSPHERE™ devices are provided sterile |
| | while the predicate T2 STRATOSPHERE™ devices are provided non-sterile.
Additionally, the subject T2 STRATOSPHERE™ Expandable Corpectomy
System Implants are provided sterile and are identical to that of Predicate 3
cleared by the FDA in K071033. S.E. 08/14/2007. The sterilization method used
for the subject devices is identical to the sterilization method used for Predicate
3T2 XVBRT™ System (K071033. S.E. 08/14/2007). |
| Performance Data | The following information is provided in support of substantial equivalence. |
| | Biocompatibility
The subject, T2 STRATOSPHERE™ Expandable Corpectomy System Implants
are permanent implants(>30days) and will be classified as body contacting
devices according to 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 within risk management process." The subject
implants are manufactured from identical materials as the predicate devices
(K181328, S.E. 08/19/2018 and K173125, S.E. 12/20/2017) in accordance with
the following standards:
ASTM F136, Standard Specification for Wrought Titanium-6
Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications The manufacturing processes performed on the subject implants are standard
industry practices and are identical to the predicates 1 and 2. |
| | Mechanical Testing
The subject implants are the same as the predicate implants in terms of
material, sizes and intended use. Mechanical testing for the predicate implants
were tested in accordance with the following standards: |
| | ASTM F2077, Test Methods For Intervertebral Body Fusion Devices ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices Staff |
| | Therefore, non-clinical mechanical testing was not performed on the Subject
sterile implants. Detailed Mechanical Testing information is provided in the
Predicate 2 (K173125, S.E 12/20/2017) submission. The subject devices do not
introduce a new worst case, hence Medtronic believes that testing conducted on
the predicate implants satisfies testing requirements for the subject devices. The
subject devices do not introduce a new worst case scenario and are substantially
equivalent to the predicate devices. |
| Pyrogenicity | |
| | The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL)
test, was performed utilizing worst case subject implants to verify that the
subject implants meet the 20 endotoxin units (EU)/device pyrogen limit
specification. Testing was successfully performed, and it was confirmed that the |
| | subject implants meet the 20 EU/device testing limit for general medical devices
that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test |
| | methods, routine monitoring, and alternatives to batch testing and USP , |
| | Medical Devices - Bacterial Endotoxin and Pyrogen Tests. |
| Conclusion | |
| | Based on the test results and additional supporting information provided in |
| | this premarket notification, Medtronic believes the subject devices are |
| | substantially equivalent to the the legally marketed predicate devices: |
| | Primary Predicate 1 - T2 STRATOSPHERE™ Expandable
Corpectomy System, (K181328 S.E. 08/19/2018) Predicate 2 - T2 STRATOSPHERE™ Expandable Corpectomy
System, (K181328 S.E. 08/19/2018) Predicate 3 - T2™ XVBR Spinal System (K071033, S.E.
08/14/2007) |
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