(82 days)
Not Found
No
The device description and intended use clearly define a mechanical implant for vertebral body replacement. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on mechanical and MRI compatibility testing, not algorithmic performance.
Yes
The device is a vertebral body replacement system used to treat conditions like tumor and trauma in the spine, which directly addresses health issues and aims to improve a patient's physical well-being.
No
The device is a vertebral body replacement system, an implant used in surgery to replace a damaged vertebral body. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "centerpieces, modular end caps, and associated instruments," which are physical hardware components. The performance studies also focus on mechanical testing of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The T2 STRATOSPHERE™ Expandable Corpectomy System is a physical implant intended for surgical replacement of vertebral bodies in the spine. It is used in vivo (within the body) during a surgical procedure.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens.
Therefore, the T2 STRATOSPHERE™ Expandable Corpectomy System falls under the category of a surgical implant or medical device used directly on the patient, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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, 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 turnors involving the thoracolumbar 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
Device Description
The T2 STRATOSPHERE™ Expandable Corpectomy System consists of centerpieces, modular end caps, and associated instruments. The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine for tumor and trauma pathologies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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
Mechanical Testing
In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing for the subject implants was completed in accordance with:
- 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
The tests completed were: - Static Compression
- Compression Fatigue
- Static Torsion
- Torsion Fatigue
- Expulsion
The subject devices met the pre-determined acceptance criteria for all tests. Therefore, Medtronic believes design verification testing demonstrated that the subject implants are substantially equivalent to the predicate Medtronic devices.
MRI Testing
In accordance with the Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. Medtronic believes that the subject implants do not present a new worst case and thus, can justifiably be classified as MR-Conditional.
Key Metrics
Not Found
Predicate Device(s)
K100976, K083186, K071033, K052931
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
December 20, 2017
Medtronic Sofamor Danek Ms. Kanesha Hines Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K173125
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 Dated: September 28, 2017 Received: September 29, 2017
Dear Ms. Hines:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Kanesha Hines
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Ronald P. Jean -S for
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) K173125
Device Name
T2 STRATOSPHERE™ Expandable Corpectomy System
Indications for Use (Describe)
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, 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 turnors involving the 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) | |
|---|---|
| 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 T2 STRATOSPHERE™ Expandable Corpectomy System
December 2017
| 1800 Pyramid Place
Memphis, Tennessee 38132
Submitter:
Telephone: (901)396-3133
Fax: (901) 346-9738
Kanesha Hines
Regulatory Affairs Specialist
Contact Person
Direct Telephone: (901)399-2670
Date Prepared
December 7, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
Name of Device
Common Name
Spinal intervertebral body fixation orthosis
Classification Name
Spinal intervertebral body fixation orthosis: 21 CFR 888.3060
Class II
Classification
Product Codes
MQP 21 CFR 888.3060
There are 4 Predicates.
Primary Predicate 1- T2 ALTITUDE™ Expandable
Corpectomy System (K100976, S.E. 10/21/2010)
Predicate 2- Aesculap HydroLift VBR (K083186, S.E.
03/04/2010)
Predicate Devices
Predicate 3- T2 XVBR™ Spinal System (K071033, S.E.
08/14/2007)
Predicate 4- VERTE-STACK Spinal System® (K052931, S.E.
| 11/16/2005) | Medtronic Sofamor Danek | |
|---|---|---|
| The predicates have not been subject to a design related recall. | ||
| The T2 STRATOSPHERE™ Expandable Corpectomy System | Description of Devices | |
| consists of centerpieces, modular end caps, and associated | ||
| instruments. The T2 STRATOSPHERE™ Expandable | ||
| Corpectomy System is intended for vertebral body replacement to | ||
| aid in the surgical correction and stabilization of the spine for | ||
| tumor and trauma pathologies. | ||
| 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. | ||
| Indications for Use | 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 the surgeon's | ||
| discretion. | ||
| T2 STRATOSPHERE™ Expandable Corpectomy System | ||
| Implants | ||
| The primary predicate is T2 ALTITUDE™ Expandable | ||
| Corpectomy System (K100976, S.E. 10/21/2010). The subject | ||
| and predicate implants have identical intended use and similar | ||
| indications and materials as Primary Predicate 1 (K100976, S.E. | ||
| Comparison of | ||
| Technological | ||
| Characteristics with the | ||
| Predicate Devices | 10/21/2010) and Predicate 2 K083186, S.E. 03/04/2010). The | |
| predicate and subject devices have identical function and similar | ||
| scientific fundamental technology. | ||
| T2 STRATOSPHERE™ Expandable Corpectomy System | ||
| Instruments | ||
| The primary predicate is T2 ALTITUDE™ Expandable | ||
| Corpectomy System (K100976, S.E. 10/21/2010). The predicate | ||
| and subject devices have identical function and similar scientific | ||
| fundamental technology. | ||
| Mechanical Testing | ||
| Performance Data | ||
| In accordance with the Guidance for Industry and FDA Staff - | ||
| Spinal System 510(k)'s,Medtronic has evaluated the subject | ||
| devices to demonstrate substantial equivalence to the | ||
| predicate devices. | ||
| Design verification testing for the subject implants was completed | ||
| in accordance with | ||
| - 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 | ||
| The tests completed were: | ||
| - Static Compression | ||
| - Compression Fatigue | ||
| - Static Torsion | ||
| - Torsion Fatigue | ||
| - Expulsion | ||
| The subject devices met the pre-determined acceptance criteria for | ||
| all tests. Therefore, Medtronic believes design verification testing | ||
| demonstrated that the subject implants are substantially equivalent | ||
| to the predicate Medtronic devices. | ||
| MRI Testing | ||
| In accordance with the Guidance for Industry and FDA Staff - | ||
| Establishing Safety and Compatibility of Passive Implants in the | ||
| Magnetic Resonance (MR) Environment, Medtronic has evaluated | ||
| the subject devices to demonstrate substantial equivalence to the | ||
| predicate devices. Medtronic believes that the subject implants do | ||
| not present a new worst case and thus, can justifiably be classified | ||
| as MR-Conditional. | ||
| Based on the test results and additional supporting information | ||
| provided in this premarket notification, Medtronic believes the | ||
| subject devices are at least as safe as and effective as the legally | ||
| marketed predicate devices: | ||
| Primary Predicate 1- T2 ALTITUDE™ Expandable | ||
| 0 | ||
| Conclusion | Corpectomy System (K100976, S.E. 10/21/2010) | |
| Predicate 2- Aesculap HydroLift VBR (K083186, S.E. | ||
| 0 | ||
| 03/04/2010) | ||
| Predicate 3- T2 XVBR™ Spinal System (K071033, S.E. | ||
| 0 | ||
| 08/14/2007) | ||
| Predicate 4- VERTE-STACK Spinal System® (K052931, | ||
| 0 | ||
| S.E. 11/16/2005) |
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