(196 days)
No
The summary describes a mechanical implantable device for spinal surgery and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a vertebral body replacement system used to treat collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, aiming to correct and stabilize the spine.
No
Explanation: The device is a vertebral body replacement system, which is a therapeutic device designed for surgical correction and stabilization of the spine, not for diagnosing medical conditions.
No
The device description clearly states the system is comprised of physical components made of titanium alloy, cobalt chrome, and nitinol, which are implanted in the spine. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The T2 ALTITUDE™ Expandable Corpectomy System is a physical implant designed to replace a vertebral body in the spine. It is a surgical device used in vivo (within the body).
- Intended Use: The intended use is to replace a damaged vertebral body due to tumor or trauma, which is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant used for structural support and stabilization within the body, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The T2 ALTITUDE™ 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 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
Product codes
MQP
Device Description
The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. T2 ALTITUDE™ Expandable Corpectomy System constructs may not be used with stainless steel supplemental fixation devices. The construct is not intended to be used as a stand alone device. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (TI-LS)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
r.
T2 ALTITUDE™ Expandable Corpectomy System 510(k) Summary October 18, 2010
| I. | Company: | Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 | | | |
|------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Contact: | Jennifer Hackney
Regulatory Affairs Specialist
OCT 21 201 | | | |
| II. | Trade Name: | T2 ALTITUDE™ Expandable Corpectomy System | | | |
| III. | Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR
888.3060) | | | |
| IV. | Product Code: | MQP | | | |
Description: The T2 ALTITUDE™ Expandable Corpectomy System is a distractible V. system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. T2 ALTITUDE™ Expandable Corpectomy System constructs may not be used with stainless steel supplemental fixation devices. The construct is not intended to be used as a stand alone device. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System.
| Anterior | Posterior | |
|---|---|---|
| VANTAGE® Anterior Fixation System | X | |
| TSRH® Spinal System | X | X |
| CD HORIZON® Spinal System | X | X |
The T2 ALTITUDE™ Expandable Corpectomy System contains an expandable centerpiece, which is made of titanium afloy, cobalt chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2 ALTITUDE™ Expandable Corpectomy System's optional end
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caps may be attached to the T2 ALTITUDE™ Expandable Corpectomy System's expandable centerpieces as needed to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
- VI. Indications for Use: The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
- Substantial Equivalence: Documentation was provided which demonstrated that the VII. T2 ALTITUDE™ Expandable Corpectomy System components are substantially equivalent to previously cleared devices such as the T2 XVBRTM Spinal System K071033 (S.E. 08/14/2007), K082112 (S.E. 08/27/2008), and K091883 (S.E. 09/21/2009).
©2010 Medtronic Sofamor Danek
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek, Inc. % Ms. Jennifer Hackney Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
OCT 2 1 2010
Re: K100976
Trade/Device Name: T2 ALTITUDE™ Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 1, 2010 Received: October 4, 2010
Dear Ms. Hackney:
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
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Page 2 - Ms. Jennifer Hackney
CFR Part 807); labeling (21 CFR Part 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcessforYou/Industry/default.htm.
Sincerely yours.
Clarence Phillip
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OCT 2 1 2010
のお気になるので、この時には、その後は、その後は、この時には、こので、このことになる。
510(k) Number (if known): K100976
Device Name: T2 ALTITUDE™ Expandable Corpectomy System
all all and the are a comment of the
Indications for Use:
The T2 ALTITUDE™ 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 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR X Per 21 CFR 801.109
Over-The-Counter Use
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KIDD976 510(k) Number_