(108 days)
Not Found
No
The summary describes a mechanical vertebral body replacement device made of titanium, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No.
The T2™ SCEPTOR™ Spinal System is a vertebral body replacement device, which is an implant designed to provide structural support and stability, rather than actively administering therapy.
No
Explanation: The device is described as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. It is a surgical implant, not a diagnostic tool.
No
The device description clearly states it is comprised of physical components made of titanium or titanium alloy, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the T2™ SCEPTOR™ Spinal System is a vertebral body replacement device used in the thoracolumbar spine to replace damaged or unstable vertebral bodies due to tumor or trauma. This is a surgical implant used in vivo (within the body).
- Device Description: The description details the physical components of the device (end caps, endcleats, materials like titanium) and how it functions as a structural support and allows for bone grafting. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
Therefore, the T2™ SCEPTOR™ Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T2™ SCEPTOR™ Spinal System is a vertebral body replacement device 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 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.
Product codes
MQP, MOP
Device Description
The Medtronic Sofamor Danek T2™ SCEPTOR™ System is comprised of a set of various angled and non-angled endcleats and end caps which are affixed to the ends of the PYRAMESH-C® implants. These devices serve to grip the inferior and superior end plates, thus allowing for expulsion resistance. The pyramid-shaped openings located along the wall of the PYRAMESH-C® device allows grafting material to be placed inside the hollow core of the device to help achieve a solid fusion.
The device is made from commercially pure titanium or titanium alloy conforming to such voluntary standards as ASTM F67 and ASTM F136 or the ISO equivalents 5832-2 and 5832-3, and is available in various sizes to match the patients' anatomical requirements.
The T2™ SCEPTOR™ device, used in conjunction with the PYRAMESH-C® device, is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine. These systems include the ZPLATE-II™ Anterior Fixation System, the CD HORIZON® Spinal System, the TSRH® Spinal System, the DYNALOK™ CLASSIC Spinal System, and the Laurain DeWald Anterior Fixation System.
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 (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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 handwritten characters and numbers. The first row contains the characters 'K', a circle with a line through it, and the numbers '6', '3', '4', '9', and '1'. The second row contains the letters 'p', 'i', 'c', 'L', and the number '2'.
MEDTRONIC Sofamor Danek T2™ SCEPTOR™ Spinal System 510(k) Summary November 2006
| I. | Company: | Medtronic Sofamor Danek, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
(901) 396-3133 |
| ---- | ---------- | --------------------------------------------------------------------------------------------------- |
|---|
MAR 0 5 2007
| II. | |
|---|---|
| Product Name: | T2 TM SCEPTOR TM Spinal System |
| Classification: | MQP |
Description: The Medtronic Sofamor Danek T2™ SCEPTOR™ System is comprised III. of a set of various angled and non-angled endcleats and end caps which are affixed to the ends of the PYRAMESH-C® implants. These devices serve to grip the inferior and superior end plates, thus allowing for expulsion resistance. The pyramid-shaped openings located along the wall of the PYRAMESH-C® device allows grafting material to be placed inside the hollow core of the device to help achieve a solid fusion.
The device is made from commercially pure titanium or titanium alloy conforming to such voluntary standards as ASTM F67 and ASTM F136 or the ISO equivalents 5832-2 and 5832-3, and is available in various sizes to match the patients' anatomical requirements.
The T2™ SCEPTOR™ device, used in conjunction with the PYRAMESH-C® device, is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine. These systems include the ZPLATE-II™ Anterior Fixation System, the CD HORIZON® Spinal System, the TSRH® Spinal System, the DYNALOK™ CLASSIC Spinal System, and the Laurain DeWald Anterior Fixation System.
- Indications for Use: The T2™ System The T2™ SCEPTOR™ Spinal System is a IV. vertebral body replacement device intended for use in the thoracolumbar spine (T) -LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the
0000 f
1
K 0 6 3 4 9 1
P 2 er 2
ﺬ
e J
V ANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.
- Substantial Equivalence: Documentation, including mechanical test results, provided V. has demonstrated that the T2™ SCEPTOR™ Spinal System is substantially equivalent to similar previously cleared devices such as the VERTE-STACK® Spinal System (K052931, SE 11/16/05 and · K060719, SE 04/14/06) as well as the PYRAMESH-C Spinal System (K011406, SE 12/27/01).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek c/o Ms. Christine Scifert 1800 Pyramid Place Memphis. Tennessee 38132
MAR 0 5 2007
Re: K063491 Trade Name: T2™ SCEPTOR™ Endcleat System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: January 9, 2007 Received: January 11, 2007
Dear Ms. Scifert:
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 (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.
3
Page 2 -- Ms. Christine Scifert
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/industry/support/index.html.
Sincerely vours,
Mark A. Milkers
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
K 0 6 3 4.91
Device Name:_____ T2™ SCEPTOR™ Spinal System
Indications for Use:
The T2™ SCEPTOR™ Spinal System is a vertebral body replacement device 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 SCEPTOR™ Spinal System consists of a series of end caps and endcleats which must be attached to a PYRAMESH-C® device to form a complete construct. The final construct is to be used with supplemental fixation. Specifically, the T2TM SCEPTOR™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the T2™ SCEPTOR™ device is intended to be used with bone graft.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millhusan
Division of Ge ral, Resto and Neurological Devices
510(k) Numb
0000 こで