(126 days)
Not Found
No
The summary describes a mechanical implant and delivery system with no mention of AI or ML capabilities. The addition of tantalum markers is for improved visualization under fluoroscopy, which is a passive imaging aid, not an AI/ML function.
Yes
The device is described as a vertebral body replacement device intended to treat a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which is a therapeutic purpose.
No
The device is a vertebral body replacement device intended for surgical implantation, not for diagnosis.
No
The device description explicitly states it is composed of physical components (wafers, expandable implant, delivery device) made from PEEK-OPTIMA and Barium Sulfate, and the submission is for adding tantalum markers. This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- StaXx® XD System Function: The StaXx® XD System is a surgical implant used to replace and restore height in the spine. It is a physical device placed within the body, not a test performed on a sample outside the body.
The description clearly indicates it's a vertebral body replacement device used in surgery, which falls under the category of implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
Product codes
MQP
Device Description
The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.
The purpose of this submission is to gain clearance for the addition of tantalum markers to the implants for added visualization under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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)
The mechanical testing performed on the modified StaXx® XD System included dynamic axial compression and dynamic torsion per ASTM F 2077. Results of mechanical testing indicated that all acceptance criteria were met, demonstrating the StaXx® XD System's substantial equivalence to predicate device.
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
SPINE WAVE
K1D/288
pg 1 of 2
SEP 1 0 2010
510(k) Summary StaXx® XD System
Submitter Information
Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1839 Telefax: 203-944-9493
Contact: Date Prepared: Roaida Rizkallah May 6, 2010
Device Information
| Trade Name: | StaXx® XD System |
|---|---|
| Common Name: | Vertebral Body Replacement |
| Classification: | Class II per 21 CFR 888.3060 |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Product Code: | MOP |
Device Description
The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.
The purpose of this submission is to gain clearance for the addition of tantalum markers to the implants for added visualization under fluoroscopy.
1
K101288
pg 2 of 2
Intended Use
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
Substantial equivalence
The StaXx® XD System described in this submission is substantially equivalent in terms of design, technological characteristics, and intended use, to the following device:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| StaXx® XD System | Spine Wave, Inc. | K090315 |
The mechanical testing performed on the modified StaXx® XD System included dynamic axial compression and dynamic torsion per ASTM F 2077. Results of mechanical testing indicated that all acceptance criteria were met, demonstrating the StaXx® XD System's substantial equivalence to predicate device. The minor differences between the StaXx® XD System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the StaXx® XD System is substantially equivalent to its predicate device.
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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine Wave, Inc. % Ms. Roaida Rizkallah Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K101288
Trade/Device Name: StaXx® XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 30, 2010 Received: August 31, 2010
Dear Ms. Rizkallah:
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
SEP 1 0 2010
3
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 (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/CDRH/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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Buelhm
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KIDL288
SEP 1 0 2010
StaXx® XD System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
///
Division of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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KI01288 510(k) Number.