(368 days)
Not Found
No
The 510(k) summary describes a mechanical vertebral body replacement device and its delivery system. There is no mention of AI, ML, or any software component that would suggest the use of such technologies. The performance studies are focused on mechanical testing.
Yes
The device is intended to replace and restore height of a collapsed, damaged, or unstable vertebral body, indicating it is used for treatment and restoration of normal bodily function.
No
This device is a vertebral body replacement device, intended for surgical implantation to restore height and stability in the spine, not to identify or diagnose a condition.
No
The device description clearly states it is composed of physical components (wafers, implant, delivery device) made from materials like PEEK-OPTIMA and tantalum, and performance studies involve mechanical testing of these physical components.
Based on the provided information, the StaXx® XDL System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "vertebral body replacement device intended for use in the thoracolumbar spine... to replace and restore height of a collapsed, damaged, or unstable vertebral body." This describes a surgical implant used in vivo (within the body).
- Device Description: The description details the materials and components of a physical implant and its delivery system, not a test or reagent used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The StaXx® XDL System is a therapeutic device used for structural support and replacement within the body.
N/A
Intended Use / Indications for Use
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.
Product codes
MQP
Device Description
The StaXx® XDL System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markers for additional visualization under fluoroscopy. The system also includes a delivery device to place and expand the system.
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
Prescription Use
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)
Non-clinical testing was performed to demonstrate that the subject StaXx® XDL System is substantially equivalent to the listed predicate devices. The testing, performed to ASTM F2077 and ASTM F2267, included:
- Static axial compression,
- Dynamic axial compression. .
- Static torsion.
- Dynamic torsion, .
- . Static subsidence.
- Static expulsion. .
- Static shear testing, and .
- Wear debris.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052670, K090315, K101288, K052210, K070218, K052746
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/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are arranged horizontally, with "Spine" on the left and "Wave" on the right. A curved line is drawn below the words, suggesting a wave-like motion.
510(k) Summary StaXx® XDL System
AUG 1 9 2011
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1847 |
| Telefax: | 203-944-9493 |
| Contact: | Denise Duchene |
| Date Prepared: | January 17, 2011 |
2. Device Information
Trade Name: Common Name: Classification Name: Classification/Code:
StaXx® XDL System Vertebral Body Replacement Spinal Intervertebral Body Fixation Orthosis Class II per 21 CFR 888.3060; MQP
3. Purpose of Submission
The purpose of this submission is to introduce to market a new vertebral body replacement device, the StaXx® XDL System.
4. Predicate Device Information
The StaXx® XDL System described in this submission is substantially equivalent to the following devices:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| StaXx® XD System | Spine Wave, Inc. | K052670 |
| StaXx® XD System | Spine Wave, Inc. | K090315 |
| StaXx® XD System | Spine Wave, Inc. | K101288 |
| Nuvasive CoRoent® System | NuVasive, Inc. | K052210 |
| Exactech Octane Device | Exactech, Inc. | K070218 |
| Concorde Bullet Device | DePuy Spine, Inc. | K052746 |
5. Device Description
The StaXx® XDL System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markers for additional visualization under fluoroscopy. The system also includes a delivery device to place and expand the system.
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6. Intended Use
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.
7. Comparison of Technological Characteristics
The substantial equivalence of the subject StaXx® XDL System is shown by similarity in intended use, indications for use, materials and performance to the cited predicate devices. The StaXx® XDL System and the predicate devices are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain wafers that are stacked into an expandable implant. These devices are all used as vertebral body replacement devices in the thoracolumbar spine.
8. Performance Data
Non-clinical testing was performed to demonstrate that the subject StaXx® XDL System is substantially equivalent to the listed predicate devices. The testing, performed to ASTM F2077 and ASTM F2267, included:
- . Static axial compression,
- Dynamic axial compression. .
- Static torsion.
- Dynamic torsion, .
- . Static subsidence.
- Static expulsion. .
- Static shear testing, and .
- Wear debris. .
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicates, the subject StaXx® XDL System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present anv new issues of safety or effectiveness.
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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 three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine Wave, Inc. % Ms. Denise Duchene Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
AUG 1 9 2011
Re: K102315
Trade/Device Name: StaXx® XDL System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 12, 2011 Received: August 15, 2011
Dear Ms. Duchene:
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
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Page 2 - Ms. Denise Duchene
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 vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
A. Indications for Use
| 510(k) Number (if known): | K102315 |
|---|---|
| Device Name: | StaXx® XDL System |
Indications for Use:
The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
KID2315 510(k) Number_
Page 1 of 1
0000012