(53 days)
Not Found
No
The 510(k) summary describes a mechanical vertebral body replacement device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a vertebral body replacement device intended to restore height due to tumor or trauma, which directly addresses a medical condition rather than just providing imaging or diagnostic information.
No
The device is a vertebral body replacement device, intended for structural support in the spine following tumor or trauma. It does not perform any diagnostic functions.
No
The device description clearly states it is composed of physical components (wafers, implant, PEEK-OPTIMA, Barium Sulfate, tantalum markers) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, 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 about a person's health.
- StaXx® XD System Function: The StaXx® XD System is a surgical implant designed to replace a damaged vertebral body in the spine. It is a physical device implanted directly into the body.
- Intended Use: The intended use clearly describes a surgical procedure to replace a vertebral body, not a test performed on a specimen outside the body.
Therefore, based on the provided information, the StaXx® XD System is a surgical implant, not an In Vitro Diagnostic device.
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. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and may contain tantalum markers for additional visualization under fluoroscopy.
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)
Non-clinical testing was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate device. No testing is required for an update to the labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052670, K090315, K101288, K102682
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 runs beneath the words, resembling a wave.
JUL 19 2011
510(k) Summary StaXx® XD System Surgical Gun
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: | June 30, 2011 |
2. Device Information
| Trade Name: | S |
|---|---|
| Common Name: | V |
| Classification Name: | S |
| Classification/Code: | C |
StaXx® XD System /ertebral 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 describe a modification to the labeling for the StaXx® XD System. In addition minor modifications have been made to the surgical gun used to deliver the StaXx® XD Expandable Device.
4. Predicate Device Information
The StaXx® XD System described in this submission is substantially equivalent to StaXx® XD System included in the following 510(k)s:
| 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 |
| StaXx® XD System | Spine Wave, Inc. | K102682 |
1
5. Device Description
The StaXx® XD 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 may contain tantalum markers for additional visualization under fluoroscopy.
6. 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.
7. Comparison of Technological Characteristics
The substantial equivalence of the subject StaXx® XD System is shown by similarity in intended use, indications for use, materials and performance to the cited predicate device. The StaXx® XD System and the predicate devices are manufactured from the same materials and have the same indications and technological characteristics.
8. Performance Data
Non-clinical testing was performed to demonstrate that the subject StaXx® XD System is substantially equivalent to the listed predicate device. No testing is required for an update to the labeling.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicates, the subject StaXx® XD System has been shown to be substantially equivalent to the predicate device identified in this submission, and does not present any new issues of safety or effectiveness.
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 stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spine Wave, Inc. % Ms. Denise Duchene Sr. Manager, Regulatory Affairs Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
JUL 19 2011
Re: K111469
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: MOP Dated: June 30, 2011 Received: July 01, 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
3
Page 2 - Ms. Denise Duchene
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 (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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
erely yours,
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):
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 (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.
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 Sign Off)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________