(207 days)
Not Found
No
The summary describes a physical implant and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on Finite Element Analysis, not AI/ML model evaluation.
Yes
The device is described as 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)." This clearly indicates an active role in treating a medical condition, which aligns with the definition of a therapeutic device.
No
The device is a vertebral body replacement device used to treat collapsed, damaged, or unstable vertebral bodies due to tumor or trauma. Its function is to replace and restore height, not to diagnose a condition.
No
The device description clearly outlines physical components made of PEEK-OPTIMA and Barium Sulfate, as well as a "Surgical Gun" delivery device. This indicates a hardware-based medical device, not a software-only one.
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 designed to replace and restore the height of a damaged vertebral body. It is a physical device implanted into 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 (comma separated list FDA assigned to the subject device)
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 contain tantalum markers for additional visualization under fluoroscopy. The system also includes the Surgical Gun, a delivery device to place and expand the 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)
Finite Element Analysis was performed to demonstrate that the subject StaXx XD System is substantially equivalent to the listed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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Image /page/0/Picture/2 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 beneath the word "Wave", resembling a wave. The text and line are black against a white background.
510(k) Summary StaXx® XD System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida Rizkallah |
| Date Prepared: | November 1, 2011 |
2. Device Information
Trade Name: Common Name: Classification Name: Classification/Code:
StaXx® XD 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 gain clearance to expand the StaXx® XD System offering to include additional sizes.
4. Predicate Device Information
The StaXx® XD System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| StaXx® XD System | Spine Wave, Inc. | K101288 |
| StaXx® XD System | Spine Wave, Inc. | K102682 |
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 contain tantalum markers for additional visualization under fluoroscopy. The system also includes the Surgical Gun, a delivery device to place and expand the system.
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6. Intended 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.
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.
8. Performance Data
Finite Element Analysis was performed to demonstrate that the subject StaXx XD System is substantially equivalent to the listed predicate devices.
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.
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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 stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is 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
DEC 1 3 2011
Spine Wave, Inc. % Ms. Roaida Rizkallah Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K111418
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: November 01, 2011 Received: November 02, 2011
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
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Page 2 - Ms. Roaida Rizkallah
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erinl Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _杉川 418
Device Name: _____________ StaXx® XD System
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)
Rishabh Shah, MD
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
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KI11418 510(k) Number_