(126 days)
Not Found
No
The document describes a mechanical vertebral body replacement device and its associated delivery system, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a vertebral body replacement system used to restore height of a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which directly treats a medical condition.
No
The device description and intended use indicate it is an implant for spinal fusion and stabilization, not a device used to diagnose medical conditions.
No
The device description clearly states it is composed of physical components (wafers, implants, delivery device) made from materials like PEEK-OPTIMA, Barium Sulfate, tantalum, and titanium. It also describes mechanical performance testing of these physical components.
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 height in the spine. It is a physical device implanted into the body, not used to test samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure to address structural issues in the spine due to tumor or trauma.
- Device Description: The description details the materials and construction of a physical implant and its delivery system.
- Performance Studies: The performance studies focus on the mechanical properties and equivalence of the implant, not on the accuracy or reliability of diagnostic tests.
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 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 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 implants are to be used with autograft or allograft and supplemental spinal fixation. The implants are manufactured from PEEK-OPTIMA with 6% Barium Sulfate, tantalum markers (ASTM F560), and a plasma-sprayed commercially pure titanium coating (ASTM F1580). The implants are available in a variety of shapes and sizes, to accommodate variations in anatomy. The system also includes a delivery device to both implant and expand the implant.
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 Performance Testing:
- Coating Microstructure (ASTM F1854)
- Shear Fatigue Testing (ASTM F1160)
- Static Shear Testing (ASTM F1044)
- Tensile Testing (ASTM F1147)
- Abrasion Testing (ASTM F1978)
- Static and dynamic axial compression (ASTM F2077)
- Dynamic torsion (ASTM F2077)
- Wear debris analysis (ASTM F1877)
- Expulsion
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of human profiles facing right, with three distinct faces layered on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2015
Spine Wave, Incorporated Ms. Roaida Johnson Senior Regulatory Affairs Manager 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K142996
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: January 20, 2015 Received: January 21, 2014
Dear Ms. Johnson:
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 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
1
Page 2 - Ms. Roaida Johnson
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
Device Name StaXx® XD System
Indications for Use (Describe)
The StaXx® XD System is a vertebral body replacement device 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ❏ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The word "Spine" is on the left, and the word "Wave" is on the right. A blue wave design is underneath the word "Wave". The wave design is a simple, stylized wave.
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 R. Johnson |
| Date Prepared: | October 15, 2014 |
2. Device Information
| Trade Name: | StaXx® XD System |
|---|---|
| Common Name: | Vertebral Body Replacement Device |
| Classification: | Class II per 21 CFR 888.3060 |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Product Code: | MQP |
3. Purpose of Submission
The purpose of this submission is to gain clearance to add a commercially pure titanium coating to the StaXx® XD System.
4. Predicate Device Information
The StaXx® XD System described in this submission is substantially equivalent to the following predicates:
| Device | Manufacturer | 510(k) No. | |
|---|---|---|---|
| Primary Predicate | StaXx® XD System | Spine Wave, Inc. | K133207 |
| Additional | |||
| Predicate | Calix™ PC Spinal | ||
| Implant System | X-Spine | K112036 |
4
5. Device Description
The StaXx® XD System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are to be used with autograft or allograft and supplemental spinal fixation. The implants are manufactured from PEEK-OPTIMA with 6% Barium Sulfate, tantalum markers (ASTM F560), and a plasma-sprayed commercially pure titanium coating (ASTM F1580). The implants are available in a variety of shapes and sizes, to accommodate variations in anatomy. The system also includes a delivery device to both implant and expand the implant.
6. 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.
7. Comparison of Technological Characteristics
The substantial equivalence of the StaXx® XD System to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Non-Clinical Performance Testing
The following tests were performed for characterization of the commercially pure titanium coating:
- Coating Microstructure (ASTM F1854) ●
- Shear Fatigue Testing (ASTM F1160)
- Static Shear Testing (ASTM F1044) ●
- Tensile Testing (ASTM F1147) ●
- Abrasion Testing (ASTM F1978)
The following tests were performed to demonstrate the substantial equivalence of the StaXx® XD System to its predicate:
- Static and dynamic axial compression (ASTM F2077) ●
- Dynamic torsion (ASTM F2077) ●
- Wear debris analysis (ASTM F1877) ●
- Expulsion ●
5
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® XD System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.