(35 days)
Not Found
No
The summary describes a physical implant and delivery system for spinal fusion, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intervertebral body fusion system used to treat degenerative disc disease, which falls under the definition of a therapeutic device as it directly treats a medical condition.
No
This device is described as an "intervertebral body fusion device" used for surgical treatment of degenerative disc disease, not for diagnosing conditions.
No
The device description explicitly states the system is composed of physical components (wafers, implants, delivery device) made from materials like PEEK-OPTIMA and tantalum markers, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- StaXx® IBL System Function: The StaXx® IBL System is a surgical implant used to fuse vertebrae in the lumbar spine. It is a physical device implanted into the body, not used to analyze samples taken from the body.
The provided information clearly describes a surgical implant and its intended use in a surgical procedure, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The StaXx® IBL System is an intervertebral body fusion device composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers. 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
lumbar spine at one or two contiguous levels from L2-L5
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified implants were compared to constructs previously tested in static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence (ASTM F2267). An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to the substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. A curved line underlines the word "Wave", suggesting a wave-like motion. The text is black against a white background, creating a high contrast.
510(k) Summary StaXx® IBL System
1. Submitter Information
Submitter: Spine Wave. Inc. Address: Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: 203-712-1839 203-944-9493 Telefax:
Contact: Roaida Rizkallah Date Prepared: August 29, 2013
OCT 0 4 2013
2. Device Information
| Trade Name: | StaXx ® IBL System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Product Code: | MAX |
3. Purpose of Submission
The purpose of this submission is to gain clearance for additional sizes of implants utilizing the StaXx® technology for intervertebral body fusion.
4. Predicate Device Information
The StaXx® IBL System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| StaXx ® IBL System | Spine Wave, Inc. | K131071 |
5. Device Description
The StaXx® IBL System is an intervertebral body fusion device composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The implant components are manufactured from PEEK-OPTIMA with 6% Barium
1
Sulfate and tantalum markers. The system also includes a delivery device to both implant and expand the implant.
6. Intended Use
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
7. Comparison of Technological Characteristics
The substantial equivalence of the StaXx® IBL System to the predicate is shown by similarity in intended use. indications for use, materials and performance.
8. Performance Data
The modified implants were compared to constructs previously tested in static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence (ASTM F2267). An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to the substantially equivalent to the predicate devices.
9. Conclusion
Based on the indications for use, technological characteristics, and comparison to the predicate, the StaXx® IBL. 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 4, 2013
Spine Wave, Incorporated Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K132719
Trade/Device Name: StaXx 18 IBI. System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 5, 2013 Received: September 6, 2013
Dear Roaida 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 cither 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
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Page 2 – Roaida Rizkallah
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,
Erin詞《eith
for
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132719
Device Name StaXx(R) IBL System
Indications for Use (Describe)
The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolistesis at the involved level(s). The StaXx® IBL System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an interverebral body fusion device.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Post Ituldmining versues | Bell | 481-f.740