(35 days)
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.
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.
This is a medical device submission (510(k)) for the StaXx® IBL System, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving acceptance criteria are not directly addressed in this document because it's not a study report. The submission leverages an "engineering rationale" and comparison to previously tested constructs rather than a new clinical or performance study with acceptance criteria.
Here's an attempt to extract the relevant information and indicate where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: - Static Axial Compression (ASTM F2077) - Dynamic Axial Compression (ASTM F2077) - Static Compression Shear (ASTM F2077) - Dynamic Compression Shear (ASTM F2077) - Subsidence (ASTM F2267) | "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 be substantially equivalent to the predicate devices." |
| Material Composition: - PEEK-OPTIMA with 6% Barium Sulfate - Tantalum markers | The device is composed of PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers, consistent with the predicate. |
| Intended Use & Indications: - Intervertebral body fusion in skeletally mature patients with DDD of the lumbar spine (L2-L5) - Up to Grade 1 spondylolisthesis or retrolisthesis - Used with autogenous bone graft and supplemental fixation - Patients should have >= 6 months non-operative treatment | The device is intended for the same indications as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for new testing. The submission states that modified implants were compared to constructs previously tested. This implies that new physical samples of the modified implants were likely tested, but the number of samples is not stated. The evaluation relies on an "engineering rationale" based on these comparisons.
- Data Provenance: Not explicitly stated as retrospective or prospective, but likely laboratory/bench-top testing performed in a controlled environment. Country of origin for data is not mentioned but assumed to be relevant to the submitting entity (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a pre-market submission based on mechanical testing and substantial equivalence, not a clinical study involving expert interpretation of patient data.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions. The "adjudication" here is the engineering rationale and comparison by the manufacturer's technical staff.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an implant for spinal fusion, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established ASTM standards for mechanical testing of spinal implants and the physical characteristics (material, dimensions) of the device itself. The ground truth for safety and effectiveness is based on the previously cleared predicate device and the assumption that the modified implants do not introduce new safety or effectiveness concerns.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
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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
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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
§ 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.