(125 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 I 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 implant. 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 submission describes a medical device, specifically an intervertebral body fusion device, and does not involve AI or machine learning. Therefore, many of the requested elements for an AI/ML study (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training) are not applicable.
Below is the information that is applicable to this medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Axial Compression (per ASTM F2077) | The StaXx® IBL System must demonstrate performance substantially equivalent to its predicate devices in terms of mechanical strength and fatigue resistance under axial compression according to ASTM F2077 standards. | Met: "The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate." The submission implies the device successfully passed these tests, demonstrating substantial equivalence. |
| Static and Dynamic Compression Shear (per ASTM F2077) | The StaXx® IBL System must demonstrate performance substantially equivalent to its predicate devices in terms of mechanical strength and fatigue resistance under compression shear according to ASTM F2077 standards. | Met: "The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate." The submission implies the device successfully passed these tests, demonstrating substantial equivalence. |
| Subsidence (per ASTM F2267) | The StaXx® IBL System must demonstrate performance substantially equivalent to its predicate devices in terms of resistance to subsidence into vertebral bodies according to ASTM F2267 standards. | Met: "The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate." The submission implies the device successfully passed these tests, demonstrating substantial equivalence. |
| Overall Conclusion | The device must be shown to be substantially equivalent to predicate devices in its indications for use, technological characteristics, materials, and performance, without presenting new issues of safety or effectiveness. | Met: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IBL 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." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a physical medical device, not an AI/ML model evaluated on a data test set. The "tests" mentioned are mechanical bench tests on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically defined for AI/ML models is not relevant here. Device performance is established through mechanical testing against ASTM standards and comparison to predicate devices, which are objective engineering measurements.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML application requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is used to evaluate human reader performance, often with and without AI assistance, which is not relevant for this physical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here. The device itself is evaluated for its mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is based on established engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate "substantial equivalence" to these benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. Since there is no training set for an AI/ML model, there is no ground truth for it to be established.
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K131071 Page 1 of 2
AUG 2 0 2013
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510(k) Summary StaXx® IBL System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise DriveSuite 210Shelton, CT 06484 |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida Rizkallah |
| Date Prepared: | July 12, 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® IB System | Spine Wave, Inc. | K123461 |
| Patriot® Spacer | Globus Medical, Inc. | K072970 |
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K131071 Page 2 of 2
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 implant. 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.
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 I 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 nonoperative 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 predicates is shown by similarity in intended use. indications for use, materials and performance.
8. Performance Data
The following mechanical tests were performed to demonstrate the substantial equivalence of the StaXx® IBL System to its predicate:
- t Static and dynamic axial compression (per ASTM F2077)
- . Static and dynamic compression shear (per ASTM F2077)
- Subsidence (per ASTM F2267) .
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IBL 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
Roaida Rizkallah Regulatory Affairs Manager Spine Wave, Incorporated Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K131071
Trade/Device Name: StaXx® IBL system Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 12, 2013 Received: July 15, 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 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
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Page 2 - Roaida Rizkallah
forth in the quality systems (OS) 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 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/deliault.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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K131071 510(k) Number (if known):
StaXx® IBL System Device Name: _____________________
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 I 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.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
Page 1 of 1
§ 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.