(153 days)
The StaXx® IB 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-S1. 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® IB 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® IB 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 both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.
The document provided describes a 510(k) submission for the StaXx® IB System, an intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the same way a novel AI/software device would.
Therefore, many of the requested categories related to AI/software device performance studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to this 510(k) submission for a physical medical device.
Here's a breakdown of the relevant information provided and an explanation of why other sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" are not defined as quantitative metrics of diagnostic performance (e.g., sensitivity, specificity) as they would be for an AI algorithm. Instead, the "acceptance criteria" are met by demonstrating substantial equivalence to predicate devices through mechanical performance testing.
| Acceptance Criteria Category | Description | Device Performance / How Met |
|---|---|---|
| Biomechanical Safety & Performance (based on standard testing) | Device must demonstrate mechanical properties comparable to predicate devices and acceptable for intended use. | The StaXx® IB System underwent the following mechanical tests to demonstrate substantial equivalence to its predicate devices: - Static and dynamic axial compression (per ASTM F2077) - Static and dynamic compression shear (per ASTM F2077) - Subsidence (per ASTM F2267) Conclusion: "Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IB 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." |
| Material Biocompatibility | Materials must be safe for implantation. | The implant components are manufactured from PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate, which are known biocompatible materials widely used in spinal implants and present in predicate devices. The document implies their use aligns with predicates, ensuring known safety. |
| Intended Use & Indications | Device must be suitable for its stated intended use and indications. | The intended use and indications for the StaXx® IB System are aligned with those of the predicate devices. The comparison table confirms "similarity in intended use, indications for use, materials and performance." |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. This is a physical intervertebral body fusion device, not a software or AI device that processes data for diagnostic purposes. The "test set" here refers to physical devices undergoing mechanical stress tests, not data samples. The document does not specify the number of devices tested, which is common for mechanical testing in 510(k) submissions where the focus is on meeting standard thresholds rather than statistical population inferences from data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This is a physical medical device. There is no "ground truth" established by human experts in the context of diagnostic data analysis. The "truth" is established by the physical testing results against recognized ASTM standards.
4. Adjudication Method for the Test Set
Not Applicable. See explanation in point 3.
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 applies to AI or image-based diagnostic devices. The StaXx® IB System is a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This applies to AI or software algorithms.
7. The Type of Ground Truth Used
Not Applicable. For mechanical testing, the "ground truth" is typically defined by the specified parameters and failure points outlined in the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267). The device's performance is measured against these engineering standards.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" for a physical medical device. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
Not Applicable. See explanation in point 8.
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APR 1 1 2013
510(k) Summary StaXx® IB System
1. Submitter Information
SPINE WAVE
| Submitter: | Spine Wave, Inc. | |
|---|---|---|
| Address: | Three Enterprise DriveSuite 210Shelton, CT 06484 | |
| Telephone: | 203-712-1839 | |
| Telefax: | 203-944-9493 | |
| Contact: | Roaida Rizkallah |
| Contact: | Roalda Rizkania |
|---|---|
| Date Prepared: | April 11, 2013 |
2. Device Information
| Trade Name: | StaXx® IB 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 a new intervertebral body fusion device.
4. Predicate Device Information
The StaXx® IB System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Distractable Wave Cage | Advanced MedicalTechnologies | K083626 |
| Caliber™ Spacer | Globus Medical, Inc. | K102293 |
| Opticage™ InterbodyFusion Device | Interventional Spine, Inc. | K113527 |
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5. Device Description
The StaXx® IB 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 both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.
6. Intended Use
The StaXx® IB 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-S1. 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® IB 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® IB 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® IB System to its predicate:
- . Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077) t
- Subsidence (per ASTM F2267) .
9. Conclusion .
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IB 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April*11, 2013
Spine Wave, Incorporated % Ms. Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K123461
Trade/Device Name: StaXx® IB System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 13, 2013 Received: March 14, 2013
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 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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure, with three abstract shapes representing the head, body, and legs. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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Page 2 - Ms. Roaida Rizkallah
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 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,
Mark NMelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. Indications for Use
:
ﻨﯽ
K123461 510(k) Number (if known): StaXx® IB System Device Name: _______________
Indications for Use:
The StaXx® IB 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-S1. 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® IB 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)
Elizabet摘@grank -S
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Division of Orthopedic Devices
§ 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.