(153 days)
Not Found
No
The summary describes a mechanical intervertebral body fusion device and its delivery system. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are mechanical tests.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which involves addressing a medical condition to restore function.
No
This device is an intervertebral body fusion system, intended for surgical treatment of degenerative disc disease, not for diagnosing it. The description focuses on its use in fusion procedures and details its mechanical properties, not diagnostic capabilities.
No
The device description explicitly states it is composed of physical components (wafers, implant, delivery device) made from PEEK materials and includes mechanical performance studies, indicating it is a hardware device.
Based on the provided information, the StaXx® IB System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The StaXx® IB System is an implantable medical device used in surgical procedures to fuse vertebrae in the lumbar spine. Its purpose is structural support and facilitating bone fusion, not analyzing biological samples.
The description clearly outlines a surgical implant and its intended use in a surgical procedure, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
MAX
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.
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-S1
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
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)
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)
- Subsidence (per ASTM F2267)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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APR 1 1 2013
510(k) Summary StaXx® IB System
1. Submitter Information
SPINE WAVE
| Submitter: | Spine Wave, Inc. | |
|---|---|---|
| Address: | Three Enterprise Drive | |
| Suite 210 | ||
| Shelton, 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 Medical | |
| Technologies | K083626 | |
| Caliber™ Spacer | Globus Medical, Inc. | K102293 |
| Opticage™ Interbody | ||
| Fusion 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