(195 days)
Not Found
No
The summary describes a physical implantable device (vertebral body replacement system) and its intended use and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is used to treat tumors and fractures, and restore anatomical integrity, which are therapeutic interventions.
No
The MaxFuse VBR System is described as a device used to replace diseased vertebral bodies, restore height, and treat fractures, indicating it is an implantable medical device for treatment or restoration, not for diagnosis.
No
The device description clearly indicates it is a "radiolucent, multilevel corpectomy system with VBR devices," which are physical implants. The performance studies also describe mechanical testing of these physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace or support vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (radiolucent, multilevel corpectomy system) with various size and angle options. This is consistent with a surgical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the implant (compression, bending, torsion, subsidence, expulsion), which are relevant to a surgical device's function.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MaxFuse VBR System does not fit this description.
N/A
Intended Use / Indications for Use
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the. treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental internal fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
Product codes
MQP
Device Description
The MaxFuse VBR System is a radiolucent, multilevel corpectomy system with VBR devices in a variety of footprint options, height options, and lordotic angle options to accommodate a wide variety of patient anatomy. The MaxFuse VBR devices may be used with bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., Ti-1.5), thoracic and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Substantial equivalence was established through side-by-side testing to legally markted predicate devices, including: ASTM F 2077: Static and Dynamic Axial Compression Bending and Static Torsion ASTM F 2267: Static Subsidence Draft Z8423Z, Submitted to ASTM F04.25.02.02: Static Expulsion.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
DEC 2 4 2013
・ 510(k) SUMMARY
MaxFuse VBR System
| Sponsor: | Manufacturer/
(Owner): | Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Phone:
Fax:
Official Contact: | (906) 225-5602
(906) 226-4459
Emily M. Downs
Sarah McIntyre |
| Device Name: | Date prepared: | December 19, 2013
MaxFuse Vertebral Body Replacement (VBR) System |
| Classification
Name: | Spinal Vertebral Body Replacement Device | |
| Classification: | 21 CFR 888.3060 - Product code MQP, Class II | |
| Predicate
Devices: | Pioneer Vertebral Spacer (K061151)
DePuy Spine Bengal Stackable Cage System (K073649)
NuVasive Mesh VBR (K032476) | |
| Description: | The MaxFuse VBR System is a radiolucent, multilevel corpectomy system
with VBR devices in a variety of footprint options, height options, and
lordotic angle options to accommodate a wide variety of patient anatomy.
The MaxFuse VBR devices may be used with bone graft. | |
| Intended Use: | The MaxFuse VBR System is indicated for use in the thoracolumbar spine
(i.e., Ti-1.5) to replace a diseased vertebral body resected or excised for the.
treatment of tumors, to achieve anterior decompression of the spinal cord and
neural tissues, and to restore the height of a collapsed vertebral body. The
MaxFuse VBR System is also indicated for treating fractures of the thoracic
and lumbar spine. The MaxFuse VBR System is designed to restore the
biomechanical integrity of the anterior, middle, and posterior spinal column
even in the absence of fusion for a prolonged period.
The MaxFuse VBR System is intended for use with supplemental internal
fixation systems cleared for the conditions listed above. The supplemental
internal fixation systems that may be used include the Quantum Spinal
Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS
Spinal Fixation System. | |
| Materials: | The MaxFuse VBR System implants are composed of ASTM F 2026
Polyetheretherketone (PEEK) with ASTM F 560 tantalum or ASTM F 136
titanium alloy radiographic markers. | |
| Performance Data: | Substantial equivalence was established through side-by-side testing to
legally markted predicate devices, including:
ASTM F 2077: Static and Dynamic Axial Compression Bending and
Static Torsion ASTM F 2267: Static Subsidence Draft Z8423Z, Submitted to ASTM F04.25.02.02: Static Expulsion | |
| Substantial
Equivalence: | The subject and predicate systems are overall similar in:
Intended Usc Basic design: Single-unit VBR with radiographic markers, toothed surface,
bone graft containment Materials: PEEK, Titanium alloy, Tantalum Sizes: Footprints, heights, lordosis comparable to predicates Mechanical Performance: equivalent results There are no significant differences between the subject MaxFuse VBR
System and the predicate devices which would adversely affect the use of the
product. This submission supports the position that the subject system is
substantially equivalent to previously cleared predicate systems. | |
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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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" 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
December 24, 2013
Pioneer Surgical Technology, Incorporated Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855
Re: K131724
Trade/Device Name: MaxFuse VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 25, 2013 Received: October 29, 2013
Dear Ms. McIntyre:
We have reviewed vour 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
3
Page 2 - Ms. Sarah McIntyre
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" (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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K131724
Device Name: MaxFuse VBR System
Indications:
The MaxFuse VBR System is indicated for use in the thoracolumbar spine (i.e., TI-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The MaxFuse VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The MaxFuse VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The MaxFuse VBR System is intended for use with supplemental internal fixation systems cleared for the conditions listed above. The supplemental fixation systems that may be used include the Quantum Spinal Fixation System, Streamline TL Spinal Fixation System, and Streamline MIS Spinal Fixation System.
Prescription Use V OR (Per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(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 Orthopedia Devices