(29 days)
Not Found
No
The device description focuses on the mechanical design and materials of a spinal fixation system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes
The device is described as a 'spinous process fixation system' intended to provide 'supplemental fixation' for conditions like degenerative disc disease, trauma, spondylolisthesis, and tumor, for the purpose of achieving 'supplemental fusion'. This indicates its use in treating medical conditions and restoring bodily function, which aligns with the definition of a therapeutic device.
No
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for surgical implantation to achieve supplemental fusion in the non-cervical spine. Its purpose is to physically stabilize the spine, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly details physical components made of titanium alloy and associated surgical instruments, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The VIA™ Spinous Process Fixation System is a physical implant designed to be surgically attached to the spinous process in the spine. It is a mechanical device used for fixation and supplemental fusion.
- Intended Use: The intended use describes the conditions the device is used to treat (degenerative disc disease, trauma, spondylolisthesis, tumor) by providing structural support and promoting fusion. This is a therapeutic use, not a diagnostic one based on analyzing biological specimens.
The description clearly indicates a surgical implant used for structural support and fusion in the spine, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:
· Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- · Trauma (i.e., fracture or dislocation)
- · Spondylolisthesis
• Tumor
The VIATM Spinous Process Fixation System is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion, and it is not intended for stand-alone use. When the VIA™ Spinous Process Fixation System is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1). The VIA Spinous Process Fixation System consists of a three-piece design. The larger male piece (plate) is comprised of a plate with teeth and a spacer in the middle. The two other additional pieces are plates (with teeth) that contain the female ends of the connection with the male spacer. The two female plates engage with the larger plate independently to accommodate variations in the spinal anatomy. The components are locked together with a set screw after assembly. The spinous process contact areas (with the teeth sections) on both the male and female plates do not vary in size. The central spacer on the male plate varies in height (cephalo-caudad), thus providing the different sizes of the device. All components are composed of titanium alloy (Ti-6A1-4V-ELI ASTM F136). Associated accessories include surgical instruments to facilitate implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1 - S1)
Indicated Patient Age Range
Not Found
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 verification tests were performed:
- · Insertion Testing
- · Grip Strength Testing (using a modified ASTM F543-13 setup)
- · Dynamic Compression Bending (per ASTM F1717-13)
The results met applicable acceptance criteria and verified the design features.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2014
Spineology, Incorporated Mr. Tim Crabtree Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K142213
Trade/Device Name: VIA™ Spinous Process Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 7, 2014 Received: August 12, 2014
Dear Mr. Crabtree:
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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Ronald DAJean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142213
Device Name
VIA™ Spinous Process Fixation System
Indications for Use (Describe)
The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:
· Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- · Trauma (i.e., fracture or dislocation)
- · Spondylolisthesis
• Tumor
The VIATM Spinous Process Fixation System is not intended for stand-alone use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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I. SUBMITTER
Spineology Inc. 7800 3rd Street N. Saint Paul, MN 55128
Contact Person: Tim Crabtree Phone: 651.256.8534 651.256.8505 Fax:
Date Prepared: September 9, 2014
II. DEVICE
Device Name: VIA™ Spinous Process Fixation System Common Name: Spinous Process Plate Regulation: 21 CFR §888.3050-Spinal Interlaminal Fixation Orthosis. Regulatory Class: II Product Code: PEK
III. PREDICATE DEVICE
Spineology Spinous Process Fixation System (K123232)
PURPOSE IV.
The purpose of this submission is to provide notification of plates with a modified spike design to the system.
V. DEVICE DESCRIPTION
The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion, and it is not intended for stand-alone use. When the VIA™ Spinous Process Fixation System is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1). The VIA Spinous Process Fixation System consists of a three-piece design. The larger male piece (plate) is comprised of a plate with teeth and a spacer in the middle. The two other additional pieces are plates (with teeth) that contain the female ends of the connection with the male spacer. The two female plates engage with the larger plate independently to accommodate variations in the spinal anatomy. The components are locked together with a set screw after assembly. The spinous
4
process contact areas (with the teeth sections) on both the male and female plates do not vary in size. The central spacer on the male plate varies in height (cephalo-caudad), thus providing the different sizes of the device. All components are composed of titanium alloy (Ti-6A1-4V-ELI ASTM F136). Associated accessories include surgical instruments to facilitate implantation.
VI. INDICATIONS FOR USE
The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:
- Degenerative disc disease defined as back pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies.
- Trauma (i.e., fracture or dislocation) ●
- Spondylolisthesis
- . Tumor
The VIATM Spinous Process Fixation System is not intended for stand-alone use.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The VIA™ Spinous Process Fixation System shares the same materials, features, intended use, manufacturing, and technological characteristics as the Spineology Spinous Process Plate.
VIII. PERFORMANCE DATA
The following verification tests were performed:
- · Insertion Testing
- · Grip Strength Testing (using a modified ASTM F543-13 setup)
- · Dynamic Compression Bending (per ASTM F1717-13)
The results met applicable acceptance criteria and verified the design features.
CONCLUSIONS IX.
The VIA™ Spinous Process Fixation System is substantially equivalent to the predicate device. the Spineology Spinous Process Fixation System (K123232). The information presented in this premarket notification demonstrates that the materials, technological characteristics, and the intended use are the same.