(141 days)
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No
The summary describes a physical implant and surgical instruments made of standard materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to restore the biomechanical integrity of the spinal column and is used to replace a vertebral body, which qualifies it as a therapeutic device.
No
This device is an implant designed to replace resected or excised vertebral bodies due to tumor or trauma/fracture, not to diagnose a condition.
No
The device description clearly states that the Blustone Synergy Silica System is comprised of physical implants made of PEEK and tantalum markers, and is implanted using stainless steel instruments. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The Blustone Synergy Silica System is an implantable device made of PEEK and tantalum markers. It is designed to be surgically placed inside the body to replace a vertebral body.
- Intended Use: The intended use is to replace a resected vertebral body due to tumor or trauma/fracture and restore biomechanical integrity. This is a surgical intervention, not a diagnostic test performed on a specimen.
The provided information clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Blustone Synergy Silica System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The Blustone Synergy Silica System will be offered in parallel and lordotic device configurations of various heights to accommodate patient anatomy. The System of devices may be implanted in the thoracolumbar spine via an anterior approach.
The Blustone Synergy Silica System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
thoracolumbar spine (from T1 to L5)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-14
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-14
- Subsidence testing, conducted in accordance with ASTM F2267-04(2011)
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Blustone Synergy Silica System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 888.3060 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 21, 2017 Blustone Synergy % Ms. Lisa Peterson Principal Consultant Kaedon Consulting LLC 14001 Hunters Pass Austin, Texas 78734
Re: K172330
Trade/Device Name: Blustone Synergy Silica System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: October 30, 2017 Received: November 24, 2017
Dear Ms. Peterson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172330
Device Name Blustone Synergy Silica System
Indications for Use (Describe)
The Blustone Synergy Silica System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Blustone Synergy Silica System Premarket Notification
| SUBMITTED BY | Blustone Synergy
5520 Ventana Ct.
Pueblo CO 81005 |
|------------------------------------------|--------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | Pending |
| OWNER/OPERATOR
NUMBER | Pending |
| CONTACT PERSON | Lisa Peterson
Kaedon Consulting, LLC
Phone: 512-507-0746
lpeterson@kaedonconsulting.com |
| DATE PREPARED | October 23, 2017 |
| CLASSIFICATION NAME | Spinal Intervertebral Body Fixation Orthosis |
| DEVICE CLASS | Class II |
| REGULATION NUMBER | 888.3060 (Product Code MQP) |
| COMMON NAME | Spinal Vertebral Body Replacement Device (MQP) |
| PROPRIETARY NAME | Blustone Synergy Silica System |
| IDENTIFICATION OF PREDICATE
DEVICE(S) | Predicate devices include various cleared Vertebral Body
Replacement systems: |
- Eminent Spine: Eminent Spine Vertebral Body i Replacement System (K090064)
DEVICE DESCRIPTION
The Blustone Synergy Silica System will be offered in parallel and lordotic device configurations of various heights to accommodate patient anatomy. The System of devices may be implanted in the thoracolumbar spine via an anterior approach.
The Blustone Synergy Silica System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
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INDICATIONS
The Blustone Syneray Silica System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.
TECHNOLOGICAL COMPARISON TO PREDICATE(S)
The purpose of this premarket notification is to obtain clearance to market the Blustone Synergy Silica System. The Blustone Synergy Silica System implants were compared to the predicate devices identified above, and performance evaluation results, design features, materials and sizes were found to be substantially equivalent to these systems.
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-14 -
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-14 -
- -Subsidence testing, conducted in accordance with ASTM F2267-04(2011)
- -Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
CONCLUSIONS
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Blustone Synergy Silica System is substantially equivalent to the predicate device.