(13 days)
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is described as an anterior screw fixation system for the cervical spine, used as an adjunct to fusion for treating various conditions like degenerative disc disease, trauma, and tumors. These are all therapeutic actions.
No
The device, "SpineNet SSP System," is described as an anterior cervical plate and screw system intended for fixation of the cervical spine. Its purpose is to physically stabilize the spine as an adjunct to fusion for various conditions, not to identify, monitor, or assess a medical condition.
No
The device description explicitly states it is an anterior cervical plate and screw system, which are physical implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- SpineNet SSP System Description: The provided text clearly describes the SpineNet SSP System as an anterior cervical plate and screw system. These are implantable medical devices used in surgical procedures to stabilize the spine.
- Intended Use: The intended use is for anterior screw fixation of the cervical spine as an adjunct to fusion for treating various spinal conditions. This is a surgical intervention, not a diagnostic test performed on samples.
The description focuses on the physical components of the device (plates and screws) and their mechanical performance, which is typical for implantable surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.
Product codes
KWQ
Device Description
The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
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)
Mechanical testing of the worst case SpineNet SSP System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion.
The mechanical test results demonstrate that the SpineNet SSP System device performance is substantially equivalent to the predicate devices.
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
February 5, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
SpineNet LLC % Karen Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K200170
Trade/Device Name: SpineNet SSP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 22, 2020 Received: January 23, 2020
Dear Karen Warden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name SpineNet SSP System
Indications for Use (Describe)
The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.
| 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
| Date: | 22 January 2020 |
|---|---|
| Sponsor: | SpineNet LLC |
| 1300 Minnesota Ave., Suite 200 | |
| Winter Park, FL 32789 | |
| 407.539.2483 | |
| Sponsor Contact: | King Floyd, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | SpineNet SSP System |
| Common Name: | Anterior cervical plate system |
| Regulatory Class: | Class II |
| Classification Name, | |
| Regulation, Product | |
| Code: | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060, KWQ |
| Device Description: | The SpineNet SSP System is an anterior cervical plate and screw system |
| which includes fixed and variable self-tapping screws and one- through four | |
| level plates. The implants are available in a variety of sizes to accommodate | |
| the individual anatomic and clinical circumstances of each patient. | |
| Indications for Use: | The SpineNet SSP System is intended for anterior screw fixation of the |
| cervical spine (C2 to T1). The system is to be used as an adjunct to fusion | |
| for the treatment of the following indications: degenerative disc disease | |
| (defined as neck pain of discogenic origin with the degeneration of the disc | |
| confirmed by history and radiographic studies), spondylolisthesis, trauma | |
| (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, | |
| lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion. | |
| Materials: | The SpineNet SSP System implants are manufactured from titanium alloy |
| as described by ASTM F136. | |
| Primary Predicate: | Zavation Cervical Plate System (Zavation LLC – K130030) |
| Additional Predicates: | Uniplate Anterior Cervical Plate (DePuy Spine – K042544) and Cervical |
| Spine Locking Plate (CSLP) (Synthes Spine – K945700) | |
| Performance Data: | Mechanical testing of the worst case SpineNet SSP System construct was |
| performed according to ASTM F1717 and included static and dynamic | |
| compression and static torsion. | |
| The mechanical test results demonstrate that the SpineNet SSP System | |
| device performance is substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The SpineNet SSP System possesses technological characteristics similar |
| to those of the predicate devices. These include basic design, material, | |
| method of stabilization and anatomic location. Therefore the fundamental | |
| scientific technology of the SpineNet SSP System devices is the same as | |
| previously cleared devices. | |
| Conclusion: | The SpineNet SSP System possesses similar intended use and |
| technological characteristics as the predicate devices. Therefore the | |
| SpineNet SSP System is substantially equivalent for its intended use. |