(294 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for anterior cervical fixation to the cervical spine C2-C7 for various medical conditions like degenerative disc disease, trauma, tumors, and deformity, which directly addresses health issues and aims to improve patient health.
No
This device is an anterior cervical plate system designed for fixation to the cervical spine, used in surgical procedures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "an assortment of plates and screws" made of "titanium alloy," indicating it is a hardware-based implant system, not software.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Slimplicity Solo Anterior Cervical Plate System is a physical implant (plates and screws) designed to be surgically placed in the cervical spine. It is used for fixation and stabilization of the spine.
- Intended Use: The intended use is for anterior cervical fixation to the cervical spine for various conditions. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
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 Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Slimplicity Solo Anterior Cervical Plate System consists of an assortment of plates and screws. Each Slimplicity Solo plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). Slimplicity Solo implants are composed of titanium alloy, as specified in ASTM F136. The components will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-C7
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 was performed per ASTM F1717 using the following test methods: Static Axial Compression Bending testing in a load to failure mode, Static Torsion testing in a load to failure mode, and Cyclical axial compression testing to estimate the maximum run out load value at 5,000,000 cycles. The mechanical strength of the Slimplicity Solo Anterior Cervical Plate System was found to be substantially equivalent to the predicate based on mechanical test results.
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
§ 888.3060 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
Image /page/0/Picture/0 description: The image shows the text "K112748." above the logo for Spinal USA. The logo is a black rectangle with the words "SPINAL" and "USA" in white. A graphic of a spine is between the two words.
JUL 1 1 2012
2050 Executive Drive Pearl, MS 39208
Ph: 601-420-4244 Fax: 601-420-5501
510(k) Summary
| Date Summary Prepared: | July 18, 2011 |
|---|---|
| Submitter Information: | Spinal USA |
| 2050 Executive Drive | |
| Pearl, MS 39208 | |
| Contact Name: | Frankie Cummins |
| Phone: | 601-420-4244 |
| Fax: | 601-420-5501 |
| E-mail: | fc@spinalusa.com |
| Device Trade Name: | Slimplicity Solo Anterior Cervical Plate System |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulatory Number: | 888.3060 |
| Classification: | Class II |
| Product Code: | KWQ |
| INTENDED USE: |
The Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
DEVICE DESCRIPTION:
The Slimplicity Solo Anterior Cervical Plate System consists of an assortment of plates and screws. Each Slimplicity Solo plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). Slimplicity Solo implants are composed of titanium alloy, as specified in ASTM F136. The components will be provided non-sterile.
1
KII2748
MECHANICAL TESTING:
The Slimplicity Solo Anterior Cervical Plate System was mechanically tested per ASTM F1717. The objective of this test battery is to mechanically test the Slimplicity Solo Anterior Cervical Plate System using the following test methods:
Static Axial Compression Bending testing in a load to failure mode
Static Torsion testing in a load to failure mode
Cyclical axial compression testing to estimate the maximum run out load value at 5,000,000 cycles
Mechanical Test Conclusion:
The Slimplicity Solo Anterior Cervical Plate System is as safe as the predicates based on the following:
-
- The design of the Slimplicity Solo Anterior Cervical Plate System is similar to the predicates in thickness, width, and length.
-
- The Slimplicity Solo Anterior Cervical Plate System bone screw is similar to the predicates in type, size, and length,
-
- The material used in the Slimplicity Solo Anterior Cervical Plate System is the same as used in the predicate systems.
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- The mechanical strength of the Slimplicity Solo Anterior Cervical Plate System is substantially equivalent to the predicate based on mechanical test results. The Slimplicity Solo Anterior Cervical Plate System test results are provided in section 18 of this 510(k) submittal. Mechanical strength substantial equivalence to predicates is shown in section 12.
The Slimplicity Solo Anterior Cervical Plate System is as effective as the predicate based on the following:
-
- The intended use of the Slimplicity Solo Anterior Cervical Plate System is the same as the predicates.
-
- The indication for use of the Slimplicity Solo Anterior Cervical Plate System is the same as the predicates.
The Slimplicity Solo Anterior Cervical Plate System is as safe and effective as its predicates.
EQUIVALENT DEVICE:
Documentation was provided which demonstrated the Slimplicity Solo Anterior Cervical Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.
The overall design of the Slimplicity Solo Anterior Cervical Plate System consists of plates and bone screws. The components are available in a variety of lengths in order to accommodate patient anatomy and are substantially equivalent to the predicate devices.
Components of the Slimplicity Solo Anterior Cervical Plate System are similar to the predicate systems. The size and shape of the Slimplicity Solo Anterior Cervical Plate System and predicate systems are similar. The Slimplicity Solo Anterior Cervical Plate System bone screw thread type, size and length are similar to the predicates. Material of both the plate and screws is the same as the predicates. Sterilization is the same as the predicates.
Predicate Devices:
Uniplate Anterior Cervical Plate System K042544 Synthes Anterior CSLP System K030866 Synthes Vectra-One System K071667
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three thick, curved lines forming the body and wings. The eagle is facing towards the right side of the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spinal USA, LLC % Mr. Frankie Cummins Engineering Manager 2050 Executive Drive Pearl, Mississippi 39208
JUL 1 1 2012
Re: K112748
Trade/Device Name: Slimplicity Solo Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 05, 2012 Received: July 05, 2012
Dear Mr. Cummins:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your your be 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 I ou may, therefore, mains 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 your device 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 1 toase be devised that I hat your device complies with other requirements of the Act than - Diederal statutes and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 – Mr. Frankie Cummins
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI I all 007); doomig (21 OFF 803); good manufacturing practice requirements as set Gorth 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 rr you doo!!e bpv.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the 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 Tou may 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,
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): __ Ku2748
Device Name: Slimplicity Solo Anterior Cervical Plate System
Indications for Use:
The Slimplicity Solo Anterior Cervical Plate System is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) . Division of Surgical. Orthopedic, and Restorative Devices
KII2748 510(k) Number