(366 days)
No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests and surgeon surveys, not evaluations of algorithmic performance.
Yes
The device is intended to treat specific medical conditions such as degenerative disc disease and trauma, and acts to facilitate fusion and stabilization of spinal segments.
No
The device is a posterior, non-pedicle supplemental fixation device, intended for surgical implantation to achieve supplemental fusion in the spine. It is not used to diagnose conditions.
No
The device description clearly states it is a physical implantable device made of titanium alloys, consisting of a Body/Post, Plates, and Fasteners. It is intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Spinal Simplicity Spinous Process Fusion (SPF) Plate is a surgical implant intended for fixation and fusion of the spine. It is a physical device used within the body, not a test performed on a sample outside the body.
- Lack of Diagnostic Function: The device's purpose is structural support and fusion, not the diagnosis of a condition. While radiographic studies are used to confirm the conditions for which the device is indicated, the device itself does not perform the diagnostic function.
Therefore, the Spinal Simplicity Spinous Process Fusion (SPF) Plate falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spinal Simplicity Spinous Process Fusion (SPF) Plate 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 plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation); and/or
- tumor.
The SPF-Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.
Product codes
PEK
Device Description
The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone graft fusion material placed within the device. The Spinal Simplicity Spinous Process Fusion (SPF) Plate consists of a Body/Post. Plates, and Fasteners that together form a construct to provide supplemental fusion and stabilization of spinal segments. The components are available in a range of sizes to accommodate varying patient anatomy. Spinal Simplicity Spinous Process Fusion (SPF) Plates are composed of titanium alloys (per ASTM F136 and ASTM F1472).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (non-cervical, 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)
Static and dynamic tests of the SPF-Plate have been performed to evaluate the mechanical performance of the device, including the following tests:
- Static Axial Compression Test
- Static Torsion Test
- Dynamic Axial Compression Testing
- Static Axial Pull-Out Test
- Static Plate Dissociation Test
- Cadaver Implantation Studies
- Bone Block Studies to Assess Material Loss and Effect on Mechanical Strength
- Cadaveric Testing to Assess Material Loss and Effect on Mechanical Strength
In all instances, the subject device functioned as intended and the results observed were as expected. Further, performance testing results demonstrated that the SPF-Plate presents substantially equivalent mechanical strength compared to the predicate device.
Spinal Simplicity also collected survey data from surgeons outside the United States who have implanted a version of the subject device. The results of the survey showed that none of the surgeons observed any instances of failure to deploy the device wings, spinous process fracture, or neurological injuries.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071877, K102195, K130438, K133091, K133052, K132411, K103205, K132968
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2015
Spinal Simplicity, LLC % Ms. Janice M. Hogan Hogan Lovells US, LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K140046
Trade/Device Name: Spinous Process Fusion (SPF) Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: December 29, 2014 Received: December 29, 2014
Dear Ms. Hogan:
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
Page 2 - Ms. Janice M. Hogan
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/Resourcesfor You/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 vours.
Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Spinous Process Fusion (SPF) Plate
Indications for Use (Describe)
The Spinal Simplicity Spinous Process Fusion (SPF) Plate 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 plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- · spondylolisthesis;
- · trauma (i.e., fracture or dislocation); and/or
- tumor.
The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4
510(k) Summary
Spinal Simplicity's Spinous Process Fusion (SPF) Plate
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Spinal Simplicity LLC 10995 Quivira Road Overland Park, KS 66210 Phone: (913) 451 4414 Facsimile: (913) 888 0075 Contact Person: Julie McKee, J.D. Date Prepared: December 29, 2014
Name of Device
Spinous Process Fusion (SPF) Plate
Common / Classification Name
21 CFR 888.3050 Spinal interlaminal fixation orthosis Class II Product code: PEK
Predicate and Reference Devices
Lanx Spinal Fixation System (Aspen) (K071877 - primary predicate) Globus SP-Fix Spinous Process Fixation Plate (K102195) X-Spine Axle Interspinous Fusion System (K130438) Aurora Spine Zip (K133091) NuVasive Affix Next Gen Spinous Process Plate System (K133052) NuVasive Affix II Spinous Process Plate System (K132411) Alphatec Bridgepoint (K103205) Stryker Universe Plate (K132968)
Intended Use / Indications for Use
The Spinal Simplicity Spinous Process Fusion (SPF) Plate 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 plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- . spondylolisthesis;
- trauma (i.e., fracture or dislocation); and/or .
- . tumor.
The SPF-Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.
5
Device Description
The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone graft fusion material placed within the device. The Spinal Simplicity Spinous Process Fusion (SPF) Plate consists of a Body/Post. Plates, and Fasteners that together form a construct to provide supplemental fusion and stabilization of spinal segments. The components are available in a range of sizes to accommodate varying patient anatomy. Spinal Simplicity Spinous Process Fusion (SPF) Plates are composed of titanium alloys (per ASTM F136 and ASTM F1472).
Technological Characteristics
The SPF-Plate and the predicate devices present very similar technological characteristics, including the device materials, components, and dimensions. The SPF-Plate assembly consists of bilateral Plates and a Body/Post that connects the Plates, similar to the predicate constructs. The SPF-Plate incorporates a deployable feature that allows the Plate to be extended from the implant body after its initial insertion. The device also incorporates a locking hex nut, which is advanced over the Body/Post of the implant, with ratchets that engage with teeth on the Plate. The Plate components of the SPF-Plate and predicate devices similarly include several spikes at the ends of each Plate for attachment to the spinous processes. The SPF- Plate and predicate devices are also available in multiple sizes to accommodate varying patient anatomy. Thus, the technological characteristics of the SPF-Plate compared to the predicate devices are very similar.
Performance Data
Static and dynamic tests of the SPF-Plate have been performed to evaluate the mechanical performance of the device, including the following tests:
- Static Axial Compression Test ●
- Static Torsion Test ●
- Dynamic Axial Compression Testing .
- Static Axial Pull-Out Test .
- Static Plate Dissociation Test .
- . Cadaver Implantation Studies
- Bone Block Studies to Assess Material Loss and Effect on Mechanical Strength .
- Cadaveric Testing to Assess Material Loss and Effect on Mechanical Strength ●
In all instances, the subject device functioned as intended and the results observed were as expected. Further, performance testing results demonstrated that the SPF-Plate presents substantially equivalent mechanical strength compared to the predicate device.
Spinal Simplicity also collected survev data from surgeons outside the United States who have implanted a version of the subject device. The results of the survey showed that none of the surgeons observed any instances of failure to deploy the device wings, spinous process fracture, or neurological injuries.
6
Substantial Equivalence
The Spinal Simplicity SPF-Plate has the same intended use and indications for use, and similar technological characteristics and principles of operation as its predicate devices. The technological differences (device dimensions and device design) between the Spinal Simplicity SPF-Plate and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Spinal Simplicity SPF-Plate is substantially equivalent to the predicate devices. Thus, the Spinal Simplicity Spinous Process Fusion (SPF) Plate meets all requirements for a finding of substantial equivalence.
Conclusion
Therefore, the information submitted by Spinal Simplicity in this premarket notification demonstrates that the SPF-Plate performs as intended and is substantially equivalent to the predicate devices.