(28 days)
Not Found
No
The summary describes a mechanical spinal plate system and its associated instrumentation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing.
Yes
The device is described as a "Plate System" intended to provide "additional support during fusion" and "temporary stabilization and augment development of a solid spinal fusion" for various spinal conditions, indicating a direct therapeutic action on the body.
No
The device description clearly states it is an anterior/anterolateral/lateral plate system used for spinal fusion and stabilization, not for identifying diseases or conditions. Its purpose is to provide "additional support during fusion" and "temporary stabilization and augment development of a solid spinal fusion."
No
The device description explicitly states that the LITe® Plate System consists of plates and screws manufactured from titanium alloy and associated manual general surgical instrumentation, indicating it is a hardware-based medical device.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the LITe® Plate System is an anterior/anterolateral/lateral plate system consisting of plates and screws used in spinal surgery to provide support during fusion and stabilize grafts. This is a surgical implant, not a device used for testing biological samples.
- Lack of IVD Keywords: The text does not mention any terms related to laboratory testing, analysis of biological samples, or diagnostic procedures performed outside the body.
Therefore, the LITe® Plate System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Pseudoarthrosis;Spondylolysis;Spondylolisthesis;Spinal stenosis;Tumors;Trauma (i.e. Fractures or Dislocation)Deformities (i.e. Scoliosis, Kyphosis or Lordosis)Failed Previous FusionThe LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) spine, T1-S1
Indicated Patient Age Range
skeletally mature patients
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)
Risk analysis was performed to demonstrate that the LITe® Plate System is substantially equivalent to its predicate devices. The risk analysis determined that the predefined acceptance criteria associated with the following mechanical testing was met:
- Static and dynamic compression testing per ASTM F1717-14
- Static torsion testing per ASTM F1717-14
- Buttress plate expulsion testing
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract 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
March 20, 2015
Stryker Spine Garry Haveck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K150449 Trade/Device Name: LITe® Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 19, 2015 Received: February 20, 2015
Dear Dr. Hayeck:
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 - Garry Hayeck, Ph.D.
forth in the quality systems (OS) 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" (21CFR 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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Indications for Use
510(k) Number (if known)
K150449
Device Name LITe® Plate System
Indications for Use (Describe)
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis;
- · Spondylolisthesis;
- · Spinal stenosis;
- Tumors;
- · Trauma (i.e. Fractures or Dislocation)
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
- · Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Type of Use (Select one or both, as applicable) 2 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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| 510(k) Summary: LITe® Plate System | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Garry T. Hayeck, Ph.D. |
| Senior Regulatory Affairs Specialist | |
| Phone: 201-760-8043 | |
| Fax: 201-962-4043 | |
| E-mail: garry.hayeck@stryker.com | |
| Date Prepared | February 19, 2015 |
| Trade Name | LITe® Plate System |
| Common Name | Appliance, fixation, spinal intervertebral body |
| Proposed Class | Class II |
| Classification Name and Number | Spinal intervertebral body fixation orthosis |
| 21 CFR §888.3060 | |
| Product Code | KWQ |
| Predicate Devices | Primary Predicate: |
| Stryker Spine, LITe® Plate System, K142699 |
Additional Predicate:
Stryker Spine, CENTAUR™ Spinal System, K994347, K001844 |
| Device Description | The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies. |
| Intended Use | The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Pseudoarthrosis;Spondylolysis;Spondylolisthesis;Spinal stenosis;Tumors;Trauma (i.e. Fractures or Dislocation)Deformities (i.e. Scoliosis, Kyphosis or Lordosis)Failed Previous FusionThe LITe® Plate System Buttress Plate is intended to stabilize the allograft |
| 510(k) Summary: LITe® Plate System | |
| or autograft at one level (T1-S1) as an aid to spinal fusion and to provide
temporary stabilization and augment development of a solid spinal
fusion. It may be used alone or with other anterior, anterolateral, or
posterior spinal systems made of compatible materials. This device is not
intended for load bearing applications. | |
| Summary of the
Technological
Characteristics | As established in this submission, the LITe® Plate System was shown to
be substantially equivalent and have equivalent technological
characteristics to its predicate devices through comparison in areas
including intended use, material composition, principles of operation
and design. |
| Summary of the
Performance Data | Risk analysis was performed to demonstrate that the LITe® Plate System
is substantially equivalent to its predicate devices. The risk analysis
determined that the predefined acceptance criteria associated with
the following mechanical testing was met:
● Static and dynamic compression testing per ASTM F1717-14
● Static torsion testing per ASTM F1717-14
● Buttress plate expulsion testing |
| Conclusions | The LITE® Plate System has identical indications, technological
characteristics, and principles of operation as its predicates. The risk
analysis performed demonstrates that any minor differences do not
impact device performance as compared to the predicates. The LITE®
Plate System was shown to be substantially equivalent to its predicate
devices. |
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