(109 days)
Not Found
No
The device description focuses on the physical components (plates, screws) and materials used in a surgical implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: This device is an implant system used to hold or buttress graft material in place in the spine, which is a supportive and stabilizing function rather than directly providing a therapeutic effect. Its purpose is to prevent graft expulsion or spinal cord impingement, not to treat a disease or condition itself.
No
This device is an implant system used in laminoplasty procedures to hold or buttress graft material in place. It is a surgical implant, not a device used to diagnose a medical condition.
No
The device description clearly states it is an "implant system that consists of various plates and screw configurations" made from metallic materials, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant system used in laminoplasty procedures to hold or buttress graft material in the spine. This is a direct surgical intervention on the patient's body.
- Device Description: The description details the physical components of the system (plates and screws) made from medical-grade materials, designed for implantation.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with such specimens.
The information provided describes a surgical implant, not a diagnostic tool used outside the body.
N/A
Intended Use / Indications for Use
The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
Product codes
NOW
Device Description
The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3 to T3)
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 4 Point Bend - Per ASTM F2193
Axial screw pull-out test - Per ASTM F543
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091994, K032534, K050082, K122822
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 19, 2018
Choice Spine, LP Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K173215
Trade/Device Name: Choice Spine Laminoplasty™ Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: October 27, 2017 Received: October 30, 2017
Dear Ms. Finch:
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
Page 2 - Ms. Kim Finch
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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173215
Device Name
Choice Spine LaminoplastyTM Fixation System
Indications for Use (Describe)
Choice Spine LaminoplastyTM Fixation System:
The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
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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7. 510(k) Summary
| Date:
Sponsor:
Phone:
Fax:
Contact Person:
Proposed
Proprietary Trade
Name:
Product Class: | Sept 25, 2017
Choice Spine, LP
400 Erin Drive
Knoxville, TN 37919
865-246-3333
865-246-3334
Kim Finch, Director of Regulatory Affairs
Choice Spine Laminoplasty™ Fixation
System
Class II |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Choice Spine Laminoplasty™ Fixation System
888.3050 - Spinal Interlaminal Fixation Orthosis
● |
| Device Product
Code: | Choice Spine Laminoplasty™ Fixation System
NQW
● |
| Purpose of Submission: | The purpose of this submission is to gain clearance for the new Choice
Spine Laminoplasty™ Fixation System. |
| Device Description: | The proposed Choice Spine Laminoplasty Fixation System is an implant
system that consists of various plates and screw configurations. |
| | The proposed plates are available in various configurations to address
surgeon and patient needs as necessary. The proposed plate devices
come preformed with holes for bone screws. The plate offered can be
affixed to allograft or autograft material and secured with a bone screw
from the system. A hinge plate is provided when additional stabilization
is necessary. Screws are used to attach the plates to bone and are
available in a variety of lengths and diameters to fit patient anatomy.
The system components are made from medical grade Titanium Alloy
Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564),
and 6061 T6 Aluminum (ASTM B221 and B209). |
| Indications for Use: | The Choice Spine Laminoplasty Fixation System is intended for use in
the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty
procedures. The Choice Spine Laminoplasty Fixation System is used to
hold or buttress the allograft or autograft material in place in order to
prevent the graft material from expulsion or impinging the spinal cord. |
| Non-Clinical Testing: | Static and Dynamic 4 Point Bend - Per ASTM F2193
Axial screw pull-out test - Per ASTM F543 |
| Materials: | The implants are made of medical grade Titanium alloy Ti-6Al-4V ELI per
ASTM F136. Instrumentation is made of medical grade 17-4 SS (ASTM
F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and
B209). |
| Substantial Equivalence: | The Choice Spine Laminoplasty Fixation System is similar in design,
materials and performance to the currently marketed predicates: DePuy
Mountaineer (K091994), Synthes Arch Fixation System (K032534),
Medtronic CENTERPIECE Plate Fixation System (K050082), and Spectrum
Spine Laminoplasty Plating System (K122822). The intended use of the
product as a buttress plate is substantially equivalent in performance
and safety. |
| Substantial Equivalence
Conclusion: | The Choice Spine Laminoplasty Fixation System is similar in design,
materials, indications for use, intended use, classification, and
performance to the currently marketed predicates: DePuy
Mountaineer, the primary (K091994); additional Synthes Arch Fixation
System (K032534); additional Medtronic CENTERPIECE Plate Fixation
System (K050082); and additional Spectrum Spine Laminoplasty Plating
System (K122822). The slight differences in the type of Ti Alloy,
variation in screw and plate offerings, and selection of allograft vs
autograft do not effect performance or safety of these devices.
Therefore, the device is substantially equivalent. |
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