(175 days)
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Not Found
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "anterior cervical spinal fixation system" intended for "stabilization as an adjunct to spinal fusion," which implies a therapeutic purpose.
No
The provided text describes a medical device, the Choice Spine Anterior Cervical Plate (ACP) System, which is a spinal fixation system. Its intended use is to provide stabilization as an adjunct to spinal fusion. While it is used in conditions that are diagnosed (e.g., tumor, deformity, degenerative disc disease), the device itself is a treatment or stabilization device, not one that gathers information or produces a diagnosis.
No
The device description explicitly states it consists of "plates and screws," which are hardware components, 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, or tissue) to provide information about a person's health.
- Device Description: The Choice Spine Anterior Cervical Plate (ACP) System is a physical implant (plates and screws) used for surgical fixation of the cervical spine. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is for "anterior screw fixation of the cervical spine... designed to provide stabilization as an adjunct to spinal fusion." This is a therapeutic and structural purpose, not a diagnostic one.
The provided information clearly describes a surgical implant used for stabilization and fusion, which falls under the category of a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Choice Spine Anterior Cervical Plate (ACP) System is intended for anterior screw fixation of the cervical spine (levels C2 to C7) and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include: failed previous fusion, pseudoarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis, or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
WARNING: The Choice Spine Anterior Cervical Plate (ACP) System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Choice Spine Anterior Cervical Plate (ACP) System is an anterior cervical spinal fixation system consisting of plates and screws. The plates are available in multiple lengths to accommodate single or multi-level surgeries and different anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine (levels C2 to 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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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).
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§ 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
K091926 (1/2)
DEC 22 2009
510(k) Summary
Sponsor:
Choice Spine, LP 306 Erin Drive Knoxville, TN 37919 ph: 865.246.3333 fax: 865.588.4045
Contact:
G. Todd Hawkins Director of Regulatory Affairs/Quality Assurance
Trade Name:
Choice Spine Anterior Cervical Plate (ACP) System
Common Name:
Anterior Cervical Plate, Anterior Cervical Spinal Fixation System
Classification Name:
888.3060 - Spinal intervertebral body fixation orthosis
Device Product Code:
KWQ
Device Description:
The Choice Spine Anterior Cervical Plate (ACP) System is an anterior cervical spinal fixation system consisting of plates and screws. The plates are available in multiple lengths to accommodate single or multi-level surgeries and different anatomies.
Intended Use:
The Choice Spine Anterior Cervical Plate (ACP) System is intended for anterior screw fixation of the cervical spine (levels C2 to C7) and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include: failed previous fusion, pseudoarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis, or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
WARNING: The Choice Spine ACP System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Page 1 of 2
1
Kc9i926 (²/₂)
510(k) Summary (continued)
Materials:
The Choice Spine Anterior Cervical Plate (ACP) System plates and screws are manufactured from titanium alloy (Ti6Al4V ELI; according to ASTM F136). The plates incorporate a screw-retention mechanism ("clip"), which is manufactured from wrought nickel-titanium alloy (NiTi; according to ASTM F2063).
Substantial Equivalence:
Documentation was provided that demonstrates the Choice Spine ACP System to be substantially equivalent to a previously cleared device. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, primary material of manufacture, and performance.
Page 2 of 2.
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" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Choice Spine, LP % G. Todd Hawkins 306 Erin Drive Knoxville, TN 37919
DEC 22 0000
Re: K091926
Trade/Device Name: Choice Spine Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 16, 2009 Received: December 17, 2009
Dear Mr. Hawkins:
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 (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.
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 forth in the quality systems (QS)
3
Page 2 -- Mr. G. Todd Hawkins
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 go to
http://www.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 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 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/defay4.htm.
Sincerely yours,
erely yours,
for Peter N. D.C
k N. Melkerson
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 Statement
510(k) Number (if known): $691924
Device Name: Choice Spine Anterior Cervical Plate (ACP) System
Indications for Use:
The Choice Spine Anterior Cervical Plate (ACP) System is intended for anterior screw fixation of the cervical spine (levels C2 to C7) and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include: failed previous fusion, pseudoarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis, or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
WARNING: The Choice Spine Anterior Cervical Plate (ACP) System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
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Over-The-Counter Use
(21 CFR 801 Subpart C)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
Prescription Use X
(Part 21 CFR 801 Subpart D)
510(k) Number K091926
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