(29 days)
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No
The document describes a mechanical implant (anterior cervical plate system) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "temporary stabilization of the anterior spine during the development of cervical spine fusions" for various medical conditions, indicating its use in treating a disease or injury.
No
The device is described as an anterior cervical plate system used for temporary stabilization of the spine during fusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states that the system consists of bone plates and screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Reflex™ Anterior Cervical Plate (ACP) System is a system of bone plates and screws designed for surgical implantation into the cervical spine. This is an implantable medical device used within the body (in vivo).
- Intended Use: The intended use is for "anterior intervertebral screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical procedure and the function of an implanted device, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Reflex™ Anterior Cervical Plate (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion and decompression of the spinal cord following total or partial cervical vertebrectomy.
Product codes (comma separated list FDA assigned to the subject device)
87 KWQ
Device Description
The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy as described in ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants will be provided non-sterile.
The design modification involves changes to the cutting flute, thread design, and color of the 14 mm length screw. In addition, several longer length screws have been added to the system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine at levels C2-T1
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been conducted demonstrating substantial equivalence to the predicate device.
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.
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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
Design Modification to the Reflex " Anterior Cervical Plate System Screws
MAR 2 9 2002 Special 510(k) Summary for the Design Modification to the Reflex™ Anterior Cervical Plate System Screws
Proprietary Name: Common Name: Classification Name and Reference
Regulatory Class: Device Product Code: For Information contact: Reflex™ Anterior Cervical Plate System Anterior Cervical Plate System Spinal Invertebral Body Fixation Orthosis 21 CFR §888.3060 Class II 87 KWQ Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 760-8187 Fax: (201) 760-8435 February 27, 2002
Date Summary Prepared:
Predicate Device Identification
The Reflex " ACP System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy as described in ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants will be provided non-sterile.
Device Description
The design modification involves changes to the cutting flute, thread design, and color of the 14 mm length screw. In addition, several longer length screws have been added to the system.
Intended Use:
The Reflex™ Anterior Cervical Plate (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion and decompression of the spinal cord following total or partial cervical vertebrectomy.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Statement of Technological Comparison:
Equivalency of this device is based on similarities in intended use, materials, and design to the predicate device. Testing has been conducted demonstrating substantial equivalence to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401
MAR 2 9 2002
Re: K020650
Trade Name: Reflex™ Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 27, 2002 Received: February 28, 2002
Dear Ms. Ariemma:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becalling in the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasure) to devices manonents, or to devices that have been reclassified in enactifield date of the Medical Doviet Famentalities, Crug, and Cosmetic Act (Act). You may, accordance with the provisions of the reachers read controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions of the receined requirentibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (sec above) into this. Controls. Existing major regulations (Fremarket Apploval), it may of sacreer to advant Federal Regulations, Title 21, Parts 800 to 895. allecting your device our be found nation assumes compliance with the current Good A Substantially Cqurvalent doterimmaters assorth in the Quality System Regulation (QS) for Manufacturing Fractice requirements, as of CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, are rood and Drug Nammoutation (xxx ) (x) addition, FDA may publish Comply with the GMI Teganaton may rounder in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might Itsponse to your premanter notins and shown of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K_(220450
Device Name: Reflex Anterior Cervical Plate System
The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies)
- Trauma (including fractures)
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis or scoliosis) .
- . Pseudoarthrosis
- Failed previous fusion
- Decompression of the spinal cord following total or partial cervical vertebrectomy.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use -Over-The-Counter Use OR
(Per 21 CFR 801.109)
(Optional. Format 1-2-96)
Mark N Millerson
(Division Sign-Off) Drision of General, Restorative and Neurological Devices
510(k) Number K02065