(36 days)
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No
The description focuses on the mechanical function and materials of a spinal fixation device, with no mention of AI or ML.
Yes
This device is intended to treat various spinal conditions, including degenerative disc disease, trauma, tumor, and deformity, by providing fixation and aiding in the fusion of the cervical spine. These actions are directly aimed at alleviating medical conditions and restoring bodily function, which aligns with the definition of a therapeutic device.
No
Explanation: The device description states that the Envision™ Anterior Cervical Plate System is a "cervical spinal fixation device" intended to "provide a means to fuse the cervical spine." This indicates it is a therapeutic or surgical device, not one used for diagnosis.
No
The device description explicitly states it consists of "bone plates and bone screws" and is manufactured from "Ti-6Al-4V alloy," indicating it is a hardware-based implant system, 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, tissue) to provide information about a person's health.
- Device Description: The Envision Anterior Cervical Plate System is a surgical implant designed to provide fixation and facilitate fusion in the cervical spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for the treatment of cervical spine conditions through surgical implantation and fusion, not for diagnostic testing.
The provided information clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Envision Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with : Degenerative disc disease (defined as neck pain of discogenic origin with degeneration . of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture), Tumer, Deformity (i.e., kyphosis, lordosis, and scoliosis), Spinal stenosis, Pseudarthrosis, Failed previous fusion. The Envision Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogeneic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implant after the attainment of a solid fusion mass. The Plate System is intended for use under the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture), Tumor, Deformity (i.e., kyphosis, lordosis, and scoliosis), Spinal stenosis, Pseudarthrosis, Failed previous fusion.
Product codes
KWQ
Device Description
The Ortho Development Envision Anterior Cervical Plate System system is a cervical spinal fixation device, which consists of a variety of bone plates and bone screws. Fixation is provided by the insertion of bone screws thought the openings at each end of the plate into the anterior portion of vertebral bodies of the cervical spine. The devices are manufactured from Ti-6Al-4V alloy per ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1)
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-clinical Performance and Conclusions: The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems. However, static and fatigue compression and static torsion testing of the Envision Anterior Cervical Plate System were performed according to ASTM F1717-96. Data regarding the functional performance of the proposed Envision Anterior Cervical Plate System has been generated. Clinical Performance and Conclusion: Clinical data and conclusion were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
Synthes Anterior CSLP System, EBI Vuelock Anterior Cervical Plate System, Window Cervical Dynamic Plate System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS:
This safety and effectiveness summary for the Ortho Development Envision Anterior Cervical Plate System is provided as required per Section 513(i)(3) of the Food, Drug, and Cosmetic Act.
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Submitter: 1.
Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020 -
Contact Person: 2. Carol Freasier Telephone: (801) 553-9991 Fax: (801) 553-9993
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Date Prepared: 3. February 27, 2002
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Name of the Device 4...
খ Trade Name: Proprietary Name: Common Name: Classification Name: Product Code: Reference:
Ortho Development Envision Anterior Cervical Plate System Envision Anterior Cervical Plate System Appliance, Fixation, Spinal Intervertebral Body Orthosis Spinal Fixation System KWQ (888.3060)
- Description of the Device: 5.
The Ortho Development Envision Anterior Cervical Plate System system is a cervical spinal fixation device, which consists of a variety of bone plates and bone screws. Fixation is provided by the insertion of bone screws thought the openings at each end of the plate into the anterior portion of vertebral bodies of the cervical spine.
The devices are manufactured from Ti-6Al-4V alloy per ASTM F-136. Materials:
The Envision Anterior Cervical Plate System functions to provide a means to fuse Function: the cervical spine.
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Intended Use: 6.
The Envision Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with : -
Degenerative disc disease (defined as neck pain of discogenic origin with degeneration . of the disc confirmed by patient history and radiographic studies)
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Spondylolisthesis ●
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Trauma (i.e., fracture) .
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Tumer .
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Deformity (i.e., kyphosis, lordosis, and scoliosis) .
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Spinal stenosis .
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Pseudarthrosis .
Page 1 of 2
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- Failed previous fusion .
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- Predicate or legally marketed devices which are substantially equivalent:
- Synthes Anterior CSLP System (Synthes) .
- . EBI Vuelock Anterior Cervical Plate System (EBI)
- Window Cervical Dynamic Plate System (Advanced Spine Technology) .
- Comparison of the technological characteristics of the device to predicate and legally marketed 8. devices:
There are no significant differences between the components of the Ortho Development Envision Anterior Cervical Plate System and other commercially available cervical plating systems currently being marketed, which would adversely affect the use of the product.
Mechanical testing shows the biomechanical performance of the subject device to be similar to the performance of previously cleared spinal systems with similar indications. It is substantially equivalent to these other devices in design, function, material and intended use.
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ഗ് Non-clinical Performance and Conclusions:
The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems. However, static and fatigue compression and static torsion testing of the Envision Anterior Cervical Plate System were performed according to ASTM F1717-96. Data regarding the functional performance of the proposed Envision Anterior Cervical Plate System has been generated. -
- Clinical Performance and Conclusion:
Clinical data and conclusion were not needed for this device.
- Clinical Performance and Conclusion:
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Freasier Regulatory Affairs Ortho Development Corporation 12187 S. Business Park Drive Draper. Utah 84020
APR = 5 2002
Re: K020649 Envision Anterior Cervical Plate System Regulation Number: 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. Freasier:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Carol Freasier
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Sincerely yours,
for Mark A Millikan
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
4
510(k) Number (if known):
K020649
ige lof
Device Name: Envision Anterior Cervical Plate System
Indications for Use
The Envision™ Anterior Cervical Plate System is intended for the treatment of the The Envical - Antenor our noal : receiving fusion by autogenous and/or cervical spine in okelotally matare pare attached to the anterior cervical spine (C2-T1) allogenie bono grant: "plants after the attainment of a solid fusion mass. The with removal of the implical Plate System is intended for use under the following indications:
- Degenerative disc disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Trauma (i.e., fracture)
- Tumor
- Deformity (i.e., kyphosis, lordosis, and scoliosis)
- Spinal stenosis
- Pseudarthrosis
- Failed previous fusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mach. N. Miller
(Division Sien-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020694
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)