(151 days)
No
The device description and performance studies focus on mechanical properties and equivalence to a predicate device, with no mention of AI/ML or related concepts.
Yes
The device is indicated for conditions like degenerative disc disease, trauma, and deformities, with the purpose of providing fixation to alleviate these issues and support healing or stability.
No
The device, the Comet Anterior Cervical Plate System, is described as a system for anterior cervical fixation to treat various spinal conditions, indicating it is an implant for treatment rather than a tool for diagnosis.
No
The device description clearly states it is a physical plate system with pins and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The Comet Anterior Cervical Plate System is a physical implant designed for surgical fixation of the anterior cervical spine. Its intended use is to provide structural support and stability for various spinal conditions. This is a surgical device, not a device that analyzes biological specimens.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, the Comet Anterior Cervical Plate System falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The Comet Anterior Cervical Plate System consists of an anterior cervical plate offered in lengths ranging from 10mm through 22mm. Four (4) barbed plate fixation pins are permanently affixed to the plate. A set of two (2) plate fixation screws are used to secure the plate to the superior and inferior vertebrae. Plate fixation screws are offered in two (2) diameters, each in 14mm, 16mm lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (anterior cervical)
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
Bench tests performed in accordance with FDA's May 2004 Guidance for Industry and Staff Spinal System 510(k)s and ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model included assessments of static and dynamic axial compression bending and static torsion. Performance data demonstrated that the Comet Anterior Cervical Plate System is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.
Key Metrics
Not Found
Predicate Device(s)
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.
0
Section 5 - 510(k) Summary - K082504
General Information
JAN 2-7 2009
| Owner's Name: | Apollo Spine |
|---|---|
| Address: | 307 Placentia Ave, Suite 111 |
| Newport Beach CA 92663 | |
| Telephone Number: | (949) 645-7746 |
| Fax Number: | (949) 645-7749 |
| Contact Person: | Kamran Aflatoon |
| Subject Device Name: | Comet Anterior Cervical Plate System |
| Trade Name: | Comet Anterior Cervical Plate System |
| Common/Usual Name: | Anterior Cervical Plate System |
| Classification Name: | KWQ - Spinal Intervertebral Body Fixation Orthosis |
| 21 CFR 888.3060; Class II | |
| Predicate Device Name: | Synthes Anterior Cervical Plate System |
| Trade Name: | Synthes Anterior Cervical Plate System |
| Common/Usual Name: | Anterior Cervical Plate System |
| Classification Name: | KWQ - Spinal Intervertebral Body Fixation Orthosis |
| 21 CFR 888.3060; Class II | |
| Premarket Notification: | K926453, SE date Oct. 12, 1993 |
Device Description
The Comet Anterior Cervical Plate System consists of an anterior cervical plate offered in lengths ranging from 10mm through 22mm. Four (4) barbed plate fixation pins are permanently affixed to the plate. A set of two (2) plate fixation screws are used to secure the plate to the superior and inferior vertebrae. Plate fixation screws are offered in two (2) diameters, each in 14mm, 16mm lengths.
Indications for Use
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Performance Testing
Performance data demonstrated that the Comet Anterior Cervical Plate System is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.
Bench tests performed in accordance with FDA's May 2004 Guidance for Industry and Staff Spinal System 510(k)s and ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model included assessments of static and dynamic axial compression bending and static torsion.
No biocompatibility testing was conducted; all materials used in the manufacture of the Comet Anterior Cervical Plate System device have been previously cleared for similar devices.
Conclusion
The Comet Anterior Cervical Plate System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Comet Anterior Cervical Plate System is substantially equivalent to the predicate device.
IO
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's stylized logo, which consists of a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the logo. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Apollo Spine, Inc. % Ms. Pamela Papineau. RAC Delphi Medical Device Consulting 5 Whitcomb Ave Aver, Massachusetts 01432
JAN 2-7 2009
Re: K082504
Trade Name: Comet Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 11, 2008 Received: December 12, 2008
Dear Ms. Papineau:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Pamela Papineau, RAC
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
510(k) Number (if known):
Device Name:
Comet Anterior Cervical Plate System
Indications for Use:
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milhum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
5100: Number
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