(217 days)
Not Found
No
The description focuses on the mechanical components and intended use of a cervical plate system, with no mention of AI or ML capabilities.
Yes.
The device is intended for "fixation, immobilization and stabilization" of vertebral bodies, acting as an "adjunct to intervertebral fusion." These actions directly treat medical conditions like degenerative disc disease, trauma, and spinal stenosis, thus providing a therapeutic effect.
No
This device is a surgical implant designed for fixation, immobilization, and stabilization of cervical vertebral bodies as an adjunct to intervertebral fusion, not for diagnosing conditions.
No
The device description clearly outlines physical components like plates, screws, and pins, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for stabilizing cervical vertebrae. This is a physical intervention within the body, not a test performed on samples taken from the body.
- Device Description: The description details physical components like plates, screws, and pins, which are used for surgical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and stabilization.
N/A
Intended Use / Indications for Use
The Comet Anterior Cervical Plate System is intended for anterior fixation, immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of discogcnic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
Multi-level anterior cervical plates and fixation screws are being added to the previously cleared single-level Comet Anterior Cervical Plate System. The multi-level device additions consist of duallevel plate lengths ranging from 24mm through 48mm and triple-level plate lengths ranging from 36mm through 72mm. Similarly to the single-level devices, the multi-level devices contain barbed plate fixation pins that are permanently affixed to the plate. Plate fixation screws are used to secure the plate to each vertebrae. An additional plate fixation screw diameter is being added in a 3.3mm diameter in 14mm, 16mm and 18mm lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical vertebral bodies (levels C2-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)
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 multi-level device additions to the Comet Anterior Cervical Plate System are substantially equivalent to the predicate single-level devices of the Comet Anterior Cervical Plate System and/or met pre-determined acceptance criteria. The risks associated with use of the new devices were found acceptable when evaluated by FMEA. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
Comet Anterior Cervical Plate System Apollo Spine, Inc.
Attachment IV.2 - 510(k) Summary (revised)
General Information
OCT 2 8 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: | 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 | |
| Premarket Notification: | K082504, SE date January 27, 2009 |
| 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
Multi-level anterior cervical plates and fixation screws are being added to the previously cleared single-level Comet Anterior Cervical Plate System. The multi-level device additions consist of duallevel plate lengths ranging from 24mm through 48mm and triple-level plate lengths ranging from 36mm through 72mm. Similarly to the single-level devices, the multi-level devices contain barbed plate fixation pins that are permanently affixed to the plate. Plate fixation screws are used to secure the plate to each vertebrae. An additional plate fixation screw diameter is being added in a 3.3mm diameter in 14mm, 16mm and 18mm lengths.
Indications for Use
The indications for use for the multi-level device additions are the same as those for the previously cleared single-level devices of the Comet Anterior Cervical Plate System. The indications are as follows:
The Comet Anterior Cervical Plate System is intended for anterior fixation, immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of discogcnic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
1
Performance Testing
Performance data demonstrated that the multi-level device additions to the Comet Anterior Cervical Plate System are substantially equivalent to the predicate single-level devices of the Comet Anterior Cervical Plate System and/or met pre-determined acceptance criteria. The risks associated with use of the new devices 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 multi-level device additions mect all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Comet Anterior Cervical Plate System multi-level device additions are substantially equivalent to the predicate device, the single-level devices of the Comet Anterior Cervical Plate System.
2
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, modern design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Apollo Spine % STD MED, Inc. Ms. Christie Santagate 75 Mill Street Stoughton, Massachusetts 02072
OCT 2 3 2009
Re: K090751
Trade/Device Name: Comet Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: October 19, 2009 Received: October 22, 2009
Dear Ms. Santagatc:
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 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) 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. Christie Santagate
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Comet Anterior Cervical Plate System Apollo Spine, Inc.
Attachment IV.1 - Indications for Use Statement (revised)
510(k) Number (if known): K090751
Device Name: Comet Anterior Cervical Plate System
Indications for Use:
The Comet Anterior Cervical Plate System is intended for anterior fixation. immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of disogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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.
AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K090751
34 年来