(82 days)
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with various spinal conditions, which are therapeutic interventions.
No
The device description indicates that the system is an "Anterior Cervical Plate (ACP) System" consisting of "bone plates, screws, and associated instruments" for "anterior interbody screw fixation of the cervical spine." This function is for stabilization and fusion, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (an anterior cervical plate system) used to stabilize the spine during fusion surgery. It is a physical device implanted into the body, not a device used to test samples outside the body.
- Intended Use: The intended use clearly states it's for "temporary stabilization of the anterior spine" and "anterior interbody screw fixation." This is a surgical procedure, not a diagnostic test.
The description focuses on the mechanical properties and surgical application of the device, which is consistent with a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- trauma (including fracture or dislocation),
- spinal stenosis,
- cervical myelopathy,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and/or
- failed previous fusion.
Product codes
KWQ
Device Description
The Cardiff™ Anterior Cervical Plate (ACP) System is intended for anterior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, Cardiff™ ACP System implants are and associated instruments. manufactured from Titanium 6AL-4V ELI and Nitinol SE508. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine from 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)
Mechanical testing results indicated that Cardiff™ possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s). Clinical data was not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032368, K974885, K994239, K926453, K945700, K000536
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
Cardiff™ Premarket Notification
510(k) Summary
Company Name:
SeaSpine, Inc. 2302 La Mirada Drive Vista, CA 92081
Contact Person:
Ethel Bernal Regulatory Affairs Manager E-mail: ebernal@seaspine.com Phone: (760) 727-8399 x218, Fax: (760) 727-8809
Date Prepared:
November 10, 2008
Trade Name:
Cardiff™
Common Name: Classification Name: Anterior Cervical Plate System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060, Product Code: KWQ, Class II Orthopedic Review Committee
Device Description:
The Cardiff™ Anterior Cervical Plate (ACP) System is intended for anterior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, Cardiff™ ACP System implants are and associated instruments. manufactured from Titanium 6AL-4V ELI and Nitinol SE508. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
This system is indicated for use in the temporary stabilization of the Intended Use: anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, trauma (including fracture or dislocation), spinal stenosis, cervical myelopathy, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
Substantial
Equivalence:
Cardiff™ was shown to be substantially equivalent in whole or in part to the following commercially available predicate device(s):
EB = 2 2009
1
Cardiff™ Premarket Notification
- . Blackstone™ Anterior Cervical Plate system (510(k) number K974885)
- Medtronic Sofamor Danek Zephir™ system (510 (k) number . K994239)
- Synthes CSLP System (510(k) numbers K926453, K945700 and . K000536)
Performance Data:
Mechanical testing results indicated that Cardiff™ possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s). Clinical data was not required for this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, clutching a staff entwined with a snake, which is a symbol of medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
FEB -2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, California 92081-7862
Re: K083338
Trade/Device Name: Cardiff™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Anterior cervical system Regulatory Class: II Product Code: KWQ Dated: November 10, 2008 Received: November 13, 2008
Dear Ms. Bernal:
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 includions for use stated in the enclosure) to legally marketed predicate devices market in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Americanse 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, noand 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 more 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 mater not not not hite 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 100-1050.
3
Page 2- Ms. Ethel Bernal
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 Biometrics' (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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours.
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Cardiff™ Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name: Cardiff™ Anterior Cervical Plate System
Indications for Use:
This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- trauma (including fracture or dislocation),
- spinal stenosis,
- cervical myelopathy,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and/or
- failed previous fusion.
Prescription Use __ × (Part 21 CFR 801 Subpart D).
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f
(Division Sign Division of General, Restorative, and Neurological Devices
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510(k) Number