(177 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an Anterior Cervical Plate (ACP) System intended for temporary stabilization and fixation of the anterior spine to aid in cervical spinal fusions, addressing conditions like degenerative disc disease, trauma, and spinal stenosis. These actions are directly involved in treating a medical condition and restoring function, which aligns with the definition of a therapeutic device.
No
The device is described as an Anterior Cervical Plate System intended for temporary stabilization and fixation during spinal fusion, not for diagnosing conditions.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for the "temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions." This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details bone plates, screws, and instruments made from Titanium and Nitinol alloys, designed for "anterior interbody screw fixation of the cervical spine." This further confirms its role as a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Cardiff™ Anterior Cervical Plate (ACP) System is a surgical implant, not an In Vitro Diagnostic device.
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 mvelopathy;
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor:
- pseudoarthrosis; and/or
- failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Cardiff™ Anterior Cervical Plate (ACP) System is interior 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, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium and Nitinol alloys. Fixation is provided by bone screws 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)
No additional non-clinical testing was required to demonstrate equivalence with the previously cleared Cardiff™ or Sonoma ACP Systems. Design Controls were used to identify any additional risks introduced by the modified device when compared with the previously submitted Cardiff™ ACP, or Sonoma ACP Systems. Engineering and Clinical rationale verified that no additional risks were introduced into the system.
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
Cardiff Special 510(k)
Special 510(k) Summary
JAN 2 5 2012
K112206 Page 1 of 2
Contact Details
| Applicant Name: | SeaSpine, Inc.
Division of Integra LifeSciences Corporation
2302 La Mirada Drive
Vista, CA 92081
Phone: (760) 727-8399
Fax: (760) 727-8809
Dan W. Miller
VP of Regulatory Affairs/ CA & QA
e-mail: dmiller@seaspine.com |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 24, 2012 |
| Device Name | |
| Trade Name: | Cardiff™ |
| Common Name: | Anterior Cervical Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis
(21 CFR 888.3060, Product Code: KWQ,
Class II) (Orthopedic Review Committee) |
Legally Marketed Predicate Device
Previously cleared Cardiff™ Anterior Cervical Plate System 510(k) (K083338) Previously cleared Sonoma™ Anterior Cervical Plate System 510(k) (K032368)
Device Description_
The Cardiff™ Anterior Cervical Plate (ACP) System is interior 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, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium and Nitinol alloys. Fixation is provided by bone screws into the vertebral body of the cervical spine using an anterior approach.
Intended 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); .
1
TM Cardiff Special 510(k)
- . spinal stenosis;
- cervical mvelopathy; .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- tumor: .
- pseudoarthrosis; and/or
- failed previous fusion �
Substantial Equivalence Comparison
This special 510(k) for Cardiff™ is a product line modification of the current Cardiff™ ACP System, which is substantially equivalent to the currently marketed system. The Cardiff™ ACP System implants are manufactured from Titanium 6Al-4V ELI per ASTM F136 and Superelastic Nitinol per ASTM F2063. System modifications include revisions to the component manufacturing process and addition of implant variations. These devices have substantially equivalent technological characteristics as the predicate devices and do not alter the fundamental scientific technology of the previously cleared system.
| Category | Previously Submitted Cardiff™
ACP System | Modified Cardiff™ ACP System | Sonoma™ ACP System |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | • Spinal Intervertebral Body
Fixation Orthosis | • Spinal Intervertebral Body
Fixation Orthosis | • Spinal Intervertebral Body
Fixation Orthosis |
| Design | • Graft windows
• Screw holes for vertebral
fixation
• Variety of levels and lengths | • Graft windows
• Screw holes for vertebral
fixation
• Variety of levels and lengths | • Graft windows
• Screw holes for vertebral
fixation
• Variety of levels and lengths |
| Materials | • Titanium and Nitinol Alloy
• Instruments of stainless
steel, Pomalux or Tecaform | • Titanium and Nitinol Alloy
• Instruments of stainless steel,
Pomalux or Tecaform | • Titanium and Nitinol Alloy
• Instruments of stainless steel,
Pomalux or Tecaform |
| Operating
Principle | • Anterior cervical plate system
• Attached to vertebral body
via bone screws
• Provides temporary
stabilization during fusion
• Screws back out prevented
by passive locking mechanism | • Anterior cervical plate system
• Attached to vertebral body via
bone screws
• Provides temporary
stabilization during fusion
• Screws back out prevented by
passive locking mechanism | • Anterior cervical plate system
• Attached to vertebral body via
bone screws
• Provides temporary
stabilization during fusion
• Screws back out prevented by
passive locking mechanism |
| Manufacturing | • Conventional machining | • Conventional machining | • Conventional machining |
| Sterilization | • Moist heat | • Moist heat | • Moist heat |
Non-clinical Testing
No additional non-clinical testing was required to demonstrate equivalence with the previously cleared Cardiff™ or Sonoma ACP Systems. Design Controls were used to identify any additional risks introduced by the modified device when compared with the previously submitted Cardiff™ ACP, or Sonoma ACP Systems. Engineering and Clinical rationale verified that no additional risks were introduced into the system.
Conclusions
The manufacturing process changes and instrument and implant size additions of the Cardiff Anterior Cervical Plate System have not altered the fundamental scientific technology of the previously cleared Cardiff™ ACP System, or the Sonoma ACP System. All modifications have been verified through Design Control activities and risks have been evaluated and are acceptable.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 25 2012
SeaSpine, Inc. % Mr. Dan W. Miller Vice President, Quality Assurance and Regulatory Affairs 2302 La Mirada Drive Vista, California 92081
Re: K112206
Trade/Device Name: Cardiff Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: December 22, 2011 Received: December 27, 2011
Dear Mr. Miller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
3
Page 2 – Mr. Dan W. Miller
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.
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,
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K112206
Page 1. of 1
Indications for Use Statement
510(k) Number (if known):
Device Name: Cardiff™
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 __ × AND/OR
Over-The-Counter-Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Of sion of Surgic=), Orthopedic, ind Restorative Devices
510(k) Number_ KII 2206