(131 days)
Not Found
No
The summary describes a physical implant and associated instrumentation for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat degenerative disc disease in the cervical spine by providing structural stability and acting as an adjunct to spinal fixation. This direct treatment of a medical condition classifies it as a therapeutic device.
No
This device is a cervical interbody fusion system designed for spinal fusion procedures, not for diagnosis. It is implanted to provide structural stability and is an adjunct to spinal fixation.
No
The device description clearly states it is a physical implant made of PEEK and Tantalum, along with associated instrumentation and sterilization trays. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for a surgical procedure (spinal fusion) and is implanted directly into the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a physical implant made of PEEK and Tantalum, designed to provide structural stability within the spine. This is consistent with a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.
Product codes
ODP
Device Description
The C.Fuse Cervical Intervertebral Body Fusion System is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an adjunct to spinal fixation. The device is trapezoidal in shape, with machined grooves on the superior and inferior surfaces, along with a hollow center core to accept autogenous bone graft. There are two materials used in the manufacture of the Southern Spine C-Fuse Cervical Intervertebral Body Fusion System devices which are the Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560. There is instrumentation for implantation and a sterilization trav for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disk levels
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
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)
The C-Fuse Cervical Intervertebral Body Fusion System was tested to the ASTM F2077 and ASTM F2267 standards as identified in "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", Dated June 12, 2007 as appropriate for characterization of intervertebral body fusion devices. Testing included static axial and compression shear testing, dynamic axial and compression shear testing, static and dynamic torsion testing, static subsidence testing, and static expulsion testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
AUG 1 4 2013
Southern Spine LLC Traditional 510(k) - C Fuse™ Cervical Intervertebral Body Fusion System
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | Southern Spine LLC
487 Cherry Street - Third Street Tower
Macon, GA 31201
Phone: (478) 745-0000 Fax: (478) 744-9996 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
Regulatory Resources Group, Inc. |
| Date Submitted: | Revised - August 5, 2013 |
Device Name and Classification:
| Trade/Proprietary Name: | C-Fuse™ Cervical Intervertebral Body Fusion System |
|---|---|
| Common Name: | Cervical Intervertebral Body Fusion System |
| Classification Name: | Intervertebral body fusion device |
| Product Code: | ODP |
| Regulation: | 21 CFR 888.3080 |
| Class: | 2 |
Legally Marketed Predicate Device:
Spinal Devices, LLC [Current Name is Amendia, Inc.] - Phenix Cervical Interbody Device (Phenix® CID) - 510(k) # K083167
Lanx, Inc. - Lanx Fusion System (Includes Breckenridge Interbody/VBR Fusion System) -510(k) # K103660
Device Description:
The C.Fuse Cervical Intervertebral Body Fusion System is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an adjunct to spinal fixation. The device is trapezoidal in shape, with machined grooves on the superior and inferior surfaces, along with a hollow center core to accept autogenous bone graft. There are two materials used in the manufacture of the Southern Spine C-Fuse Cervical Intervertebral Body Fusion System devices which are the Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560. There is instrumentation for implantation and a sterilization trav for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.
Indications for Use:
The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.
1
Southern Spine LLC Traditional 510(k) - C·Fuse™ Cervical Intervertebral Body Fusion System
510(k) SUMMARY
Similarities and Differences to the Predicate Devices:
Similarities
The same materials, the same performance standards, and the same indications for use are used in the C.Fuse™ Cervical Intervertebral Body Fusion System and the predicate devices. The C-Fuse and predicate devices include approximately the same size ranges for use in cervical C-3 to C-7 disc levels. The devices all have a hollow center core to accept autogenous bone graft. The C-Fuse and predicate devices provide instrumentation sets and sterilization travs as accessories for use during implantation.
Differences
The PEEK resin and tantalum materials are from different manufacturers than the predicates; however, no issue with biocompatibility was shown with the C·Fuse device. The C-Fuse and the predicate devices have roughly the same device dimensions and characteristics.
Summary of Testing:
The C-Fuse Cervical Intervertebral Body Fusion System was tested to the ASTM F2077 and ASTM F2267 standards as identified in "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", Dated June 12, 2007 as appropriate for characterization of intervertebral body fusion devices. Testing included static axial and compression shear testing, dynamic axial and compression shear testing, static and dynamic torsion testing, static subsidence testing, and static expulsion testing.
Substantial Equivalence Conclusions:
The C-Fuse Cervical Intervertebral Body Fusion System has the same intended use and fundamental scientific technology as the predicate devices. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence for the C-Fuse Cervical Intervertebral Body Fusion System against the predicate devices.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14. 2013
Southern Spine, LLC % Regulatory Resources Group, Incorporated Ms. Julie Stephens President/Consultant 111 Laurel Ridge Drive Alpharetta. Georgia 30004
Re: KI30948
Trade/Device Name: C.Fuse™ Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 28, 2013 Received: June 28, 2013
Dear Ms. Stephens:
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 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
3
Page 2 - Ms. Julie Stephens
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Enclosure
4
Indications for Use
510(k) Number (if known): K130948
Device Name: C·Fuse™ Cervical Intervertebral Body Fusion System
Indications for Use:
The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment with the device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
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