(192 days)
No
The device description and performance studies focus on the mechanical properties and design of a physical intervertebral body fusion device and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for intervertebral body fusion of the spine, specifically for patients with degenerative disc disease. Its purpose is to treat a medical condition by facilitating fusion, which aligns with the definition of a therapeutic device.
No
The device is an intervertebral body fusion device used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it consists of a PEEK spacer and titanium bone screws, which are physical hardware components, not software.
Based on the provided information, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The A-CIFT™ SoloFuse™ is a physical implant (a PEEK spacer with titanium screws) intended for surgical implantation into the spine to facilitate fusion. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Activity: The description focuses on the physical characteristics of the implant and its mechanical testing. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the A-CIFT™ SoloFuse™ is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
Product codes
OVE
Device Description
The A-CIFT™ SoloFuse™ consists of a PEEK OPTIMA LT1 spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The lordotic and nonlordotic PEEK-OPTIMA® LT1 spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm. The titanium bone screws traverse the PEEK-OPTIMA® LTI interbody device either through the body or a posterior/inferior flange to anchor into the patient's vertebral body, thereby securing the interbody into the final placement location. The cage has endplate teeth for additional fixation, ports for bone graft and an anti-screw backout.
The spacers are manufactured from PEEK-OPTIMA® LT1 (ASTM F2026) and Tantalum (ASTM F560-05) markers.
The bone screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one level from the C2-C3 disc to the C7-T1 disc
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 A-CIFT™ SoloFuse™ has been tested in the following test modes:
- Static Axial Compression (ASTM F-2077) .
- Static Compression-Shear (ASTM F-2077) .
- Static Torsion (ASTM F-2077) .
- Dynamic Axial Compression (ASTM F-2077) .
- Dynamic Compression-Shear (ASTM F-2077) ●
- . Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077) .
- Expulsion (ASTM Draft F-04.25.02.02) .
The results of this non-clinical testing show that the strength of the A-CIFT™ SoloFuse™ is sufficient for its intended use and legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LDR ROI-C (K091088, K113559), NuVasive CoRoent (K102547)
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
JAN - 3 2014
K131880 Page 1 of 3
5.510(K) SUMMARY
| Submitter's Name: | SpineFrontier, Inc. |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915, U.S.A. | |
| Submitter's Telephone: | 978.232.3990 x116 |
| Spine Frontier contact | |
| Person: | Paul Speidel |
| Regulatory Affairs Manager: 978.232.3991 | |
| Prepared by and official | |
| contact person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was | |
| Prepared: | 03 January 2014 |
| Trade or Proprietary Name: | SpineFrontier® A-CIFTTM SoloFuse™ Cervical |
| Intervertebral Body Fusion Device | |
| Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation, |
| Cervical | |
| Intervertebral Fusion Device With Bone Graft, Cervical | |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | LDR ROI-C (K091088, K113559) |
| NuVasive CoRoent (K102547) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The A-CIFT™ SoloFuse™ consists of a PEEK OPTIMA LT1 spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The lordotic and nonlordotic PEEK-OPTIMA® LT1 spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm. The titanium bone screws traverse the PEEK-OPTIMA® LTI interbody device either through the body or a posterior/inferior flange to anchor into the patient's vertebral body, thereby securing the interbody into the final placement location. The cage has endplate teeth for additional fixation, ports for bone graft and an anti-screw backout.
SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Fusion Device System Abbreviated 510(k)
1
INDICATIONS FOR USE
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
TECHNICAL CHARACTERISTICS
The spacers are manufactured from PEEK-OPTIMA® LT1 (ASTM F2026) and Tantalum (ASTM F560-05) markers. Both materials have a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The LDR ROI-C (K091088. K113559) and NuVasive CoRoent (K102547) are manufactured from PEEK-OPTIMA® LTIand titanium alloy along with Tantalum markers.
The bone screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The LDR ROI-C (K091088, K113559) and NuVasive CoRoent (K102547) bone screws are also manufactured from titanium alloy.
PERFORMANCE DATA
The A-CIFT™ SoloFuse™ has been tested in the following test modes:
- Static Axial Compression (ASTM F-2077) .
- Static Compression-Shear (ASTM F-2077) .
- Static Torsion (ASTM F-2077) .
- Dynamic Axial Compression (ASTM F-2077) .
- Dynamic Compression-Shear (ASTM F-2077) ●
- . Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077) .
- Expulsion (ASTM Draft F-04.25.02.02) .
The results of this non-clinical testing show that the strength of the A-CIFT™ SoloFuse™ is sufficient for its intended use and legally marketed predicate devices.
SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Fusion Device System Abbreviated 510(k)
2
Conclusion
The overall technology characteristics and mechanical performance data lead to the conclusion that the A-CIFT™ SoloFuse™ is substantially equivalent to the predicate device.
SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Fusion Device System Abbreviated 510(k)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2014
SpineFrontier, Incorporated % Empirical Testing Corporation Meredith May, MS, RAC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K131880
Trade/Device Name: SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II · Product Code: OVE
Dated: November 26, 2013 Received: November 29, 2013
Dear Ms. May:
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
4
Page 2 - Meredith May, MS, RAC
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ronald###Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
Device Name: SpineFrontier® A-CIFT™ SoloFusc™ Ccrvical Intervertebral Body Fusion Device
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degencrative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
David Hwang Ph.D. Division of Orthodedic Devices