(188 days)
Not Found
No
The summary describes a physical implant device and its material properties and mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an intervertebral body fusion device intended to treat degenerative disc disease, which explicitly addresses a medical condition.
No
The device is an implantable fusion device used to treat degenerative disc disease, not to diagnose a condition. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of PEEK Optima® with titanium coating and tantalum markers, intended for surgical implantation. It also details physical dimensions and configurations. The performance studies listed are for mechanical testing of the physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a spinal intervertebral body fusion device intended for surgical implantation in the cervical spine to facilitate fusion. It is a physical implant used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing. The "radiographic visualization" mentioned is for confirming the position of the implant, not for diagnosing a condition using a biological sample.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SpineFrontier® Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.
The SpineFrontier® Arena-C® Cervical IBFD is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP
Device Description
The purposed of this submission is to add titanium coating to the existing Arena-C® product line. The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima® with titanium coating, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.
The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm. in 1mm increments.
The SpineFrontier Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating implants are supplied sterile, are single use, and are fabricated from PEEK-OPTIMA® LT1® with titanium coating and tantalum markers for radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one disc 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 Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device has been tested in the following test modes:
- Static Axial Compression per ASTM F2077 ●
- Static Compression-Shear per ASTM F2077 ●
- Static Torsion per ASTM F2077 ●
- Dynamic Axial Compression per ASTM F2077 ●
- . Dynamic Compression-Shear per ASTM F2077
- Dynamic Torsion per ASTM F2077 .
- Wear Particulate Analysis per ASTM F1877 on all dynamic test samples
The Titanium coating has been evaluated with the following tests:
- Microstructure characterization per ASTM F1854 ●
- Tensile testing per ASTM F1147 ●
- Static shear testing per ASTM F1044 ●
- Shear fatigue testing per ASTM F1160 ●
- Abrasion per ASTM F1978
The results of this non-clinical testing show that the strength of the Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are layered, creating a sense of depth and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
SpineFrontier, Incorporated % Ms. Meredith May Senior Manager Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K141333
Trade/Device Name: Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: October 14, 2014 Received: October 30, 2014
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Mark N. Melkerson -S
Mark N. Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. | |
| 510(k) Number ( if known ) | K141333 |
| Device Name | Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device |
| Indications for Use ( Describe ) | |
| The SpineFrontier® Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with | |
| degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. | |
| The SpineFrontier® Arena-C® Cervical IBFD is intended to be used with supplemental spinal fixation | |
| system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation). | |
| Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by | |
| history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of | |
| non-operative treatment prior to treatment with an intervertebral cage. | |
| Type of Use (Select one or both, as applicable) | |
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| FORM FDA 3881 (9/13) | |
| Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete
3
and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
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5. 510(K) SUMMARY
| Submitter's Name: | SpineFrontier |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915 | |
| Submitter's Telephone: | 978.232.3990 x116 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Consulting LLC | |
| 719.337.7579 | |
| Date Summary was Prepared: | 25-Nov-14 |
| Trade or Proprietary Name: | Arena-C® TiFuse™ Cervical Intervertebral Body Fusion |
| Device | |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 Device Classification |
| Product Code: | ODP |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The purposed of this submission is to add titanium coating to the existing Arena-C® product line. The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of Peek Optima® with titanium coating, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.
The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm. in 1mm increments.
The SpineFrontier Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Arena-C Cervical Intervertebral Body Fusion Device with Titanium Coating implants are supplied sterile, are single use, and are fabricated from PEEK-OPTIMA® LT1® with titanium coating and tantalum markers for radiographic visualization.
SpineFrontier Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device Confidential
5
INDICATIONS FOR USE
The SpineFrontier® Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.
The SpineFrontier® Arena-C® Cervical IBFD is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The indications for use for the Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is made from material that is identical to the previously cleared and predicate devices. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Materials of manufacture
- Structural support mechanism
Table 5-1 Primary Predicate
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K141337 | Arena-C®™ Cervical IBFD | SpineFrontier |
Table 5-1 Additional Predicates
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K090064 | Interbody Fusion System | Eminent Spine |
| K130573 | Interbody System | Tyber Medical |
6
PERFORMANCE DATA
The Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device has been tested in the following test modes:
- Static Axial Compression per ASTM F2077 ●
- Static Compression-Shear per ASTM F2077 ●
- Static Torsion per ASTM F2077 ●
- Dynamic Axial Compression per ASTM F2077 ●
- . Dynamic Compression-Shear per ASTM F2077
- Dynamic Torsion per ASTM F2077 .
Wear Particulate Analysis per ASTM F1877 on all dynamic test samples The Titanium coating has been evaluated with the following tests:
- Microstructure characterization per ASTM F1854 ●
- Tensile testing per ASTM F1147 ●
- Static shear testing per ASTM F1044 ●
- Shear fatigue testing per ASTM F1160 ●
- Abrasion per ASTM F1978 ●
The results of this non-clinical testing show that the strength of the Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device is substantially equivalent to the predicate device.