(110 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of Peek Optima® and focuses on its mechanical properties and intended use for spinal fusion. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies mentioned are engineering rationale and finite element analysis, which are standard methods for evaluating the mechanical performance of such devices, not AI/ML performance.
Yes
The device is described as an intervertebral body fusion device intended to facilitate fusion in patients with degenerative disc disease, which is a therapeutic purpose.
No
The device is described as a "spinal intervertebral body fusion device" intended for fusion of the spine, not for diagnosing conditions.
No
The device description clearly states it is a "spinal intervertebral body fusion device" made of "Peek Optima®" with "raised contours," indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Arena-C® Cervical Intervertebral Body Fusion System is a physical implantable device made of Peek Optima® intended for surgical implantation in the spine. It is used to facilitate bone fusion.
- Intended Use: The intended use is for intervertebral body fusion in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Arena-C® Cervical Intervertebral Body Fusion System 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 Intervertebral Body Fusion System 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
This 510(k) Submission is seeking add new sizes to the previously cleared Arena-C device. The SpineFrontier Cervical Interbody Fusion Device System (Arena-C® Cervical Intervertebral) 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 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.
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
Engineering rationale and finite element analysis were used to demonstrate that the modifications to the Arena-C Cervical Intervertebral Fusion Device do not generate new worst case compared to the predicate device.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are arranged in a way that creates a sense of depth and continuity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2014
SpineFrontier, Incorporated % Meredith May, MS, RAC Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K141337
Trade/Device Name: SpineFrontier Arena-C® Cervical Intervertebral Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 19, 2014 Received: July 10, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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. 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 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 yours.
Ronald和Nean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K141337
Device Name
SpineFrontier Arena-C® Cervical Intervertebral Body Fusion System
Indications for Use (Describe)
The Arena-C® Cervical Intervertebral Body Fusion System 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 Intervertebral Body Fusion System 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 with an intervertebral cage.
Type of Use (Select one or both, as applicable)
| ☑ 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 ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13) 6740 EF
PSC Publishing Services (301) 443-
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 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."
FORM FDA 3881 (9/13)
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5.510(K) SUMMARY
| Submitter's Name: | SpineFrontier |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915, U.S.A. | |
| Contact Person: | Paul L. Speidel |
| Regulatory Affairs Manager | |
| Tel: 978.279.9272 | |
| Fax: 978.232.3991 | |
| PaulSpeidel@spinefrontier.com | |
| Prepared by: | Meredith May MS, RAC |
| Empirical Consulting | |
| Tel: 719-337-7579 | |
| Mmay@EmpiricalTesting.com | |
| Date Summary was Prepared: | 28-Aug-14 |
| Trade or Proprietary Name: | Arena-C® |
| Common or Usual Name: | Cervical Interverterbal Body Fusion System |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Division of Orthopedic Devices – Anterior Spine Device |
| Branch |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
This 510(k) Submission is seeking add new sizes to the previously cleared Arena-C device. The SpineFrontier Cervical Interbody Fusion Device System (Arena-C® Cervical Intervertebral) 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 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.
Indications for Use
The Arena-C® Cervical Intervertebral Body Fusion System 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 Intervertebral Body Fusion System is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
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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® Cervical Intervertebral Fusion Device is identical to that of the previously cleared devices.
TECHNICAL CHARACTERISTICS
Arena-C® Cervical Intervertebral Fusion Device is made from material that is identical to the previously cleared and predicate device. 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 ●
Trade or Proprietary or Model Name Manufacturer 510k Number Eminent Spine K090064 Copperhead System K110733 Daytona Anterior Cervical Cage SpineNet K113518 Arena-C® Cervical Intervertebral Fusion Device SpineFrontier
Table 5-1: Previously cleared and predicate devices
PERFORMANCE TESTING SUMMARY
Engineering rationale and finite element analysis were used to demonstrate that the modifications to the Arena-C Cervical Intervertebral Fusion Device do not generate new worst case compared to the predicate device.
CONCLUSION
The subject modified is Arena-C® Cervical Intervertebral Fusion Device very similar to previously cleared Arena-C® Cervical Intervertebral Fusion Device and the referenced predicate device. The subject Arena-C® Cervical Intervertebral Fusion Device has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance analysis lead to the conclusion that the Arena-C® Cervical Intervertebral Fusion Device is substantially equivalent to the predicate devices.