(79 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of Peek Optima® with mechanical testing results, and there is no mention of AI or ML in the intended use, device description, or other sections.
Yes
The device is intended to facilitate fusion in patients with degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is described as an "intervertebral body fusion device" intended for surgical fusion of the spine, not for diagnosing medical conditions. It is used in patients already confirmed to have degenerative disc disease.
No
The device description explicitly states it is comprised of devices made of Peek Optima® with various heights and 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 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: The description clearly states that the Arena-C™ Cervical Intervertebral Body Fusion Device is a physical implant intended for surgical insertion into the spine. It is a mechanical device used to facilitate bone fusion.
- Intended Use: The intended use is for intervertebral body fusion in the cervical spine, a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used in the treatment of degenerative disc disease, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Arena-C™ 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 Intervertebral Body Fusion Device 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 (comma separated list FDA assigned to the subject device)
ODP
Device Description
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, 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)
Mechanical testing includes performance assessments per the following recognized test methods:
- ASTM F2077-03, Static and Dynamic Axial Compression, Static and -Dynamic Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04, Subsidence Under Static Axial Compression -
- ASTM Draft Standard F-04.25.02.02, Static Expulsion -
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
§ 888.3080 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
K 113518
FFEB 1 6 2012
5.0 510(k) Summary
1. Sponsor
SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915
| Primary Contact: | Fredy H. Varela, RAC |
|---|---|
| Telephone: | 1- 978-232-3990 |
November 23, 2011 Date Prepared:
2. Device Name and Classification:
| Proprietary Name: | Arena-C™ Cervical Intervertebral Body Fusion
System, Arena-C™ Intervertebral Body Fusion
Device System, Arena-C™ IBFD, Arena-C™
IBF, Arena-C™ |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Intervertebral Fusion Device With Bone Graft,
Cervical |
| Classification Name: | Intervertebral Fusion Device With Bone Graft,
Cervical, (21 CFR 888.3080), Class II |
| Product Code: | ODP |
3. Predicate Devices
K090064 Eminent Spine Interbody Fusion System
4. Device Description
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.
Pg 1 of 2
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Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K113518". The handwriting is somewhat stylized, but the characters are still legible. The image is simple and only contains the text.
5. Intended Use
The Arena-C™ 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 Intervertebral Body Fusion Device 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.
6. Technological Characteristics
The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.
7. Basis for Substantial Equivalence
The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device was evaluated in accordance with FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing). Clinical data was not required for this device. Mechanical testing includes performance assessments per the following recognized test methods:
- ASTM F2077-03, Static and Dynamic Axial Compression, Static and -Dynamic Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04, Subsidence Under Static Axial Compression -
- ASTM Draft Standard F-04.25.02.02, Static Expulsion -
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
SpineFrontier, Inc. % Mr. Christopher Chang Director of Operations 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915
FEB 1 6 2012
Re: K113518
Trade/Device Name: Arena-C Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: November 23, 2011 Received: November 29, 2011
Dear Mr. Chang:
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
3
Page 2 - Mr. Christopher Chang
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
00016
510(k) Number (if Known):
Device Name: Arena-C Cervical Intervertebral Body Fusion System
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: Antieror 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.
Prescription Use: X
OR
Over-The-Counter Use: (Part 21 CFR 807.109)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIT3518 510(k) Number_