(90 days)
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for intervertebral fusion to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is an intervertebral fusion system designed for implantation to facilitate fusion, not to diagnose a condition. The "Intended Use" section clearly states its purpose as a treatment.
No
The device description explicitly states the system consists of instruments and implants made of PEEK and tantalum, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for intervertebral fusion in the cervical spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a system of instruments and implants made of PEEK and tantalum, designed for surgical implantation. This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the mechanical properties and stability of the implant (compression, shear, torsion, subsidence, expulsion), which are relevant to a surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least 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 Cervical Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) and tantalum (per ASTM F560) implants which are designed for implantation via an anterior cervical approach. The Cervical Interbody Fusion System is comprised of various sizes to accommodate individual patient anatomy. The implants are single use and the system is provided non-sterile.
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)
Static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested using a widely accepted and validated methodology. The above listed non-clinical testing on the Subject device indicate that the Cervical Interbody Fusion System is substantially equivalent to a predicate device(s).
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
Evolution Spine, LLC % Mr. John D. Siegel Chief Operating Officer LeoNine, LLC 819 South 5th Street, Suite B Temple, Texas 76504
Re: K160324
Trade/Device Name: Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 6, 2016 Received: April 8, 2016
Dear Mr. Siegel:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K160324
Device Name Cervical Interbody Fusion System
Indications for Use (Describe)
This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to 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) |
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Cervical Interbody Fusion System Premarket Notification 510(k) Summary
| DATE PREPARED | February 4, 2016 |
|---|---|
| MANUFACTURER | Evolution Spine |
| 4225 Office Parkway | |
| Dallas, TX 75204 | |
| CONTACT PERSON | Ashton Kouzbari |
| President | |
| 214-682-8536 | |
| mak@strategicancillaryservices.com | |
| PREPARED BY | John Siegel |
| COO | |
| LeoNine, LLC | |
| 819 South 5th Street, Suite B | |
| Temple, TX 76504 | |
| 610-457-5324 | |
| john@leoninellc.com | |
| PANEL CODE | |
| CLASSIFICATION NAME | Orthopaedics/87 |
| ODP 888.3080 - Intervertebral Fusion Device with Bone | |
| Graft, Cervical | |
| CLASS | |
| COMMON NAME | |
| TRADE NAME | Class II |
| Intervertebral Body Fusion Device, Cervical (ODP) | |
| Cervical Interbody Fusion System | |
| PREDICATE DEVICES | Primary: Copperhead manufactured by Eminent Spine |
| (K090064) | |
| Reference: K7C Spacer manufactured by K7 LLC | |
| (K123388) |
DEVICE DESCRIPTION
The Cervical Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) and tantalum (per ASTM F560) implants which are designed for implantation via an anterior cervical approach. The Cervical Interbody Fusion System is comprised of various sizes to accommodate individual patient anatomy. The implants are single use and the system is provided non-sterile.
INDICATIONS and INTENDED USE
This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Documentation was provided to demonstrate that the Subject Cervical Interbody Fusion is substantially equivalent to the predicate Copperhead Interbody Fusion Device (K090064). The Subject device is substantially equivalent to the predicate device in intended use, indications for use, materials, technological characteristics, and labelling.
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PERFORMANCE DATA
Static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested using a widely accepted and validated methodology. The above listed non-clinical testing on the Subject device indicate that the Cervical Interbody Fusion System is substantially equivalent to a predicate device(s).
CONCLUSION
The Cervical Interbody Fusion System and its predicate(s) have the same intended use, to provide mechanical stability in the cervical disc space to facilitate biologic fusion. The indications for use of the Subject device are identical to those of the predicate device. Minor differences between the Subject and predicate devices do not raise any new questions of safety or efficacy. Bench testing demonstrated that the differences do not adversely impact device mechanical performance. Based on the intended use, indications for use, technological characteristics, materials, and comparison to the predicate devices, the Subject Cervical Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.