(102 days)
Not Found
No
The summary describes a passive implantable device (interbody fusion system) and its mechanical testing, with no mention of AI/ML, image processing for diagnostic purposes, or any software-driven analysis.
Yes
The device is intended for intervertebral body fusion of the spine in patients with degenerative disc disease, which involves treating a medical condition and restoring function.
No
The device is an interbody fusion system intended for spinal fusion, not for diagnosing medical conditions. Its purpose is to facilitate fusion by acting as a spacer and providing a structure for bone graft, rather than identifying or characterizing a disease state.
No
The device description clearly states it is a physical implant made of PEEK-OPTIMA® LT120 HA with tantalum beads, designed for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral body fusion of the spine, specifically for anterior cervical interbody fusion in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device.
- Device Description: The device is a physical implant made of PEEK-OPTIMA® LT120 HA, designed to be placed between vertebral bodies.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition. Its purpose is to provide structural support and facilitate bone fusion.
- Input Imaging Modality: While fluoroscopy is used for visualization during the procedure to aid in placement, it's not the primary function of the device itself to process or analyze images for diagnostic purposes.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a therapeutic implant.
N/A
Intended Use / Indications for Use
The EVOL® ha - C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha - C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The EVOL® ha - C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have a central window for autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical (from C2 - T1)
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 mechanical tests were performed in accordance to these test methods: ASTM F2077, ASTM F2267, Expulsion Testing. The tests performed include: static & dynamic tests for compression, torsion, and compression shear. Subsidence and expulsion tests were also performed. Comprehensive, clinical literature review of published data for cervical interbody fusion devices, similar to the EVOL® ha - C Cervical Interbody Fusion System, was performed to support the Indications for Use at two levels. Based on the published clinical literature review, it was determined that the cervical interbody fusion device, similar to the EVOL® ha - C Cervical Interbody Fusion System, used in the treatment of two-level cervical degenerative disc disease has a safety and effectiveness profile that is similar to the predicate device. In all, the biomechanical testing results demonstrate the EVOL® ha - C Cervical Interbody Fusion System is substantially equivalent to the predicate devices.
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.
K150362, K142026, K081730, K150321
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
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Cutting Edge Spine, LLC Kyle Kuntz Manager R&D 101 Waxhaw Professional Park, Suite A Waxhaw, North Carolina 28173
Re: K180674
Trade/Device Name: EVOL® ha-C Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 13, 2018 Received: June 13, 2018
Dear Mr. Kuntz:
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 801); medical device 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);
June 25, 2018
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Melissa Hall-S" in a clear, sans-serif font. The text is horizontally oriented and appears to be part of a larger document or presentation. The background is plain, ensuring the focus remains on the name.
For 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
510(k) Number (if known)
K180674
Device Name
EVOL® ha - C Cervical Interbody Fusion System
Indications for Use (Describe)
The EVOL® ha - C Cervical Interbody Fusion System is intervertebral body fusion of the spine in sketally mature patients. The EVOL® ha - C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha – C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
| 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)
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510(k) Summary
SUBMITTER I.
Date Prepared: 03/05/2018
Applicant: Cutting Edge Spine, LLC 101 Waxhaw Professional Park Dr., Suite A Waxhaw, NC 28173 Contact Person: Kyle Kuntz, Manager R&D Tel: (704) 243-0892 e-mail: k.kuntz@cuttingedgespine.com
Application Correspondents:
| Contact Person: | Kyle Kuntz, Manager R&D
Tel: (704) 243-0892
e-mail: k.kuntz@cuttingedgespine.com |
|--------------------|----------------------------------------------------------------------------------------|
| Alternate Contact: | Shyam Patel, R&D Biomedical Engineer |
| Alternate Contact: | Shyam Patel, R&D Biomedical Engineer |
|---|---|
| Tel: (704) 243-0892 | |
| e-mail: s.patel@cuttingedgespine.com |
II. DEVICE
| Trade Name: | EVOL® ha – C Cervical Interbody Fusion System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Per 21 CFR as follows: |
| 888.3080 | |
| Intervertebral Fusion Device with Bone Graft, Cervical | |
| Regulatory Class: | II |
| Product Codes: | ODP |
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III. PREDICATE DEVICES
| 510(k) Number | Device | Manufacturer | |
|---|---|---|---|
| Primary | |||
| Predicate | K150362 | CoRoent Small | |
| Interbody System | Nuvasive | ||
| Additional | |||
| Predicate | K142026 | Arena-C (HA) | Spine Frontier |
| Additional | |||
| Predicate | K081730 | Novel Spacer System | Alphatec Spine |
| Additional | |||
| Predicate | K150321 | EVOS Lumbar | |
| Interbody System | Cutting Edge Spine |
DEVICE DESCRIPTION IV.
The purpose of this application is to introduce a new medical device in commercial distribution (marketing). The EVOL® ha - C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have a central window for autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.
INDICATIONS FOR USE V.
The EVOL® ha - C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha - C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of nonoperative treatment.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
Documentation was submitted which demonstrated that the EVOL® ha - C Cervical Interbody Fusion System is substantially equivalent to the predicate devices based on a comparison of the following characteristics:
- FDA product codes
- Indications for Use
- Surgical Approach
- Anatomical Region ●
- Implant Materials ●
- Product Dimensions
- Device Features
- Mechancial Performance ●
- Available by prescription only ●
- Made for single use ●
VII. NON-CLINICAL AND CLINICAL PERFORMANCE TESTING
Testing was performed for the EVOL® ha – C Cervical Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicates. The mechanical tests were performed in accordance to these test methods:
- ASTM F2077
- . ASTM F2267
- Expulsion Testing
The tests performed include: static & dynamic tests for compression, torsion, and compression shear. Subsidence and expulsion tests were also performed.
Comprehensive, clinical literature review of published data for cervical interbody fusion devices, similar to the EVOL® ha - C Cervical Interbody Fusion System, was performed to support the Indications for Use at two levels. Based on the published clinical literature review, it was determined that the cervical interbody fusion device, similar to the EVOL® ha - C Cervical Interbody Fusion System, used in the treatment of two-level cervical degenerative disc disease has a safety and effectiveness profile that is similar to the predicate device.
In all, the biomechanical testing results demonstrate the EVOL® ha - C Cervical Interbody Fusion System is substantially equivalent to the predicate devices.
CONCLUSIONS VIII.
Based upon a comparison of technological characteristics, intended use, design features, and mechanical performance, the EVOL® ha – C Cervical Interbody Fusion System has demonstrated substantial equivalence to the identified predicates.