(117 days)
Not Found
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The testing described is mechanical and biomechanical, not related to software performance.
No
This device is an implant for spinal fusion and is not described as providing therapy directly. Its purpose is to facilitate fusion and provide stabilization.
No
The device is an interbody fusion system designed for surgical implantation in the spine to facilitate fusion. Its function is to provide structural support and promote bone growth, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant made from PEEK-OPTIMA® LT120 HA with tantalum beads, designed for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EVOL® ha – D Lateral Interbody Fusion System is an implantable medical device designed to be surgically placed in the spine to facilitate bone fusion. It is a physical device used within the body, not to test samples from the body.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion of the spine" and "treatment of degenerative disc disease." This is a surgical intervention, not a diagnostic test.
- Device Description: The description details the physical characteristics of the implant (material, size, features) and its purpose in supporting the spine.
- Performance Studies: The performance studies focus on mechanical testing (compression, shear, expulsion, subsidence) to ensure the device's structural integrity and function within the body.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The EVOL® ha - D Lateral Interbody Fusion System is intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha – D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – D Lateral Interbody Fusion System is designed for use with autogenous and/ or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The EVOL® ha -D Lateral Interbody Fusion System is designed for use as a lumbar 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 two central windows for 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
Fluoroscopy
Anatomical Site
Lumbar spine (L2-S1)
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)
Testing was performed for the EVOL® ha – D Lateral Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicate. 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, and compression shear. Subsidence and expulsion tests were also performed.
In all, the biomechanical testing results demonstrate the EVOL® ha – D Lateral Interbody Fusion System is substantially equivalent to the predicate device.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 6, 2020
Cutting Edge Spine, LLC Mr. Kyle Kuntz Manager R&D 101 Waxhaw Professional Park. Suite A Waxhaw, North Carolina 28173
Re: K192497
Trade/Device Name: EVOL® ha - D Lateral Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 10, 2019 Received: December 11, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent L. Showalter Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K192497
Device Name
EVOL® ha - D Lateral Interbody Fusion System
Indications for Use (Describe)
The EVOL® ha - D Lateral Interbody Fusion System is intervertebral body fusion of the spine in sketally mature patients. EVOL® ha – D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – D Lateral Interbody Fusion System is designed for use with autogenous and/ or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Image /page/3/Picture/1 description: The image shows the logo for Cutting Edge Spine. The logo features three curved lines in orange, green, and blue above the letters "CES" in a bold, sans-serif font. Below the letters, the words "CUTTING EDGE SPINE" are written in a smaller font.
6. 510(k) Summary
I. SUBMITTER
Date Prepared: 9/6/2019
| 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 | ||
| Tel: (704) 243-0892 | |||
| e-mail: s.patel@cuttingedgespine.com |
II. DEVICE
| Trade Name: | EVOL® ha – D Lateral 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, Lumba | |
| Regulatory Class: | II |
| Product Codes: | MAX |
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Image /page/4/Picture/1 description: The image shows the logo for Cutting Edge Spine. The logo consists of the letters CES in a stylized font, with the words "CUTTING EDGE SPINE" written below. Above the letters is a graphic of three curved lines in orange, blue, and green. Below the logo are the words "PREDICATE DEVICES".
| 510(k) Number | Device | Manufacturer | |
|---|---|---|---|
| Primary | |||
| Predicate | K153782 | Lumbar Interbody | |
| Implants | NuVasive | ||
| Additional | |||
| Predicate | K180674 | EVOL® ha – C Cervical | |
| Interbody Fusion System | Cutting Edge Spine | ||
| Additional | |||
| Predicate | K102957 | Spinal Interbody Device | |
| (EVOL) | Cutting Edge Spine |
DEVICE DESCRIPTION IV.
The purpose of this submission to request approval for a new product. The EVOL® ha -D Lateral Interbody Fusion System is designed for use as a lumbar 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 two central windows for 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.
V. INDICATIONS FOR USE
The EVOL® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha - D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha - D Lateral Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
5
Image /page/5/Picture/1 description: The image contains the logo for Cutting Edge Spine. The logo features a stylized, colorful swirl above the text "CES" in a bold, sans-serif font. Below "CES" is the text "CUTTING EDGE SPINE" in a smaller, thinner font. The swirl consists of three curved lines in orange, green, and blue.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
Documentation was submitted which demonstrated that the EVOL® ha – D Lateral 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 ●
NON-CLINICAL AND CLINICAL PERFORMANCE TESTING VII.
Testing was performed for the EVOL® ha – D Lateral Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicate. 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, and compression shear. Subsidence and expulsion tests were also performed.
In all, the biomechanical testing results demonstrate the EVOL® ha – D Lateral Interbody Fusion System is substantially equivalent to the predicate device.
CONCLUSIONS VIII.
Based upon a comparison of technological characteristics, intended use, design features, and mechanical performance, the EVOL® ha – D Lateral Interbody Fusion System does not raise any new safety or efficacy concerns and has demonstrated substantial equivalence to the identified predicates.