(30 days)
Not Found
No
The description focuses on the physical characteristics, materials, and surgical instruments of an interbody fusion device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an intervertebral body device used to treat Degenerative Disc Disease of the lumbar spine, facilitating fusion and alleviating discogenic back pain.
No
This device is an implantable intervertebral body device used for spinal fusion, not for diagnosing medical conditions.
No
The device description clearly states that the EVOS Lumbar Interbody System is comprised of physical implants made from PEEK and Tantalum, along with associated surgical instruments. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description: The EVOS Lumbar Interbody System is a physical implant made of PEEK and Tantalum, designed to be surgically placed in the lumbar spine.
- Intended Use: The intended use is to facilitate fusion in patients with Degenerative Disc Disease by providing structural support and space for bone graft. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant and associated instrumentation for a therapeutic procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The EVOS Lumbar Interbody System is an intervertebral body device in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 (per ASTM F-2026) and PEEK Optima LT120HA, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.
The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.
Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.
The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.
The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
The data presented in this submission demonstrates that the devices listed above are 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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 2, 2020
Cutting Edge Spine, LLC Mr. Kyle Kuntz Manger R&D 101 Waxhaw Professional Park, Suite A Waxhaw, North Carolina 28173
Re: K200552
Trade/Device Name: EVOS Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 25, 2020 Received: March 3, 2020
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K200552
Device Name EVOS Lumbar Interbody System
Indications for Use (Describe)
The EVOS Lumbar Interbody System is an intervertebral body device in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.
| 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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Image /page/3/Picture/1 description: The image is a logo for Cutting Edge Spine (CES). The logo features a stylized, abstract design above the text. The abstract design consists of two curved lines, one in orange and the other in blue, that appear to be intertwined. The text "CES" is written in bold, black letters, with the words "CUTTING EDGE SPINE" written in a smaller font size below it.
510(k) Summary
SUBMITTER I.
Date Prepared: 03/28/2020
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: | Brad Roof, Director of Operations
Tel: (704) 243-0892 |
II. DEVICE
EVOS Lumbar Interbody System
| Trade Name: | EVOS Lumbar Interbody 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 |
e-mail: b.roof@cuttingedgespine.com
Image /page/3/Figure/12 description: The image shows three horizontal bars stacked on top of each other. The top bar is orange, the middle bar is green, and the bottom bar is light blue. The bars are all the same width and height, and they are evenly spaced apart.
4
Image /page/4/Picture/1 description: The image is a logo for Cutting Edge Spine (CES). The logo features a stylized, abstract design above the text. The abstract design consists of three curved lines in different colors: orange, green, and blue. Below the abstract design is the text "CES" in a bold, sans-serif font, with three horizontal lines stacked on top of each other to form the letter "E". Underneath "CES" is the text "CUTTING EDGE SPINE" in a smaller, sans-serif font.
III. PREDICATE DEVICES
| | 510(k)
Number | Device | Manufacturer |
|-------------------------|------------------|----------------------------------------|--------------------|
| Primary
Predicate | K150321 | EVOS Lumbar
Interbody System | Cutting Edge Spine |
| Additional
Predicate | K102957 | Cutting Edge Spine
Interbody Device | Cutting Edge Spine |
DEVICE DESCRIPTION IV.
The EVOS Lumbar Interbody System is comprised of a variety of Implants manufactured from PEEK (Polyetheretherketone) -Optima LT1 (per ASTM F-2026) and PEEK Optima LT120HA, with Tantalum bead markers per ASTM F-560. There are three main configurations; STRAIGHT, CURVED, and ROTATE. The different configurations allow for multiple surgical technique options. The EVOS STRAIGHT and the EVOS ROTATE are generally rectangular in shape while the EVOS CURVED is curved. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs.
The EVOS device(s) are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. The angle of lordosis on each lordotic EVOS device is oriented in a way that will provide a true anterior/posterior lordotic orientation once the device has been implanted in its final intervertebral location. For example, the True Oblique Lordotic (TOL) devices have a lordotic orientation to the device that will provide a correct anterior/posterior lordotic orientation once they have been inserted at 30 degrees from the anterior/posterior midline.
Implant heights range from 6mm to 16mm in maximum height (minus the height of the teeth). Widths range from 8mm to 12mm and lengths range from 22mm to 30mm. The variety of implant shapes and sizes accommodate various surgical technique options. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The EVOS Lumbar Interbody System includes the instrumentation to facilitate the implantation of the implants.
The approach and the discectomy are conducted using standard instruments while subsequent steps are conducted using standard and/or custom instruments. The system is
Image /page/4/Figure/10 description: The image shows three horizontal bars of different colors stacked on top of each other. The top bar is orange, the middle bar is green, and the bottom bar is blue. The bars are of equal width and are aligned to the left.
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Image /page/5/Picture/1 description: The image is a logo for Cutting Edge Spine (CES). The logo features a stylized, curved design in three colors: orange, green, and blue. Below the curved design, the letters "CES" are displayed in a bold, sans-serif font. Underneath "CES", the words "CUTTING EDGE SPINE" are written in a smaller, sans-serif font.
comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel and/or polymeric materials.
The EVOS rotate and non-rotate Inserter(s) are instruments intended for use with the EVOS Lumbar Interbody System. The inserter(s) are designed specifically to implant the EVOS device into a prepared disc space. The EVOS non-rotate inserters are designed to work with the EVOS straight and curved devices while the EVOS rotate inserter is designed to work with the EVOS rotate devices.
INDICATIONS FOR USE V.
The EVOS Lumbar Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The EVOS Lumbar Interbody System is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
Documentation was submitted which demonstrated that the EVOS Lumbar Interbody System are substantially equivalent to the predicate devices based on a comparison of the following characteristics:
- FDA product codes ●
- Indications for Use
- Anatomical Region
- . Implant Materials
- . Product Dimensions
- Device Features ●
- Mechancial Performance
- Available by prescription only ●
- Made for single use .
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Image /page/6/Picture/1 description: The image shows the logo for Cutting Edge Spine (CES). The logo features three curved lines in orange, green, and blue above the letters CES in bold, black font. Below the letters, the words "CUTTING EDGE SPINE" are written in a smaller font.
NON-CLINICAL AND CLINICAL PERFORMANCE TESTING VII.
No design changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
CONCLUSIONS VIII.
No design changes were made to the existing devices, nor were any new components added to the system. The sterilization method was expanded to include the use of steam sterilization. The data presented in this submission demonstrates that the devices listed above are substantially equivalent to the predicate devices.
Image /page/6/Figure/8 description: The image shows a bar graph with three bars of different colors. The values associated with the bars are 92, 59, and 73, respectively. The bars are orange, green, and blue, in that order.