The EVOL® Spinal 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 EVOL® Spinal 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, transforaminal or anterior approach. The CES-LIF is implanted in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

Device Description

The EVOL® Spinal Interbody System is a family of PEEK-OPTIMA® HA Enhanced spacers offered in a variety of widths and lengths. The CES-LIF are generally rectangular in shape. The CES-LIF is used in pairs.

The EVOL® Spinal Interbody System implants are available in a range of sizes to accommodate variations in patients' anatomy. In addition, tantalum beads are embedded in the spacers to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. The CES-LIF HA implants themselves are made of biocompatible PEEK-Optima® HA Enhanced (LT120) polymer material and provided non-sterile for single-use.

Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).

The purpose of this submission is to add a new sterilization method.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "EVOL® Spinal Interbody System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that a new, novel device would require.

Therefore, the document does not contain the kind of information you are asking for regarding acceptance criteria and a study that proves the device meets those criteria, as typically seen for AI/ML-driven medical devices or devices requiring clinical performance studies to establish performance claims.

Here's why the requested information cannot be extracted from this document:

Device Type: The EVOL® Spinal Interbody System is a spinal implant (a physical medical device), not an independent diagnostic or AI/ML-driven device that would output performance metrics like sensitivity, specificity, or image analysis results.
Regulatory Pathway (510(k)): A 510(k) simply requires demonstrating that the new device is "substantially equivalent" to an already legally marketed device (predicate device). This is primarily done through a comparison of technological characteristics, materials, intended use, and sometimes non-clinical performance (e.g., mechanical testing, biocompatibility). It generally doesn't involve clinical performance studies with pre-defined acceptance criteria, expert ground truth establishment, or MRMC studies for quantifying human-AI collaboration.
Purpose of Submission: The specific purpose of this K200991 submission is to add a new sterilization method (steam sterilization) for an already cleared device line (EVOL® Spinal Interbody System). It explicitly states: "No additional testing is required to determine if Steam as a sterilization method will impact the safety or efficacy of this implant."

In summary, this document does not describe a study that proves the device meets specific acceptance criteria related to its diagnostic or performance accuracy, as it is a physical implant and the submission focuses on a change in sterilization method.

If this were an AI/ML device, the detailed information requested would be crucial for its 510(k) clearance or de novo authorization.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

May 13, 2020

Cutting Edge Spine, LLC Mr. Kyle Kuntz Manager R&D 101 Waxhaw Professional Park, Suite A Waxhaw, North Carolina 28173

Re: K200991

Trade/Device Name: EVOL® Spinal Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 13, 2020 Received: April 15, 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

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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)

K200991

Device Name EVOL® Spinal Interbody System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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 contains the logo for Cutting Edge Spine. The logo features a stylized, colorful graphic above the text "CES" in bold, black letters. Below "CES" is the text "CUTTING EDGE SPINE" in a smaller, lighter font.

510(k) Summary

I. SUBMITTER

Date Prepared: 05/13/2020

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, R&D Biomedical Engineer
	Tel: (704) 243-0892
	e-mail: b.roof@cuttingedgespine.com

II. DEVICE

Trade Name:	EVOL® Spinal Interbody System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Per 21 CFR as follows:888.3080Intervertebral Fusion Device with Bone Graft, Lumbar
Regulatory Class:	II
Product Codes:	MAX

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Image /page/4/Picture/1 description: The image is a logo for Cutting Edge Spine (CES). The logo features a stylized, curved design 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, sans-serif font.

III. PREDICATE DEVICES

	510(k) Number	Device	Manufacturer
PrimaryPredicate	K102957	Cutting Edge SpineInterbody Device	Cutting Edge Spine
AdditionalPredicate	K180891	EVOL® SpinalInterbody System(formerly Cutting EdgeSpine Interbody Device)	Cutting Edge Spine
AdditionalPredicate	K192497	EVOL® ha - D LateralInterbody FusionSystem	Cutting Edge Spine

DEVICE DESCRIPTION IV.

Teeth on top and bottom of the implants improve fixation. They are symmetrical so that the implant will resist motion equally in either direction (anterior or posterior).

The purpose of this submission is to add a new sterilization method.

INDICATIONS FOR USE V.

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Image /page/5/Picture/1 description: The image shows the logo for Cutting Edge Spine (CES). The logo features a stylized design above the text "CES" in bold, black letters. Below the letters, the words "CUTTING EDGE SPINE" are written in a smaller font. The stylized design above the letters consists of three curved lines in orange, green, and blue, respectively.

The EVOL® Spinal 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, transforaminal or anterior approach. The CES-LIF is implanted in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICES

Documentation was submitted which demonstrated that the EVOL® Spinal Interbody System is 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 ●
Sterilization Method

NON-CLINICAL AND CLINICAL PERFORMANCE TESTING VII.

No additional testing is required to determine if Steam as a sterilization method will impact the safety or efficacy of this implant.

CONCLUSIONS VIII.

Based upon a comparison of technological characteristics, intended use, design features, and mechanical performance, the addition of steam sterilization to EVOL® Spinal Interbody System spacers does not raise any new concerns of safety or efficacy. The data presented in this submission demonstrates that the devices listed above are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.