(28 days)
Not Found
No
The document describes a physical spinal implant made of PEEK material with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The submission is focused on adding a new sterilization method.
Yes
Explanation: The device is an intervertebral body device intended for use in patients with Degenerative Disc Disease (DDD) of the lumbar spine to facilitate fusion and treat back pain, which constitutes a therapeutic purpose.
No
The device is an intervertebral body implant used for treatment of Degenerative Disc Disease, not for diagnosing it.
No
The device is a physical implant made of PEEK-OPTIMA® HA Enhanced material, intended for surgical implantation in the spine. The description focuses on the material, shape, sizes, and sterilization of a physical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The EVOL® Spinal Interbody System is a physical implant made of PEEK material, designed to be surgically placed in the lumbar spine to facilitate fusion. It is a medical device used in vivo (within the body), not in vitro (in a test tube or lab setting).
- Intended Use: The intended use clearly describes a surgical procedure to treat Degenerative Disc Disease by implanting a device, not a diagnostic test performed on a sample.
The document describes a surgical implant and its intended use in treating a spinal condition, which falls under the category of a surgical medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, lumbosacral spine
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 additional testing is required to determine if Steam as a sterilization method will impact the safety or efficacy of this implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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
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
2
Indications for Use
510(k) Number (if known)
K200991
Device Name EVOL® Spinal Interbody System
Indications for Use (Describe)
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.
| 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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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: |
| 888.3080 | |
| Intervertebral 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 | |
|---|---|---|---|
| Primary | |||
| Predicate | K102957 | Cutting Edge Spine | |
| Interbody Device | Cutting Edge Spine | ||
| Additional | |||
| Predicate | K180891 | EVOL® Spinal | |
| Interbody System | |||
| (formerly Cutting Edge | |||
| Spine Interbody Device) | Cutting Edge Spine | ||
| Additional | |||
| Predicate | K192497 | EVOL® ha - D Lateral | |
| Interbody Fusion | |||
| System | Cutting Edge Spine |
DEVICE DESCRIPTION IV.
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.
INDICATIONS FOR USE V.
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.
5
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.