(217 days)
The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.
Here's an analysis of the provided FDA 510(k) summary, specifically focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test) | Criterion (Pass/Fail) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Substantial equivalent performance to predicate devices | "The mechanical testing results demonstrate that the EVOL® -SI Joint Fusion System is substantially equivalent to the predicate device." |
| Static 3-point bending | Per ASTM F543 | Passed |
| Axial Pullout | Per ASTM F543 | Passed |
| Torque to Failure | Per ASTM F543 | Passed |
| Dynamic Three-Point | Per ASTM F1264 | Passed |
| Non-Pyrogenicity Endotoxin Testing | < 20 Endotoxin Units (EU)/device (per ANSI/AAMI ST72 and USP <161>) | "The subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical and endotoxin tests. It refers to "the worst-case subject EVOL® -SI Joint Fusion System implants" for endotoxin testing, implying a limited number. The data provenance is not specified, but these are typically laboratory-based tests performed by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's performance is objectively measured against engineering standards (ASTM) and biological contamination limits (ANSI/AAMI, USP), not against expert interpretations of data.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no human interpretation or adjudication involved in the mechanical or endotoxin testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a medical device (surgical implant) and not an AI/imaging diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established through:
- Established engineering standards: ASTM F543 and ASTM F1264 for mechanical properties.
- Established biological safety standards: ANSI/AAMI ST72 and USP <161> for endotoxin limits.
- Comparison to predicate devices: The "substantial equivalence" is based on the new device's performance meeting or exceeding that of legally marketed predicate devices, which serve as a benchmark for safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (see point 8).
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Image /page/0/Picture/0 description: The image shows 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.
August 12, 2019
Cutting Edge Spine, LLC Mr. Kyle Kuntz Manager R&D 101 Waxhaw Professional Park Drive, Suite A Waxhaw, North Carolina 28173
Re: K190025
Trade/Device Name: EVOL® -SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: July 3, 2019 Received: July 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
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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,
Ronald P. Jean, Ph.D. Assistant Director 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) K190025
Device Name EVOL® -SI Joint Fusion System
Indications for Use (Describe)
The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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 contains the logo for Cutting Edge Spine. 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, thinner font.
6. 510(k) Summary
I. SUBMITTER
Date Prepared: 8/12/2019
| 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® -SI Joint Fusion System |
|---|---|
| Common or Usual Name: | Sacroiliac Joint Fixation Device |
| Classification Name: | Per 21 CFR as follows:888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class: | II |
| Product Codes: | OUR |
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Image /page/4/Picture/1 description: The image shows the logo for Cutting Edge Spine (CES). The logo features a stylized design with three curved lines in orange, green, and blue above the letters CES. Below the letters, the words "CUTTING EDGE SPINE" are printed in a smaller font. The words "PREDICATE DEVICES" are printed in bold letters on the bottom right.
| 510(k) Number | Device | Manufacturer | |
|---|---|---|---|
| PrimaryPredicate | K171595 | M.U.S.T. Sacral IliacScrews | MedactaInternational |
| AdditionalPredicate | K021932 | Synthes 6.5 mmCannulated Screw | Depuy Synthes |
| ReferenceDevice | K150321 | EVOS LumbarInterbody System | Cutting Edge Spine |
| ReferenceDevice | K101225 | Promimic DentalImplant | Promimic AB |
IV. DEVICE DESCRIPTION
The purpose of this application is to introduce a new medical device in commercial distribution (marketing). The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.
INDICATIONS FOR USE V.
The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICES
Documentation was submitted which demonstrated that the EVOL® -SI Joint Fusion System is substantially equivalent to the predicate devices based on a comparison of the following characteristics:
- Same FDA product codes
- Same Indications for Use
- Same Surgical Approach
- o Anatomical Region: SI Joint
- o Same Implant Materials
- Similar Product Dimensions ●
- Similar Device Features
- Equivalent Mechancial Performance
- o All Available by prescription only
- All Made for single use ●
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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 orange, green, and blue above the letters CES. Below the letters, the words "CUTTING EDGE SPINE" are written in a smaller font.
NON-CLINICAL AND CLINICAL PERFORMANCE TESTING VII.
Mechanical Testing
Testing was performed for the EVOL® -SI Joint Fusion System and demonstrated substantial equivalent performance to the identified predicates. The mechanical tests were performed in accordance to these test methods:
Static 3-point bending, Axial Pullout, Torque to Failure, and Dynamic Three-Point
- o ASTM F543
- o ASTM F1264
In all, the mechanical testing results demonstrate that the EVOL® -SI Joint Fusion System is substantially equivalent to the predicate device.
Non-Pyrogenicity Endotoxin Testing
The bacterial endotoxin test, also known as Limulus Amebocyte Lysate (LAL) on the worst case subject EVOL® -SI Joint Fusion System implants verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification, as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices.
VIII. CONCLUSIONS
Based upon a comparison of technological characteristics, intended use, design features, and mechanical performance, the EVOL® -SI Joint Fusion System does not raise any new safety or efficacy concerns and has demonstrated substantial equivalence to the identified predicates.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.