(14 days)
The KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).
The KASILOF Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6A-I4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, KASILOF Cervical Plates come with a pre-lordosed curve. Various instruments are available to facilitate the implantation of the device.
This document describes a 510(k) premarket notification for the KASILOF Cervical Plate System. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data with detailed acceptance criteria and performance metrics for a novel AI/software device.
Therefore, the requested information regarding acceptance criteria, study that proves the device meets the acceptance criteria (including sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) is not present in this document.
This document describes a medical device (a cervical plate system), not a software or AI device. The "Performance Testing" section refers to bench performance testing (Static Compression, Static Torsion, and Dynamic Compression) against an ASTM standard (ASTM F1717-18) for the physical device, and not a study validating AI performance. The conclusion states that the device is substantially equivalent based on these test results and comparison to predicate devices.
To answer your request, if this were an AI/software device submission, the relevant sections would typically describe a clinical validation study or performance testing study addressing algorithm output against a ground truth. None of that information is contained within this 510(k) notification for a physical spinal implant.
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November 5, 2020
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Kahtnu Surgical, Inc % Ann Dunahoo Principal Regulatory and Quality Consultant MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K203154
Trade/Device Name: KASILOF Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 9, 2020 Received: October 22, 2020
Dear Ms. Dunahoo:
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,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203154
Device Name KASILOF Cervical Plate System
Indications for Use (Describe)
The KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).
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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510(k) Summary
KASILOF Cervical Plate System October 9, 2020
| Company: | Kahtnu Surgical, Inc.170 E. Corral Ave. Suite 1Soldotna, AK 99669 |
|---|---|
| Primary Contact: | Ann DunahooPrincipal Quality and Regulatory Consultant901-299-9390ann.dunahoo@askmrcglobal.com |
| Company/Secondary Contact: | Craig WilcoxPresident and CEO907-202-3111craig.wilcox@kahtnu.com |
| Trade Name: | KASILOF Cervical Plate System (Previously known as Axis AnteriorCervical Plate) |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3060 (Appliance, Fixation, Spinal Intervertebral Body) |
| Panel: | 87-Orthopedic |
| Product Code: | KWQ |
Device Description:
The KASILOF Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6A-I4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, KASILOF Cervical Plates come with a pre-lordosed curve. Various instruments are available to facilitate the implantation of the device.
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Indications for Use:
The KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).
Substantial Equivalence:
The subject devices are substantially equivalent to the following predicate devices:
Primary Predicate:
-
. KASILOF Cervical Plates (Previously known as Axis Anterior Cervical Plate System) -K173867
Secondary Predicates: -
Medtronic Atlantis Vision Anterior Cervical Plate System (K021461)
The subject four and five level plates are to be used in the stabilization of the anterior cervical spine during the development of cervical spinal fusion, like the predicate device. The subject device is identical in indication and materials and similar in geometry to the predicate.
Performance Testing:
Bench performance testing including Static Compression, Static Torsion, and Dynamic Compression were completed on the predicate KASILOF Cervical Plates with respect to testing recommended in ASTM F1717-18.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.