(39 days)
Not Found
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is intended to treat various medical conditions of the cervical spine, such as degenerative disc disease, spondylolisthesis, and trauma, and is designed to provide stabilization as an adjunct to fusion or for spinal correction. This aligns with the definition of a therapeutic device which is used to treat or alleviate disease or injury.
No
The device is a surgical implant designed for stabilization and fusion of the cervical spine, not for diagnosing medical conditions.
No
The device is described as an anterior cervical plating fixation system consisting of implants (plates, bone screws, locking screws) and associated instrumentation, all of which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to provide structural support and stabilization.
- Device Description: The description reinforces this by stating it's an "anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies." This is a physical device implanted during surgery.
- Lack of IVD Characteristics: The text does not mention any of the characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment based on the analysis of these samples.
- Reagents, calibrators, or control materials used in laboratory testing.
In summary, the Skyway Anterior Cervical Plate System is a surgical implant used for spinal fixation, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, OVE
Device Description
The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach.
The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7), C2-T1
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)
The Skyway Anterior Cervical Plate System has been tested in the following test modes:
- Static torsion per ASTM F1717-22
- Cage to plate disassociation testing
Compression bending per ASTM F1717 was previously performed to the worst-case sizes under K231766 and was not required for this 510(k) submission. The results of this non-clinical testing show that the strength of the Skyway Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed 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
§ 888.3060 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.
0
November 5, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kyocera Medical Technologies, Inc. % Nathan Wright Engineer and Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K243015
Trade/Device Name: Skyway Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ, OVE Dated: September 26, 2024 Received: September 27, 2024
Dear Nathan Wright:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Ethan R. Naylor -S
for Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological
Enclosure
3
Indications for Use
510(k) Number (if known) K243015
Device Name Skyway Anterior Cervical Plate System
Indications for Use (Describe)
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDEDThis section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K) SUMMARY
| Submitter's Name: | Kyocera Medical Technologies, Inc. (KMTI) |
|---|---|
| Submitter's Address: | 1289 Bryn Mawr Avenue, Suite A |
| Redlands, California 92374 | |
| Submitter's Telephone: | 909-557-2360 |
| Contact Person: | Nathan Wright, MS, RAC |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | September 26, 2024 |
| Trade or Proprietary Name: | Skyway Anterior Cervical Plate System |
| Device Classification Name: | Spinal Intervertebral Body Fixation Orthosis, |
| Intervertebral Fusion Device with Integrated Fixation, Cervical | |
| Classification & Regulation #: | Class II per 21 CFR §888.3060, 21 CFR §888.3080 |
| Product Code: | KWQ, OVE |
| Classification Panel: | Orthopedic - Spinal (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach.
The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.
INDICATIONS FOR USE
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The 4-Hole 1-Level Plates are limited to use at one contiguous level.
The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.
5
TECHNOLOGICAL CHARACTERISTICS
The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences in screw self-tapping features do not raise any new questions of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of Manufacture
- Structure and Function and Design Features
- Plate style, Levels, and Sizes ●
- Screw Sizes ●
Predicate Devices
| 510k # | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | KWQ, OVE | Primary |
| K190227 | Boomerang™ Anterior Cervical Plate System | Choice Spine, LP | KWQ | Additional |
PERFORMANCE DATA
The Skyway Anterior Cervical Plate System has been tested in the following test modes:
- Static torsion per ASTM F1717-22
- Cage to plate disassociation testing
Compression bending per ASTM F1717 was previously performed to the worst-case sizes under K231766 and was not required for this 510(k) submission. The results of this non-clinical testing show that the strength of the Skyway Anterior Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the Skyway Anterior Cervical Plate System is substantially equivalent to the predicate device.