(62 days)
The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.
This document is related to a 510(k) premarket notification for a medical device called the "Fortis and Hana Anterior Cervical Plate System." This is a spinal implant, and the FDA letter indicates that the device has been found substantially equivalent to previously marketed devices.
Based on the provided text, the document describes performance testing for mechanical properties, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria as typically understood for AI/ML radiology devices is not present.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed." However, it does not provide specific acceptance criteria values or the reported performance values from these mechanical tests. It only states that the testing was done and that the device was found substantially equivalent, implying that it met the necessary performance standards to be considered equivalent to the predicate devices.
| Acceptance Criteria (Not Specified in Document) | Reported Device Performance (Implied, but Not Quantified) |
|---|---|
| Mechanical properties (e.g., strength, durability under bending and torsion) as specified by ASTM 1717. | Met mechanical performance requirements to be deemed substantially equivalent to predicate devices. |
2. Sample Size for the Test Set and Data Provenance:
Not applicable. This was mechanical testing, not a study on a test set of data (e.g., medical images). The testing was performed on the physical device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. This document describes mechanical testing of a physical implant.
4. Adjudication Method:
Not applicable for a mechanical test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML device for diagnostic interpretation.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is not an AI/ML algorithm.
7. Type of Ground Truth Used:
For this type of device, the "ground truth" for mechanical testing would be the engineering specifications and performance values derived from validated test methods (e.g., ASTM F1717). The document implies that the device met these engineering standards by stating "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed" and that the device was found "substantially equivalent."
8. Sample Size for the Training Set:
Not applicable. This is a physical implant, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of Device and Study Information:
- Device: FORTIS and HANA Anterior Cervical Plate System (spinal intervertebral body fixation orthosis)
- Purpose: Anterior fixation to the cervical spine C2-C7 for various indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, failed previous fusion).
- Study Type: Mechanical testing.
- Tests Performed: Static compression bending, Dynamic compression bending, and Static torsion test.
- Standard Followed: ASTM F1717.
- Result: The device demonstrated substantial equivalence to predicate systems based on technical characteristics, performance, and intended use, implying it met the necessary mechanical performance criteria.
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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 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.
November 30, 2017
Huvexel Co., Ltd % Milan George Senior R&D Director Dio Medical Corporation 8770 W Bryn Mawr Ave. Ste. 1250 Chicago, Illinois 60631
Re: K173099
Trade/Device Name: Fortis and Hana Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 28, 2017 Received: September 29, 2017
Dear Milan George:
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. 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 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); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Fortis and Hana Anterior Cervical Plate System
Indications for Use (Describe)
Fortis and Hana Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include:
degenerative disc disease (DD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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510(k) SUMMARY
HUVEXEL Co., Ltd's FORTIS and HANA Anterior Cervical Plate System
| Sponsor: | Manufacturer: | HUVEXEL Co., Ltd.101-105 Megacenter, SK Technopark124 Sagimakgol-ro, Jungwon-gu Seongnam-siGyeonggi-do, South Korea |
|---|---|---|
| Official Contact: | Milan Georgemgeorge@dio-us.com267-737-9496 x102847-795-1079 | |
| Date Prepared: | November 30, 2017 | |
| Device Name: | FORTIS and HANA Anterior Cervical Plate System | |
| Common Name: | Anterior Cervical Plate System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis | |
| ClassificationNumber: | 21 CFR 888.3060 | |
| ProductCode/Classification: | KWQ, class II | |
| Description: | The FORTIS and HANA Anterior Cervical Plate System consists of a variety ofshapes and sizes of Main Plates, screw, lock-plate and the associatedinstruments. The lock-plate is pre-assembled to the main plate anddesigned to prevent screws from backing out. Each component is subjectedto a color anodizing process to differentiate the screw type and diameterand to make the surgical process easy. The plates range in length toaccommodate one and two-level procedures for HANA and one, two, three,and four level procedures for FORTIS. Main plate is available from 13mm to46mm for HANA and 10mm to 112mm for FORTIS. Screws are available inlengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mmincrements for FORTIS. The screws have either a 4.5mm or 5.1mm diameterfor HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling.The FORTIS and HANA Anterior Cervical Plate System components aresupplied non-sterile, are single use and are fabricated from titanium allow(Ti-6Al-4V ELI) that conforms to ASTM F136. | |
| Intended Use: | The FORTIS and HANA Anterior Cervical Plate System is intended foranterior fixation to the cervical spine C2-C7. The specific clinical indicationsinclude: | |
| degenerative disc disease (DDD) (defined as neck pain of discogenic originwith degeneration of the disc confirmed by history and radiographicstudies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinalstenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),tumor, pseudoarthrosis, and failed previous fusion. | ||
| Performance Data: | Mechanical testing (Static compression bending, Dynamic compressionbending, and Static torsion test) in accordance with the ASTM 1717 wasperformed. | |
| Predicate Device: | Primary predicate: Huvexel - Rex Anterior Cervical Plate System (K121862)Additional predicate: Globus Medical – VIP Anterior Cervical Plate System(K081391), Synthes Spine - Synthes Anterior CSLP System (K000742), EBI -EBI Anterior Cervical Plate System (K001794) and Aesculap – Aesculap ABCCervical Plating System (K974706) | |
| Performance and SEDetermination: | The FORTIS and HANA Anterior Cervical Plate System has beendemonstrated to be substantially equivalent to the predicate system(s) withrespect to technical characteristics, performance, and intended use. Theinformation provided within this premarket notification supportssubstantial equivalence of the subject device to the predicate device(s). |
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§ 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.