(126 days)
No
The device description focuses on the mechanical components (plates and screws) and their physical properties and intended use in spinal fixation. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The performance studies are mechanical and biocompatibility tests, not AI/ML performance metrics.
Yes.
The device is an anterior cervical plate system intended to restore the integrity of the spinal column, which is a therapeutic function.
No
This device is an Anterior Cervical Plate System, which is an implantable medical device designed for fixation and stabilization of the cervical spine. Its purpose is to restore the integrity of the spinal column, not to diagnose a condition.
No
The device description clearly details physical components (plates and screws) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for restoring the integrity of the spinal column in patients with advanced stage tumors. This is a surgical implant used directly on the patient's body.
- Device Description: The description details plates and screws designed for anterior cervical fixation. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body.
N/A
Intended Use / Indications for Use
The icotec Anterior Cervical Plate System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.
Product codes
KWQ
Device Description
The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine.
The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded.
The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
Indicated Patient Age Range
Not Found
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 testing of the icotec Anterior Cervical Plate System includes:
- Static compression bending, static torsion and dynamic compression bending per ASTM F1717
- Biocompatibility Assessment
- Clinical Data
The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria. The results of the performed tests demonstrate that the icotec Anterior Cervical Plate System is substantially equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2020
icotec ag % Margeaux Rogers Associate Director, Regulatory Affairs MCRA, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K201587
Trade/Device Name: icotec Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: September 18, 2020 Received: September 18, 2020
Dear Margeaux Rogers:
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.
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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) 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-reporting-
combination-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 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 medical devices and radiation-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.
for 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) K201587
Device Name icotec Anterior Cervical Plate System
Indications for Use (Describe)
The icotec Anterior Cervical Plate System is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of 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
| Device Trade Name: | icotec Anterior Cervical Plate System |
|---|---|
| Manufacturer: | icotec ag |
| Industriestrasse 12 | |
| 9450 Altstätten | |
| Switzerland | |
| www.icotec-medical.com | |
| Phone: +41 71 757.0000 | |
| Contact: | Ms. Marina Hess |
| CQO/Management Representative | |
| icotec ag | |
| Prepared by: | Ms. Margeaux Rogers |
| Associate Director, Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| mrogers@mcra.com | |
| Date Prepared: | September 18th, 2020 |
| Classifications: | 21 CFR §888.3060, Spinal intervertebral body fixation orthosis |
| Class: | II |
| Product Codes: | KWQ |
Indications for Use:
The icotec Anterior Cervical Plate System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.
Device Description:
The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine.
The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21
4
up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded.
The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.
Primary Predicate Devices:
The icotec Anterior Cervical Plate System is substantially equivalent in device indications, design, and performance to the following primary predicate device.
- Aesculap, Inc. (AIS) ABC2 Cervical Plating System (K050813) ●
Additional Predicate Devices:
The following additional predicate devices are presented to further demonstrate substantial equivalence since these devices contribute incremental benefit to the substantial equivalence profile with the device indications, design, mechanical performance, and clinical performance:
- EBI VueLock™ Anterior Cervical Plate System (K023133)
- Synthes Spine Anterior CSLP System (K030866) ●
The following reference device is substantially equivalent to the subject device with respect to materials and manufacturing technology and methods:
Performance Testing Summary:
The testing of the icotec Anterior Cervical Plate System includes:
- Static compression bending, static torsion and dynamic compression bending per ASTM F1717
- -Biocompatibility Assessment
- Clinical Data -
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited above with respect to indications, design, materials, function, manufacturing, and performance. The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria. The results of the performed tests demonstrate that the icotec Anterior Cervical Plate System is substantially equivalent to the legally marketed predicate devices.
5
Conclusion:
The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the icotec Anterior Cervical Plate System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.