(68 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a cervical plate and screws, with no mention of AI or ML.
Yes.
The device is intended for anterior fixation to the cervical spine to treat conditions such as degenerative disc disease, spondylolisthesis, spinal stenosis, and deformities, which are therapeutic interventions.
No.
The Aggeris™-C device is intended for anterior fixation to the cervical spine, meaning it is an implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a cervical plate manufactured from titanium alloy, which is a physical hardware component.
Based on the provided information, the Aggeris™-C device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior fixation to the cervical spine from C2 to C7" for various spinal conditions. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a cervical plate and bone screws made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Aggeris™-C is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
-
- Spondylolisthesis
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Pseudoarthrosis
-
- Revision of previous surgery
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels. The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine from C2 to C7
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)
Biocompatibility: CLARIANCE performed biocompatibility tests on the Aggeris™-C plate. Although the system uses established materials and manufacturing methods, confirmatory testing per ISO 10993-5 and -18 has been performed.
Sterility and Cleaning: The Aggeris™-C is provided in a non-sterile state and is intended to be sterilized by the final user. CLARIANCE performed cleaning and sterilization on the Aggeris™ C plate. Cleaning validation per ISO 19227 has shown acceptable limits of residues. Sterilization validation demonstrated a SAL of 10-6.
Mechanical Testing: Performance testing was conducted per ASTM F1717-18. Specifically, CLARIANCE performed static and dynamic axial compression testing and static torsion testing. The results of these studies were determined to be substantially equivalent to legally marketed 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.
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
March 30, 2022
Image /page/0/Picture/1 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 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.
Clariance % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K220182
Trade/Device Name: Aggeris™-C Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 21, 2022 Received: January 21, 2022
Dear Janice Hogan:
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
1
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page
510(k) Number (if known) K220182
Device Name Aggeris™_C
Indications for Use
The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc 1. confirmed by patient history and radiographic studies)
-
- Spondvlolisthesis
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Pseudoarthrosis
-
- Revision of previous surgery
Type of Use
(Select one or both, as applicable)
区 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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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:
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3
510(k) SUMMARY
CLARIANCE's Aggeris™-C
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CLARIANCE 18 rue Robespierre F-62217 Beaurains, France Phone: +33 (0)3 21 16 12 15 Facsimile: +33 (0)3 21 15 50 73 Contact Person: Mélody LAPORTE, Regulatory Affairs Specialist Date Prepared: March 28, 2022
Name of Device
Aggeris™-C
Common or Usual Name
KWQ - Appliance, Fixation, Spinal Intervertebral Body
Classification Name
§ 888.3060 Spinal intervertebral body fixation orthosis, Class II
Predicate Devices
K103491 - SKYLINE Anterior Cervical Plate - Spinal USA, Inc. (primary)
K133518 - MaxAn Anterior Cervical Plate System - Zimmer Biomet (reference)
Intended Use / Indications for Use
The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
-
- Spondylolisthesis
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Pseudoarthrosis
-
- Revision of previous surgery
Technological Characteristics
The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels.
4
The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.
Performance Data
Biocompatibility
CLARIANCE performed biocompatibility tests on the Aggeris™-C plate. Although the system uses established materials and manufacturing methods, confirmatory testing per ISO 10993-5 and -18 has been performed.
Sterility and Cleaning
The Aggeris™-C is provided in a non-sterile state and is intended to be sterilized by the final user. CLARIANCE performed cleaning and sterilization on the Aggeris™ C plate. Cleaning validation per ISO 19227 has shown acceptable limits of residues. Sterilization validation demonstrated a SAL of 10-6.
Mechanical Testing
Performance testing was conducted per ASTM F1717-18. Specifically, CLARIANCE performed static and dynamic axial compression testing and static torsion testing. The results of these studies were determined to be substantially equivalent to legally marketed devices.
Substantial Equivalence
The Aggeris™ - C is substantially equivalent to the Skyline Anterior Cervical Plate (K103491). The Aggeris™ C has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate device. The minor technological differences between the Aggeris™-C and its predicate device do not raise any new questions of safety or effectiveness. In addition, performance data demonstrate that the Aggeris™ C is as safe and effective as its predicate device. Thus, the Aggeris™-C is substantially equivalent.