(162 days)
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach.
Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.
The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.
The provided text describes the 510(k) summary for the HUVEXEL Co., Ltd's AEON-C™ Stand Alone System. This is a medical device for orthopedic surgery, specifically for intervertebral fusion, and the information presented is related to its mechanical performance and substantial equivalence to existing devices, not an AI/ML algorithm.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and ground truth for training set) are not applicable to this type of device and study.
However, I can provide the acceptance criteria and reported device performance from a mechanical testing perspective, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Testing Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM F2077 (Static & Dynamic) | Demonstrated substantial equivalence to predicate device |
| ASTM F2267 (Static & Dynamic) | Demonstrated substantial equivalence to predicate device |
| Static & Dynamic compression | Performed; demonstrated substantial equivalence |
| Static & Dynamic compression shear | Performed; demonstrated substantial equivalence |
| Static & Dynamic Torsion | Performed; demonstrated substantial equivalence |
| Subsidence | Performed; demonstrated substantial equivalence |
| Expulsion | Performed; demonstrated substantial equivalence |
Description of the Study that Proves the Device Meets Acceptance Criteria:
The study conducted to demonstrate the AEON-C™ Stand Alone System meets acceptance criteria was a non-clinical performance testing study. This study aimed to show that the subject device is substantially equivalent to legally marketed predicate devices.
Specifics of the Study:
- Type of Study: Non-clinical (mechanical) testing.
- Standards Followed: The testing was performed in accordance with ASTM F2077 (Standard Test Methods for Determining Durability of Intervertebral Body Fusion Device Materials and Constructs in a Corpectomy Model) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).
- Tests Performed:
- Static & Dynamic compression
- Static & Dynamic compression shear
- Static & Dynamic Torsion
- Subsidence
- Expulsion
- Objective: To demonstrate that the AEON-C™ Stand Alone System is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices.
- Conclusion: The non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.
2. Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This was mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/ML. The sample size would refer to the number of physical devices tested, but this detail is not provided in a 510(k) summary for mechanical testing as it is assumed to be adequate for the standards.
- Data Provenance: Not applicable, as this refers to mechanical testing results, not clinical data or data from a specific country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. Ground truth as defined in this request (expert consensus, pathology) is relevant for clinical or diagnostic AI/ML studies. This study is mechanical performance testing against established engineering standards. The "ground truth" here is the performance metrics defined by the ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in studies where human judgment is involved in establishing ground truth for a clinical or diagnostic outcome. This was mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This applied to AI/ML devices, not a physical intervertebral fusion device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This applies to AI/ML algorithms. The device itself is described as a "Stand Alone System" in the sense that it is a physical implant, but not in the context of an AI algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Performance Standards: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F2077, ASTM F2267) and substantial equivalence to predicates as demonstrated through comparative mechanical testing and material characterization.
8. The sample size for the training set:
- Not applicable. This applies to AI/ML algorithms, not mechanical device testing.
9. How the ground truth for the training set was established:
- Not applicable. This applies to AI/ML algorithms, not mechanical device testing.
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November 13, 2019
HUVEXEL Co., Ltd % Milan George Vice President, R&D Dio Medical Corporation 2000 Campus Lane, Suite 200 Eagleville, Pennsylvania 19403
Re: K191477
Trade/Device Name: AEON-C™ Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 15, 2019 Received: October 16, 2019
Dear Mr. 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. 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
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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-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 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,
Brent Showalter, Ph.D. Assistant Director (Acting) 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: 06/30/2020 See PRA Statement below.
510(k) Number K191477
Device Name AEON-C™ Stand Alone System
Indications for Use (Describe)
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach.
Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device.
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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PSC Publishing
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K191477
510(k) SUMMARY
HUVEXEL Co., Ltd's AEON-C™ Stand Alone System
| Sponsor: | |
|---|---|
| ---------- | -- |
| Manufacturer | HUVEXEL Co., Ltd.101-105 Megacenter, SKn Technopark124 Sagimakgol-ro, Jungwon-gu Seongnam-siGyeonggi-do, South Korea |
|---|---|
| -------------- | ---------------------------------------------------------------------------------------------------------------------------------- |
| Official Contact | Milan George |
|---|---|
| Phone: | 267-737-9496 x102 |
| Fax: | 847-795-1079 |
| Date: | October 15, 2019 |
| Device Name: | AEON-C™ Stand Alone System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device, Cervical |
| Classification Name: | Intervertebral fusion device with integrated fixation, cervical |
| ClassificationNumber: | Class II |
| ProductCode/Classification: | OVE |
| Description: | The AEON-C™ Stand Alone System includes PEEK interbodies and titaniuminterbodies, which utilize a titanium alloy locking mechanism that is eitherintegrated in an anterior fixation plate or within the interbody. Both PEEKinterbodies and titanium interbodies, with or without fixation plates, are tobe anchored to patient anatomy via two (2) titanium alloy bone screws. Theimplant design includes multiple footprints, heights and lordosis optionsand the screw design includes multiple diameters and lengths, to fit avariety of patient anatomies. |
| Intended Use: | The AEON-C™ Stand Alone System is a stand-alone anterior cervicalintervertebral fusion device indicated for use in skeletally mature patientswith degenerative disc disease (DDD) with accompanying radicularsymptoms at one or two contiguous levels from C2-T1. DDD is defined asdiscogenic pain with degeneration of the disc confirmed by history andradiographic studies. The AEON-C™ Stand Alone System should be packed |
K191477 - 510k Summary Page 1 of 2
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| with autograft and/or allograft comprised of cancellous, cortical and/orcorticocancellous bone graft and implanted with an anterior approach. | |
|---|---|
| Performance Data: | Non-clinical testing was performed to demonstrate that the subjectAEON-C™ Stand Alone System is substantially equivalent to the predicatedevice. The following testing was performed in accordance with theASTM F2077 and ASTM F2267:- Static & Dynamic compression- Static & Dynamic compression shear- Static & Dynamic Torsion- Subsidence- ExpulsionThe nonclinical tests demonstrate that the AEON-C™ Stand AloneSystem is as safe, as effective, and performs as well as or better than thelegally marketed predicate devices. |
| Predicate Device: | Primary predicate: Globus Medical Inc. – COALITION® and COALITION AGX®(K083389 and K173115)Additional predicates: Spinal Elements, Inc.— Vertu, and Vertu Ti-Bond(K122771 and K181837), and K2M, Inc. - CASCADIA™ Interbody System(K160125) |
| Reference Device: | K111362 – Rexious Spinal Fixation System |
| TechnologicalCharacteristics | The AEON-C™ Stand Alone System was shown to be substantially equivalentand has equivalent technological characteristics to its predicate andreference devices through comparison in areas including design,labeling/intended use, material composition, function, range of sizes, andpackaging. |
| Performance and SEDetermination: | The AEON-C™ Stand Alone System has been demonstrated to besubstantially equivalent to the predicate system(s) with respect totechnical characteristics, performance, and intended use. Theinformation provided within this premarket notification supportssubstantial equivalence of the subject device to the predicate device(s)and demonstrates that the device is as safe, as effective, and performs aswell as or better than the legally marketed device predicate. |
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.