(162 days)
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "anterior cervical intervertebral fusion device" intended for "degenerative disc disease (DDD) with accompanying radicular symptoms," which directly aims to treat a medical condition.
No
The device is described as an anterior cervical intervertebral fusion device, which is an implant used for treatment (fusion), not for diagnosing a condition.
No
The device description explicitly details physical components such as PEEK and titanium interbodies, titanium alloy locking mechanisms, and titanium alloy bone screws. The performance studies also focus on mechanical testing of these physical components. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device description details physical components like interbodies, plates, and screws, which are all surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted directly into the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
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.
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
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)
Non-clinical testing was performed to demonstrate that the subject AEON-C™ Stand Alone System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F2077 and ASTM F2267:
- Static & Dynamic compression
- Static & Dynamic compression shear
- Static & Dynamic Torsion
- Subsidence
- Expulsion
The nonclinical tests 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.
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.
K083389, K173115, K122771, K181837, K160125
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
§ 888.3080 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.
0
Image /page/0/Picture/0 description: The image shows 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 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
1
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
2
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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FORM FDA 3881 (7/17) Services (301) 443-6740 EF
Page 1 of 1
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 Technopark
124 Sagimakgol-ro, Jungwon-gu Seongnam-si
Gyeonggi-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 |
| Classification | |
| Number: | Class II |
| Product | |
| Code/Classification: | OVE |
| Description: | 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. | |
| Intended Use: | 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 |
K191477 - 510k Summary Page 1 of 2
4
| | with autograft and/or allograft comprised of cancellous, cortical and/or
corticocancellous bone graft and implanted with an anterior approach. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Non-clinical testing was performed to demonstrate that the subject
AEON-C™ Stand Alone System is substantially equivalent to the predicate
device. The following testing was performed in accordance with the
ASTM F2077 and ASTM F2267:
- Static & Dynamic compression
- Static & Dynamic compression shear
- Static & Dynamic Torsion
- Subsidence
- Expulsion
The nonclinical tests 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. |
| 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 |
| Technological
Characteristics | The AEON-C™ Stand Alone System was shown to be substantially equivalent
and has equivalent technological characteristics to its predicate and
reference devices through comparison in areas including design,
labeling/intended use, material composition, function, range of sizes, and
packaging. |
| Performance and SE
Determination: | The AEON-C™ Stand Alone System has been demonstrated to be
substantially equivalent to the predicate system(s) with respect to
technical characteristics, performance, and intended use. The
information provided within this premarket notification supports
substantial equivalence of the subject device to the predicate device(s)
and demonstrates that the device is as safe, as effective, and performs as
well as or better than the legally marketed device predicate. |