(77 days)
Not Found
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. The performance study section explicitly states the device is identical to a previously cleared device and no testing is required, further suggesting a lack of complex software or AI/ML components.
Yes
Explanation: The device is indicated for use in treating degenerative disc disease (DDD) with accompanying radicular symptoms, which indicates a therapeutic purpose.
No
Explanation: This device is a cervical fusion device used to treat degenerative disc disease by providing stability and promoting fusion between vertebrae. It is an implantable medical device for treatment, not for diagnosing a condition.
No
The device description explicitly states it includes PEEK and titanium interbodies, a titanium alloy locking mechanism, and titanium alloy bone screws, which are all hardware components.
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 anterior cervical fusion. This is a therapeutic device used in vivo (within the body) to treat a medical condition (degenerative disc disease).
- Device Description: The description details physical components like interbodies, plates, and screws, which are typical of 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 to provide diagnostic information. This device is a physical implant used to stabilize the spine.
N/A
Intended Use / Indications for Use
The AEON-C™ Stand Alone System is a stand-alone anterior cervical 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 with a cervical intervertebral 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)
The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K191477. No testing is required.
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.
Not Found
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.
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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 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.
December 20, 2022
Dio Medical Inc Milan George VP of R&D 2100 Campus LaneSuite 100 East Norriton, Pennsylvania 19403
Re: K223140
Trade/Device Name: AEON-CTM Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 30, 2022 Received: October 4, 2022
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. 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,
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. 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) K223140
Device Name AEON-C™ Stand Alone System
Indications for Use (Describe)
The AEON-C™ Stand Alone System is a stand-alone anterior cervical 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 with a cervical intervertebral 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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510(k) SUMMARY
Dio Medical AEON-C™ Stand Alone System
| Sponsor: | Manufacturer: | Dio Medical Corp.
2100 Campus Lane, Suite 100
East Norriton, PA 19403 |
|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact:
Email:
Phone: | Milan George
mgeorge@dio-us.com
1-877-394-5407 ext.102 |
| Date Prepared: | September 30, 2022 | |
| 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: | 21 CFR 888.3080 | |
| Product Code/
Classification: | OVE, Class II | |
| 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 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. | | |
| Predicate
Device: | Primary predicate:
Huvexel Co. Ltd. - AEON-C™ Stand Alone System (K191477) | |
| Substantial
Equivalence: | The AEON-C™ Stand Alone System is identical to the predicate
device and is as safe and effective as the Huvexel - AEON-C™ Stand
Alone System. The Subject device has the same intended uses and
similar indications, technological characteristics, and principles of
operation as its predicate device. There are no technological
differences between the Subject device and its predicate devices
resulting in no K191477 issues of safety or effectiveness. Thus, the
Dio Medical- AEON-C™ Stand Alone System is
identical/substantially equivalent to the predicates. | |
| Performance
Data: | The subject and predicate devices are identical and therefore, no
performance testing is required. Submission is only transferring
name of a system that has already been cleared under K191477.
No testing is required. | |
| Conclusion: | The Dio Medical AEON-C™ Stand Alone System has the same
intended uses and similar indications, technological characteristics,
and principles of operation as its predicate device. Thus, the
subject device is identical/substantially equivalent to the predicate
device. | |
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