(77 days)
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.
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 is a 510(k) summary for the Dio Medical AEON-C™ Stand Alone System, which is an intervertebral body fusion device.
1. Table of Acceptance Criteria and Reported Device Performance
This type of medical device (intervertebral body fusion device) does not typically have "acceptance criteria" in the same way software or diagnostic AI devices do, which might involve performance metrics like sensitivity, specificity, or AUC. Instead, for devices like this, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing, biocompatibility, and material characterization.
However, the provided document explicitly states the following under "Performance Data":
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K191477) | The subject and predicate devices are identical. No performance testing required as the submission is only transferring the name of a system already cleared under K191477. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "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."
Therefore, there was no new test set used for this particular 510(k) submission (K223140). The device is asserted to be identical to a previously cleared predicate device (K191477).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new test set or performance study was conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no new test set or performance study was conducted for this submission.
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 device is an intervertebral body fusion device, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no new performance study was conducted. For mechanical devices, "ground truth" typically refers to established engineering standards, biomechanical testing results, and clinical outcomes data from prior studies on equivalent devices, which would have been part of the original predicate device's clearance.
8. The sample size for the training set
Not applicable. The device is a physical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 100East Norriton, PA 19403 |
|---|---|---|
| Official Contact:Email:Phone: | Milan Georgemgeorge@dio-us.com1-877-394-5407 ext.102 | |
| Date Prepared: | September 30, 2022 | |
| Device Name: | AEON-C™ Stand Alone System | |
| Common Name: | Intervertebral Body Fusion Device, Cervical | |
| ClassificationName: | Intervertebral fusion device with integrated fixation, cervical | |
| ClassificationNumber: | 21 CFR 888.3080 | |
| Product Code/Classification: | OVE, Class II | |
| Description: | The AEON-C™ Stand Alone System includes PEEK interbodies andtitanium interbodies, which utilize a titanium alloy lockingmechanism that is either integrated in an anterior fixation plate orwithin the interbody. Both PEEK interbodies and titaniuminterbodies, with or without fixation plates, are to be anchored topatient anatomy via two (2) titanium alloy bone screws. Theimplant design includes multiple footprints, heights and lordosisoptions and the screw design includes multiple diameters andlengths, to fit a variety of patient anatomies. | |
| Intended Use: | The AEON-C™ Stand Alone System is a stand-alone anterior cervicalintervertebral fusion device indicated for use in skeletally maturepatients with degenerative disc disease (DDD) with accompanyingradicular symptoms at one or two contiguous levels from C2-T1.DDD is defined as discogenic pain with degeneration of the discconfirmed by history and radiographic studies. The AEON-C™ StandAlone System should be packed with autograft and/or allograftcomprised of cancellous, cortical and/or corticocancellous bonegraft and implanted with an anterior approach. | |
| Patients should receive at least six (6) weeks of non-operativetreatment prior to treatment with a cervical intervertebral fusiondevice. | ||
| PredicateDevice: | Primary predicate:Huvexel Co. Ltd. - AEON-C™ Stand Alone System (K191477) | |
| SubstantialEquivalence: | The AEON-C™ Stand Alone System is identical to the predicatedevice and is as safe and effective as the Huvexel - AEON-C™ StandAlone System. The Subject device has the same intended uses andsimilar indications, technological characteristics, and principles ofoperation as its predicate device. There are no technologicaldifferences between the Subject device and its predicate devicesresulting in no K191477 issues of safety or effectiveness. Thus, theDio Medical- AEON-C™ Stand Alone System isidentical/substantially equivalent to the predicates. | |
| PerformanceData: | The subject and predicate devices are identical and therefore, noperformance testing is required. Submission is only transferringname 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 sameintended uses and similar indications, technological characteristics,and principles of operation as its predicate device. Thus, thesubject device is identical/substantially equivalent to the predicatedevice. |
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§ 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.