(202 days)
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual applians (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodonties, as well as to have received a dedicated training in the use of the software.
iOrtho (hereafter referred to as "Proposed Device") includes modifications to the currently marketed software included in K203688, cleared October 8, 2021 (hereafter referred to as "Reference Device"). The Proposed Device is an orthodontic appliance design and treatment simulation software is for use by dental professionals to aid in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate 3D dental models using standard stereolithographic (STL) files for use in 3D printers. These models can then be used as a template for thermoforming aligners or retainers by Angel Align technicians.
The provided text is a 510(k) summary for the iOrtho device. It describes the device, its intended use, and compares it to predicate and reference devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a specific study that proves the device meets those criteria in detail.
The summary states:
"Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015) the Proposed Device, iOrtho underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use."
And:
"The software has been designed, integrated, verified, and validated in accordance with IEC 62304-Medical device software – software life cycle processes."
These statements confirm that testing was performed and passed, and that it followed relevant standards and guidance. However, the document does not provide the specific acceptance criteria, the detailed results (e.g., in a table), sample sizes, ground truth establishment methods, or expert qualifications that are typically found in a clinical or performance study summary.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, as this information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence through comparison of specifications and general statements about passing validation testing, rather than presenting a detailed performance study with specific metrics and methodologies.
{0}------------------------------------------------
Image /page/0/Picture/0 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.
June 13, 2023
Shanghai EA Medical Instruments Co., Ltd. % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K223518
Trade/Device Name: iOrtho Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: May 19, 2023 Received: May 19, 2023
Dear Breanne Butler:
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.
{1}------------------------------------------------
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 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 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.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K223518
Device Name iOrtho
Indications for Use (Describe)
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual applians (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodonties, as well as to have received a dedicated training in the use of the software.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY - K223518
A summary of 510(k) substantial equivalence information for this traditional 510(k) in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Shanghai EA Medical Instruments Co., Ltd.No.1619 Huishan Avenue, Huishan Economic Development ZoneWuxi, Jiangsu ProvinceChina |
|---|---|
| Company Contact Person:Phone:Email: | Jessica Luo, Regulatory Affairs, Angel Align+86.0510.83591717(181)luoyuqing@angelalign.com |
| Submission Correspondent:Address:Phone:Email: | Breanne Butler, Regulatory Affairs Consultant1321 Upland Dr. Suite 6792 Houston, TX 77043860-810-5594bbutler@primepathmedtech.com |
| Date Prepared: | June 12, 2023 |
| Trade Name Name: | iOrtho |
| Common Name: | Orthodontic plastic bracket (Software) |
| Classification Name: | Orthodontic plastic bracket (Software) |
| Product Code: | PNN |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Predicate Device: | 3Shape A/S Ortho System (K171634) |
| Reference Device: | Wuxi EA Medical Instruments Technologies Limited Clear Aligner(K203688) |
| Reference Device: | Dentsply Sirona CEREC Ortho Software (K171122) |
Device Description:
iOrtho (hereafter referred to as "Proposed Device") includes modifications to the currently marketed software included in K203688, cleared October 8, 2021 (hereafter referred to as "Reference Device"). The Proposed Device is an orthodontic appliance design and treatment simulation software is for use by dental professionals to aid in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate 3D dental models
{4}------------------------------------------------
using standard stereolithographic (STL) files for use in 3D printers. These models can then be used as a template for thermoforming aligners or retainers by Angel Align technicians.
Indications for Use:
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. Comparison to Predicate Devices:
The Proposed Device is functionally equivalent to the following device: 3Shape A/S Ortho System (K171634, cleared Jan 17, 2018) (hereafter referred to as "Predicate Device"), and possesses minor differences to the previously cleared Reference Device to allow treating physicians include mandible repositioning and traction accessories during treatment planning and simulation. The following table demonstrates the functional specifications of the Proposed Device are substantially equivalent to the Predicate Device, minorly different to the Reference Device, and raises no new questions regarding safety and effectiveness of the device.
| Proposed Device: | Predicate Device: | Reference | Reference | ||
|---|---|---|---|---|---|
| Specification | iOrtho | 3Shape A/S OrthoSystem (K171634) | Device: WuxiEA MedicalInstrumentsTechnologiesLimited. ClearAligner(K203688) | Device:DentsplySironaCERECOrthoSoftware(K171122) | ComparisonResult |
| RegulationNumber | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR872.5470 | Same |
| ClassificationName | Orthodontic PlasticBracket (Software) | Orthodontic PlasticBracket (Software) | OrthodonticPlastic Bracket | OrthodonticPlastic Bracket(Software) | Same asPredicate |
| Product Code | PNN | PNN | NXC | PNN | Same |
| Classification | Class II | Class II | Class II | Class II | Same |
| Indication forUse | iOrtho | The 3Shape OrthoSystem™is intended for useas a medical front-enddeviceproviding tools formanagement oforthodontic | Clear Aligners areindicated for thealignment ofteeth duringorthodontictreatment ofmalocclusionin patients with | CEREC OrthoSoftware isintended foruse with imagedata acquiredfrom handheldintra oral 3Dcameras and | Similar topredicate |
| is intended for useas a medical front-end device | is intended for useas a medical front-enddevice | alignment of | intended for | ||
| providing tools formanagement oforthodontic cases. | providing tools formanagement oforthodontic | teeth during | use with image | ||
| orthodontic cases. | orthodontic | in patients with | cameras and | ||
| Specification | Proposed Device:iOrtho | Predicate Device:3Shape A/S OrthoSystem (K171634) | Reference Device: WuxiEA MedicalInstrumentsTechnologiesLimited. ClearAligner(K203688) | Reference Device:DentsplySironaCERECOrthoSoftware(K171122) | ComparisonResult |
| systematicinspection, detailedanalysis, treatmentsimulation andvirtual appliancedesign options(Export of Models,Indirect BondingTransfer Media,Sequential aligners)based on 3D modelsof the patient'sdentition before thestart of anorthodontictreatment. It canalso be appliedduring thetreatment toinspect and analyzethe progress of thetreatment. It can beused at the end ofthe treatment toevaluate if theoutcome isconsistent with theplanned/desiredtreatmentobjectives. | models, systematicinspection, detailedanalysis, treatmentsimulation andvirtual appliancedesign options(Custom MetalBands, Export ofModels, IndirectBonding TransferMedia) based on3D models of thepatient's dentitionbefore the start ofan orthodontictreatment. It canalso be appliedduring thetreatment toinspect and analyzethe progress of thetreatment. It canbe used at the endof the treatment toevaluate if theoutcome isconsistent with theplanned/desiredtreatmentobjectives. | permanentdentition (i.e. allsecond molars). | desktoplaboratoryscanners tocreate 3Dvirtual modelsto be used fordata acquisitionand modelinganalysis fororthodonticpatients andconditions. TheCEREC OrthoSoftware 3Dmodel data canbe exported toorthodonticdesign softwareto aid in thedesign oforthodonticappliances. | ||
| The use of iOrthorequires the user tohave the necessarytraining and domainknowledge in thepractice of | The use of theOrtho System™requires the userto have thenecessary trainingand domainknowledge in the | ||||
| Specification | Proposed Device:iOrtho | Predicate Device:3Shape A/S OrthoSystem (K171634) | ReferenceDevice: WuxiEA MedicalInstrumentsTechnologiesLimited. ClearAligner(K203688) | ReferenceDevice:DentsplySironaCERECOrthoSoftware(K171122) | ComparisonResult |
| orthodontics, aswell as to havereceived adedicated trainingin the use of thesoftware. | practice oforthodontics, aswell as to havereceived adedicated trainingin the use of thesoftware. | ||||
| TechnologicalFeatures | Stand Alone Software Imports Digital Dental Data Useful for as an aid in Diagnosis, and treatment planning Virtual Planning of tooth movement Patient follow-up monitoring and management Cephalometry | Stand Alone Software Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement | Produce 3D-model file of the PVS impression or digital scan. Identifies the individual teeth that will require treatment (i.e. repositioning) Creates a treatment plan (i.e. 3-D models that represent the treatment plan). The treating dental practitioner reviews these images using software and has the option to reject or request modifications | Stand Alone Software Imports Digital Patient Scans Can be used to design Dental Models | Similar toPredicate |
| Specification | Proposed Device:iOrtho | Predicate Device:3Shape A/S OrthoSystem (K171634) | ReferenceDevice: WuxiEA MedicalInstrumentsTechnologiesLimited. ClearAligner(K203688) | ReferenceDevice:DentsplySironaCERECOrthoSoftware(K171122) | ComparisonResult |
| MinimumHardware/SoftwareRequirements | • OS: Windows7 )/Mac OS 10.12• RAM: 2 GB• Video Card: Anythat supportswebGL• Hard Drive Space:50MB• Web browser(iOrtho): Chrome63+, Firefox 58+,Safari 12+, Edge79+• Internet Access | • OS: Windows 7,8, 10 64-bit• RAM: 8 GB• Video CardMemory: 1 GB• Hard DriveSpace: 250 GB• CPU: Intel Corei5 or equivalent• Mouse: withwheel button | • OS: Windows7, 10, Mac OSX• RAM: 2 GB(minimum)• Hard DriveSpace: 50 MB• Video Card:GraphicsDisplay CardsupportingwebGL• Web Browser:Chrome 9+,Firefox 4+,Safari 5.1+,Edge 5.1+,IE11+• InternetAccess | • OS:Windows 7,64-bit• RAM: 8 GB• Video CardMemory: 1GB• Hard DriveSpace: 250GB• CPU: IntelQuadCore1.6 GHzprocessor | Similar |
| Login Method | Username andpassword | Username andpassword | Username andpassword | Unknown | Same |
| SupportedAnatomic Areas | Maxilla/Mandible | Maxilla/Mandible | Maxilla/Mandible | Maxilla/Mandible | Same |
| Intended Use | |||||
| Specification | Proposed Device:iOrtho | Predicate Device:3Shape A/S OrthoSystem (K171634) | ReferenceDevice: WuxiEA MedicalInstrumentsTechnologiesLimited. ClearAligner(K203688) | ReferenceDevice:DentsplySironaCERECOrthoSoftware(K171122) | ComparisonResult |
| ManagingPatient andcase base data | Yes | Yes | Yes | Yes | Same |
| Collection ofstudy material | Yes | Yes | Yes | Yes | Same |
| Segmenting ofstudy material(Segmentinggums/bone) | Yes — auto-segmented withmanual adjustment | Yes — manualselection | Yes — manualselection | Yes — auto-segmentedwith manualadjustment | Similar |
| Alignment ofstudy material | Yes | Yes | Yes | Yes | Same |
| Measuringstudy material | Yes | Yes | Yes | Yes | Same |
| Measurementpoint selection | Automatic withmanual adjustment | Manual selection | Manual selection | Automatic withmanualadjustment | Similar |
| Analyzing studymaterial | Yes | Yes | Yes | Yes | Same |
| Treatmentsimulation | Yes | Yes | Yes | N/A | Same |
| TreatmentOptions | Up to unlimitednumber of stages | No limit on numberof stages | Up to unlimitednumber of stages | N/A | Similar |
| Virtualappliancedesign | Yes | Yes | Yes | Yes | Same |
| Surface scanfor intraoralscanner | Yes | Yes | Yes | Yes | Same |
| Surface scanfrom STL file | Yes | Yes | Yes | Yes | Same |
| Analysis and Treatment | |||||
| Arch shape | Yes | Yes | Yes | Yes | Same |
Device Comnarison Tahle
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
| Specification | Proposed Device:iOrtho | Predicate Device:3Shape A/S OrthoSystem (K171634) | ReferenceDevice: WuxiEA MedicalInstrumentsTechnologiesLimited. ClearAligner(K203688) | ReferenceDevice:DentsplySironaCERECOrthoSoftware(K171122) | ComparisonResult | |||
|---|---|---|---|---|---|---|---|---|
| Overbite/overjet | Yes | Yes | No | Yes | Same asPredicate | |||
| Occlusal map | Yes | Yes | Yes | Yes | Same | |||
| 3D treatmentsimulation | Yes | Yes | Yes | N/A | Same | |||
| OrthodonticApplianceSearch | Yes | Yes | Yes | N/A | Same | |||
| Appliancevirtualpreparation | Yes | Yes | Yes | N/A | Same | |||
| Orthodonticappliancedesign | Yes | Yes | Yes | N/A | Same | |||
| Orthodonticapplianceexport | Yes | Yes | Yes | N/A | Same | |||
| Managing Patient and Case Base Data | ||||||||
| Creating,editing, andcopying patientdata | Yes | Yes | Yes | Yes | Same | |||
| Creating,editing, andcopying casedata | Yes | Yes | Yes | Yes | Same |
Comparison of Indications for Use to the Predicate and Reference Devices:
Based on the above comparison, the indications of use of the Proposed Device is nearly identical to that of the Predicate Device and similar to the Reference Device.
Based on the similarity of indication for use, the Proposed Device can be considered substantially equivalent to the Predicate Device.
{10}------------------------------------------------
Comparison of Technological Characteristics to Predicate and Reference Devices:
Based on the above comparisons, the design, construction, and performance characteristics of the Proposed Device are similar to that of the Predicate Device, and similar to the Reference Devices. The differences identified are not substantially different in operation of the device. Thus, the Proposed Device can be considered substantially equivalent to the Predicate Device.
Summary of Performance Data and Substantial Equivalence:
Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015) the Proposed Device, iOrtho underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use.
The software has been designed, integrated, verified, and validated in accordance with IEC 62304-Medical device software – software life cycle processes.
Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation testing, the Proposed Device, iOrtho, is substantially equivalent to the legally marketed Predicate Device, 3Shape Ortho System (K171634).
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.