Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes software for orthodontic treatment planning and simulation based on 3D models, but it does not mention or imply the use of AI or ML technologies. The focus is on user-driven tools and standard software validation.

Therapeutic

No
The device is described as an "orthodontic appliance design and treatment simulation software" that provides tools for "management of orthodontic cases" and aids in "diagnosis and design solutions." It does not directly provide therapy but rather assists in the planning and evaluation of orthodontic treatments.

Diagnostic

Yes

Explanation: The device description states that the software is used by dental professionals "to aid in diagnosis and design solutions for patients."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a software and describes its function as software for orthodontic appliance design and treatment simulation. It also mentions modifications to a previously cleared software device. While it facilitates the creation of physical models, the device itself is the software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that iOrtho is a "medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual applians... based on 3D models of the patient's dentition". It focuses on planning, simulation, and design for orthodontic treatment.
Device Description: The description reinforces this by stating it's "orthodontic appliance design and treatment simulation software" used by dental professionals to "aid in diagnosis and design solutions for patients".
Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens. Its input is 3D digital scans of the patient's dentition, which are not considered in vitro diagnostic specimens in the traditional sense.
Focus on Treatment Planning and Design: The core function of iOrtho is to assist dental professionals in planning and designing orthodontic treatments and appliances, not to perform diagnostic tests on biological samples.

Therefore, based on the provided text, iOrtho falls under the category of a medical device used for treatment planning and design, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

PNN

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Digital scans (3D)
Surface scan for intraoral scanner
Surface scan from STL file

Anatomical Site

Maxilla/Mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professionals

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)

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.

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.

K171634

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.

K203688, K171122

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

Regulation Number and Section

§ 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.

Summary

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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.

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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

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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)

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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 Zone
Wuxi, Jiangsu Province
China |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Consultant
1321 Upland Dr. Suite 6792 Houston, TX 77043
860-810-5594
bbutler@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 Ortho
System (K171634)	Device: Wuxi
EA Medical
Instruments
Technologies
Limited. Clear
Aligner
(K203688)	Device:
Dentsply
Sirona
CEREC
Ortho
Software
(K171122)	Comparison
Result
Regulation
Number	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470	21 CFR
872.5470	Same
Classification
Name	Orthodontic Plastic
Bracket (Software)	Orthodontic Plastic
Bracket (Software)	Orthodontic
Plastic Bracket	Orthodontic
Plastic Bracket
(Software)	Same as
Predicate
Product Code	PNN	PNN	NXC	PNN	Same
Classification	Class II	Class II	Class II	Class II	Same
Indication for
Use	iOrtho	The 3Shape Ortho
System™
is intended for use
as a medical front-end
device
providing tools for
management of
orthodontic	Clear Aligners are
indicated for the
alignment of
teeth during
orthodontic
treatment of
malocclusion
in patients with	CEREC Ortho
Software is
intended for
use with image
data acquired
from handheld
intra oral 3D
cameras and	Similar to
predicate
	is intended for use
as a medical front-
end device	is intended for use
as a medical front-end
device	alignment of	intended for
	providing tools for
management of
orthodontic cases.	providing tools for
management of
orthodontic	teeth during	use with image
	orthodontic cases.	orthodontic	in patients with	cameras and
Specification	Proposed Device:
iOrtho	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)	Comparison
Result
	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.	models, systematic
inspection, detailed
analysis, treatment
simulation and
virtual appliance
design options
(Custom Metal
Bands, Export of
Models, Indirect
Bonding Transfer
Media) 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.	permanent
dentition (i.e. all
second molars).	desktop
laboratory
scanners to
create 3D
virtual models
to be used for
data acquisition
and modeling
analysis for
orthodontic
patients and
conditions. The
CEREC Ortho
Software 3D
model data can
be exported to
orthodontic
design software
to aid in the
design of
orthodontic
appliances.
	The use of iOrtho

requires the user to
have the necessary
training and domain
knowledge in the
practice of | The use of the
Ortho System™

Device Comnarison Tahle

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6

7

8

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| Specification | Proposed Device:
iOrtho | 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) | Comparison
Result | | | |
|------------------------------------------------------|-------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------|--|--|--|
| Overbite/overj
et | Yes | Yes | No | Yes | Same as
Predicate | | | |
| Occlusal map | Yes | Yes | Yes | Yes | Same | | | |
| 3D treatment
simulation | Yes | Yes | Yes | N/A | Same | | | |
| Orthodontic
Appliance
Search | Yes | Yes | Yes | N/A | Same | | | |
| Appliance
virtual
preparation | Yes | Yes | Yes | N/A | Same | | | |
| Orthodontic
appliance
design | Yes | Yes | Yes | N/A | Same | | | |
| Orthodontic
appliance
export | Yes | Yes | Yes | N/A | Same | | | |
| | Managing Patient and Case Base Data | | | | | | | |
| Creating,
editing, and
copying patient
data | Yes | Yes | Yes | Yes | Same | | | |
| Creating,
editing, and
copying case
data | 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.

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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).