Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI or ML, and the device description focuses on physical aligners and proprietary 3D software without specifying AI/ML capabilities.

Therapeutic

Yes
The device is described as an orthodontic appliance that moves teeth to a target position to deliver a desired clinical effect, which fits the definition of a therapeutic device.

Diagnostic

No

Explanation: The Clear Aligner System is designed for the alignment of teeth during orthodontic treatment, which is a therapeutic purpose, not a diagnostic one. While it uses an intraoral scan, this input is for creating the treatment plan and fabricating the aligners, not for diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of both software and physical aligners made of plastic materials. The performance studies also include testing of the physical aligners and accessories.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Clear Aligner System is a physical device used to mechanically move teeth for orthodontic treatment. It is applied directly to the patient's teeth and does not involve testing samples taken from the body.
Intended Use: The intended use is for "alignment of teeth during orthodontic treatment of malocclusion," which is a mechanical and physical process, not a diagnostic test.
Device Description: The description focuses on the physical components (aligners, software, traction accessory) and how they apply force to the teeth.
Performance Studies: The performance studies focus on biocompatibility, software validation, risk analysis, and mechanical strength, which are relevant to a physical medical device, not an IVD.

Therefore, the Clear Aligner System falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

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

NXC

Device Description

The Proposed Device is an update device to the previous cleared Angel Align System (K171674) including added optional traction accessory.

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity

Indicated Patient Age Range

patients with permanent dentition (i.e. all second molars)

Intended User / Care Setting

Prescription Use

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)

Real-world data was submitted to demonstrate that the traction accessory was effective to aid the movement of teeth and that an analysis of adverse events was provided that showed less than 0.001 % of adverse events were occurred since 2019.

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.

K171674

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.

K181739

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

October 8, 2021

Wuxi EA Medical Instruments Technologies Limited. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K203688

Trade/Device Name: Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 28, 2021 Received: September 08, 2021

Dear Ivy Wang:

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, 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203688

Device Name Clear Aligner

Indications for Use (Describe)

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Wuxi EA Medical Instruments Technologies Limited.

No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

510(K) Summary

K203688

Summary prepared date: 2021-10-06

A. Applicant:

Wuxi EA Medical Instruments Technologies Limited. Address: No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China Contact Person: Ms. Yan He Tel: +86 0510-83591717

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Clear Aligner Common Name: Sequential Aligners Regulatory Information Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental

C. Predicate device:

K171674 Angel Align System Smile Development Corp.

Reference device K181739 Invisalign System with Mandibular Advancement Feature

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Align Technology, Inc.

D. Indications for use of the device:

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

E. Device Description:

The Proposed Device is an update device to the previous cleared Angel Align System (K171674) including added optional traction accessory.

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

F. Comparison to predicate device

The Clear Aligner is substantially equivalent in intended use, indications for use, mode of action, mode of use, design to the predicate Smile Angel Align (K171674). Only minor differences exist between the subject product and the predicate, which do not affect the safety or effectiveness of the subject device.

Table 1 provides a comparison of the subject and predicate device.

Table 1: Comparison to Predicate Device

Device	Subject Device	Predicate Device	Reference Device	Result
Manufacturer	Wuxi EA Medical
Instruments
Technologies Limited.	Smile Development
Corp.	Align Technology,
Inc.	-
510K number	K203688	K171674	K181739	-
Model Name	Clear Aligner	Angel Align System	Invisalign System
with Mandibular
Advancement
Feature	-
Classification	Class II Device, NXC
(21 CFR 872.5470)	Class II Device, NXC
(21 CFR 872.5470)	Class II Device, NXC
(21 CFR 872.5470)	Same
Classification Name	Aligner, Sequential	Aligner, Sequential	Aligner, Sequential	Same
Indications for use	Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).	Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.	The Invisalign System is intended for the orthodontic treatment of malocclusion	Same
Mode of Action	Orthodontic tooth movement occurs through forces applied by the device to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Orthodontic tooth movement occurs through forces applied by the device to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Orthodontic tooth movement occurs through forces applied by the device to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Same
Anatomical Site of Use	Oral cavity	Oral cavity	Oral cavity	Same
Mode of Use	Each aligner is worn by the patient as determined by the treating dental practitioner, generally for 2 weeks prior to being replaced by the next aligner in sequence.	Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence.	Aligners are worn for approximately 1-2 weeks of 20-22 hours of wear per day, after which it is replaced by the next stage aligners. This is repeated for duration as prescribed by the Dental Practitioner	Same
Description of Appliance Application	Removable	Removable	Removable	Same
Method of manufacturing	Thermoforming	Thermoforming	Thermoforming	Same
Manufacturing Method	A digital model of the patient's teeth is created from either	A digital model of the patient's teeth is created from either	A digital model of the patient's teeth is created from	Same

	impression or directly
from an intraoral scan
of the patient's teeth.
From the digital
model, following a
dental practitioner's
prescription, the
software generates
model transforms
describing the
provisional final,
treated state and
then interpolates a
series of model
transforms that
represent
intermediate states of
alignment.
The resulting
computer "setups"
relay this information
to rapid prototyping
machines that
produce physical
positive models. The
aligners are produced
by thermoforming on
each physical model
to fabricate the
sequence of aligners.	impression
or
directly from an
intraoral scan of the
patient's teeth.
From the digital
model, following a
dental practitioner's
prescription,
software generates
model transforms
describing the
provisional final,
treated state and
then interpolates a
series of model
transforms that
represent
intermediate states
of alignment.
The resulting
computer "setups"
relay this
information to rapid
prototyping
machines that
produce physical
positive models. The
aligners are
produced
by
thermoforming on
each physical model
to
fabricate
the
sequence
of
aligners.	a PVS impression
or directly from an
intraoral scan of
the patient's teeth.
From the digital
model, following a
dental
practitioner's
prescription, the
software generates
model transforms
describing the
provisional final,
treated state and
then interpolates a
series of model
transforms that
represent
intermediate states
of alignment.
The
computer "setups"
relay
this
information
to
rapid prototyping
machines that
produce physical
positive models.
The aligners
are
produced
by
thermoforming on
each
physical
model to fabricate
the sequence of
aligners.
Material	The clear aligner uses
either

Multilayer
thermoformed
copolyester
and
polyurethane
composite
or
Thermoformed | Thermoformed
polyurethane | The Invisalign
System uses either:
Multilayer
aromatic
thermoplastic
polyurethane
/copolyester.
or
thermoformed | Same with
the
reference
device. |
| | polyurethane | | polyurethane | |
| Traction
accessory | Yes
Thermoformed
polyurethane | No | No | Different.
Same
material as
aligner, no
new
concerns
raised. |
| OTC or Rx | Rx | Rx | Rx | Same |
| Sterile | No | No | No | Same |
| Biocompatibility | In compliance with
ISO 10993 | In compliance with
ISO 10993 | In compliance with
ISO 10993 | Similar.
Both are in
compliance
with
ISO
10993 |

5

Wuxi EA Medical Instruments Technologies Limited. No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

6

7

No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

G. Non-clinical Test

1) Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The testing included the following tests:

Cytotoxicity
Irritation
Sensitization
Acute Toxicity
Subchronic toxicity
Genetic Toxicity

The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.

2) Software validation & risk analysis

The software system used in the process of clear aligner manufacturing has been verified and validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".

A Risk Analysis was performed according to ISO 14971:2019 and documentation was included in the 510(k) to assess the performance and safety of subject device.

3) Performance Testing

Verification and validation testing were conducted to demonstrate the Clear Aligner showed conformity with pre-established specifications and acceptance criteria. The shear and tensile strength testing performed for the Angel button were tested according to EA internal specifications and the

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results passed the pre-defined acceptance criteria.

A 3-year shelf life accelerated aging testing were conducted and the test results showed conformity with the pre-established specifications and acceptance criteria.

H. Clinical Test Conclusion

Real-world data was submitted to demonstrate that the traction accessory was effective to aid the movement of teeth and that an analysis of adverse events was provided that showed less than 0.001 % of adverse events were occurred since 2019.

l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K171674.