K Number

Device Name

Signature Orthodontic System

Manufacturer

Signature Orthodontics

Date Cleared

2019-01-02

(13 days)

Product Code

NJM

Regulation Number

872.5470

Intended Use

The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

Device Description

The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K181271

Reference Devices

K181271

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The software is described as a treatment planning tool used by operators and orthodontists to generate prescriptions, not as an autonomous or learning system.

Therapeutic

Yes
The device is described as an "orthodontic appliance system used to correct malocclusions," indicating it provides a direct therapeutic benefit by correcting a medical condition.

Diagnostic

The device is described as a "treatment planning software and orthodontic appliance system used to correct malocclusions." It focuses on planning and providing tools for correction, not on identifying or diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly states that the system includes both treatment planning software and physical orthodontic appliances (patient-specific ceramic brackets, placement jigs, arch wire templates). While software is a component, it is not the sole component of the medical device system.

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 is to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. This is a therapeutic and treatment-planning purpose, not a diagnostic one performed in vitro (outside the body).
Device Description: The components are treatment planning software, patient-specific ceramic brackets, bracket placement jigs, and arch wire templates. These are all tools used for orthodontic treatment and planning, not for analyzing biological samples to diagnose a condition.
Input: The input is a digital impression of teeth, which is used for planning and manufacturing the appliances, not for analyzing biological markers or substances.
Anatomical Site: The anatomical site is teeth, which are being treated, not being sampled for diagnostic analysis.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

Product codes

NJM

Device Description

The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

The change is to replace Meshmixer 3.4 as the software component of the SO System with Treatment Planning 3.1 The software component of the SO System was originally cleared in K181271. Meshmixer is Off-the-Shelf (OTS) Software, the new software has been developed by SO exclusively. The functional requirements of the software component are unchanged. A comparison of Treatment Planning 3.1 and Meshmixer 3.4 that both software provide the same features and functional workflows is evidence of substantial equivalence. The replacement software is identical in performance and function to the previously used software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Orthodontists / Dental Offices

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)

Non-clinical Performance Testing: Validation testing of the TPS was performed in accordance with SO's design control activities for software and to the software's Test Plan. Validation results show that the version of the TPS tested performed equivalent to the software component of the primary predicate (K181271).
Clinical Performance Testing: No clinical performance testing was conducted on SO System brackets.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181271

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Signature Orthodontics % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313

Re: K183542

Trade/Device Name: Signature Orthodontic System Regulation Number: 21 CFR Orthodontic Plastic Bracket Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: December 17, 2018 Received: December 20, 2018

Dear Mark Job:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

January 2, 2019

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Marv S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.02

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

Device Name Signature Orthodontic System

Indications for Use (Describe)

The Signature Orthodontic System is a treatment planning software and orthodonic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

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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TAB 6

510K SUMMARY

510(k) SUMMARY

Signature Orthodontics' Signature Orthodontic System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Signature Orthodontics 1035 Cambridge Street Cambridge, MA 02141

Phone: 540-229-1236 Facsimile: N/A Email: alfred@soiboston.com

Contact Person: Alfred Charles Griffin III

Date Prepared: November 13, 2018

Name of Device and Name/Address of Sponsor

Signature Orthodontic System

Signature Orthodontics 1035 Cambridge Street Cambridge, MA 02141

Trade/Proprietary Name of Device: Signature Orthodontic System

Common or Usual Name: Orthodontic Ceramic Bracket and Accessory

Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470

Regulatory Class: II

Product Code: NJM

Predicate Devices:

Primary Predicate: Signature Orthodontics' Signature Orthodontic System (K181271)

Device Description and Justification

Intended Use / Indications for Use

The indications for use are the same between this submission and the primary predicate K181271.

The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.

The Signature Orthodontic System (K181271) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.

Non-clinical Performance Testing

Validation testing of the TPS was performed in accordance with SO's design control activities for software and to the software's Test Plan. Validation results, Table 6-1, show that the version of the TPS tested performed equivalent to the software component of the primary predicate (K181271).

| Primary PREDICATE K181271
Signature Orthodontic System;
TPS Off-the-shelf | Signature Orthodontic System;
TPS 3.1 | Equivalence Result |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------|
| 4.1 Diagnosis - viewing patient's
digital impression | 4.1 Diagnosis - viewing patient's
digital impression | Equivalent (Test
Report) |
| 4.1 Diagnosis - successful diagnosis
of patient's malocclusion | 4.1 Diagnosis - successful diagnosis
of patient's malocclusion | Equivalent (Test
Report) |

| 4.4 Data Handling - case data
delivered securely and un-corrupted | 4.4 Data Handling - case data
delivered securely and un-corrupted | Equivalent (Test
Report) |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------|
| 4.1 Diagnosis - viewing and
measuring patient's digital impression | 4.1 Diagnosis - viewing and
measuring patient's digital impression | Equivalent (Test
Report) |

Clinical Performance Testing

No clinical performance testing was conducted on SO System brackets.

Device Comparison Tables

The following tables, Tables 6-2 and 6-3, provide a comparison of the device features, functions, and performance characteristics between the Signature Orthodontic System and its predicate devices.

Table 6-2 - SO System TPS Feature Comparison
Workflow
Function	SO System TPS -
Off-the-shelf	SO System TPS -
TPS 3.1	Similarities	Differences
4.1 Diagnosis -
viewing patient's
digital
impression	Rendering of
impression using
triangle meshes
read from STL
files	Rendering of
impression using
triangle meshes
read from STL
files	Identical
4.1 Diagnosis -
successful
diagnosis of
patient's
malocclusion	Hide/show
individual arches	Hide/show
individual arches	Identical	TPS 3.1 enables
hide/show arches
with a single
click. OTS
requires multiple
clicks.
4.4 Data
Handling - case
data delivered
securely and un-
corrupted	Secure link used
to download STL
files, then File ->
Open in device.	Open secure link
in web browser.	Secure link
communicated
using the
orthodontist's
confirmed e-
mail addresses
Impression data
transmitted over
HTTPs	TPS 3.1 removes
the download
STL files step
and integrates
the transfer with
the loading of the
software by the
user's web
browser.
4.1 Diagnosis -
viewing and
measuring
patient's digital
impression	Rotate impression
display	Rotate impression
display	Identical
	Pan impression
display	Pan impression
display	Identical
	Zoom impression
display	Zoom impression
display	Identical

--	-------------------------------	-----	---------------------------------------------------------------------------------------------------------

Table 6-3 - Device Comparison
ITEM	Primary PREDICATE K181271
Signature Orthodontic
System; TPS Off-the-shelf	Signature Orthodontic
System; TPS 3.1	Comments
Description	The Signature Orthodontic
System (SO System) is a
treatment planning software
(TPS) and orthodontic
appliance system used to
correct malocclusions in
orthodontic patients using
patient-matched orthodontic
appliances. The SO System
consists of patient-specific
ceramic brackets, patient-
specific bracket placement jigs,
arch wire templates, and a TPS
for viewing, measuring, and
modifying cases. Signature
Orthodontics' (SO) operators
and the orthodontists use the
TPS to generate a prescription
of their choosing. SO then
manufactures the patient-
specific brackets and
placement jigs using proprietary
additive manufacturing
techniques. The orthodontist
then bonds the brackets to the
teeth using the optional
placement jig and ligates wires
to enable tooth movement. The
SO System does not contain
commercially-available or
patient-specific shaped arch
wires, ligatures, or adhesives
that affixes the brackets to the
teeth.	The Signature Orthodontic
System (SO System) is a
treatment planning software
(TPS) and orthodontic
appliance system used to
correct malocclusions in
orthodontic patients using
patient-matched orthodontic
appliances. The SO System
consists of patient-specific
ceramic brackets, patient-
specific bracket placement
jigs, arch wire templates, and
a TPS for viewing,
measuring, and modifying
cases. Signature
Orthodontics' (SO) operators
and the orthodontists use the
TPS to generate a
prescription of their choosing.
SO then manufactures the
patient-specific brackets and
placement jigs using
proprietary additive
manufacturing techniques.
The orthodontist then bonds
the brackets to the teeth
using the optional placement
jig and ligates wires to enable
tooth movement. The SO
System does not contain
commercially-available or
patient-specific shaped arch
wires, ligatures, or adhesives
that affixes the brackets to
the teeth.	Identical
Product Codes/
Regulations	NJM (Orthodontic Ceramic
Bracket, 21CFR§872.5470)	NJM (Orthodontic Ceramic
Bracket, 21CFR§872.5470)	Identical
Indications for
Use	The Signature Orthodontic
System is a treatment planning
software and orthodontic
appliance system used to
correct malocclusions in
orthodontic patients using
patient-matched orthodontic
appliances.	The Signature Orthodontic
System is a treatment
planning software and
orthodontic appliance system
used to correct malocclusions
in orthodontic patients using
patient-matched orthodontic
appliances.	Identical
Sequence of
Treatment Plan
or Mode of Use	Signature Orthodontics (SO)
receives the patient's digital
data via commercially available
communications tools from the
DDS/DMD. SO prepares a final
tooth setup and bracket
placement plan and returns the
digital data back to the
DDS/DMD. The orthodontist
can then view, measure and
modify the case using the TPS.
Once approved, brackets and
jigs are manufactured and
shipped to the DDS/DMD.	Signature Orthodontics (SO)
receives the patient's digital
data via commercially
available communications
tools from the DDS/DMD. SO
prepares a final tooth setup
and bracket placement plan
and returns the digital data
back to the DDS/DMD. The
orthodontist can then view,
measure and modify the case
using the TPS. Once
approved, brackets and jigs
are manufactured and
shipped to the DDS/DMD.	Identical
Manufacturing
Method	Final desired arrangement of
teeth, brackets, wires and jigs
are designed with the guidance
of SO internal computer
software using a 3-D model of
the patient. The Treatment
Planning Software allows the
clinician to review, measure,
and modify the case. Internal
SO software generates the 3D
image file that proprietary
additive manufacturing
equipment uses to create the
brackets and indirect bonding
(IDB) tray.	Final desired arrangement of
teeth, brackets, wires and jigs
are designed with the
guidance of SO internal
computer software using a 3-
D model of the patient. The
Treatment Planning Software
allows the clinician to review,
measure, and modify the
case. Internal SO software
generates the 3D image file
that proprietary additive
manufacturing equipment
uses to create the brackets
and indirect bonding (IDB)
tray.	Identical

Conclusion

The Signature Orthodontics' Signature Orthodontic System presented in this 510(k) submission and its predicate the Signature Orthodontic System (K181271) are substantially equivalent in materials, performance and safety characteristics.