Ortho System

K163677 · 3Shape A/S · PNN · Apr 20, 2017 · Dental

Device Facts

• Record ID: K163677
• Device Name: Ortho System
• Applicant: 3Shape A/S
• Product Code: PNN · Dental
• Decision Date: Apr 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

3Shape Ortho System™ for dental retainers is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ 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.

Device Story

3Shape Ortho System™ is a software-only medical device used by dental professionals in clinical settings for orthodontic treatment planning. It ingests 3D scanned dental models (STL), CT image data (DICOM), and 2D images (JPG, BMP, PNG). The software provides tools for managing patient case data, performing 2D/3D measurements, analyzing dentition (e.g., arch shape, Bolton analysis, space analysis), simulating tooth movements, and designing orthodontic appliances, including dental retainers. The clinician uses the software interface to visualize models and plan treatments; the output is a digital design file for appliance fabrication. By enabling virtual treatment simulation and precise appliance design, the device assists clinicians in orthodontic diagnosis and planning, potentially improving treatment outcomes and efficiency.

Clinical Evidence

No clinical data. Bench testing only. Software, hardware, and integration verification and validation were performed per FDA guidance. Validation included testing of implemented mitigations for identified device hazards.

Technological Characteristics

Software-only device programmed in Delphi. Operates on Windows 7/8 64-bit PCs with minimum 8GB RAM, 1GB video memory, and Intel Core i5 or equivalent. Supports DICOM, STL, JPG, BMP, PNG formats. No patient contact. Connectivity via network/internet. No specific sterilization required as it is non-contact software.

Indications for Use

Indicated for dental professionals to manage orthodontic models, perform inspection, analysis, treatment simulation, and virtual appliance design for patients requiring orthodontic treatment, including dental retainers.

Regulatory Classification

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.

Predicate Devices

• Ortho System (K152086)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2017

3Shape A/S Hanne Nielsen Regulatory Affairs Manager Holmens Kanal 7 Copenhagen, 1060 DENMARK

Re: K163677

Trade/Device Name: 3Shape Ortho System™ Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN Dated: March 9, 2017 Received: March 13, 2017

Dear Hanne Nielsen:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{1}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration,

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163677

Device Name 3Shape Ortho System™

#### Indications for Use (Describe)

3Shape Ortho System™ for dental retainers is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design based on 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of the Ortho System™ 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.

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)

#### 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 [e-mail]

"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 - Traditional 510(K)

#### Submitter Information

| A | Company Name: | 3Shape A/S |
|-----------------------|--------------------------------|---------------------------------------------|
| B | Company Address: | Holmens Kanal 7<br>DK-1060 Copenhagen K |
| C | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D | Contact Person: | Hanne Nielsen<br>Regulatory Affairs Manager |
| E | Date Summary Prepared: | March 6, 2017 |
| Device Identification | | |
| A | Trade/proprietary Name: | 3Shape Ortho System™ |
| B | Common Name: | Dental Retainers |
| C | Device Classification Name: | Orthodontic Plastic Bracket |
| C | Regulation Number: | 872.5470 |

#### D Product Code: PNN (Orthodontic Software)

# Predicate Device

The 3Shape Ortho System™ intended for dental retainers has the same intended use and technical characteristics as the predicate Ortho System (K152086) from 3Shape A/S as listed in "Volume 005, Comparison to Predicate Devices, Table 1: Predicates".

Based on the information and supporting documentation provided, the 3Shape Ortho System™ and the predicate (K152086) have same intended use. Both software devices are used by Dental Professionals in orthodontic treatment planning (before, durinq, after treatment) covering management of patients and models, inspection, 2D and 3D measurement and orthodontic analysis of models, 2D & 3D treatment simulation, as well as virtual appliance preparation, handling and export, and they are both providing device output. Therefore, the 3Shape Ortho System™ and the predicate (K152086) are found to be similar in their intended use, supported anatomic areas and the majority of the available features and functionalities.

{4}------------------------------------------------

### Indications for Use

3Shape Ortho System™ for dental retainers is intended for use as a medical frontend device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design based on 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of the Ortho System™ 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.

#### Device Description

3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzinq, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models. Output includes Dental Retainers. All devices are to be fabricated from FDA cleared or listed materials currently available in the software.

The device has no patient contact.

# Scientific Concept

The underlying scientific concept of the 3Shape Ortho System™ is to apply digital imaging tools for in orthodontic case archiving, diagnosis, treatment planning and CAD design of customized appliances.

The system supports the following types of digital data: DICOM, STL, JPG, BMP, PNG.

#### Summary of the technological characteristics

3Shape Ortho System™ is a software only device programmed in Delphi and has the following PC/laptop hardware requirements:

| Item | Minimum Requirements |
|----------------------|-----------------------------|
| OS: | Windows 7 or 8 64-bit |
| RAM: | 8 GB |
| Monitor Resolution: | 1280x800 or similar |
| Video Card Memory: | 1 GB GeForce |
| Available HDD Space: | 250 GB |
| CPU: | IntelCore i5 or equivalent |
| Network: | Network Internet connection |
| Mouse: | With the wheel button |

{5}------------------------------------------------

# The 3Shape Ortho System™ Software has the same intended uses and technical
characteristics as Ortho System™ (K152086) from 3Shape A/S:

| Feature name | 3Shape<br>Ortho System™<br>K163677 | 3Shape<br>Ortho System™<br>K152086 |
|------------------------------------------------------|------------------------------------|------------------------------------|
| Supported anatomic areas | Maxilla | Maxilla |
| | Mandible | Mandible |
| Intended use | | |
| Managing patient and case base data | Yes | Yes |
| Collection of study material | Yes | Yes |
| Alignment of study material | Yes | Yes |
| Measuring study material | Yes | Yes |
| Analyzing study material | Yes | Yes |
| Treatment simulation | Yes | Yes |
| Virtual appliance design | Yes | Yes |
| Supported PC formats | Windows | Windows |
| Managing patient and case base data | | |
| Creating, editing, deleting and copying patient data | Yes | Yes |
| Creating, editing, deleting and copying case data | Yes | Yes |
| Collection of study material | | |
| Surface scan for intra-oral scanner | Yes | Yes |
| Surface scan from STL file | Yes | Yes |
| CT image data | DICOM | DICOM |
| 2D overlay | PNG, JPG, BMP | PNG, JPG, BMP |
| Feature name | 3Shape<br>Ortho System™<br>K163677 | 3Shape<br>Ortho System™<br>K152086 |
| Alignment of study material | | |
| Aligning surface scan and CT image | Yes | Yes |
| Aligning cephalometric images | Yes | Yes |
| Alignment of 2D overlays (e.g. ideal arch) | Yes | Yes |
| Ability to check/adjust DICOM visibility | Yes | Yes |
| DICOM scan segmentation | No | No |
| Measuring study material | | |
| 2D measurement toolbox | Yes | Yes |
| 3D measurement toolbox | Yes | Yes |
| Analyzing study material | | |
| Arch shape | Yes | Yes |
| Wire length | Yes | Yes |
| Tooth width | Yes | Yes |
| Bolton | Yes | Yes |
| Space analysis | Yes | Yes |
| Overjet/overbite | Yes | Yes |
| Occlusion map | Yes | Yes |
| Treatment simulation | | |
| 2D & 3D simulation | Yes | Yes |
| Virtual appliance design | | |
| Orthodontic appliance search | Yes | Yes |
| Orthodontic appliance virtual preparation | Yes | Yes |
| Orthodontic appliance design | Yes | Yes |
| Orthodontic appliance export | Yes | Yes |
| Output | | |
| Custom Metal Bands | Yes | Yes |
| Export Models | Yes | Yes |
| Directly Printed Transfer Tray | Yes | Yes |
| Vacuum Pressed Transfer Media | Yes | Yes |
| Dental Retainers | Yes | No |

sshapel

{6}------------------------------------------------

# 3SHAPE ORTHO SYSTEM™ SOFTWARE 510(K) SUBMISSION

sshap

AD

{7}------------------------------------------------

#### 3SHAPE ORTHO SYSTEM™ SOFTWARE 510(K) SUBMISSION

### Nonclinical Testing

Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).

The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.

All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the predicates.

### Clinical Testing

Clinical testing is not a requirement and has not been performed.

#### Conclusion

Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the 3Shape Ortho System™ is found to be as safe and effective as the predicate device. Intended use and performance is found to be substantially equivalent to the Predicate Device.