LYTHOS DIGITAL IMPRESSION SYSTEM

K141611 · Ormco Corp. · NOF · Dec 5, 2014 · Dental

Device Facts

• Record ID: K141611
• Device Name: LYTHOS DIGITAL IMPRESSION SYSTEM
• Applicant: Ormco Corp.
• Product Code: NOF · Dental
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3661
• Device Class: Class 2

Intended Use

The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

Device Story

Lythos Digital Impression System is a point-of-care turnkey imaging system for dental professionals. Hardware includes a handheld wand with a video camera and a base unit with a PC and touch screen. Operator moves wand over teeth; video camera captures images; software algorithms process images into real-time 3D digital impressions. Output is a 3D digital data file (.stl) stored locally and transmitted via wireless network to a data cloud. Data is accessed by licensed dental professionals for transfer to third-party manufacturers for CAD/CAM or 3D printing of orthodontic and restorative appliances. Device does not perform design, diagnosis, or treatment planning. Benefits include accurate, high-resolution digital impressions replacing traditional physical impressions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including accuracy testing, sterilization validation (ANSI/AAMI ST 79:2010), electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2), and usability engineering (IEC 62366).

Technological Characteristics

Optical impression system using interferometry measurement of video camera images. Light source: 405 nm blue-violet laser diode. Components: handheld wand, PC base unit (120 GB SSD, 16 GB RAM), touch screen. Connectivity: wireless network for cloud data transfer. Sterilization: steam sterilization for reusable wand tips per ANSI/AAMI ST 79:2010. Software: PC-based for image acquisition, processing, and storage. Biocompatibility per ISO 10993-1:2009.

Indications for Use

Indicated for dental professionals to record topographical characteristics of teeth, gingiva, palate, or stone models for the production of orthodontic and restorative dental appliances, including orthodontic aligners.

Regulatory Classification

Identification

An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.

Special Controls

*Classification.* Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).

Predicate Devices

• Digital Impression System (K122065)

Submission Summary (Full Text)

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

December 5,2014

Ormco Corporation C/O Ms. Courtney Clark Regulatory Affairs Manager, Submissions Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K141611

Trade/Device Name: Lythos Digital Impression System Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: November 4, 2014 Received: November 6, 2014

## Dear Ms. Clark:

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, 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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Page 2 - Ms. Clark

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141611

Device Name Lythos Digital Impression System

### Indications for Use (Describe)

The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

Type of Use (Select one or both, as applicable)

| <div style="display:flex; align-items:center;"><input checked="true" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
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| <div style="display:flex; align-items:center;"><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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## SECTION 5. 510(k) SUMMARY

Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, cursive font, with a swooping line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font.

## Lythos Digital Impression System

- 1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

| Contact Person: | Courtney Clark |
|-------------------|----------------|
| Telephone Number: | 714-516-7426 |
| Fax Number: | 714-516-7472 |

Date Prepared: 3 December 2014

- 2. Device Name:
- Proprietary Name: Lythos Digital Impression System ●
- Classification Name: System, Optical Impression, Computer Assisted Design ● and Manufacturing (CAD/CAM) of Dental Restorations
- Regulation Description: Optical Impression Systems for CAD/CAM ●
- CFR Number: 872.3661 .
- Device Class: II .
- . Product Code: NOF

#### 3. Predicate Device:

The Lythos Digital Impression System is substantially equivalent to the legally marketed device Digital Impression System K122065 cleared on February 8, 2013, product code NOF.

#### 4. Description of Device:

The Lythos Digital Impression System (DIS) is an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva, and/or palate or stone models. The Lythos DIS is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

The Lythos DIS is a point-of-care turnkey imaging system used in the dental industry; the intra-oral wand hardware and personal computer (PC) based software form an integrated system that produces accurate, high resolution three dimensional (3D) digital images. The

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end result of an intra-oral patient scan is a 3D digital impression data file that accurately describes the surfaces of teeth, gingiva, and palate within a patient's oral cavity, or the surfaces of a stone model.

The system consists of a handheld wand connected to a computer which is housed in a base unit. The computer contains proprietary software to acquire, process, and store the digital 3D image data. Patient information is entered into the software using a touch screen monitor connected to the computer. To capture a 3D image of the patient's dental arch and/or bite, the operator moves the wand along the surface of the teeth to be scanned. A video camera inside the wand captures images of the teeth surfaces. Algorithms in the software process these images into a 3D image and display the 3D image on the computer monitor in real time. The software also saves the 3D image data and identifying patient information to be used by orthodontic or restorative appliance manufacturers to design and manufacture customized appliances. The Lythos DIS device is also equipped with wireless network capability for secure transfer of the 3D image data to the orthodontic or restorative appliance manufacturer.

The Lythos DIS is only used to gather the topography of the mouth and teeth, and to upload the data file (.stl) to the data cloud. The data is available to the licensed dental professional to send to a third party manufacturer. The Lythos DIS .stl data file is used in conjunction with CAD/CAM or 3D printing manufacturing processes. The proposed Lythos DIS is not used for the design, diagnosis or treatment planning of orthodontic aligners.

- న్. Statement of Intended Use:
The Lythos Digital Impression System in an optical impression system intended for use by dental professionals to record the topographical characteristics of teeth, gingiva. and/or palate or stone models. The Lythos Digital Impression System is intended for use in conjunction with the production of orthodontic and restorative dental appliances, including orthodontic aligners.

#### 6. Description of Safety and Substantial Equivalence: Technological Characteristics

The technological characteristics of the proposed Lythos DIS are very similar to the predicate device, Digital Impression System (K122065). The indications for use have been expanded to include restoratives and orthodontic aligners. There are no substantial technical or functional differences between the Lythos DIS and the predicate (K122065) device. See Table 1 below for technological characteristics and comparisons of the CAD/CAM devices.

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| Element | Digital Impression System<br>K122065 | Lythos Digital Impression<br>System |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Digital Impression System for<br>Orthodontic Use is an optical<br>impression system intended for use by<br>dental professionals to record the<br>topographical characteristics of teeth,<br>gingiva, and/or palate. The Digital<br>Impression System is intended for use<br>in conjunction with the production of<br>orthodontic appliances. | The Lythos Digital<br>Impression System is an<br>optical impression system<br>intended for use by dental<br>professionals to record the<br>topographical characteristics<br>of teeth, gingiva, and/or palate<br>or stone models. The Lythos<br>Digital Impression System is<br>intended for use in<br>conjunction with the<br>production of orthodontic and<br><b>restorative dental<br/>appliances, including<br/>orthodontic aligners.</b> |
| Target users | Dental Professionals trained in<br>orthodontics | Dental Professionals |
| Anatomical Sites | Upper and lower arches of teeth, left<br>and right bite | Upper and lower arches of<br>teeth, left and right bite |
| Technique to produce<br>3D images | Interferometry measurement of video<br>camera images | Interferometry measurement<br>of video camera images |
| Light used for<br>illumination | Blue-violet (405 nm) | Blue-violet (405 nm) |
| Light source | Diode (laser) | Diode (laser) |
| Tooth coating | No tooth coating required | Optional tooth coating |
| Components | Handheld scanning wand containing a<br>high accuracy video camera | Handheld scanning wand<br>containing a high accuracy<br>video camera |
| Components | Computer mounted in housing that can<br>be moved from room to room | Computer mounted in housing<br>that can be moved from room<br>to room |
| Components | Cable connecting wand with computer | Cable connecting wand with<br>computer |
| Components | Touch screen monitor | Touch screen monitor |
| Key characteristics | Handheld wand is moved over the<br>teeth to acquire 3D images | Handheld wand is moved over<br>the teeth to acquire 3D images |
| Key characteristics | Real-time display of 3D images while<br>patient is being scanned | Real-time display of 3D<br>images while patient is being<br>scanned |
| Device Output | Output is a software file that can be<br>used as input to CAD/CAM dental | Output is a software file that<br>can be used as input to |
| Element | Digital Impression System<br>K122065 | Lythos Digital Impression<br>System |
| | processes | CAD/CAM dental processes |
| Storage Temperature | Storage Temp = -10C - +50C | Storage Temp = -10C - +50C |
| Operating<br>Temperature and<br>Humidity | Operating Temp = +10C - +35C,<br>Operating Humidity = 30-85% non-<br>condensing | Operating Temp = +10C - +35C, Operating Humidity =<br>30-85% non-condensing |
| Patient contact areas;<br>cross-contamination<br>control | Wand tip is single use and disposable | Wand tip is single use and<br>disposable |
| Operator contact<br>areas - cross-<br>contamination control | Surfaces disinfected using CaviCide | Surfaces disinfected using<br>CaviCide |
| Checks of software<br>and hardware<br>function | Scan of verification target | Scan of verification target |
| Biocompatibility<br>testing of patient<br>contact areas | Passed based on ISO 10993-1:2009<br>Biological evaluation of medical<br>devices - Part 1 Evaluation and testing<br>within a risk management process | Has not changed since<br>predicate (K122065) |
| Sterilization | Validated parameters for wrapped per<br>ANSI/AAMI ST 79:2010<br>Comprehensive guide to steam<br>sterilization and sterility assurance in<br>health care facilities | Validated parameters for<br>wrapped per<br>ANSI/AAMI ST 79:2010<br>Comprehensive guide to<br>steam<br>sterilization and sterility<br>assurance in<br>health care facilities |
| Safety Testing | IEC 60601-1, IEC 60601-1-2, IEC<br>62366 | IEC 60601-1, IEC 60601-1-2,<br>IEC 62366 |
| Internal temperature | Upper temp 85 | Upper temp 60 |
| Drives | 500 GB HD - disk based drive | 120 GB SSD - solid state<br>drive |
| Memory | 8GB Ram | 16 GB Ram |

# Table 1: Comparison of Proposed and Predicate Devices

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## Non-Clinical Performance Data

The sterilization of the reusable tip assembly for the Lythos Digital Impression System has been validated using the following standards

- AAMI TIR 12: 2010 Designing, Testing and Labeling Reusable Medical Devices for ● Reprocessing in Health Care Facilities: A Guide for Manufacturers
- ANSI/AAMI ST 79:2010 Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
- AAMI TIR 39: 2009 Guidance on selecting microbial challenge and inoculation sites for . sterilization validation of medical devices

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- ISO 17665-1:2006 Sterilization of health care products Moist Heat Part 1: . Requirements for the development, validation and routine control of a sterilization process for medical devices
Electromagnetic compatibility testing was performed in accordance with:

- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2: 2004 Medical electrical equipment -- Part 1-2: General requirements for
- basic safety and essential performance - Electromagnetic compatibility
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices
- . IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Additional testing was performed as recommended by the following guidance documents:

- FDA guidance for Optical Impression Systems for Computer Assisted Design and . Manufacturing (CAD/CAM) of Dental Restorations
- . FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- FDA guidance for Off-The-Shelf Software Use in Medical Devices (September 9, 1999)
- . FDA draft guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical devices (June 14, 2013)
- . ISTA Procedure 2A: Partial Simulation Performance Tests, shipping validation testing was performed.
- Internal specification and testing for Aligner Accuracy
- . Internal specification and testing for Lythos Accuracy
- Internal specification and testing to verify use of Surface Enhancement Products

Accuracy testing was performed per internal methods to demonstrate substantial equivalence between the proposed Lythos DIS and the predicate (K122065). The results of the non-clinical performance testing conclude that the Lythos DIS is safe and effective for its intended use.

## Clinical Performance Data

No human clinical data has been provided to support substantial equivalence.

## Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of the Lythos Digital Impression System with the legally marketed predicate Digital Impression System (K122065) support substantial equivalence.