Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard digital radiography image processing techniques and does not mention AI, ML, or related concepts.

Therapeutic

No
The device is an imaging system designed to process x-ray images, not to treat or cure a disease or condition. Its intended use is for capturing, digitizing, and processing intraoral x-ray images.

Diagnostic

No

The device is an imaging system used to capture, digitize, and process intra-oral x-ray images. While these images can be used for diagnostic purposes, the device itself is not performing a diagnosis but rather providing the raw data for a professional to interpret. The "Summary of Performance Studies" states that it provides "diagnostic-quality images," which further supports its role as an image acquisition and processing tool, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like a scanning laser, optical system, and photo electronic system, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the DIGORA® Optime imaging system is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
DIGORA® Optime Function: The DIGORA® Optime system is described as a digital radiography system that captures, digitizes, and processes intraoral x-ray images. It works with imaging plates exposed to x-rays of the intraoral complex of the skull.
No Sample Analysis: The system does not analyze biological samples taken from the body. It processes images generated by external radiation (x-rays) interacting with the patient's anatomy.

Therefore, the DIGORA® Optime system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
SOREDEX® DIGORA® Optime system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.

Product codes

MUH

Device Description

DIGORA® Optime (DXR-60) is a digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional xray film or digital sensor. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
Further image processing, display and achieving are carried out with auxiliary software.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

intraoral complex of the skull

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist and other qualified 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)

Non-clinical Test Data:
Testing was conducted to all applicable requirements according to FDA's guidance ""Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Comparison between DIGORA® Optime (DXR-60) and the predicate device was performed with the same technical phantoms. Anthropomorphic phantom images of perianical and bitewing views were provided to demonstrate the system is capable of providing diagnostic-quality images. Anthropomorphic phantom images were deemed appropriate instead of human patient images because the primary target anatomy does not involve moving tissue or soft tissues of similar contrast.
Validations have been performed successfully to ensure the safety and effectiveness of the DIGORA® Optime (DXR-60) system.

Clinical Test Data:
Clinical testing was not deemed necessary on DIGORA® Optime (DXR-60) device.

Conclusion:
Based upon the similar technological/performance characteristics to the predicate device and the successful validation of the DIGORA Optime (K041050), the clinical performance of the DIGORA® Optime (DXR-60) is deemed to be substantially equivalent to the predicate device.

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

Not Found

Predicate Device(s)

K041050

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.

Summary

0

KB3231
Page 1 of 4.

PALODEX GROUP

510(k) Summary

Date: October 10, 2013, revised February 4, 2014

PaloDEx Group O

ww.palodexeroup.com

Street nodress Nahkelantie 160 04300 Tuusula Finland

Posta! address P.O Box 6-Fl-04301 Tuusula Fininne

Phone +358 10 270 2000

Fax +358 & 851 +048

VAT F119774137

BI code 1977413-7

Barch Nordea Sank SWIFT NDEAFIHH Account F19015963000046864

Manufacturer: PaloDEx Group Oy Nahkelantie 160 Tuusula, Finland 04300

Tel: +358 10 270 2000 Fax: +358 9 701 5263

Contact person: Mr. Terho Turkumäki, Tel +358 50 320 9113

Trade Name: DIGORA® Optime

Common Name: Imaging plate reader

Classification Name:

872.1800 Extraoral source x-ray system. Product Code MUH.

Description:

DIGORA® Optime (DXR-60) is a digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional xray film or digital sensor. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.

Further image processing, display and achieving are carried out with auxiliary software.

Indications for Use:

The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Intended Use:

SOREDEX® DIGORA® Optime system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.

1

PALODEx GROUP

·

Summary of Technological Characteristics:

DIGORA® Optime (DXR-60) is substantially equivalent in design, composition and function to the current DIGORA Optime unit (K041050).

PaloDEx Group Oy

www.palodexgroup.com

Streer address Nahkelantie 160 04300 Tuusula Fieland
Postal address P.O Box 64 FI-04301 Tuusula Finland

Ріюль +358 ID 270 2000

Fax +158 9 851 4048

VAT FII 977 4137

BI (ode 1977413-7

Bank Nordes Bank 5WIFT NDEAFIHH Aとくのいか F19015963000046864

2

PALODEX GROUP

PaloDEx Ciroup Or

.palodegroup.com

Street address Nahkelantis 160 04300 Tuusula Finland

Postal Address P.C) Box 54 FLO4301 Tuusula Furtame

Phone +358 10 270 2000

Fax +358 9 851 4048

VAT F119774137

BI code 1977413.7

Bank Nordea Bank SWIFT NDEAFIHH Account F19015963000046864

In DXR-60, representative machined aluminium components in the predicate device DXR-50 have been replaced by equivalent plastic components. This has been done as part of device evolution to support modern manufacturing techniques. The most significant components that have been modified to plastic are device chassis, plate carrier and the door. All replaced components provide equivalent functionality to the predicate device DXR-50. This functionality has undergone design verification / validation, and system testing where applicable to ensure that the material change has no impact on safety, effectiveness, and overall performance of the device including image quality and expected lifetime of the device

In DXR-60, the User interface Control Panel has been modified from DXR-50 (the predicate device) for better visual communication and usability. In addition to relocating the power and start buttons, the modifications to the User Interface control panel consist of lighted numeric LED's and other relevant symbols which depict plate positioning, device status and error codes. It has been verified and validated that this change does not affect safety or efficacy of the device.

DXR-60 has Comfort Occlusal 4C image processing ability. In DXR-60 this ability means that two size 3 plates can be stilched together to form a larger image for an occlusal view. Image plates are processes and supplied separately to the user, and also stitched together to form a single Comfort Occlusal 4C projection image. This makes this feature safe. It has been verified and validated that this feature does not affect safety or effectiveness of a device.

The results of the design verification and validation demonstrated that modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.

Non-clinical Test Data:

Testing was conducted to all applicable requirements according to FDA's guidance ""Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".

Comparison between DIGORA® Optime (DXR-60) and the predicate device was performed with the same technical phantoms. Anthropomorphic phantom images of perianical and bitewing views were provided to demonstrate the system is capable of providing diagnostic-quality images. Anthropomorphic phantom images were deemed appropriate instead of human patient images because the primary target anatomy does not involve moving tissue or soft tissues of similar contrast.

Validations have been performed successfully to ensure the safety and effectiveness of the DIGORA® Optime (DXR-60) system.

Clinical Test Data:

Clinical testing was not deemed necessary on DIGORA® Optime (DXR-60) device.

3

K133231
Page 4 of 24

PaloDEx Group

Conclusion:

PaloDEx Croup Oy

www.palodexg: oup.com

Street address Nahkelantie 160 04300 Tuusula Finland

Postal address P.C) Box 64 FI-04301 Tuusula Finl.ind

የነው። የ • 358 10 7 /D 2000

ﺮ ﺩﺭ +358 9 851 4048

VAT F119774137

BI ८००८: 1977413-7

Bank Nordea Bank SWJFT NDEAFIHH Account F19015963000046864 Based upon the similar technological/performance characteristics to the predicate device and the successful validation of the DIGORA Optime (K041050), the clinical performance of the DIGORA® Optime (DXR-60) is deemed to be substantially equivalent to the predicate device.

4

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 20, 2014

Instrumentarium Dental, PaloDEx Group Oy % Mr. Terho Turkumaki Quality & Regulatory Manager Nahkelantie 160 Tuusula. 04300 FINLAND

Re: K133231 Trade/Device Name: DIGORA® Optime Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 17, 2014 Received: February 19, 2014

Dear Mr. Turkumaki:

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 10 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 forlannual 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 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.

5

Page 2-Mr. Turkumaki

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 tollfree number (800) 638 2041 or (301) 796-7100 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/delault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Smh7)

for

Janine M. Morris j Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

6

| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | K133231 | |
| Device Name | DIGORA® Optime | |
| Indications for Use (Describe) | The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media. | |
| 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) | |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
| FOR FDA USE ONLY | | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |
| 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 | |
| | PRAStaff@fda.hhs.gov | |
| "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." | | |
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 |

FORM FDA 3881 (1/14)

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