PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K141700 · Genoray Co., Ltd. · MUH · Oct 31, 2014 · Dental

Device Facts

• Record ID: K141700
• Device Name: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
• Applicant: Genoray Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PAPAYA Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And this system can be equipped CUST (Tomographic) option, which is capable of taking cross-sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted teeth.

Device Story

Digital extraoral X-ray system; produces panoramic, cephalometric, and cross-sectional (CUST) images of oral/craniofacial anatomy. Input: ionizing radiation exposure to digital image receptor. Transformation: CUST option reconstructs tomographic images from pre-acquired projection radiographic images. Output: digital radiographic images for dental/skull diagnosis. Used in dental clinics; operated by trained dental professionals. Healthcare providers use images for treatment planning, implant positioning, and identifying impacted teeth. Benefits: provides dimensional anatomical information for precise clinical decision-making.

Clinical Evidence

Bench testing and clinical evaluation. Bench testing included electrical/mechanical safety (IEC 60601 series), EMC (IEC 60601-1-2), and imaging performance (MTF, DQE, dynamic range) per FDA guidance for solid-state X-ray devices. Clinical evaluation involved a licensed dentist reviewing panoramic, cephalometric, and CUST images to confirm diagnostic quality. No specific sensitivity/specificity metrics provided; qualitative assessment deemed images sufficient for diagnosis.

Technological Characteristics

Extraoral X-ray system; CdTe sensor; 60-90 kV tube voltage; 4-12 mA tube current; 0.5 mm focal spot. Connectivity: DICOM (NEMA PS 3.1-3.18) compliant. Standards: IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 61223-3-4, 60601-1-2; 21 CFR 1020.30/31. CUST mode uses tomographic reconstruction.

Indications for Use

Indicated for dental and skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull in adult and pediatric patients, including dental implant planning and localization of impacted teeth.

Regulatory Classification

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.

Predicate Devices

• PAPAYA Plus (K130419)
• Volumetric Tomography (K063773)
• Orthopantomograph OP 200 (K046312)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a bird. The emblem is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the emblem.

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

October 31, 2014

GENORAY Co., Ltd. % Ms. Kaitlynn Min Business Development Manager GENORAY America, Inc. 3002 Dow Avenue, Suite 420 TUSTIN CA 92780

Re: K141700

Trade/Device Name: PAPAYA Plus, Digital Extraoral Source X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 2, 2014 Received: October 6, 2014

Dear Ms. Min:

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.

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 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.

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

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/Resourcesfor You/Industry/default.htm. 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 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 yours.

for

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

Enclosure

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

# Indications for Use

510(k) Number (if known) K141700

Device Name

Digital X-ray Imaging System (Model: PAPAYA Plus)

# Indications for Use (Describe)

PAPAYA Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And this system can be equipped CUST (Tomographic) option, which is capable of taking cross-sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted teeth.

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

2 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."

{3}------------------------------------------------

#### Exhibit 5 510(k) Summary

Date of Summary Preparation: July 25, 2014

- 1. Submitter and US Official Correspondent

| Submitter: | GENORAY Co., Ltd. |
|----------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | #512, Byucksan Technopia<br>434-6, Sangdaewon 1-dong,<br>Jungwon-gu, Seongnam-city<br>Gyeonggi-do, 462-716, Korea |
| Telephone No.: | [phone] |
| Fax: | [phone] |

Official Correspondent (U.S): Kaitlynn Min - Business Manager Correspondent: GENORAY America Inc. Address: 3002 Dow Avenue, Suite 420, Tustin, CA 92780 Telephone No.: 714-289-8020 Fax: [phone] Email: [e-mail]

- Establishment Registration Number 2. 3005843418
- 3. Device Information

| Proprietary/Trade Name: | PAPAYA Plus |
|-------------------------|-----------------------------------------|
| Common/Usual Name: | Digital X-ray Imaging System |
| Classification Name: | Extraoral Source x-ray system |
| Product Code: | MUH |
| Device Class: | Class II per regulation 21 CFR 872.1800 |

- 4. Predicate Device (Equivalent Legally Marketed Device) PAPAYA Plus (K130419, GENORAY Co., Ltd) Volumetric Tomography (K063773, Instrumentarium Dental) Orthopantomograph OP 200 (K046312, Instrumentarium Dental)
- ડ . Description of the Device

PAPAYA Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric. And proposed PAPAYA Plus has the CUST imaging option which is used to reconstruct tomographic images from a set of preacquired projection radiographic images of the object.

CUST algorithm has already been used for existing panoramic units as the predicate device OP200 (k046312) use the VT (k063773) imaging method. VT imaging method which is similar with CUST is described in the following scientific publication.

CEDERLUND, A; KALKE, M.; WELANDER, U. Volumetric tomography-a new tomographic technique for panoramic units. Dentomaxillofacial Radiology, 2009, 38: 104-111

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

#### Indications for use (intended use) 6.

PAPAYA Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And this system can be equipped CUST (Tomographic) option, which is capable of taking cross sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted teeth.

| Name | Proposed device<br>PAPAYA Plus | Predicate device<br>PAPAYA Plus | Volumetric Tomography | Orthopantomograph®<br>OP200, OP200D,<br>Orthoceph®OC200,<br>OC200D |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | GENORAY Co., Ltd. | GENORAY Co., Ltd. | Instrumentarium Dental | Instrumentarium Dental |
| 510(k)<br>No. | K141700 | K130419 | K063773 | K046312 |
| Figure | Image: PAPAYA Plus | Image: PAPAYA Plus | *The Volumetric<br>Tomography imaging<br>option is used for<br>Orthopantomograph®<br>OP100 and OP200 product<br>families. | Image: Orthopantomograph |
| Indications<br>for use | PAPAYA Plus is a digital<br>extraoral source X-ray<br>system intended to<br>produce panoramic and<br>cephalometric(option)<br>images of the oral and<br>craniofacial anatomy for a<br>precise treatment planning<br>in adult and pediatric care.<br>The system is used for<br>dental & skull<br>radiographic examination<br>and diagnosis of teeth, jaw,<br>oral structure, and skull by<br>exposing an X-ray image<br>receptor to ionizing<br>radiation, with a digital<br>imaging capability for<br>taking both panoramic and<br>cephalometric images.<br>And This system can be<br>equipped<br>Cust(Tomographic) option,<br>which is capable of taking<br>cross-sectional | PAPAYA Plus is a digital<br>extraoral source X-ray<br>system intended to produce<br>panoramic and<br>cephalometric(option)<br>images of the oral and<br>craniofacial anatomy for a<br>precise treatment planning<br>in adult and pediatric care.<br>The system is used for<br>dental & skull radiographic<br>examination and diagnosis<br>of teeth, jaw, oral<br>structure, and skull by<br>exposing an X-ray image<br>receptor to ionizing<br>radiation, with a digital<br>imaging capability for<br>taking both panoramic and<br>cephalometric images. | Volumetric Tomography is<br>intended to be used for<br>producing cross-sectional<br>(tomographic)<br>radiographic images from<br>the edentulous or dentate<br>area of the jaws. The<br>cross-sectional images<br>provide dimensional<br>information for dental<br>implant planning and<br>information about location<br>of impacted teeth. | Orthopantomograph®<br>OP200 (film unit) and<br>OP200 D (digital unit)<br>devices are intended to be<br>used for producing X-ray<br>radiographs of dentition,<br>TM-joints and other oral<br>structures. The units are<br>capable of taking<br>panoramic, TM-joint and<br>maxillary sinus<br>radiographs from patients.<br>When the units are<br>equipped with<br>cephalometric option<br>Orthoceph® OC200 (film<br>unit) or OC200 D (digital<br>unit) units can be used for<br>cephalometric radiography<br>and examinations related<br>thereto. OP200 or OC200<br>units can also be<br>equipped with Ortho<br>Trans (OT) option, which<br>is capable of taking both |
| | radiographic<br>images.<br>These images provide<br>dimensional information<br>for dental implant planning<br>and information about<br>location of impacted teeth. | | | cross and longitudinal<br>slices of region of interest.<br>Ortho Trans uses linear<br>tomography imaging<br>principle. |
| Perform<br>ance<br>Specific<br>ation | Panoramic and<br>cephalometric | Panoramic and<br>cephalometric | - | Panoramic and<br>cephalometric |
| Input<br>Voltage | 120 V~ | 120 V~ | - | 110 V~, 50/60 Hz,<br>1.65kVA |
| Tube<br>Voltage | 60-90 kV | 60-90 kV | - | 57 - 85 kV |
| Tube<br>Current | 4-12 mA | 4-12 mA | - | 2-16 mA |
| Focal<br>Spot<br>Size | 0.5 mm | 0.5 mm | - | 0.5 mm |
| Exposur<br>e Time | Standard panorama: 12 sec<br>Cephalo (Normal): 8 sec | Standard panorama: 12 sec<br>Cephalo (Normal): 8 sec | - | Panorama: 2.7-16 sec<br>Cephalo: 0.2-19 sec |
| Exposu<br>re<br>mode | Panorama:<br>Panoramic mode<br>TMJ mode<br>SINUS mode<br>CUST mode<br>Cephalo: Cephalo mode | Panorama:<br>Panoramic mode<br>TMJ mode<br>SINUS mode<br>Cephalo: Cephalo mode | Volumetric Tomography | Panorama:<br>Panoramic mode<br>TMJ mode<br>SINUS mode<br>Linear Tomography<br>Volumetric Tomography<br>Cephalo: Cephalo mode |
| Image<br>Receptor | Panoramic &<br>cephalometric sensor :<br>CdTe Sensor | Panoramic &<br>cephalometric sensor :<br>CdTe Sensor | - | Panoramic, Cephalometric<br>sensor: CCD Detector |

#### 7. Substantial equivalence chart

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

The proposed PAPAYA Plus has the same specification for mechanism as predicate device, PAPAYA Plus (k130419). The primary difference is to add the CUST mode in exposure modes which shows the cross-sectional images through reconstruction. CUST mode is similar with Volumetric Tomography (k063773) which reconstructs tomographic images.

The image performances and dosimetry of CUST mode have evaluated through clinical evaluation report. Evaluation results of dosimetry and images for safe and effective use of PAPAYA Plus are satisfied. We also had a licensed dentist review of panoramic, cephalometric and CUST images. She found them to have enough quality for diagnosis.

Therefore, PAPAYA Plus is deemed to be substantially equivalent to the predicate devices in safety and effectiveness.

# 8. Safety, EMC and Performance data comparison to Predicate

Device Safety, EMC and Performance data is same to predicate device which has been established in 510(k) submission K130419 as below. All test results were satisfactory.

- Electrical, mechanical, environmental safety and performance testing according to standard IEC i 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32, and IEC 61223-3-4 were performed.

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

- EMC testing was conducted in accordance with standard IEC 60601-1-2. i
- FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. The tests include the MTF, DQE and the dynamic range of the panoramic sensor and the cephalometric sensor. Both the MTF of the two detectors shows the resolution more than 80% at 21p / mm and the DQE of them shows the performance of about 80% at 01p / mm. The dynamic range of them shows more than 72dB.
- PAPAYA Plus meets the EPRC standards (21 CFR 1020.30. 31) i
- PAPAYA Plus also meets the provisions of NEMA PS 3.1-3.18. Digital Imaging and । Communications in Medicine (DICOM) Set.
- i PAPAYA Plus was tested for safety and effectiveness related of the CUST in Clinical Evaluation report.

# 9. Conclusion

In reference to the comparison information provided in substantial equivalence chart, most of functions and electronic features are similar with predicate devices. The addition of CUST option was evaluated through the performance data. Thus PAPAYA Plus is substantially equivalent as compared with the predicate devices.