PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K130419 · Genoray Co., Ltd. · MUH · Nov 6, 2013 · Dental

Device Facts

• Record ID: K130419
• Device Name: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
• Applicant: Genoray Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Nov 6, 2013
• 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 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.

Device Story

PAPAYA Plus is a digital extraoral X-ray imaging system for dental and craniofacial diagnostics. It utilizes a high-frequency stationary X-ray tube (60-90 kV, 4-12 mA) and a CdTe (Cadmium Telluride) digital detector to capture panoramic and optional cephalometric images. The device is operated by dental professionals in a clinical setting. Patients are positioned standing during the scan. The system transforms X-ray exposure into digital images, which are displayed for the clinician to assist in treatment planning and diagnosis of teeth, jaw, and skull structures. It supports DICOM standards for image communication. The primary benefit is the acquisition of high-quality diagnostic images for precise treatment planning.

Clinical Evidence

Bench testing only. Performance evaluated against IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 61223-3-4, and EMC standard IEC 60601-1-2. Compliance with 21 CFR 1020.30/31 (EPRC) and NEMA PS 3.1-3.18 (DICOM) confirmed. No clinical trial data reported.

Technological Characteristics

Extraoral X-ray system; high-frequency stationary tube; CdTe digital detector (100um pixel size); 60-90 kV, 4-12 mA; 0.5mm focal spot; standing patient position; DICOM connectivity; compliant with IEC 60601 series and 21 CFR 1020.30/31.

Indications for Use

Indicated for adult and pediatric patients requiring panoramic and cephalometric radiographic imaging of the oral and craniofacial anatomy for dental and skull examination and diagnosis.

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

• PCH-2500 (PaX-i) (K122155)

Submission Summary (Full Text)

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KI30419

NOV - 6 2013

## 510(k) Summary Exhibit 5

ST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.. ...

Date of Summary Preparation: January 18, 2013

- Submitter and US Official Correspondent 1.

| 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): Jae Kim - Business Manager Correspondent : GENORAY America Inc. Address: 1073 N. Batavia St. Orange, CA 92867, USA

Telephone No.: 855-436-6729 714-786-8919 Fax: [e-mail] Email:

## 2. Establishment Registration Number 3005843418

### 3. Device Information

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

#### Equivalent Legally Marketed Device 4.

| < PCH-2500 (PaX-i)> | |
|---------------------|------------------------------------------------|
| Manufacturer: | Vatech Co., Ltd. |
| Device Name: | PCH-2500 (PaX-i) |
| 510(k) Number: | K122155 (Decision Date: Sep 04, 2012) |
| Classification: | System, X-ray, Extraoral Source, Digital: MUH, |
| | Class II per regulation 21 CFR 872.1800 |

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# Description of the Device

રું .

PAPAYA Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric. PAPAYA Plus is designed for dental radiography of the oral and craniofacial anatomy. PAPAYA Plus is equipped with extra oral x ray detector based on CdTe digital X ray detector, panoramic & cephalometric radiography with an extra oral xray tube. CdTe digital X-ray detector is used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. Cephalometric radiography is optional function. It can be choice to use the cephalo function as user's need.

| Product<br>Items | PAPAYA Plus |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Specification | Panoramic and cephalometric |
| X-ray Source | High Frequency. Stationary tube,<br>60 ~ 90 kV, 4 ~ 12mA |
| Focal Spot | 0.5mm |
| Image Detector | CdTe detector<br>- Pixel size: 100um x 100um<br>- Image field:<br>Panoramic&Cephalometric sensor : 240mm x 4.8mm<br>Panoramic sensor : 150mm x 4.8mm |
| Scan time /<br>exposure time | Standard panorama program (Normal, Average): 12 sec<br>Cephalo (Normal): 8 sec |
| Power Voltage /<br>Input power | 120 V~, 60 Hz, 2.2 kVA |
| Total filtration | CEJ Tube: 2.5mmAl (inherent:0.5mmAl, Added:2.0mmAl)<br>Toshiba Tube: 2.8mmAl (inherent:0.8mmAl, Added:2.0mmAl) |
| Patient position | Standing |
| Main body weight | 140 kg ± 5% |
| Dimension<br>(W×H×D mm) | 1775.4 × 2312 × 1010 mm |

#### 6. Indications for use

PAPAYA Plus is a digital extraoral source X ray system intended to produce panoramic and Cephalometric 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.

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## Substantial equivalence chart 7.

500

| Name | PAPAYA Plus | PCH-2500 (PaX-i) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | GENORAY Co., Ltd. | Vatech Co., Ltd. |
| 510(k) No. | K130419 | K122155 |
| Classification | System, X-ray, Extraoral Source, Digital:<br>MUH, Class II per regulation 21 CFR<br>872.1800 | System, X-ray, Extraoral Source, Digital:<br>MUH, Class II per regulation 21 CFR<br>872.1800 |
| Figure | | |
| Indications<br>for use | PAPAYA Plus is a digital extraoral<br>source X-ray system intended to produce<br>panoramic and Cephalometric images of<br>the oral and craniofacial anatomy for a<br>precise treatment planning in adult and<br>pediatric care. The system is used for<br>dental & skull radiographic examination<br>and diagnosis of teeth, jaw, oral structure,<br>and skull by exposing an X-ray image<br>receptor to ionizing radiation, with a<br>digital imaging capability for taking both<br>panoramic and cephalometric images. | PCH-2500 (PaX-i) is a digital extraoral<br>source x-ray system intended to take<br>panoramic and cephalometric images of<br>the oral and maxillofacial anatomy to<br>provide diagnostic information for adult<br>and pediatric patients. The device should<br>be operated and used by dentists, x-ray<br>technicians and other professionals<br>licensed by the law of the state in which<br>the device is used. |
| Performance<br>Specification | Panoramic and cephalometric | Panoramic and cephalometric |
| Input Voltage | 120 V~ | 100-120 V~ |
| Tube Voltage | 60-90 kV | 50-90 KV |
| Tube Current | 4-12 mA | 4-10 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max. 17 sec | Max. 20.2 sec |
| Total Filtration | 2.5 mmAl (CEI tube)<br>2.8 mmAl (Toshiba tube) | 2.8 mmAl |
| Pixel Size | Panoramic & cephalometric sensor: 100 x<br>100 um | Panoramic & cephalometric sensor:<br>100 x 100 um<br>Cephalometric (one shot type) sensor: 127<br>x 127 um |
| Image Receptor | Panoramic & cephalometric sensor : CdTe<br>Sensor | Panoramic & Cephlometric sensor:<br>CMOS Photodiode array<br>Cephalometric sensor(scan type):<br>Amorphous silicon TFT with scintillator |

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Indications for use, performance specification and technical characteristics of PAPAYA Plus and PCH-2500 (PaX-i) are similar. The primary difference is to offer a CdTe sensor for Panorama and Cephalometric mode of PAPAYA Plus. The Performance data for the CdTe sensor are provided in this submission.

Therefore, PAPAYA Plus is deemed to be substantially equivalent to the predicate device. PCH-2500 (PaX-i) in safety and effectiveness.

- 8. Safety, EMC and Performance data comparison to Predicate
- Electrical, mechanical, environmental safety and performance testing according to standard IEC -60601-1. IEC 60601-1-1. IEC 60601-1-3. IEC 60601-2-7. IEC 60601-2-28. IEC 60601-2-32 and IEC 61223-3-4 were performed.
- 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 i Devices" was performed.
- . PAPAYA Plus meets the EPRC standards (21 CFR 1020.30. 31).
- PAPAYA Plus also meets the provisions of NEMA PS 3.1-3.18. Digital Imaging and . Communications in Medicine (DICOM) Set.

All test results were satisfactory.

The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

- 9. Conclusion
In reference to the comparison information provided in substantial equivalence chart, most of function and electronic feature are similar in both products. We believe that the PAPAYA Plus is safe, effective and substantially equivalent in clinical & technical expect with the predicate devices. PCH-2500 (PaX-i),

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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

November 6, 2013

Genoray Co., Ltd. % Mr. Jae Kim Business Development Manager 1073 N. Batavia Street ORANGE CA 92867

Re: K130419

Trade/Device Name: PAPAYA Plus, Digital X-ray Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 03, 2013 Received: October 07, 2013

Dear Mr. Kim:

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.

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Page 2-Mr. Kim

... ..........................................................................................................................................................................

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 [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,

ரோ

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K130419

## Device Name

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

## Indications for Use (Describe)

PAPA YA Plus is a digital extraoral source X-ray system intended to produce panoramic and Cephalometric images of the oral and craniofacial anatomy for a precise treating in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images.

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)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.