(129 days)
Not Found
No
The summary describes a standard digital X-ray imaging system with panoramic, cephalometric, and tomographic capabilities. There is no mention of AI, ML, or any related terms, nor are there descriptions of training or test sets typically associated with AI/ML development. The performance studies focus on image quality and dosimetry, not AI/ML performance metrics.
No.
The device is described as a "diagnostic imaging system" intended for producing X-ray images for "examination and diagnosis," which are diagnostic rather than therapeutic functions.
Yes
The "Intended Use" explicitly states that the system is used for "diagnosis of teeth, jaw, oral structure, and skull". The "Device Description" also directly calls it a "diagnostic imaging system." Additionally, the "Summary of Performance Studies" mentions a licensed dentist reviewing images and finding them of "enough quality for diagnosis."
No
The device description clearly states it is a "digital extraoral source X-ray system" and a "diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric." This indicates it is a hardware system that produces images using X-rays, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that PAPAYA Plus is an X-ray system used to produce images of the oral and craniofacial anatomy directly on the patient. It does not analyze samples like blood, urine, or tissue.
- The device's function is diagnostic imaging. It captures images of internal structures using X-rays for visual interpretation by a healthcare professional. This is distinct from the analytical testing performed by IVD devices.
The information provided consistently describes a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral and craniofacial anatomy, teeth, jaw, oral structure, skull
Indicated Patient Age Range
adult and pediatric care
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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Exhibit 5 510(k) Summary
Date of Summary Preparation: July 25, 2014
-
- Submitter and US Official Correspondent
| Submitter: | GENORAY Co., Ltd. |
|---|---|
| Address: | #512, Byucksan Technopia |
| 434-6, Sangdaewon 1-dong, | |
| Jungwon-gu, Seongnam-city | |
| Gyeonggi-do, 462-716, Korea | |
| Telephone No.: | +82-31-740-4100 |
| Fax: | +82-31-737-8025 |
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: 714-786-8919 Email: kaitlynn@genorayamerica.com
- Establishment Registration Number 2. 3005843418
-
- 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 |
- 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
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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
PAPAYA Plus | Predicate device
PAPAYA Plus | Volumetric Tomography | Orthopantomograph®
OP200, OP200D,
Orthoceph®OC200,
OC200D |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | GENORAY Co., Ltd. | GENORAY Co., Ltd. | Instrumentarium Dental | Instrumentarium Dental |
| 510(k)
No. | K141700 | K130419 | K063773 | K046312 |
| Figure | Image: PAPAYA Plus | Image: PAPAYA Plus | *The Volumetric
Tomography imaging
option is used for
Orthopantomograph®
OP100 and OP200 product
families. | Image: Orthopantomograph |
| Indications
for 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 | 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. | Volumetric Tomography is
intended to be used for
producing cross-sectional
(tomographic)
radiographic images from
the edentulous or dentate
area of the jaws. The
cross-sectional images
provide dimensional
information for dental
implant planning and
information about location
of impacted teeth. | Orthopantomograph®
OP200 (film unit) and
OP200 D (digital unit)
devices are intended to be
used for producing X-ray
radiographs of dentition,
TM-joints and other oral
structures. The units are
capable of taking
panoramic, TM-joint and
maxillary sinus
radiographs from patients.
When the units are
equipped with
cephalometric option
Orthoceph® OC200 (film
unit) or OC200 D (digital
unit) units can be used for
cephalometric radiography
and examinations related
thereto. OP200 or OC200
units can also be
equipped with Ortho
Trans (OT) option, which
is capable of taking both |
| | radiographic
images.
These images provide
dimensional information
for dental implant planning
and information about
location of impacted teeth. | | | cross and longitudinal
slices of region of interest.
Ortho Trans uses linear
tomography imaging
principle. |
| Perform
ance
Specific
ation | Panoramic and
cephalometric | Panoramic and
cephalometric | - | Panoramic and
cephalometric |
| Input
Voltage | 120 V~ | 120 V~ | - | 110 V~, 50/60 Hz,
1.65kVA |
| Tube
Voltage | 60-90 kV | 60-90 kV | - | 57 - 85 kV |
| Tube
Current | 4-12 mA | 4-12 mA | - | 2-16 mA |
| Focal
Spot
Size | 0.5 mm | 0.5 mm | - | 0.5 mm |
| Exposur
e Time | Standard panorama: 12 sec
Cephalo (Normal): 8 sec | Standard panorama: 12 sec
Cephalo (Normal): 8 sec | - | Panorama: 2.7-16 sec
Cephalo: 0.2-19 sec |
| Exposu
re
mode | Panorama:
Panoramic mode
TMJ mode
SINUS mode
CUST mode
Cephalo: Cephalo mode | Panorama:
Panoramic mode
TMJ mode
SINUS mode
Cephalo: Cephalo mode | Volumetric Tomography | Panorama:
Panoramic mode
TMJ mode
SINUS mode
Linear Tomography
Volumetric Tomography
Cephalo: Cephalo mode |
| Image
Receptor | Panoramic &
cephalometric sensor :
CdTe Sensor | Panoramic &
cephalometric sensor :
CdTe Sensor | - | Panoramic, Cephalometric
sensor: CCD Detector |
7. Substantial equivalence chart
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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.
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- 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.