WeSensor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration". October 10, 2023 % Mr. Edward Park CEO LightenBridge LLC 4408 Tortuga Ln McKINNEY TX 75070 Re: K230916 Trade/Device Name: WeSensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: April 3, 2023 Received: April 3, 2023 Dear Mr. Park: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230916 Device Name WeSensor Indications for Use (Describe) The WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple and modern, and it is likely used to represent the company's brand. # 510(k) Summary - Traditional 510(k) K230916 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. #### Submitter Information | Submitter Name: | PICOPACK Inc. | |---------------------|-------------------------------------------------------------------------------| | Address: | #106, 91, Sinilseo-ro 85beon-gil, Daedeok-gu, Daejeon 34325 Republic of Korea | | Phone/Fax | +82-42-362-5050 / +82-42-362-5055 | | Contact Person: | Edward Park, official correspondent of Picopack Co., Ltd. | | Date of submission: | April 01, 2023 | ### Device Information | Proprietary Name(s): | WeSensor | |-----------------------|--------------------------------| | Model Name: | F350A / G350A / F150A / G150A | | Common Name: | Intraoral digital X-ray sensor | | Regulation Name: | Extraoral Source X-Ray System | | Product Code: | MUH | | Regulation Number: | 21 CFR 872.1800 | | Classification Panel: | Radiology | | Device Class: | II | ### Device Description The WeSensor is an intraoral digital x-ray sensor. It comprises three components: (1) an intraoral digital X-ray sensor which connects to a PC via a USB port; (2) WeSensor Software package; and (3) a sensor holder as an accessory. The sensor part of WeSensor comes in four distinct models according to active area size and scintillator type: G350A, F350A, G150A, and F150A. Both 'G' models (G350A and G150A) use a scintillator made from Gadolinium Oxysulfide (Gd2O2S:Tb), and there is no filter layer in these models. Both 'F' models (F350A and F150A) use a different type of scintillator made from Thallium-doped Cesium Iodide (Csl:Tl) and Sodium Iodide (NaI:T1). These models also include an extra filter layer in the sensor. This unique structure of the scintillator and filter layer further enhances image quality. And model 350 having a larger active area than model 150. There is no electrical or physical connection between the x-ray generator. Images are automatically acquired when x-rays are present in a dose which is perceptible to the sensor. An X-ray image sensor is positioned in the patient's mouth just like Intra-oral film. Digital x- {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Picopack. The logo is written in a sans-serif font, with the first "p" in a lighter blue color than the rest of the word. The logo is simple and modern, and it is likely used to represent the company's brand. ray images are quickly displayed on the screen. Images can be optimized for viewing via imaging software, stored as image files. PICOPACK offers technical support for this device to ensure proper operation and to answer any questions regarding the function of the device. The type of x-ray systems that integrate with the G350A/F350A/G150A/F150A are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. This device cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver. G350A/F350A/G150A/F150A must be connected to a PC through the standard USB 2.0 port. The WeSensor Viewer is a software component designed to be operated within Windows Desktop environment for medical device acquisition, storage, transmission along with simple editing functions. Using Picopack's provided SDK in local settings allows users to connect this software directly to an oral sensor for X-ray image acquisition and patient image viewing. This software has moderate level of concern and this software has not been previously FDA-cleared with other similar detectors. ## Primary Predicate Device - . QuickRay HD (Denterprise International, Inc., K151926) - Common Name: Intraoral Digital X-Ray Sensor - Regulation Name: Extraoral Source X-Ray System - Device Class: II - Product Code: MUH - Regulation Number: 21 CFR 872.1800 - Medical Specialty: Dental - Review Panel: Radiology ### Additional Predicate Devices - XVD2121 Plus, XVD2530 (Shenzhen Xpectvision Technology Co., Ltd., K220277) . - Common Name: Intraoral Digital X-Ray Sensor - Regulation Name: Extraoral Source X-Ray System - Device Class: II - Product Code: MUH - Regulation Number: 21 CFR 872.1800 - Medical Specialty: Dental - Review Panel: Radiology {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PICOPACK" in blue font. The first letter "P" is in a lighter blue color. The word is written in all lowercase letters. - . EzSeonsor Classic (Rayence Co., Ltd., K153060) - Common Name: Digital Dental Intra Oral Sensor - Regulation Name: Extraoral Source X-Ray System - Device Class: II - Product Code: MUH - Regulation Number: 21 CFR 872.1800 - Medical Specialty: Dental - Review Panel: Radiology ### Indications for Use WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. ### Intended Use WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. WeSensor is located in the patient's mouth and used together with a separate medical device, X-ray generator, used once for one patient, and can be used for another patient by replacing the designated protective cover after use. WeSensor should only be used by dentists. {6}------------------------------------------------ # picopack Picopack.co.Ltd 206, Venture Town Dasan,91, Sinilseo-ro85beon-gil, Daedeok-gu Daejeon, Chungcheongbuk-do 34325 South Korea Tel. +82-42-362-5050 / Fax. +82-42-362-5055 | Device Name | WESENSOR | QuickRay HD<br>(Primary Predicate) | XVD2121 Plus,<br>XVD2530 | EzSeonsor Classic | Differences | 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| 510k number | K230916 | K151926 | K220277 | K153060 | | | Manufacturer | Picopack Co., Ltd. | Denterprise<br>International, Inc. | Shenzhen Xpectvision<br>Technology Co., Ltd. | Rayence Co., Ltd. | | | Indications<br>for Use | The WeSensor is used for a<br>radiographic examination by<br>a dental professional to<br>assist in the diagnosing of<br>diseases of the teeth, jaw<br>and oral structures. | QuickRay HD is used for a<br>radiographic examination by<br>a dental professional to<br>assist in the diagnosing of<br>diseases of the teeth, jaw<br>and oral structures. | The digital intraoral X-ray<br>sensors XVD2121 Plus,<br>XVD2530 are intended for<br>any dental practice that uses<br>X-ray equipment for<br>intraoral diagnostic<br>purposes.<br>Each can be used by trained<br>dental professionals for<br>patients receiving intraoral<br>X-ray examinations and<br>produces digital images that<br>can be displayed and<br>archived digitally. | Digital Dental Intra Oral<br>Sensor is intended to collect<br>dental x-ray photons and<br>convert them into electronic<br>impulses that may be stored,<br>viewed and manipulated for<br>diagnostic use by dentists | Identical to<br>K151926 | | Intended Use | Radiographic examination<br>to assist with diagnosis of<br>diseases of the teeth, jaw,<br>and oral structure. | Radiographic examination<br>to assist with diagnosis of<br>diseases of the teeth, jaw,<br>and oral structure. | Radiographic examination<br>to assist with diagnosis of<br>diseases of the teeth, jaw,<br>and oral structure. | Radiographic examination<br>to assist with diagnosis of<br>diseases of the teeth, jaw,<br>and oral structure. | Identical | | Principle of<br>operation | X-ray (radiation) =><br>scintillator (convert to light)<br>=> fiber optic layer (only in<br>F type) (filtering) => CMOS<br>(convert to digital) =><br>electronics => PC (capture<br>& display image) | X-ray (radiation) =><br>scintillator (convert to light)<br>=> fiber optic layer<br>(filtering) => CMOS<br>(convert to digital) =><br>electronics => PC (capture<br>& display image) | X-ray (radiation) =><br>Scilicon-based chip (direct<br>imaging) => Solder bump<br>=> Readout chip (convert to<br>digital) => PC (capture &<br>display image) | X-ray (radiation) =><br>scintillator (convert to light)<br>=> fiber optic layer<br>(filtering) => CMOS<br>(convert to digital) =><br>electronics => PC (capture<br>& display image) | Similar or<br>Identical | | Device Name | WESENSOR | QuickRay HD<br>(Primary Predicate) | XVD2121 Plus,<br>XVD2530 | EzSeonsor Classic | Differences | | 510k number | K230916 | K151926 | K220277 | K153060 | Differences | | Manufacturer | Picopack Co., Ltd. | Denterprise<br>International, Inc. | Shenzhen Xpectvision<br>Technology Co., Ltd. | Rayence Co., Ltd. | | | Software<br>- Firmware | Firmware combined on<br>sensor electronic board | Firmware combined on<br>sensor electronic board | Unknown | Unknown | Identical | | Software<br>- Image<br>Management | WeSensor Viewer<br>(Picopack, Korea) | Xray Vision (OTS package<br>from Apteryx, USA) | XLinearVision | Easydent | Identical | | Sensor<br>technology | F350A/F150A<br>: CMOS chip + optical fiber<br>plate + CSi scintillator<br>G150A/G350A<br>: CMOS chip + CSi<br>scintillator | CMOS chip + optical fiber<br>plate + CSi scintillator | Scilicon-based<br>Semiconductor<br>+ CMOS ASIC | CMOS chip + optical fiber<br>plate + FOS scintillator<br>(FOP + CsI) | Identical for<br>F350A and F150A<br>Similar for G150A<br>and G350A | | Sensor<br>Dimension<br>(mm) | G150A: $37.0 \times 27.0 \times 1.0$<br>F150A: $37.0 \times 27.0 \times 1.2$<br>G350A: $43.0 \times 33.0 \times 1.0$<br>F350A: $43.0 \times 33.0 \times 1.2$ | $36.8 \times 25.4 \times 4.4$<br>$41.9 \times 30.4 \times 4.4$ | XVD2121: $32.0 \times 26.5 \times 5.8$<br>XVD2530: $38.5 \times 31.5 \times 6.0$ | Size 1.0: $36.8 \times 25.4 \times 4.8$<br>Size 1.5: $39.5 \times 29.2 \times 4.8$<br>Size 2.0: $42.9 \times 31.3 \times 4.8$ | Similar | | Active Area | G150A/F150A<br>: $30.0 \text{ mm } \times 21.6 \text{ mm}$<br>G350A/F350A<br>: $34.4 \text{ mm } \times 26.2 \text{ mm}$ | $600 \text{ mm}^2 \text{ (Size 1)}$<br>$884 \text{ mm}^2 \text{ (Size 2)}$ | XVD2121<br>: $20.0 \text{ mm } \times 19.8 \text{ mm}$<br>XVD2530<br>: $29.5 \text{ mm } \times 24.6 \text{ mm}$ | Size 1.0: $30.01 \times 20.01$<br>Size 1.5: $33.00 \times 23.98$<br>Size 2.0: $35.99 \times 25.99$ | Similar | | Device Name | WESENSOR | QuickRay HD<br>(Primary Predicate) | XVD2121 Plus,<br>XVD2530 | EzSeonsor Classic | Differences | | 510k number | K230916 | K151926 | K220277 | K153060 | | | Manufacturer | Picopack Co., Ltd. | Denterprise<br>International, Inc. | Shenzhen Xpectvision<br>Technology Co., Ltd. | Rayence Co., Ltd. | | | Number of<br>Pixels | G150A/F150A<br>: 1500 × 1080<br>G350A/F350A<br>: 1700 × 1300 | 1500 × 1000 (Size 1)<br>1700 × 1300 (Size 2) | Unknown | Normal Resolution Mode<br>Size 1.0: 1014 × 676<br>Size 1.5: 1115 × 810<br>Size 2.0: 1216 × 878<br>High Resolution Mode<br>Size 1.0: 2028 × 1352<br>Size 1.5: 2230 × 1620<br>Size 2.0: 2462 × 1756 | Similar | | Lifespan CMOS | Min. 100,000 cycles | Min. 100,000 cycles | 5 years | Unknown | Identical | | Max. Image<br>Resolution<br>(lp/mm) | G150A & G350A: 14.3<br>F150A & F350A: 16.6 | ≥ 20pl/mm | 7 lp/mm | Unknown | Similar | | Pixel Size | 20 × 20µm | 20 × 20µm | Unknown | Unknown | Identical | | Gray Levels | 14 bits | 14 bits | 16 bits | Unknown | Identical | | DQE | 0.464 at 0 lp/mm<br>0.060 at 6 lp/mm | 0.45 at 0 lp/mm<br>0.16 at 6 lp/mm | | Full Resolution<br>: 0.38 at 6 lp/mm<br>Binning Resolution<br>: 0.34 at 6 lp/mm | Similar | | MTF | 0.594 at 3 lp/mm<br>0.1 at 13 lp/mm | 0.65 at 3 lp/mm<br>0.09 at 13 lp/mm | | Full Resolution<br>: 0.642 at 3 lp/mm<br>Binning Resolution<br>: 0.630 at 3 lp/mm | Similar | | Device Name | WESENSOR | QuickRay HD<br>(Primary Predicate) | XVD2121 Plus,<br>XVD2530 | EzSeonsor Classic | Differences | | 510k number | K230916 | K151926 | K220277 | K153060 | | | Manufacturer | Picopack Co., Ltd. | Denterprise<br>International, Inc. | Shenzhen Xpectvision<br>Technology Co., Ltd. | Rayence Co., Ltd. | | | Sensor board | All control electronics<br>directly integrated on<br>CMOS sensor chip. | All control electronics<br>directly integrated on<br>CMOS sensor chip. | All control electronics<br>directly integrated on<br>CMOS sensor chip. | All control electronics<br>directly integrated on<br>CMOS sensor chip. | Identical | | Sensor shell | ABS (flammability is FV-0)<br>(UL File No. E257054) | ABS (flammability is HB if<br>YK-94 (UL File No.<br>49895)) | Unknown | Silicon | Similar | | Cable material<br>and design | PVC, ETFE, copper, plug<br>connector<br>Diameter: $\phi$ 3.8 ±0.3<br>Cable length: 2.5 meters. | PVC, ETFE, copper, plug<br>connector, and sensor<br>connector<br>Diameter: $\phi$ 3.7 ±0.3<br>Cable length: 2 meters. | Unknown | Unknown | Similar | | Connection to<br>imaging practice<br>PC | USB 2.0 High-Speed | USB 2.0 High-Speed | USB 2.0 High-Speed | USB 2.0 | Identical | | Operating<br>temperature | 10°C to 35°C | 0°C to 35°C | 10°C to 40°C | 10°C to 30°C | Similar | | Sensor input<br>voltage and<br>current | 5VDC<br>(via USB connection)<br>0.5A Max | 5VDC<br>(via USB connection)<br>0.15A Max | 5VDC<br>(via USB connection)<br>0.25A Max | 5VDC<br>(via USB connection)<br>0.5A Max | Similar | # Comparison of Technological Characteristics with Predicate {7}------------------------------------------------ # picopack Picopack.co.Ltd 206, Venture Town Dasan,91, Sinilseo-ro85beon-gil, Daedeok-gu Daejeon, Chungcheongbuk-do 34325 South Korea Tel. +82-42-362-5050 / Fax. +82-42-362-5055 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "picopack" in a stylized font. The first letter "p" is teal, while the rest of the letters are blue. The font is sans-serif and has a modern look. Picopack.co.Ltd 206, Venture Town Dasan,91, Sinilseo-ro85beon-gil, Daedeok-gu Daejeon, Chungcheongbuk-do 34325 South Korea Tel. +82-42-362-5050 / Fax. +82-42-362-5055 {9}------------------------------------------------ # picopack Picopack.co.Ltd 206, Venture Town Dasan,91, Sinilseo-ro85beon-gil, Daedeok-gu Daejeon, Chungcheongbuk-do 34325 South Korea Tel. +82-42-362-5050 / Fax. +82-42-362-5055 {10}------------------------------------------------ ## Performance Data Sensor performance testing and software function test have been undergone for the WeSensor intraoral digital x-ray detector. The successful test results including max.image resolution, DQE, and MTF indicate that the subject device performance is comparable to or exceed those of the predicate devices. Also, clinical images were examined by Dr.Park, a qualified dentist in the state of Nevada. The results demonstrated no significant difference in diagnosing dental diseases between the subject device and the predicate device. # Electrical Safety and EMC Non-clinical test was performed in accordance with the following international standards, - IEC 60601-1:2012 ed.3.1 - - IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment Part 1-6: General -Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability - IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests - ANSI AAMI IEC 62304:2006+AMD1:2015 Medical Device Software Software Life -Cycle Processes - EN ISO 14971:2012 Medical devices Applications of risk management to medical devices - ANSI AAMI IEC IEC 62366:2007 Medical devices Part 1: Application of usability engineering to medical devices ## Conclusion The subject device is substantially equivalent with the predicate device in the areas of indications for use, intended use, general functions & features, principle of operation, and technological characteristics. The new device does not introduce fundamentally new scientific technology. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.