Pixx2430 Digital Diagnostic X-Ray Receptor Panel

K190691 · Pixxgen Corporation · MQB · Apr 4, 2019 · Radiology

Device Facts

• Record ID: K190691
• Device Name: Pixx2430 Digital Diagnostic X-Ray Receptor Panel
• Applicant: Pixxgen Corporation
• Product Code: MQB · Radiology
• Decision Date: Apr 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

Device Story

PIXX2430 is a digital radiography system featuring an integrated flat panel digital detector (FPD) with a Cesium Iodide (CsI) scintillator. It captures X-ray radiation to produce digital radiographic images, replacing conventional film. The device operates wirelessly via IEEE802.11ac or through a hard-wired Ethernet connection. It is powered by a rechargeable lithium battery or AC line. The system is used in clinical settings for general diagnostic procedures. Healthcare providers view the output as DICOM images, which are used to support clinical decision-making in general radiography. The device offers finer pixel pitch (85 µm) compared to previous models, potentially improving image resolution and diagnostic quality for the patient.

Clinical Evidence

Clinical image evaluation performed in accordance with FDA guidance for Solid State X-ray Imaging Devices. Images were reviewed by a Board Certified Radiologist and determined to be of excellent diagnostic quality. No comparative statistical metrics (e.g., sensitivity/specificity) were reported; the evaluation was qualitative.

Technological Characteristics

Flat panel digital detector (FPD) with CsI scintillator. Pixel pitch: 85 µm. Interface: Gigabit Ethernet (1000BASE-T) and IEEE802.11ac Wi-Fi (2.4/5 GHz). Power: Rechargeable lithium battery (6 hours/360 images) or AC line. Standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 62133 (Battery Safety), ISO 14971 (Risk Management), EN 62304 (Software Lifecycle). Output: DICOM images.

Indications for Use

Indicated for use in general radiographic imaging of human anatomy. Intended to replace film/screen systems in general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• PIXX 1717; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels (K182533)

Submission Summary (Full Text)

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April 4, 2019

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

PIXXGEN Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FLORIDA 34114

Re: K190691

Trade/Device Name: PIXX2430 Digital Diagnostic X-Ray Receptor Panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: March 10, 2019 Received: March 18, 2019

Dear Mr. Kamm:

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. 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 located 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.

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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K190691

Device Name PIXX2430 Digital Diagnostic X-Ray Receptor Panel

Indications for Use (Describe)

Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic applications

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

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
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| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Summary, 510(k) Number K190691 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14056, Korea Tel [phone] Date Prepared: March 28, 2019 Contact: Young Kim, President

- 1. Identification of the Device: Proprietary-Trade Names: PIXX2430 Digital Diagnostic X-Ray Receptor Panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB
- 2. Equivalent legally marketed device: K182533 PlXX 1717; PlXX 1212; Digital Diagnostic X-Ray Receptor Panels Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB
- 3. Indications for Use (intended use) Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

### 4. Description of the Device:

The PIXX2430 is s digital radiography system, featuring an integrated flat panel digital detector (FPD). It is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panels (K182533, PIXX 1717, PIXX 1212) retaining the Wi-Fi wireless features and rechargeable battery operation. The scintillator is Csl only. The only size available is 12 x 10 inch. It operates either wirelessly or by hard wired Ethernet connection. The power source is rechargeable battery, which lasts for 360 images or 6 hours in standby. It has a finer than usual pixel pitch at 85 µm (finer resolution). Our imaging software is unchanged from our predicate device, K182533. Image storage functionality: PIXX2430 supports the internal storage of raw image data. Wireless Information: This digital panel employs the same wireless functionality as our predicate panels (K182533) using IEEE802.11ac, backward compatible. The operational characteristics can be summarized this way: Transfer power, ~ 100mW; Frequency: 2.4 gHz, or 5 gHz. Security, WPA2; Signal range: Approximately 100 feet. Both medical and nonmedical devices can use IEEE802.11ac Wi-Fi, and this technology is designed to handle multiple devices using the same technology simultaneously.

- 5. Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.

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## 6. Substantial Equivalence Chart

| | K182533, PIXX 1717, PIXX 1417, PIXX 1212 | PIXX2430 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | Indicated for use in general radiographic<br>images of human anatomy. It is intended to<br>replace radiographic film/screen systems in<br>all general-purpose diagnostic procedures,<br>excluding fluoroscopic, angiographic, and<br>mammographic applications | UNCHANGED |
| Configuration | This submission is for the Digital Panel and<br>Software only, no generator or stand<br>provided. | UNCHANGED |
| Pixel Pitch | 140um | 85 µm (finer resolution) |
| Limiting Resolution | Over 3 lp/mm | 5.8 lp/mm (finer resolution) |
| DQE(CSI) | At 2 lp/mm 26.5% | At 2 lp/mm 50 % (better) |
| MTF(CSI) | At 2 lp/mm 44% | At 2 lp/mm 60 % (better) |
| DQE(GOS) | At 2 lp/mm 21 | N/A |
| MTF(GOS) | At 2 lp/mm 35% | N/A |
| A/D Conversion | 16 bits | SAME |
| Active Area | 17 x 17 inch<br>14 x 17 inch<br>12 x 12 inch | 12 x 10 inch |
| Dimensions(mm)/<br>Weights(Kg) | 460(W)x461(L)x15(H)/3.0Kg<br>385(W) x 460(L) x 15(H)/ 2.8Kg<br>308.5(W) x 319.5(L) x 15(H)/ 1.9Kg | 328(W)X265(L)X15(H) / 1.3Kg |
| Pixels | 3,072 x 3,072<br>2,560 x 3,072<br>2,048 x 2,048 | 2816 X 3584 |
| Software | Outputs a DICOM image | SAME |
| DICOM | Yes | Yes |
| Scintillator | Csl or GOS | CsI ONLY |
| Interface | Wired: Gigabit Ethernet<br>(1000BASE-T)<br>Wireless: IEEE802.11ac, backward compatible | SAME |
| Power source | AC Line and/or Rechargeable Lithium<br>Battery;<br>5 hours/300 images | AC Line and/or Rechargeable Lithium<br>Battery;<br>6 hours/360 images |
| Standards | Electrical Safety per IEC 60601-1:2012 and<br>EMC per IEC 60601-1-22007+AC:2010 as well<br>as IEEE802.11ac. Meets FCC requirements<br>plus IEC 62133 Battery safety. | SAME |

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- 7. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility, and Battery Safety Tests. Standards met: Electrical safety per: IEC/UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety. (General) Electromagnetic Compatibility per IEC 60601-1-2, Collateral Standard: Electromagnetic compatibility Requirements and tests. IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Risk Analysis was conducted in accordance with ISO 14971:2012 and EN 62304. The software remains the same as in K182533. MTF and DQE measurements were made in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016 Battery life testing was conducted to confirm that the PIXX2430 runs for 6 hours/300 images. Cybersecurity precautionary labeling was added per the FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Document Issued on: October 2, 2014.
- 8. Summary of Clinical Testing: Clinical images obtained in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices 1 Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016. The images were evaluated by a Board Certified Radiologist and found to be of excellent diagnostic quality.
- 9. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the PIXX2430 Digital Diagnostic X-Ray Receptor Panel is as safe and effective as the predicate device, have few technological differences, and has the identical indications for use, thus rendering them substantially equivalent to the predicate device.