(17 days)
No
The summary describes a digital radiography system that replaces film/screen systems. It focuses on hardware features, connectivity, and image storage, explicitly stating the imaging software is unchanged from the predicate device and there is no mention of AI, DNN, or ML.
No
The device is described as a digital radiography system intended for imaging human anatomy, replacing film/screen systems in diagnostic procedures. It produces images for diagnosis, rather than directly treating or preventing disease.
Yes
The device is indicated for use in "general-purpose diagnostic procedures" to replace radiographic film/screen systems. Clinical images were also evaluated by a radiologist and found to be "of excellent diagnostic quality."
No
The device description explicitly states it is a "digital radiography system, featuring an integrated flat panel digital detector (FPD)" and mentions hardware components like a scintillator, battery, and physical dimensions. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general radiographic images of human anatomy" and to "replace radiographic film/screen systems in all general-purpose diagnostic procedures." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a "digital radiography system, featuring an integrated flat panel digital detector (FPD)." This is consistent with an X-ray imaging system.
- Input Imaging Modality: The input imaging modality is "X-Ray," which is a form of medical imaging, not an in vitro diagnostic technique.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is used to capture images of the body itself.
N/A
Intended Use / Indications for 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 applications
Product codes
MQB
Device Description
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 CsI 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 +82.70.4846.8888 Date Prepared: March 28, 2019 Contact: Young Kim, President
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- 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
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- 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
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- 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.
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- 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 | |
| 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 | UNCHANGED | |
| Configuration | This submission is for the Digital Panel and | |
| Software only, no generator or stand | ||
| 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 | |
| 14 x 17 inch | ||
| 12 x 12 inch | 12 x 10 inch | |
| Dimensions(mm)/ | ||
| Weights(Kg) | 460(W)x461(L)x15(H)/3.0Kg | |
| 385(W) x 460(L) x 15(H)/ 2.8Kg | ||
| 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 | |
| 2,560 x 3,072 | ||
| 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 | |
| (1000BASE-T) | ||
| Wireless: IEEE802.11ac, backward compatible | SAME | |
| Power source | AC Line and/or Rechargeable Lithium | |
| Battery; | ||
| 5 hours/300 images | AC Line and/or Rechargeable Lithium | |
| Battery; | ||
| 6 hours/360 images | ||
| Standards | Electrical Safety per IEC 60601-1:2012 and | |
| EMC per IEC 60601-1-22007+AC:2010 as well | ||
| as IEEE802.11ac. Meets FCC requirements | ||
| plus IEC 62133 Battery safety. | SAME |
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- 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.
-
- 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.
-
- 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.