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 Description

The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are 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 panel retaining the Wi-Fi wireless features. The modification involves adding battery power capability to the devices in our previous submission K180976.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Predicate Device)	Reported Device Performance (New Devices)
Intended Use	Indicated for general radiographic images of human anatomy, replacing film/screen systems in general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).	UNCHANGED (Same)
Pixel Pitch	140um	SAME
Limiting Resolution	Over 3 lp/mm	SAME
DQE (CSI) at 2 lp/mm	26.5%	SAME
MTF (CSI) at 2 lp/mm	44%	SAME
DQE (GOS) at 2 lp/mm	21%	SAME
MTF (GOS) at 2 lp/mm	35%	SAME
A/D Conversion	16 bits	SAME
Active Area	17x17 inch, 14x17 inch, 12x12 inch	PIXX 1717: 17x17 inch PIXX 1417: 14x17 inch PIXX 1212: 12x12 inch
Dimensions (mm) / Weights (Kg)	PIXX 1717: 460(W)x461(L)x15(H)/3.0Kg PIXX 1417: 385(W) x 460(L) x 15(H)/2.8Kg PIXX 1212: 308.5(W) x 319.5(L) x 15(H)/1.9Kg	SAME
Pixels	PIXX 1717: 3,072x3,072 PIXX 1417: 2,560 x 3,072 PIXX 1212: 2,048 x 2,048	SAME
Software Output	DICOM image	SAME
DICOM Compatibility	Yes	Yes
Scintillator	CsI or GOS	UNCHANGED
Interface	Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11ac, backward compatible	SAME
Power Source	AC Line only	AC Line and/or Rechargeable Lithium Battery; PIXX 1717/1417: 5 hours/300 images PIXX 1212: 8 hours/480 images (New feature)
Electrical Safety	IEC/UL 60601-1	SAME (plus IEC 62133 Battery safety for new devices)
EMC	IEC 60601-1-2	SAME (plus IEC 62133 Battery safety for new devices)
Battery Safety	Not applicable (for predicate)	IEC 62133 Edition 2.0 2012-12 (for new devices)
Risk Analysis	ISO 14971:2012 and EN 62304	SAME
Cybersecurity	Not specified for predicate	Precautionary labeling per FDA guidance (new for these devices)

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated for specific image evaluations. The device modification primarily involved adding battery power, and the manufacturer stated that "Clinical images were not required because the panel technology did not change from K180976."
Data provenance: Not explicitly stated, as no clinical image study was conducted for this submission. The predicate device (K180976) would have had its own testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical image study requiring expert review of a test set was conducted for this submission.

4. Adjudication method for the test set:

Not applicable, as no clinical image study requiring adjudication was conducted for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The submission is for Digital Diagnostic X-ray Receptor Panels, which are imaging hardware, not an AI-enabled diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance study was done or is applicable for this type of hardware device.

7. The type of ground truth used:

Not applicable for image-based ground truth related to a diagnostic algorithm, as this is a hardware device. The ground truth for this submission was based on bench testing against established engineering and safety standards (e.g., IEC/UL for electrical safety, IEC for EMC, IEC for battery safety) and performance specifications (Pixel Pitch, Limiting Resolution, DQE, MTF, A/D Conversion, etc.) which were determined to be identical to the predicate device. For the new battery feature, battery life testing was conducted to verify its stated performance.

8. The sample size for the training set:

Not applicable, as this is a hardware device and not an AI/algorithm-based system requiring a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is a hardware device and not an AI/algorithm-based system requiring a training set or its associated ground truth establishment.

Summary

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October 4, 2018

Pixxgen Corporation % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K182533

Trade/Device Name: PIXX 1717; PIXX 1417; PIXX 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: MOB Dated: September 12, 2018 Received: September 14, 2018

Dear Daniel 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/cfpmp/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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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.

Hol 2. Nils

Robert A. Ochs, 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)

K182533

Device Name

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels

Indications for Use (Describe)

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 K182533 PIXXGEN Corporation 5F, SMART BAY, 123, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 14056, Korea Tel +82.70.4846.8888 Date Prepared: September 28, 2018 Contact: Young Kim, President

1. Identification of the Device:
  2

Device Class:

Proprietary-Trade Names: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels Device: Solid State X-Ray Imager (Flat Panel/Digital Imager) Regulation Name: Stationary x-ray system. Product Code: MQB Regulation Number: 892.1680

1. Equivalent legally marketed device: PIXX 1717; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels.

Manufacturer:	PIXXGEN Corporation
510(k) Number:	K180976
Device:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Name:	Stationary x-ray system.
Product Code:	MQB
Regulation Number:	892.1680
Device Class:	2

1. 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, and mammographic applications. (Rx Only)

4. Description of the Device:

1. Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory results indicates that the new devices are as safe and effective as the predicate devices.

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6. Substantial Equivalence Chart

	K180976, PIXX 1717,PIXX 1417, PIXX 1212	PIXX 1717	PIXX 1417	PIXX 1212
Intended Use	Indicated for use in generalradiographic images of humananatomy. It is intended toreplace radiographic film/screensystems in all general-purposediagnostic procedures, excludingfluoroscopic, angiographic, andmammographic applications	UNCHANGED	UNCHANGED	UNCHANGED
Configuration	This submission is for theDigital Panel and Softwareonly, no generator or standprovided.	UNCHANGED	UNCHANGED	UNCHANGED
Pixel Pitch	140um	SAME	SAME	SAME
LimitingResolution	Over 3 lp/mm	SAME	SAME	SAME
DQE(CSI)	At 2 lp/mm 26.5%	SAME	SAME	SAME
MTF(CSI)	At 2 lp/mm 44%	SAME	SAME	SAME
DQE(GOS)	At 2 lp/mm 21	SAME	SAME	SAME
MTF(GOS)	At 2 lp/mm 35%	SAME	SAME	SAME
DQE and MTFComments	Adding battery power capability did not change the panel performance.
A/D Conversion	16 bits	SAME	SAME	SAME
Active Area	17 x 17 inch14 x 17 inch12 x 12 inch	17 x 17 inch	14 x 17 inch	12 x 12 inch
Dimensions(mm)/Weights(Kg)	460(W)x461(L)x15(H)/3.0Kg385(W) x 460(L) x 15(H)/2.8Kg308.5(W) x 319.5(L) x 15(H)/1.9Kg	SAME	SAME	SAME
Pixels	3,072x3,0722,560 x 3,0722,048 x 2,048	3,072 x 3,072	2,560 x 3,072	2,048 x 2,048
Software	Outputs a DICOM image	SAME	SAME	SAME
DICOM	Yes	Yes	Yes	Yes
Scintillator	Csl orGOS	UNCHANGED	UNCHANGED	UNCHANGED
Interface	Wired: Gigabit Ethernet(1000BASE-T)Wireless:IEEE802.11ac,backward compatible	SAME	SAME	SAME
Power source	AC Line only	AC Line and/orRechargeable LithiumBattery;5 hours/300 images	AC Line and/orRechargeableLithium Battery;5 hours/300 images	AC Line and/orRechargeable LithiumBattery 8 hours/480images
	K180976, PIXX 1717,PIXX 1417, PIXX 1212	PIXX 1717	PIXX 1417	PIXX 1212
Standards	Electrical Safety per IEC60601-1:2012 and EMC perIEC 60601-1-22007+AC:2010as well as IEEE802.11ac.Meets FCC requirements.	SAME plus IEC 62133Battery safety	SAME plus IEC 62133Battery safety	SAME plus IEC 62133Battery safety

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1. 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 nonacid 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 K180976. MTF and DQE measurements were not needed because the panel characteristics are identical to our predicate cleared earlier this year.

Battery life testing was conducted to confirm that the PIXX 1212 runs for 8 hours/480 images and for the PIXX 1717/1417 for 5 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.

1. Summary of Clinical Testing: Clinical images were not required because the panel technology did not change from K180976.
1. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Pixxgen that the PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-Ray Receptor Panels are 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.

Regulation Number and Section

§ 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.