CLAROX plus (Model: VX-100) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed X-ray tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients and pediatrics. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.

Device Description

VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the Clarox Plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware). The device software is of Moderate level of concern and it is not based on the predicate software. The device uses a rechargeable battery to allow for the use of the VX-100 where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility. The VX-100 is an X-ray device with AC/DC adaptor. The handheld device features a main body (tube head), cone to limit the exposure range of the beam, cradle, and AC/DC adaptor. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a main body. This facilitates portability of the device. A beam-limiting cone is mounted to the device before use. The tube voltage is adjustable from 70kV to 100kV. Tube current is fixed 1.0mA. The exposure time is also manually adjustable by the operators. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, display, and an exposure button provide the primary operator interface. Exposures settings can be selected and displayed. The voltage and the exposure time varies based on patient type, detector type, and anatomical feature. Exposures can be completed using the exposure button. The VX-100 should be used with an X-ray detector, and the x-ray detector may be digital or analog, and it is not included in the VX-100 package.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a mobile X-ray system, CLAROX plus (Model: VX-100). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of comparative effectiveness with human readers or standalone algorithm performance.

Specifically, the document states:

"Clinical testing was not necessary for the VX-100, based on the nature of the device (an x-ray generator marketed without image detector). Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence."

Therefore, the information requested for acceptance criteria and a study demonstrating device performance, as detailed in your prompt, is not available in the provided text. The document is concerned with regulatory clearance based on substantial equivalence through non-clinical performance and safety standards, rather than clinical efficacy against metrics like those used for AI/CAD devices.

If this were a device with AI components and clinical performance claims, the following information would be expected but is absent:

A table of acceptance criteria and the reported device performance: This would typically show metrics like sensitivity, specificity, AUC, or detection rates for a specific task (e.g., detecting a condition) and the target values for these metrics.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned as there was no clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as there was no clinical study with a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 study was done, and no effect size is reported.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study was done or reported.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as there's no mention of an algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

The document primarily lists non-clinical performance data, referring to compliance with various IEC and ANSI standards related to medical electrical equipment, software, risk management, usability, and radiation protection for diagnostic X-ray equipment. This demonstrates basic safety and essential performance, but not clinical performance or efficacy in a diagnostic task.

Summary

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September 13, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

VSI Co., Ltd. % Mr. Edward Park CEO LightenBridge, LLC 4408 Tortuga Lane McKINNEY TX 75070

Re: K221417

Trade/Device Name: CLAROX plus (Model: VX-100) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 12, 2022 Received: August 12, 2022

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 (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

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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/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 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 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221417

Device Name CLAROX plus (Model: VX-100)

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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Image /page/3/Picture/0 description: The image contains a logo for Value Service Innovation (VSI). The logo features a blue symbol resembling three interconnected circles on the left. To the right of the symbol, the letters "VSI" are displayed in a bold, black font, with the words "Value Service Innovation" appearing in a smaller font size above the letters.

VSI Co., Ltd. 151-33. Namseok-ro Nami-myeon, Seowon-gu Cheongju-si, Chungcheongbuk-do 28182 South Korea Tel. +82-43-267-9039 / Fax. +82-43-269-4039

510(k) Summary - Traditional 510(k) K221417

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:	VSI Co., Ltd.
Address:	151-33, Namseok-ro Nami-myeon, Seowon-gu, Cheongju-si,Chungcheongbuk-do, 28182 Republic of Korea
Phone/Fax	+82-43-267-9039 / +82-43-269-4039
Contact Person:	Edward Park, official correspondent of AssembleCircle Corp.
Date of submission:	Apr 15, 2022
Device Information
Proprietary Name(s):	CLAROX plus
Model Name:	VX-100
Common Name:	Portable X-ray System
Regulation Name:	Mobile X-ray System
Product Code:	IZL
Regulation Number:	21 CFR 892.1720
Classification Panel:	Radiology

Device Class:

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Value Service Innovation (VSI). The logo consists of a blue symbol on the left, resembling three interconnected circles. To the right of the symbol, the text "Value Service Innovation" is written in a smaller font size above the letters "VSI", which are in a larger, bold font. The text and letters are black.

VSI Co., Ltd. 151-33. Namseok-ro Nami-mveon. Seowon-gu Cheongju-si, Chungcheongbuk-do 28182 South Korea Tel. +82-43-267-9039 / Fax. +82-43-269-4039

ray device with AC/DC adaptor. The handheld device features a main body (tube head), cone to limit the exposure range of the beam, cradle, and AC/DC adaptor. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a main body. This facilitates portability of the device. A beam-limiting cone is mounted to the device before use. The tube voltage is adjustable from 70kV to 100kV. Tube current is fixed 1.0mA. The exposure time is also manually adjustable by the operators. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, display, and an exposure button provide the primary operator interface. Exposures settings can be selected and displayed. The voltage and the exposure time varies based on patient type, detector type, and anatomical feature. Exposures can be completed using the exposure button. The VX-100 should be used with an X-ray detector, and the x-ray detector may be digital or analog, and it is not included in the VX-100 package.

Principle of Operation / Mechanism of Action:

The VX-100 is used like any other Xray source for general radiographic application. An x-ray image receptor (not part of the device) is placed under the body extremity intended for radiography. The appropriate exposure time is manually set by the operator. The operator should follow adequate instructions to ensure proper alignment of the x-ray beam and the image receptor. To prevent inadvertent exposure to X-rays, the value adjusted by the MCU electronically controls the semiconductor switching element. Using this X-ray, it passes through the body part to be diagnosed to obtain an image with a detector so that it can be used for diagnosis. The irradiation time setting method sets the irradiation time by the user and can select a value from 0.1 seconds to 1.0 seconds by turning the jog dial manually.

Predicate Device

. EzRay M (Model: VMX-P300) (Vatech Co., Ltd. K203667, February 2, 2021)
- Common Name: Medical Portable X-ray System
- Regulation Name: Mobile X-ray System
- Device Class: II
- Product Code: IZL
- Regulation Number: 21 CFR 892.1720
- Classification Panel: Radiology

Indications for Use

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Image /page/5/Picture/0 description: The image shows the logo for VSI, which stands for Value Service Innovation. The logo consists of a blue symbol on the left, resembling three interconnected circles. To the right of the symbol, the text "Value Service Innovation" is stacked above the letters "VSI" in a larger, bold font. The text and symbol are aligned horizontally.

radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.

Technological Characteristics

The VX-100 retains same basic design components and operating features as the predicate device, EzRay M (Model: VMX-P300, K203667). The handheld device features a main body, cone, and cradle for charging. The X-ray tube and the battery pack are integrated in the main body. The functionality of the user interface is also similar to the predicate device. Power of the both devices is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. The subject device has 22.2 VDC but VMX-P300 has 21.6 VDC. The battery core packs in both devices are compliant with IEC 62133. Testing has been completed on basic safety and essential performance and the device complies with AAMI ES60601-1; IEC 60601-1-2 (Ed. 4); IEC 60601-1-3, and IEC 60601-2-54.

Device Name	CLAROX plus (VX-100)	EzRay M (Model: VMX-P300)
510k number	K221417	K203667
Manufacturer	VSI Co., Ltd.	Vatech Co., Ltd.
DeviceClassificationName	Mobile X-ray System	Mobile X-ray System
ClassificationProduct Code	IZL	IZL
RegulationNumber	21 CFR 892.1720	21 CFR 892.1720
RegulationClass	II	II
Indicationsfor Use	CLAROX plus (Model: VX-100) is aportable general-purpose X-ray system thatusers can operate with one hand. The deviceuses a fixed X-ray tube current and voltage(kVp) and, therefore, is limited to takingdiagnostic X-rays of extremities. It isintended to be used by a qualified andtrained clinician on adult patients andpediatrics. It is not intended to replace aradiographic system with variable tubecurrent and voltage (kVp), which may berequired for full optimization of imagequality and radiation exposure for differentexam types.	EzRay M (Model: VMX-P300) is a portablegeneral-purpose X-ray system that users canoperate with one hand. The device uses afixed tube current and voltage (kVp) and,therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used bya qualified and trained clinician on adultpatients. It is not intended to replace aradiographic system with variable tube currentand voltage (kVp), which may be required forfull optimization of image quality andradiation exposure for different exam types.
Device Name	CLAROX plus (VX-100)	EzRay M (Model: VMX-P300)
510k number	K221417	K203667
Manufacturer	VSI Co., Ltd.	Vatech Co., Ltd.
Principle ofOperation	General Purpose Diagnostic X-Ray	General Purpose Diagnostic X-Ray
Body Size	413mm(W) × 144mm(D) × 284mm(H)	279.4mm(L) × 137.2mm(W) ×282mm(H)
Weight	2.5kg	1.88kg
Source toimage receptordistance	650mm
Focal Spot	0.6 mm (complied with IEC 60336)	0.5mm
Collimator		Four manually and steplessly adjustableshutters with x-ray field indicator
User Interface	Jog dial for operating mode selection,control panel, control buttons (icons),display, and an exposure button	Jog dial for operating mode selection,display module, and exposure icons onit.
Energy Source	Rechargeable 22.2 V DC Li-ionpolymer battery core pack	Rechargeable 21.6 V DC Li-ion polymerbattery core pack
BatteryCapacity	1.46 A-hr
Rechargecapability	80% or above remaining capacity after300 cycles
Exposure time	0.1 - 1.0 seconds0.2 in 0.02 sec increments	0.05 - 1.0 secondsin 0.01 sec increments
TimerAccuracy	±(10% + 1 ms)
mA	1.0 mA	3.0 mA
kVp	70 kV - 100 kV (5kV step)	65 kVp fixed
Waveform	Constant Potential (DC)	Constant Potential (DC)

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Image /page/6/Picture/0 description: The image shows the logo for VSI, which stands for Value Service Innovation. The logo consists of a blue symbol on the left, which is made up of three circles connected together. To the right of the symbol is the text "Value Service Innovation" in a smaller font, followed by the letters "VSI" in a larger, bold font.

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Image /page/7/Picture/0 description: The image contains a logo with a blue circular design on the left and the text "Value Service Innovation VSI" on the right. The circular design consists of three interconnected circles, forming a trefoil shape. The text is in black, with "Value Service Innovation" appearing in a smaller font size above the larger "VSI" abbreviation.

Performance Data

Non-clinical test was performed in accordance with the following international standards,

-ANSI AAMI IEC 62304:2006 Medical Device Software - Software Life Cycle Processes
-EN ISO 14971:2019 Medical devices - Applications of risk management to medical devices
ANSI AAMI IEC 62366-1:2015+AMD1:2020 Medical devices Part 1: Application of usability engineering to medical devices
AAMI ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And -A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1; General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD)
EN 60601-1-2:2015, Electromagnetic Compatibility (EMC) Testing for Medical Devices including the NEW IEC 60601-1-2 4th Edition
-IEC 60601-1-3 Edition 2.1 2013-04 Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
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 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-54 Edition 1.2 2018-06 Medical Electrical Equipment Part 2-54: Particular -Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy
IEC/EN 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium systems

Clinical testing was not necessary for the VX-100, based on the nature of the device (an x-ray generator marketed without image detector). Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence.

Conclusion

The subject device is substantially equivalent in the areas of indications for use, general functions & features, principle of operation, and technological characteristics. The new device does not introduce a fundamentally new scientific technology. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.