(120 days)
Not Found
No
The summary describes a portable X-ray generator with manually adjustable settings and firmware for basic device functions. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies listed are standard electrical and safety tests for X-ray equipment.
No.
The device is described as a portable general-purpose X-ray system intended for taking diagnostic X-rays, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "limited to taking diagnostic X-rays of extremities" and is "intended to be used by a qualified and trained clinician on adult patients and pediatrics." Furthermore, the "Device Description" section notes that it is "designed to produce diagnostic quality X-ray images."
No
The device description clearly states it is a "portable general-purpose X-ray system" and describes physical components like a "main body (tube head), cone, cradle, and AC/DC adaptor." While it mentions software (firmware) supporting the functions, the core device is a hardware X-ray generator.
Based on the provided information, the CLAROX plus (Model: VX-100) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- CLAROX plus Function: The CLAROX plus is an X-ray system. It generates X-rays that pass through the body to create images of internal structures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is for taking diagnostic X-rays of extremities. This is an imaging procedure performed directly on the patient, not on a sample taken from the patient.
Therefore, the CLAROX plus falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
IZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
extremities
Indicated Patient Age Range
adult patients and pediatrics
Intended User / Care Setting
qualified and trained clinician
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)
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.
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
§ 892.1720 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name CLAROX plus (Model: VX-100)
Indications for Use (Describe)
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.
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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3
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:
II
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-
4
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
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
5
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. |
| Device | ||
| Classification | ||
| Name | Mobile X-ray System | Mobile X-ray System |
| Classification | ||
| Product Code | IZL | IZL |
| Regulation | ||
| Number | 21 CFR 892.1720 | 21 CFR 892.1720 |
| Regulation | ||
| Class | II | II |
| Indications | ||
| for Use | 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. | EzRay M (Model: VMX-P300) is a portable | |
| general-purpose X-ray system that users can | ||
| operate with one hand. The device uses a | ||
| fixed 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. 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 Name | CLAROX plus (VX-100) | EzRay M (Model: VMX-P300) |
| 510k number | K221417 | K203667 |
| Manufacturer | VSI Co., Ltd. | Vatech Co., Ltd. |
| Principle of | ||
| Operation | 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 to | ||
| image receptor | ||
| distance | 650mm | |
| Focal Spot | 0.6 mm (complied with IEC 60336) | 0.5mm |
| Collimator | Four manually and steplessly adjustable | |
| shutters 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 on | ||
| it. | ||
| Energy Source | Rechargeable 22.2 V DC Li-ion | |
| polymer battery core pack | Rechargeable 21.6 V DC Li-ion polymer | |
| battery core pack | ||
| Battery | ||
| Capacity | 1.46 A-hr | |
| Recharge | ||
| capability | 80% or above remaining capacity after | |
| 300 cycles | ||
| Exposure time | 0.1 - 1.0 seconds | |
| 0.2 in 0.02 sec increments | 0.05 - 1.0 seconds | |
| in 0.01 sec increments | ||
| Timer | ||
| Accuracy | ±(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) |
6
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.
7
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.