The TOPA 12 Portable X-Ray Unit is intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures for acquiring X-ray images of the desired parts of patient anatomy of extremities.

Device Description

This portable radiographic unit (Model: TOPA12) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator. A cart or a stand can be used with the TOPA12. In addition, this unit has preset memory keys to store and select kV, The TOPA12 is used with a film-cassette or flatpanel detector.

This device is a mains-powered portable X-ray unit, designed and manufactured by NEUF.

Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.

The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), and system control software running on the SYS board. The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators.

The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.

Since the kV range of this device is 40~90kVp, which is not suitable for breast exams, the device is not intended for mammography.

The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This portable X-ray unit is designed for handheld or stand-mounted imaging. This portable X-ray unit can be configured to an optional portable stand/rack or use a stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.

AI/ML Overview

The provided text is a 510(k) summary for the TOPA12 Portable X-ray Unit. It outlines the device's indications for use, comparison with a predicate device, and performance data. However, it explicitly states:

"Clinical studies were not performed."

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance. The acceptance criteria and performance data provided are based on non-clinical testing and conformity to various electrical and safety standards.

Here's the information that can be extracted from the provided text regarding acceptance criteria and performance, as well as the limitations for your request:

A table of acceptance criteria and the reported device performance
- Since no clinical studies were performed, there are no acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) based on expert review of clinical images.
- The "reported device performance" in this document is primarily in relation to meeting recognized electrical, safety, and radiation protection standards, and a qualitative clinician review of sample images.

Acceptance Criterion (Implicit)	Reported Device Performance
Non-clinical Performance
Image Quality and Clinical Utility	Sample clinical images of extremities (Elbow, Hand, Knee, Ankle, Foot) were reviewed by a qualified clinician, who found them to be of good quality and clinical utility.
Software Validation	Performed.
Risk Analysis	Performed.
Standards Compliance (Examples from the list provided)
EN 60601-1:2006 (General requirements for basic safety)	Laboratory testing performed according to this standard.
IEC 60601-1-3:2008 (Radiation protection)	Laboratory testing performed according to this standard.
IEC 60601-1-6:2010 (Usability)	Laboratory testing performed according to this standard.
IEC 60601-2-54:2009 (Safety of X-ray equipment for radiography)	Laboratory testing performed according to this standard.
IEC 60601-1-2:2014 (Electromagnetic disturbances)	Laboratory testing performed according to this standard.
IEC 62133-2:2017 (Safety requirements for Lithium batteries)	Laboratory testing performed according to this standard.
IEC 62304:2006 (Medical device software life-cycle)	Laboratory testing performed according to this standard.
IEC 62366-1:2015 (Usability engineering)	Laboratory testing performed according to this standard.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set was used. The document mentions "Sample clinical images of extremities (Elbow, Hand, Knee, Ankle, Foot) were reviewed by a qualified clinician." The exact number of samples is not provided, nor is the data provenance (country, retrospective/prospective). This was likely a qualitative review for technical image quality rather than a diagnostic performance 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)
- "a qualified clinician" reviewed the sample images. The exact number of clinicians or their specific qualifications (e.g., specialty, years of experience) are not provided. Given the nature of the review (qualitative assessment of image quality), this was not a ground truth establishment for diagnostic performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no formal diagnostic performance test set with adjudication was described. Only a single "qualified clinician" is mentioned for reviewing sample images.
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 performed. The device is an X-ray unit, not an AI-powered diagnostic tool. The document states, "Clinical studies were not performed."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a portable X-ray unit for image acquisition, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for diagnostic performance, as no clinical study for diagnostic performance was conducted. For the qualitative review of sample images, the "ground truth" was implicitly the judgment of a "qualified clinician" regarding image quality and clinical utility.
The sample size for the training set
- Not applicable, as this is an X-ray imaging device, not an AI/CADe/CADx algorithm requiring a training set in the conventional sense.
How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned in the context of an AI algorithm.

Summary

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August 16, 2023

NEUF Inc. % Yeonwoo Lee Senior Staff CTI co., Ltd A-1712. 43. Iliik-ro Gwangmyeong-si, Gyeonggi-do 14353 SOUTH KOREA

Re: K230581

Trade/Device Name: TOPA12 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 3, 2023 Received: July 19, 2023

Dear Yeonwoo Lee:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of 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) K230581

Device Name TOPA12 Portable X-ray Unit

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 shows the logo for NEUF. The logo consists of a stylized X shape on the left, with the word "NEUF" in bold, black letters on the right. The X shape is divided into four sections, colored gray, pink, and blue. The word "NEUF" is in a sans-serif font and is slightly italicized.

510(k) Summary - K230581

I. SUBMITTER

NEUF Inc.

#103 Production Bldg. 13, Yulchonsandan 4-ro, Haeryong-myeon, Suncheon-si, Jeollanam-do, Republic of Korea

Woo Sang Lee CEO of NEUF Inc. Email: ceo@@neufgen.com TEL: +82-61-740-2847 FAX: +82-61-743-5331

Date Prepared: May 12, 2023

II. DEVICE

Trade or Proprietary Name:	TOPA12 Portable X-ray Unit
Common or Usual Name:	Mobile X-ray System
Classification Name:	System, X-Ray, Mobile
Regulation Number:	892.1720
Regulatory Class:	II
Product Code:	IZI

III. PREDICATE DEVICE

510(k) Number:	K222896
Trade/Device Name:	AirRay
Product Name:	Diagnostic X-ray Unit
Model Name:	AirRay
Manufacturer:	POSKOM CO., LTD
Regulation Number:	892.1720

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Image /page/4/Picture/0 description: The image contains the logo for NEUF. The logo consists of a stylized, abstract symbol to the left of the word "NEUF" in bold, sans-serif, black font. The symbol is composed of four curved shapes, each in a different color: gray, pink, blue, and light green. The word "NEUF" is positioned to the right of the symbol, with each letter clearly defined and evenly spaced.

Regulatory Class:	II
Product Code:	IZL

DEVICE DESCRIPTION IV.

This device is a mains-powered portable X-ray unit, designed and manufactured by NEUF.

Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.

The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.

Since the kV range of this device is 40~90kVp, which is not suitable for breast exams, the device is not intended for mammography.

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Image /page/5/Picture/0 description: The image contains the logo for NEUF. The logo consists of a stylized, four-pointed star-like shape to the left of the word "NEUF" in bold, sans-serif font. The star shape is divided into four sections, each with a different color: gray, pink, purple, and white. The word "NEUF" is in black.

INDICATIONS FOR USE V.

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Image /page/6/Picture/0 description: The image contains the logo for "NEUF". The logo consists of a stylized, abstract symbol on the left and the word "NEUF" in bold, black letters on the right. The symbol is a geometric shape with three distinct sections colored gray, pink, and blue. The word "NEUF" is written in a sans-serif font.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Item	Subject Device	Predicate Device
	TOPA12 Portable X-ray Unit	AirRay
	510(k) number : K230581	510(k) number : K222896
Indications for use	The TOPA 12 Portable X-Ray Unit is intendedfor use by a qualified/trained doctor ortechnician on adult subjects for takingdiagnostic radiographic exposures for acquiringX-ray images of the desired parts of patientanatomy of extremities.	The POSKOM Portable X-ray unit is a devicethat can conveniently generate X-rays fordiagnosis when the patientcondition is difficult to move. Mainly used bytrained specialists, doctors or radiologists.Indication:The POSKOM Battery Type Portable X-rayUnit is intended for use by a qualified/traineddoctor or technician on bothadult and pediatric subjects for takingdiagnostic radiographic exposures of the bodyparts.The device must be used for stand mounteddiagnostic imaging of head, abdomen, orextremities.The device must be used for stand mountedimaging of the chest.Applications can be performed with the patientsitting, standing, or lying in the prone orsupine position.Contraindication:The use of X-radiation for diagnostic purposesin the following subjects is contraindicated.- Pregnancy, especially first trimester	Similar
	Dimension	293×138×144mm	325 X 268 X 250 mm	Similar
	Item	Subject DeviceTOPA12 Portable X-ray Unit510(k) number : K230581	Predicate DeviceAirRay510(k) number : K222896
	Weight	5.5kg	5.0kg	Similar
	Output Power	1.2 kW	1.6kW	Similar
	Energy source	25.2VDC 5000mAh	Lithium Polymer Battery 3.7V5000mAh	Similar
	Exposure times	0.04 sec – 2 sec	0.02 sec – 2 sec	Similar
	Tube current	40kV ~ 50kV / 20mA / 0.4 ~ 20mAs51kV ~ 60kV / 15mA / 0.4 ~ 16mAs61kV ~ 70kV / 15mA / 0.4 ~ 16mAs71kV ~ 80kV / 15mA / 0.4 ~ 3.2mAs71kV ~ 80kV / 10mA / 4.0 ~ 20mAs81kV ~ 90kV / 10mA / 0.4 ~ 20mAs	20mA (50 ~ 80kV / 0.4 ~ 3.2mAs)10mA (50 ~ 70kV / 3.6 ~ 20mAs)10mA (71 ~ 80kV / 3.6 ~ 16mAs)15mA (81 ~ 90kV / 0.4 ~ 3.2mAs)8mA (81 ~ 90kV / 3.6 ~ 16mAs)	Similar
	Tube Voltage Range	40 – 90 kV	50 – 90 kVp	Similar
Memory settings	4 Memories	10 Memories	Different
HF Generator	High frequency	High frequency	Same
X-ray Tube	OX/80-0.8(CEI)	OX/70-1.0 (C.E.I.)	Different
Collimator	≥ 160 lx, max size 47 * 47 cm @ 1m	Double slit type and manually operation withLED Light indicator	Different
Product image	Image: TOPA12 Portable X-ray Unit	Image: AirRay	-

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Image /page/7/Picture/0 description: The image contains the word "NEUF" in bold, black, sans-serif font. To the left of the word is a stylized logo. The logo is composed of four triangular shapes, each in a different color: gray, pink, dark blue, and light blue. The logo is arranged in a way that creates a star-like or abstract geometric design.

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Image /page/8/Picture/0 description: The image contains the logo for NEUF. The logo consists of a stylized, abstract symbol on the left and the word "NEUF" in bold, sans-serif font on the right. The abstract symbol is composed of four curved shapes in different colors: gray, pink, and blue. The word "NEUF" is in black.

PERFORMANCE DATA VII.

Non-clinical testing

Sample clinical images of extremities (Elbow, Hand, Knee, Ankle, Foot) were reviewed by a qualified clinician, who found them to be of good quality and clinical utility. Software validation and risk analysis was performed.

Laboratory testing was performed according to the following standards:

EN 60601-1:2006/A1:2013/A12:2014/A2:2021AAMI ES60601-1:2005,ES60601-1:2005/AMD1:2012,ES60601-1:2005/AMD2:2021IEC 60601-1-3:2008	Medical electrical equipment -- Part 1: Generalrequirementsfor basic safety and essential performance
IEC 60601-1-3:2008/AMD1:2013IEC 60601-1-3:2008/AMD2:2021	Medical electrical equipment - Part 1-3: Generalrequirements for basic safety and essential performance- Collateral Standard: Radiation protection in diagnosticX-ray equipment
IEC 60601-1-6:2010,AMD1:2013, AMD2:2020	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability
IEC 60601-2-54:2009+A1:2015+A2:2018	Medical electrical equipment -- Part 2-54: Particularrequirements for the basic safety and essentialperformance of X ray equipment for radiography andradioscopy
IEC 60601-1-2:2014+A1:2020IEC 60601-1-2:2015/A1:2021	Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances –Requirements and tests
IEC 62133-2:2017	Secondary cells and batteries containing alkaline orother non-acid electrolytes - Safety requirements forportable sealed secondary cells, and for batteries madefrom them, for use in portable applications - Part 2:Lithium systems
IEC 62304:2006/AMD1:2016	Medical device software - Software life-cycle processes
IEC 62366-1:2015	Medical devices - Application of usability engineeringto medical devices

Clinical studies

Clinical studies were not performed.

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Image /page/9/Picture/0 description: The image shows the logo for NEUF. The logo consists of a stylized, four-pointed star-like shape on the left, with each point a different color: gray, pink, purple, and blue. To the right of the shape is the word "NEUF" in bold, black, sans-serif font. The letters are closely spaced, giving the word a solid, impactful appearance.

VIII. CONCLUSIONS

After analyzing bench tests, it is the conclusion of NEUF Inc. that the TOPA 12 Portable X-ray Unit is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it 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.