The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, lumbar spine, pelvis or extremities. The device may be used for imaging of the chest when used without a grid.

This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.

Device Description

This SR-8100 Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. Its high-definition imaging and low-dose X-ray significantly minimize harm to patients and practitioners. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit.

The device can be used with an X-ray detector (see the table below for the basic requirements), a computer for receiving and detecting signal results and image processing software.

The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery 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, the battery power status, 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 40~100kVp, which is not suitable for breast exams, the device is not intended for mammography.

AI/ML Overview

The provided text is a 510(k) summary for the SIUI SR-8100 Portable X-ray Unit. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics. Crucially, it explicitly states that "Clinical testing is not necessary for the SR-8100 Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device."

This means the document does not contain information about a clinical study involving human subjects or AI algorithms that would require acceptance criteria, sample sizes for test sets, expert ground truth establishment, or MRMC studies. The device described is a traditional X-ray unit, not an AI-powered diagnostic tool. Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following requested information cannot be found or is not applicable:

A table of acceptance criteria and the reported device performance: This is typically for clinical performance or AI algorithm performance. The document only discusses performance in terms of technical specifications (kV, mA, etc.) comparable to a predicate.
Sample sized used for the test set and the data provenance: No clinical test set is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set is described.
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: Not applicable, as this is solely an X-ray imaging device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical study with ground truth is mentioned.
The sample size for the training set: Not applicable, as this is not an AI algorithm.
How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

The document states that the "performance tests of the device shows that the performance specifications of the device comply with the requirements of mobile X-ray system." and "As confirmed by the radiologist, the results of the image quality test show that the clinical diagnostic requirements of the image quality of each part meet the criteria requirements." However, these are general statements about the device's image quality meeting clinical needs, not a structured clinical study with specific acceptance criteria and detailed performance metrics as would be required for an AI device.

Summary

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Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Flower Cai Liaison Manager 77 Jinsha Road Shantou. Guangdong 515041 CHINA

Re: K200637

Trade/Device Name: SR-8100 Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: June 12, 2020 Received: June 15, 2020

Dear Flower Cai:

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

July 9, 2020

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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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K200637

Device Name SR-8100 Portable X-ray Unit

Indications for Use (Describe)

The device may be used for handheld diagnostic imaging of body extremities.

This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is: K200637

Submitter 5.1

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)

77 Jinsha Road, Shantou, Guangdong 515041, China

Tel: 86-754-88250150

Fax: 86-754-88251499

Contact Person: Flower Cai

Shantou Institute of Ultrasonic Instruments Co., Ltd.

77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: June 12, 2020

5.2 Device

Name of Device: SR-8100 Portable X-ray Unit

Classification Name: Mobile x-ray system (21 CFR 892.1720)

Regulatory Class: II

Product Code: IZL

Predicate Device 5.3

The SR-8100 Portable X-ray Unit is for X-ray imaging, diagnosis and image acquisition with mobile or fixing sites, and is substantially equivalent to the predicate device:

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Legally MarketedDevice	Manufacturer	Model	510(k) ControlNumber
Primarypredicate device	MinXray, Inc	TR90BH	K182207
Reference device	DRGEM Corporation	JADE Mobile X-Ray	K183388

The reference device is for comparing the collimator parameters and output rating parameters of the portable X-ray units.

5.4 Device Description

This SR-8100 Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. Its high-definition imaging and low-dose X-ray significantly minimize harm to patients and practitioners. A detailed comparison table with an equivalent device is provided below. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit. See the photos below.

The device can be used with an X-ray detector (see the table below for the basic requirements), a computer for receiving and detecting signal results and image processing software.

The detector that can be used with SR-8100 shall comply with the following basic conditions:

Acceptable minimum X-ray range	40kV-100kV
Image Sensor	a-Si (Amorphous Silicon) TFT
Minimum Effective Array	2304 x 2800
Minimum Effective Area (H x V)	343 x 416 mm
Software	Configured with a basic imaging test toolfor image acquisition and display

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SIUI SR-8100 Portable X-ray Unit

Image /page/5/Picture/2 description: The image shows an X-ray main unit with several labeled components. The components labeled are the handle, control panel, enclosure, and collimator. The X-ray main unit is light blue and white and has a handle on top for easy transport.

The wavelength of medical X-ray spectrum used by the portable X-ray unit SR-8100 shall have a range 0.001-0.1nm.

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Indications for Use ર્સ રાજ્યના સાથે તેમની સાથે તેમની સાથે છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂ

The device may be used for handheld diagnostic imaging of body extremities.

The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.

The device may be used for imaging of the chest when used without a grid.

This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.

5.6 Comparison of Technological Characteristics with the Predicate Device

The comparison between the overall specifications of predicate device (TR90BH) and the new device (SR-8100) is shown in table 1, and the comparison between the Collimator specifications of reference device (JADE Mobile X-ray) and the new device (SR-8100) is shown in table 2. Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.

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Table 1 Subject and Predicate (TR90BH) Device Comparison

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Description	Subject DeviceSR-8100	Predicate DeviceTR90BH (K182207)
Comment onIndications	Original Indications	Certain limitations apply because of the lower maximum kVp output as compared to the predicate and because of the possibility of handheld use on extremities. See indications above.
Weight	12kgs (26.46lb)(Including Collimator)	7.5kgs (16.53lb)(Including Collimator)
Size	227mm×522mm×217mm	219 mm x 442 mm x 190 mm
Energy Source	Lithium-ion RechargeableBattery (29.6V DC),300 exposures per charge	Lithium-ion Rechargeable Battery(57.6VDC),300 exposures per charge.
Use Interface	Soft touch push buttons	Soft touch push buttons
Exposure times	0.02 sec – 2.5 sec: R'10 secStep	0.01 sec - 1.0 sec :0.01 sec StepHigh Power Mode0.01 sec – 0.3 sec:0.01 sec Step
mA	25 mA @ 40kVDC – 60kVDC (1kVP steps)20 mA @ 61kVDC – 100kVDC (1kVP steps)	20 mA @ 40kVDC – 60kVDC (2kVP steps)15 mA @ 62kVDC – 80kVDC (2kVP steps)10 mA @ 82kVDC – 90kVDC (2kVP steps)High Power Mode15 mA @ 82kVDC – 90kVDC (2kVP steps)0.02 Comment: 90 kVP maximum instead of 120 kVP maximum.

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SIUI SR-8100 Portable X-ray Unit

Description	Subject DeviceSR-8100	Predicate DeviceTR90BH (K182207)
Memory Settings(technique)	5 memories via pushbutton	5 memories via pushbutton
HF Generator	High Frequency	High Frequency
kW	2.0kW	1.35kW
kVp	40-100kVp	40-90kVp
X-ray Tube	D-125SB	D-0814
FDAPerformanceStandard	Complies	Complies
Collimator	SIUI SR-8100-19L	Mikasa BLD34L

Table 2 Subject and Reference Device (JADE-32) Comparison

Table 2 Subject and Reference Device (JADE-32) Comparison
Description	Subject Device	Reference Device
	SR-8100	JADE-32 (K183388)
Output Rating	Max. 2.0kW(20mA@100kV)	Max. 3.2kW(40mA@ 80kV,32mA@100kV,25mA@120kV)
Type	Microprocessor controlledHigh Frequency inverter	Microprocessor controlled HighFrequency inverter
kV Range	40~100kV,61 Step (1kV Step)	40~120kV,81 Step (1kV Step)
mA Range	20~25mA, 2 Step(20,25mA)	10~80mA, 10 Step(10,12.5,16,20,25,32,40,50,64,80mA)
Exposure Time	0.02~2.5 seconds,21 Step (in 25% Steps)	0.01~10 seconds,21 Step (in 25% Steps)
mAs Range	0.4~50mAs,35 Step ( in 25% Steps)	0.1~250mAs,35 Step ( in 25% Steps)
X-ray Tube Type	Stationary Anode	Stationary Anode
Focal Spot Size(Small/Large)	1.2mm	0.5/1.5mm
Anode Heat Storage Capacity	50,000HU (35,000J)	56,000HU (40,000J)

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SIUI SR-8100 Portable X-ray Unit

Description	Subject DeviceSR-8100	Reference DeviceJADE-32 (K183388)
Power CordLength	3m	5m
ExposureHand-switchCord Length	3m (Max. Length)	5m (Max. Length)
X-ray switchingfrequency	100kHz	100kHz
Control	2 Point Control (kV, mAs)	2 Point Control (kV, mAs)
AnatomicalPrograms	Preprogrammed 9 APR data-User Programmable	Preprogrammed 9 APR data-User Programmable

Table 3 Collimator Specs Comparison

Description	Subject DeviceSIUI SR-8100	Reference DeviceDRGEM JADE Mobile X-RaySystem (K183388)
Model	SR-8100-19L	KM1
Manufacturer	SIUI	DRGEM
Control	Manualwith 15,30,45,60sec. Lamp timer	Manual with 15, 30, 45, 60sec.Lamp timer
Field Shape	Rectangular	Rectangular
Max. Field Size	44x44cm (at 100cm SID)	44x44cm (at 100cm SID)
LeakageRadiation	< 40mR/hr. (at SID 1m)	< 40mR/hr. (at SID 1m)
Max. kVp shield	150kV	150kV
InherentFiltration	1.2mmAl eq.	2.0mmAl eq.
Light source	9W LED	19W LED
Standard	Rotating flange	Rotating flange

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Description	Subject DeviceSIUI SR-8100	Reference DeviceDRGEM JADE Mobile X-RaySystem (K183388)
Option	Tape measure (Max.200cm)	Tape measure (Max.200cm)
Electrical Rating	3-12VDC,10W	12 – 45VDC, 20W
Dimension/weight	170(W)×180(D)×105(H)mm /1.2kg(2.65lb)	172(W)×172(D)×97(H)mm/2.5kg(5.51lb)

5.7 Non-clinical Testing Summary

The SR-8100 Portable X-ray Unit complies with and/or was tested in accordance with the following FDA guidance and International Standards:

IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC60601-2-54: 2015 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-Ray equipment for radiography and radioscopy
IEC60601-1-3: 2013 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-Ray equipment
ISO 14971: 2007 Medical device -Application of risk management to medical devices
ISO 10993-1: 2018 Biological evaluation of medical devices-Part1: Evaluation and testing
ISO 10993-5:2009 Tests for in vitro cytotoxicity
ISO 10993-10:2010 Tests for irritation and delayed-type hypersensitivity
IEC 62304:2006+AMD1:2015 Medical device software – Software life-cycle processes
IEC 60601-1-6:2015 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – collateral standard: Usability
IEC 62366-1:2015/COR1:2016 Medical devices - Application of usability

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engineering to medical devices

. ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 13485 Quality management for medical devices
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

The subject device and the predicate device are comparable in terms of technical features, general functions, applications and intended uses. The test results showed compliance with the above standards. The performance tests of the device shows that the performance specifications of the device comply with the requirements of mobile X-ray system. As confirmed by the radiologist, the results of the image quality test show that the clinical diagnostic requirements of the image quality of each part meet the criteria requirements. Furthermore, the device runs stably during the test without any operating obstacles or failures. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate.

Software Description 5.8

The system control software of SR-8100 is new software designed by SIUI. The software adopts development languages of keil, the program language is C language, the hardware platform is ARM. 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, the battery power status, and control the display of the status indicators. The Level of Concern for the Software Device is Moderate.

5.9 Clinical Testing

Clinical testing is not necessary for the SR-8100 Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device.

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5.10 Conclusion

The subject device SR-8100 system and the predicate device are comparable in terms of technical features, general functions, applications and indications for use. The subject device SR-8100 system and reference device are comparable in terms of technical features, general functions, and collimator specs comparison.

The SR-8100 can be used for imaging including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities, and the predicate device TR90BH can be used for imaging of head, abdomen, extremities and chest. Compared with TR90BH, the SR-8100 can be used for additional imaging of cervical spine, lumbar spine and pelvis. In terms of safety, the exposure conditions and radiation doses used for X-ray exams of cervical spine, lumbar spine and pelvis are equivalent to the parameters and radiation doses required for head, abdomen, extremities and chest exams, which is not intended to increase risks of user safety; In terms of effectiveness, the clinical images of bone and soft tissues of the subject device can address doctor's diagnostic requirements for the sites. Nevertheless, it does not affect the safety and effectiveness of the SR-8100, nor does it change the indications for use of the SR-8100 unit.

The indications for use of the SR-8100 Portable X-ray Unit do not create new potential safety risks, and its performance is comparable as that of the marketed products. Therefore, the device is as safe and effective as the legally marketed 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.