The new MODEL HF 718BD X-RAY SYSTEM is a stationary x-ray system for imaging of peripheral extremities. The new MODEL HF 718BD X-RAY SYSTEM is based on the predicate Model 715BD Series X-Ray System. The modifications to the Model 715BD Series X-Ray System to create the new MODEL HF 718BD X-RAY SYSTEM are summarized as:

The analog high voltage power supply in the predicate Model 715BD Series is replaced by a high-frequency high-voltage power supply in the new MODEL HF 718BD X-RAY SYSTEM.
The line frequency counting technology of the exposure timer in the predicate Model 715BD Series is replaced by a crystal controlled digital exposure timing system in the new MODEL HF 718BD X-RAY SYSTEM.
The current technique factors are moderately decreased from fixed 15 mA to fixed 10 mA in the new MODEL HF 718BD X-RAY SYSTEM.
The voltage display on the predicate Model 715BD is an analog meter. With the new MODEL HF 718BD X-RAY SYSTEM, the user sets the kV and exposure time (can be stored as a user preset) and the pre-set values are presented to the user on a digital display.
The Source to Detector distance for the new MODEL HF 718BD X-RAY SYSTEM is 29 inches, which is identical to the predicate Model 715BD. In addition to the exposure control microcontroller in the predicate Model 715BD Series, an additional microcontroller is applied in the power supply to receive communication of kV by the xray control unit in the new MODEL HF 718BD X-RAY SYSTEM.

AI/ML Overview

The provided document describes the acceptance criteria and study for the X-Cel X-Ray Corporation's HF 718BD X-Ray System. The submission is a 510(k) premarket notification, indicating the device is being deemed substantially equivalent to a legally marketed predicate device rather than undergoing a de novo approval process with extensive clinical trials. Therefore, the "acceptance criteria" here largely refer to demonstrating conformance to safety and performance standards relevant to X-ray systems, and "device performance" refers to its technical specifications and compliance with these standards, not clinical diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (based on predicate device equivalence and regulatory standards)	Reported Device Performance (HF 718BD X-Ray System technical characteristics)
Indications for Use: General purpose peripheral radiographic applications.	Indications for Use: Intended for use by qualified clinicians for the x-ray of hands and feet. (Equivalent to predicate, with added specificity for 'peripheral' as hands and feet).
Tube: Same as predicate.	Tube: Same. (Identical)
Tube Housing Assembly: Same as predicate.	Tube Housing Assembly: Same. (Identical)
Controller: Firmware exposure control.	Controller: Firmware exposure control. (Identical)
Display: Analog knob & numeric keypad.	Display: Touch Screen. (Similar, increased flexibility)
Exposure Timer: Firmware with AC line timing.	Exposure Timer: Firmware with crystal timing. (Similar, both methods set exposure time)
Orthoposer (Film Holder, Image Detector): Same as predicate.	Orthoposer (Film Holder, Image Detector): Same. (Identical)
High voltage Power Supply: Half wave rectified.	High voltage Power Supply: High frequency generator. (Similar, tested successfully to IEC 60601-1)
Beam Limiting Device: Same as predicate.	Beam Limiting Device: Same. (Identical)
High Voltage Setting: Pre-set by rotary control, 50kV to 70kV +/- 10%.	High Voltage Setting: Pre-set and by user entry, 50kV to 90kV +/- 10% adjustable in 2 kV steps. (Similar, both support preset kVp and time)
mA Setting: Fixed at 15mA.	mA Setting: Fixed at 10mA +/- 1%. (Similar, both support preset kVp and time)
Technique Factors Display: Analog display of Voltage and mA technique factors, Digital display of exposure time.	Technique Factors Display: Digital display of user-set Voltage and Exposure Time technique factors. (Similar, analog replaced by digital)
Exposure Timer Settings: User-defined exposure timer.	Exposure Timer Settings: Pre-set and user-defined exposure time settings. (Similar, additional feature of pre-sets)
Exposure Timer Display: Digital display of count of 60Hz line frequency of exposure.	Exposure Timer Display: Digital display of seconds of exposure. (Similar, modified display)
Power: 60Hz AC mains; 105 VAC to 130 VAC.	Power: 60Hz AC mains; 105 VAC to 130 VAC. (Identical)
Exposure Time: 0.10 to 3.0 seconds, +/- 10%, adjustable in steps.	Exposure Time: 0.050 to 0.500 seconds, +/- 10%, adjustable in steps. (Similar, high frequency generator allows shorter exposure time)
Source to Detector Distance: 29 inches.	Source to Detector Distance: 29 inches. (Identical)
Compliance with Regulatory Standards: Safety and effectiveness demonstrated through compliance with relevant standards.	Compliance with Regulatory Standards: Tested to and in compliance with standards including 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601-1 (3rd Ed), IEC 60601-1-2 (3rd Ed), IEC 60601-1-6, IEC 62304:2006, IEC 60601-2-54:2009, IEC 60601-3:2008, IEC TR 60878, EN ISO 14971, ISO 15223-1.
Software Validation: Ensure all design inputs and performance requirements are met.	Software Validation: Undergone software validation.
Performance Verification and Validation: Ensure all design inputs and performance requirements are met.	Performance Verification and Validation: Undergone performance verification and validation.

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

The document explicitly states: "This submission does not contain clinical data." Therefore, there is no clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for clinical performance evaluation. The "test set" in this context refers to non-clinical testing against engineering and safety standards.

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

Not applicable. As no clinical data was submitted, there was no ground truth establishment by experts for a clinical test set. The validation focused on engineering characteristics against standards.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring an adjudication method. Non-clinical testing involves comparing device output or characteristics against defined engineering specifications and standard requirements.

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

Not applicable. This device is an X-ray system, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is an X-ray system, not an algorithm, and its performance (e.g., image generation) is inherently part of a human-operated system for image acquisition.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was established by applicable regulations and standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601 series, ISO 14971) and engineering design inputs/performance requirements. The device was tested to ensure it met these established technical and safety benchmarks. There was no clinical ground truth (expert consensus, pathology, outcomes data, etc.) because no clinical data was presented.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" of data is used in the traditional sense. The device is a hardware X-ray system.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Arquilla, Inc. DBA X-Cel X-Ray Corporation % Cynthia J. Pillar, RAC Regulatory Consultant CJP Consulting, Inc. 5831 N. Kostner Avenue CHICAGO IL 60646

Re: K160857

Trade/Device Name: HF 718BD X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: November 29, 2016 Received: February 13, 2017

Dear Ms. Pillar:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

February 24, 2017

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Michael D. O'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160857

Device Name HF 718BD X-Ray System

Indications for Use (Describe)

The HF 718BD X-Ray System is intended for use by qualified clinicians for the x-ray of hands and feet.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/1 description: The image shows the logo for X-Cel X-Ray Corporation. The logo consists of a red circle with a white stylized image of an X-ray tube inside. To the right of the circle is the company name "X-CEL" in large, blue letters, with the words "X-RAY CORPORATION" in smaller letters below.

SECTION 5: 510(k) SUMMARY

510(k) Summary - TRADITIONAL 510(k)

Date Prepared:	November 28, 2016
Submitter:	X-Cel X-Ray Corporation4220 Waller StreetCrystal Lake, IL 60012Phone: 1 (815) 455-2470Facsimile: 1 (815) 455-4732
Contact:	Cynthia J. Pillar, Regulatory Consultant1 (773) 677-8886
Trade/ProprietaryName of Device:	Model HF 718BD X-Ray System
Common Name ofDevice:	Stationary x-ray system
Classification:	Class II per 21 CFR 892.1680, System, X-Ray, Stationary, ProductCode KPR
Legally MarketedPredicate Device:	X-Cel X-Ray Model 700 Series P-75W/P-75M, manufactured by X-Cel X-Ray Corporation (K811230)

Description of the New MODEL HF 718BD X-RAY SYSTEM 5.1

1. The analog high voltage power supply in the predicate Model 715BD Series is replaced by a high-frequency high-voltage power supply in the new MODEL HF 718BD X-RAY SYSTEM.

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Image /page/4/Picture/1 description: The image contains the logo for X-Cel X-Ray Corporation. The logo consists of a red circle on the left with a white stylized image inside, resembling an X-ray tube. To the right of the circle is the company name "X-CEL" in large, blue, bold letters, with a line extending from the "X" to the "E". Below "X-CEL" is the text "X-RAY CORPORATION" in a smaller, sans-serif font.

1. The line frequency counting technology of the exposure timer in the predicate Model 715BD Series is replaced by a crystal controlled digital exposure timing system in the new MODEL HF 718BD X-RAY SYSTEM.
1. The current technique factors are moderately decreased from fixed 15 mA to fixed 10 mA in the new MODEL HF 718BD X-RAY SYSTEM.
1. The voltage display on the predicate Model 715BD is an analog meter. With the new MODEL HF 718BD X-RAY SYSTEM, the user sets the kV and exposure time (can be stored as a user preset) and the pre-set values are presented to the user on a digital display.

The Source to Detector distance for the new MODEL HF 718BD X-RAY SYSTEM is 29 inches, which is identical to the predicate Model 715BD. In addition to the exposure control microcontroller in the predicate Model 715BD Series, an additional microcontroller is applied in the power supply to receive communication of kV by the xray control unit in the new MODEL HF 718BD X-RAY SYSTEM.

5.2 Intended Use of the Device

The intended use of the new MODEL HF 718BD X-RAY SYSTEM is identical to the predicate device. Both devices are stationary X-ray systems intended for use in clinical settings by qualified clinical professionals for X-ray of peripheral extremities such as the hand and foot.

5.3 Indication for Use Statements

The Indications for Use of the new MODEL HF 718BD X-RAY SYSTEM is equivalent to the predicate device:

The Model HF 718BD X-Ray System is intended for use by qualified clinicians for the x-ray of hands and feet.

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Image /page/5/Picture/1 description: The image contains the logo for X-Cel X-Ray Corporation. The logo consists of a red circular emblem on the left, featuring a stylized white figure resembling a person with radiating lines. To the right of the emblem, the text "X-CEL" is displayed in a bold, dark blue font. Below "X-CEL", the words "X-RAY CORPORATION" are printed in a smaller, lighter font.

5.3 Summary of Technological Characteristics

The following table provides a side-by-side comparison the new MODEL HF 718BD X-RAY SYSTEM to the predicate device applied to support this notification.

Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature orComponent	NEW Model HF718BD X-Ray System	Predicate Model 700SeriesP-75W/P-75M(K811230)	Variance Explanation:
Indicationsfor Use	The Model HF 718BDX-Ray System isintended for use byqualified clinicians forthe x-ray of hands andfeet.	The HF718 X-RaySystem is intendedfor general purposeperipheralradiographicapplications.	Equivalent - addedspecification for use byclinicians and specified'peripheral' as hands andfeet.
Tube	Same	Same	Identical
TubeHousingAssembly	Same	Same	Identical
Controller	Firmware exposurecontrol.	Firmware exposurecontrol.	Identical
Display	Touch Screen	Analog knob &numeric keypad	Similar, increased flexibilityfor user selection of settings.
ExposureTimer	Firmware with crystaltiming	Firmware with ACline timing	Similar, both methods set theexposure time.
Orthoposer,(Film Holder,ImageDetector)	Same	Same	Identical
High voltagePowerSupply	High frequencygenerator	Half wave rectified	Similar, tested successfullyto IEC 60601-1.
BeamLimitingDevice	Same	Same	Identical
High VoltageSetting	Pre-set and by userentry50kV to 90kV +/- 10%adjustable in 2 kV steps	Pre-set by rotarycontrol50kV to 70kV+/-10%	Similar, both devicessupport preset of the kVpand time technique factors.

X-CEL X-RAY CORPORATION 4220 WALLER STREET CRYSTAL LAKE, IL 60012 U.S.A. O: 815-455-2470 F: 815-455-4732 www.xcelxray.com

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Image /page/6/Picture/1 description: The image is a logo for X-Cel X-Ray Corporation. The logo consists of a red circle with a white design inside, followed by the text "X-CEL" in blue, and the text "X-RAY Corporation" in gray below it. The design inside the red circle appears to be a stylized representation of an X-ray tube.

mA Setting	Fixed at 10mA +/-1%	Fixed at 15mA	Similar, both devicessupport preset of the kVpand time technique factors.
TechniqueFactorsDisplay	Digital display of user-set Voltage andExposure Timetechnique factors	Analog display ofVoltage and mAtechnique factors.Digital display ofexposure time	Similar, analog display ofVoltage and mA replaced bydigital display.
ExposureTimerSettings	Pre-set and user-defined exposure timesettings	User-definedexposure timer	Similar - additional featureof pre-sets.
ExposureTimerDisplay	Digital display ofseconds of exposure	Digital display ofcount of 60Hz linefrequency ofexposure	Similar - modified displayto show seconds ofexposure.
Power	60Hz AC mains; 105VAC to 130 VAC	60Hz AC mains; 105VAC to 130 VAC	Identical
ExposureTime	0.050 to 0.500 seconds,+/-10%, adjustable insteps	0.10 to 3.0seconds,+/-10%,adjustable in steps	Similar, High frequencygenerator allows for shorterexposure time.
Source toDetectorDistance	29 inches	29 inches	Identical

TABLE 5.3-1 – SUBSTANTIAL EQUIVALENCE TECHNICAL CHARACTERISTICS

The new MODEL HF 718BD X-RAY SYSTEM has been tested for performance. The technological differences between the new MODEL HF 718BD X-RAY SYSTEM and the predicate have raise no new question with regard to safety or effectiveness.

5.4 Determination of Substantial Equivalence – Clinical

This submission does not contain clinical data.

5.4 Determination of Substantial Equivalence - Non-clinical

The new MODEL HF 718BD X-RAY SYSTEM was subjected to testing to applicable regulations and standards to support the claim of substantial equivalence as shown in Table 5.4-1 below:

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Image /page/7/Picture/1 description: The image is a logo for X-Cel X-Ray Corporation. The logo features a red circle on the left with a white stylized image of an X-ray tube inside. To the right of the circle is the company name "X-CEL" in large, blue letters, with a line extending from the "X" to the "C". Below the company name is the text "X-RAY CORPORATION" in smaller, black letters.

Table 5.4-1: Regulation and Standards
Test/PerformanceStandard Reference:	Test/Standard Title:
21 CFR 1020.30	Diagnostic x-ray systems and their major components.
21 CFR 1020.31	Radiographic equipment
60601-1 3rd Edition	Medical electrical equipment - Part 1: General requirements for safety
60601-1-2 3rd Edition	Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance – Collateral Standard:Electromagnetic compatibility – Requirements and tests
60601-1-6	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance – Collateral Standard: Usability
62304:2006	Medical device software – Software life cycle processes
60601-2-54:2009 –Ed.1.0	Medical electrical equipment - Part 2-54: Particular requirements forthe basic safety and essential performance of X-ray equipment forradiography and radioscopy
60601-3:2008-Ed. 2.0	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance – Collateral Standard:Radiation protection in diagnostic X-ray equipment
IEC TR 60878	Graphical symbols for electrical equipment in medical practice
EN ISO 14971	Application of risk management to medical devices
ISO 15223-1	Medical devices – Symbols to be used with medical device labels,labeling, and information to be supplied

The new MODEL HF 718BD X-RAY SYSTEM was designed by X-Cel X-Ray Corporation in compliance with 21 CFR 820. The new MODEL HF 718BD X-RAY SYSTEM has undergone software validation as well as performance verification and validation to ensure it meets all design inputs and performance requirements.

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Image /page/8/Picture/1 description: The image contains the logo for X-CEL X-Ray Corporation. The logo features a red circle on the left with a white abstract design inside, resembling a stylized human figure with radiating lines. To the right of the circle, the text "X-CEL" is written in a bold, blue font. Below "X-CEL", the words "X-RAY CORPORATION" are written in a smaller, lighter font, also in blue.

5.5 Conclusion

The conclusions drawn from the specifications and performance testing of the new MODEL HF 718BD X-RAY SYSTEM demonstrate that the new MODEL HF 718BD X-RAY SYSTEM is at least as safe and effective and performs as well or better than the predicate X-Cel X-Ray Model 700 Series P-75W/P-75M, manufactured by X-Cel X-Ray Corporation (K811230). For these reasons, we believe the new MODEL HF 718BD X-RAY SYSTEM device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.