(332 days)
Not Found
No
The device description focuses on hardware modifications and digital control systems, with no mention of AI or ML algorithms for image processing, analysis, or other functions.
No
This device is an X-ray system used for imaging hands and feet, which is a diagnostic purpose, not therapeutic.
Yes
Explanation: The device is an X-ray system intended for the imaging of hands and feet by qualified clinicians, which generates images used for diagnosis.
No
The device description clearly outlines hardware components such as a high-frequency high-voltage power supply, a crystal controlled digital exposure timing system, and microcontrollers, indicating it is a physical X-ray system, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The HF 718BD X-Ray System is an imaging device that uses X-rays to create images of the hands and feet. It does not perform any tests on biological samples.
- Intended Use: The intended use is for "x-ray of hands and feet," which is a diagnostic imaging procedure, not an in vitro diagnostic test.
The information provided clearly describes a medical imaging system, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
The HF 718BD X-Ray System is intended for use by qualified clinicians for the x-ray of hands and feet.
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
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 analog high voltage power supply in the predicate Model 715BD Series is replaced by a high-frequency high-voltage power supply. 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. The current technique factors are moderately decreased from fixed 15 mA to fixed 10 mA. The voltage display on the predicate Model 715BD is an analog meter, while 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
hands and feet (peripheral extremities)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinicians / clinical settings
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)
This submission does not contain clinical data.
Non-clinical testing was performed to applicable regulations and standards: 21 CFR 1020.30, 21 CFR 1020.31, 60601-1 3rd Edition, 60601-1-2 3rd Edition, 60601-1-6, 62304:2006, 60601-2-54:2009 – Ed.1.0, 60601-3:2008-Ed. 2.0, IEC TR 60878, EN ISO 14971, ISO 15223-1.
The device underwent software validation as well as performance verification and validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
X-Cel X-Ray Model 700 Series P-75W/P-75M, manufactured by X-Cel X-Ray Corporation (K811230)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 Corporation |
| 4220 Waller Street | |
| Crystal Lake, IL 60012 | |
| Phone: 1 (815) 455-2470 | |
| Facsimile: 1 (815) 455-4732 | |
| Contact: | Cynthia J. Pillar, Regulatory Consultant |
| 1 (773) 677-8886 | |
| Trade/Proprietary | |
| Name of Device: | Model HF 718BD X-Ray System |
| Common Name of | |
| Device: | Stationary x-ray system |
| Classification: | Class II per 21 CFR 892.1680, System, X-Ray, Stationary, Product |
| Code KPR | |
| Legally Marketed | |
| Predicate 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
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.
4
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.
-
- 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.
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.
5
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 or | ||||||
| Component | NEW Model HF | |||||
| 718BD X-Ray System | Predicate Model 700 | |||||
| Series | ||||||
| P-75W/P-75M | ||||||
| (K811230) | Variance Explanation: | |||||
| Indications | ||||||
| for Use | The Model HF 718BD | |||||
| X-Ray System is | ||||||
| intended for use by | ||||||
| qualified clinicians for | ||||||
| the x-ray of hands and | ||||||
| feet. | The HF718 X-Ray | |||||
| System is intended | ||||||
| for general purpose | ||||||
| peripheral | ||||||
| radiographic | ||||||
| applications. | Equivalent - added | |||||
| specification for use by | ||||||
| clinicians and specified | ||||||
| 'peripheral' as hands and | ||||||
| feet. | ||||||
| Tube | Same | Same | Identical | |||
| Tube | ||||||
| Housing | ||||||
| Assembly | Same | Same | Identical | |||
| Controller | Firmware exposure | |||||
| control. | Firmware exposure | |||||
| control. | Identical | |||||
| Display | Touch Screen | Analog knob & | ||||
| numeric keypad | Similar, increased flexibility | |||||
| for user selection of settings. | ||||||
| Exposure | ||||||
| Timer | Firmware with crystal | |||||
| timing | Firmware with AC | |||||
| line timing | Similar, both methods set the | |||||
| exposure time. | ||||||
| Orthoposer, | ||||||
| (Film Holder, | ||||||
| Image | ||||||
| Detector) | Same | Same | Identical | |||
| High voltage | ||||||
| Power | ||||||
| Supply | High frequency | |||||
| generator | Half wave rectified | Similar, tested successfully | ||||
| to IEC 60601-1. | ||||||
| Beam | ||||||
| Limiting | ||||||
| Device | Same | Same | Identical | |||
| High Voltage | ||||||
| Setting | Pre-set and by user | |||||
| entry | ||||||
| 50kV to 90kV +/- 10% | ||||||
| adjustable in 2 kV steps | Pre-set by rotary | |||||
| control | ||||||
| 50kV to 70kV+/- | ||||||
| 10% | Similar, both devices | |||||
| support preset of the kVp | ||||||
| and 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 devices
support preset of the kVp
and time technique factors. |
|-----------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Technique
Factors
Display | Digital display of user-
set Voltage and
Exposure Time
technique factors | Analog display of
Voltage and mA
technique factors.
Digital display of
exposure time | Similar, analog display of
Voltage and mA replaced by
digital display. |
| Exposure
Timer
Settings | Pre-set and user-
defined exposure time
settings | User-defined
exposure timer | Similar - additional feature
of pre-sets. |
| Exposure
Timer
Display | Digital display of
seconds of exposure | Digital display of
count of 60Hz line
frequency of
exposure | Similar - modified display
to show seconds of
exposure. |
| Power | 60Hz AC mains; 105
VAC to 130 VAC | 60Hz AC mains; 105
VAC to 130 VAC | Identical |
| Exposure
Time | 0.050 to 0.500 seconds,
+/-10%, adjustable in
steps | 0.10 to 3.0
seconds,+/-10%,
adjustable in steps | Similar, High frequency
generator allows for shorter
exposure time. |
| Source to
Detector
Distance | 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/Performance | |
| Standard 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 for |
| basic safety and essential performance – Collateral Standard: | |
| Electromagnetic compatibility – Requirements and tests | |
| 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for |
| basic 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 for |
| the basic safety and essential performance of X-ray equipment for | |
| radiography and radioscopy | |
| 60601-3:2008-Ed. 2.0 | Medical electrical equipment - Part 1-3: General requirements for |
| basic 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.