(121 days)
The TR90BH is a portable X-ray system with following limitations of use:
The device may be used for handheld diagnostic imaging of body extremities
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device may be used for stand mounted imaging of the chest when used without a grid.
- Not to be used on bariatric patients, unless imaging body extremities
- Not for mammography use
- The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
We have developed compact, lightweight, battery powered easy-carry TR90BH based on the technology of HF1202H. This device can be used with a stand or hand-held. A detailed comparison table with an equivalent device is provided below. The MinXray TR90BH consists of a battery powered X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, battery charger, AC adaptor and AC power cord, and those are provided in a portable carry case with wheels. If a stand is purchased with the TR90BH, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the TR90BH are included with the stand. The device works with a dedicated secondary Lithiumion battery, therefore it can be operated at no power supply places such as disaster sites. A few number of shots can be taken in short chanks to the newly designed and superior patent licensed battery. The x-ray tube is Toshiba Electron Tubes & Devices D-0814 0.8mm, 9.86kHU which is designed for diagnostic x-ray applications. 2-stage exposure switch: The exposure switch has 2-stage button. The first stage preheats the filament of the x-ray tube and lights collimator enabling operator to confirm exposure area. After keeping the button position at the first stage end for approximately 1 second, exposure preparation will be done and the STAND BY indicator will light. The second stage initiates the x-ray exposure for the sec display in advance. When the second stage is fully pressed, x-ray will be emitted, the X-RAY indicator will light, and an audible signal will be heard. One must PRESS AND HOLD THE SECOND STAGE END POSITION UNTIL THE EXPOSURE HAS TERMINATED. The switch operates in a "dead man" mode in that x-ray exposure will terminate immediately as a safety feature when the button is released.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic imaging AI would. Instead, this document is a 510(k) summary for an X-ray system (TR90BH), focusing on demonstrating substantial equivalence to a predicate device based on technical specifications, safety standards compliance, and intended use.
However, I can extract the information that is present concerning testing and validation.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) or image quality metrics. Instead, it relies on demonstrating compliance with recognized safety and performance standards for X-ray equipment and a general assessment of its functionality and image output.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Safety Standards | The device complies with numerous IEC standards including IEC 60601-1 (General Requirements for Safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (Radiation Protection), IEC 60601-1-6 (Usability), IEC 60601-2-28 (X-ray source assemblies), IEC 60601-2-54 (Radiography/Radioscopy), IEC 62304 (Software life-cycle), and IEC 62366 (Usability Engineering). |
| Battery Safety & Performance | Battery performance testing performed according to UN "Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria." Successfully passed: Altitude simulation, Thermal test, Vibration, Shock, External short circuit, Impact, Overcharge, and Forced discharge. |
| Image Quality / Functionality | "Overall operation by taking and reviewing test images" confirmed. (No specific quantitative metrics for image quality are provided beyond this general statement.) |
| Ability to image non-extremities | "A limited clinical test was performed to demonstrate that the device could image anatomy other than extremities." This test was "successful." |
| Software Performance | Software is "unchanged" from predicate, with a "moderate level of concern" and risk analysis performed. A power-on password routine added for cybersecurity. |
| Safety for Hand-Held Use | Took into account FDA Guidance: "Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use; Document issued on December 24, 2008." Involved extra shielding and cautionary labeling. Meets US Performance standard on leakage. |
| Substantial Equivalence | Concluded to be as safe and effective as the predicate device (HF1202H PowerPlus™ K153059), with few technological differences and similar indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for clinical test: The document states "A limited clinical test was performed." No specific number of patients or images is provided.
- Data provenance: Not specified. It's likely an internal test conducted by MinXray Inc. or a contracted entity, given the nature of a 510(k) submission for an X-ray system rather than a diagnostic AI. The test was clinical in nature, implying prospective data collection, but details are absent.
3. 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)
- Number of experts: One expert.
- Qualifications of experts: "A Board Certified Radiologist performed a successful review." No details on years of experience or specialization beyond being Board Certified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. Only one expert was involved in the review.
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
- MRMC study: No, an MRMC comparative effectiveness study was not done. This device is an X-ray system, not an AI-powered diagnostic tool for interpretation. Its evaluation focuses on hardware performance, safety, and image generation, not reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable in the context of diagnostic AI. This device is an X-ray machine. The "clinical test" assessed its ability to image anatomy, not its performance as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth for clinical test: The "successful review" by a Board Certified Radiologist served as the ground truth, confirming the device's ability to image anatomy. This is essentially expert review/opinion on imaging capability rather than a ground truth for a specific disease diagnosis.
8. The sample size for the training set
- Training set sample size: Not applicable. This document describes an X-ray hardware system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2018
MinXray, Inc % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FLORIDA 34114
Re: K182207
Trade/Device Name: TR90BH Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: October 9, 2018 Received: October 22, 2018
Dear Daniel Kamm:
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/cfpmp/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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Nils
for Robert A. 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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Indications for Use
510(k) Number (if known) K182207
Device Name TR90BH (Portable Diagnostic X-Ray System)
Indications for Use (Describe)
The TR90BH is a portable X-ray system with following limitations of use:
The device may be used for handheld diagnostic imaging of body extremities
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device may be used for stand mounted imaging of the chest when used without a grid.
-
Not to be used on bariatric patients, unless imaging body extremities
-
Not for mammography use
-
The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
Type of Use (Select one or both, as applicable)
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: 510(k) Number K182207 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Date Prepared: December 11, 2018 Contact: Keith Kretchmer, President
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- Identification of the Device: Trade/Device Names: TR90BH Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL Common/Usual Name: Mobile Diagnostic X-Ray System
- Equivalent legally marketed device: K153059 Trade/Device Name: HF1202H PowerPlus™ Portable X-Ray Equipment Manufacturer: MinXray, Inc. Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL Common/Usual Name: Mobile Diagnostic X-Ray System
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- Indications for Use (intended use): The TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid.
- Not to be used on bariatric patients, unless imaging body extremities
- Not for mammography use
-
The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
-
- Reference Device: MinXray Model HF80H cleared for general purpose radiography in K945707. This device provides a range of technique factors closely comparable to the new TR90BH but using older technology. The HF80H was a 10 mA model. It was soon followed by a 15 mA model known as the HF80H+. FDA advised us that it was not necessary to submit a new 510(k) when we released HF80H+ with 15 mA and the same kV range. The concern is that higher mAs factors needed for properly imaging thicker body parts (e.g. chest, abdomen) would need to be achieved via longer exposure times leading to patient motion artifact, but this reference device has a fixed ma capability of 15 ma and a maximum kVp of 80, whereas the new TR90BH has the same ma capability of 15 mA at a maximum kVp of 90. Therefore longer exposure times would not be needed with the new device as compared to this reference device. The same Technique Chart we provided for the HF80H+ could be used for the TR90BH. The new device does have higher mA capability, 20 mA at up to 60 kVp. A comparison chart follows.
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| HF80H+ K945707 | TR90BH K182207 | |
|---|---|---|
| mA & kVp | 15 mA, fixed | 20 mA @ 40 kVDC – 60 kVDC (2 kVP steps) |
| 50-80 kVp | 15 mA @ 62 kVDC – 80 kVDC (2 kVP steps) | |
| 10 mA @ 82 kVDC – 90 kVDC (2 kVP steps) | ||
| High Power Mode | ||
| 15 mA @ 82 kVDC – 90 kVDC (2 kVP steps) | ||
| Exposure | 0.08-3.98 sec, 0.02 steps. | 0.01-1.0 sec in 0.01 sec steps. |
| times | High Power Mode 82-90 kV @ 15 mA the | |
| maximum exposure time is 0.30 sec. | ||
| HF1202H PowerPlus™ K153059 | TR90BH | |
| Intended Use: | This radiographic system is intended for useby a qualified/trained physician or technicianon both adult and pediatric subjects fortaking diagnostic x-rays. Not formammographic use. | The TR90BH is a portable X-ray system withfollowing limitations of use:The device may be used for handheld diagnosticimaging of body extremities. The device may beused for stand mounted diagnostic imaging ofhead, abdomen, or extremities. The device maybe used for stand mounted imaging of the chestwhen used without a grid. - Not to be used onbariatric patients, unless imaging bodyextremities - Not for mammography use- The TR90BH is not intended to replace astationary radiographic system, which may berequired for full optimization of image qualityand radiation exposure for different exam types. |
| Comment onIndications | Original Indications | Certain limitations apply because of the lowermaximum kVp output as compared to thepredicate and because of the possibility ofhandheld use on extremities. See indicationsabove. |
| Weight: | 19.5kgs | 7.5kgs |
| Size / | 305 x 460 x 225 mm | 219 x 442 x 190 mm |
| Energy Source: | 120/240 V 50 - 60AC | Lithium-ion Rechargeable Battery(57.6DC), 300 exposures per charge. |
| Use Interface: | Soft touch push buttons | SAME |
| Exposure times: | (0.02–0.2sec) in 0.01sec. Step(0.2-0.4sec) in 0.02sec. Step(0.4-1.0sec) in 0.05sec Step(1.0-5.0sec) in 0.1sec Step | 0.01 sec – 1.0 sec : 0.01 sec StepHigh Power Mode0.01 sec - 0.3 sec : 0.01 sec Step |
| mA: | 60 mA(0.02-0.05sec), 45mA (0.06 –0.2sec),33 mA(0.22-5.0sec), @ 40 – 60 kVDC55 mA(0.02-0.05sec), 41.3mA (0.06 –0.2sec),30.3 mA(0.22-5.0sec), @ 62 – 70 kVDC50 mA(0.02-0.05sec), 37.5mA (0.06 –0.2sec),27.5 mA(0.22-5.0sec), @ 72 – 80 kVDC45 mA(0.02-0.05sec), 33.8mA (0.06 – 0.2sec),24.8 mA(0.22-5.0sec), @ 82 – 90 kVDC40 mA(0.02-0.05sec), 30.0mA (0.06 – 0.2sec),22.0 mA(0.22-5.0sec), @ 92 – 100 kVDC30 mA(0.02-0.05sec), 22.5mA (0.06 – 0.2sec),16.5 mA(0.22-5.0sec), @ 102 – 110 kVDC25 mA(0.02-0.05sec), 18.8mA (0.06 –0.2sec),13.8 mA(0.22-5.0sec), @ 112 – 120 kVDC | 20 mA @ 40 kVDC - 60 kVDC (2 kVP steps)15 mA @ 62 kVDC - 80 kVDC (2 kVP steps)10 mA @ 82 kVDC - 90 kVDC (2 kVP steps)High Power Mode15 mA @ 82 kVDC – 90 kVDC (2 kVP steps)Comment: 90 kVP maximum instead of 120 kVPmaximum. |
| HF1202H PowerPlus™ K153059 | TR90BH | |
| Memorysettings(technique) | 10 memories via pushbutton | 5 memories via pushbutton |
| HF Generator | High Frequency | SAME |
| kW | 1.5 kW | 1.35 kW |
| kVp: | 40 – 120kVp | 40 – 90kVp |
| X-ray Tube | SXR 130-15-1.2 | D-0814 |
| FDAPerformanceStandard | Complies | Complies |
| Collimator | Collimare® | Mikasa BLD34L |
| Photo |
-
- Description of the Device: We have developed compact, lightweight, battery powered easy-carry TR90BH based on the technology of HF1202H. This device can be used with a stand or hand-held. A detailed comparison table with an equivalent device is provided below. The MinXray TR90BH consists of a battery powered X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, battery charger, AC adaptor and AC power cord, and those are provided in a portable carry case with wheels. If a stand is purchased with the TR90BH, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the TR90BH are included with the stand. The device works with a dedicated secondary Lithiumion battery, therefore it can be operated at no power supply places such as disaster sites. A few number of shots can be taken in short chanks to the newly designed and superior patent licensed battery. The x-ray tube is Toshiba Electron Tubes & Devices D-0814 0.8mm, 9.86kHU which is designed for diagnostic x-ray applications. 2-stage exposure switch: The exposure switch has 2-stage button. The first stage preheats the filament of the x-ray tube and lights collimator enabling operator to confirm exposure area. After keeping the button position at the first stage end for approximately 1 second, exposure preparation will be done and the STAND BY indicator will light. The second stage initiates the x-ray exposure for the sec display in advance. When the second stage is fully pressed, x-ray will be emitted, the X-RAY indicator will light, and an audible signal will be heard. One must PRESS AND HOLD THE SECOND STAGE END POSITION UNTIL THE EXPOSURE HAS TERMINATED. The switch operates in a "dead man" mode in that x-ray exposure will terminate immediately as a safety feature when the button is released.
Technology: The basic technology has not changed, however the TR90BH uses a new designed secondary battery unit. Our labeling shows that it is possible to operate the unit in a "hand held" mode. We took the following FDA guidance into account: Guidance for Industry and FDA Staff Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use; Document issued on December 24, 2008. The software and microprocessors are the same as those used in our predicate design, with a moderate level of concern applicable to this kind of software. A power-on password routine has been added to address cybersecurity concerns. This would prevent unauthorized use of the device.
- Description of the Device: We have developed compact, lightweight, battery powered easy-carry TR90BH based on the technology of HF1202H. This device can be used with a stand or hand-held. A detailed comparison table with an equivalent device is provided below. The MinXray TR90BH consists of a battery powered X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, battery charger, AC adaptor and AC power cord, and those are provided in a portable carry case with wheels. If a stand is purchased with the TR90BH, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the TR90BH are included with the stand. The device works with a dedicated secondary Lithiumion battery, therefore it can be operated at no power supply places such as disaster sites. A few number of shots can be taken in short chanks to the newly designed and superior patent licensed battery. The x-ray tube is Toshiba Electron Tubes & Devices D-0814 0.8mm, 9.86kHU which is designed for diagnostic x-ray applications. 2-stage exposure switch: The exposure switch has 2-stage button. The first stage preheats the filament of the x-ray tube and lights collimator enabling operator to confirm exposure area. After keeping the button position at the first stage end for approximately 1 second, exposure preparation will be done and the STAND BY indicator will light. The second stage initiates the x-ray exposure for the sec display in advance. When the second stage is fully pressed, x-ray will be emitted, the X-RAY indicator will light, and an audible signal will be heard. One must PRESS AND HOLD THE SECOND STAGE END POSITION UNTIL THE EXPOSURE HAS TERMINATED. The switch operates in a "dead man" mode in that x-ray exposure will terminate immediately as a safety feature when the button is released.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.
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- Summary of non-clinical testing: The software is unchanged with a moderate level of concern. Risk analysis was performed. Laboratory testing was performed according to the following standards:
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) Medical Electrical Equipment, Part 1: General Requirements for Safety
- Summary of non-clinical testing: The software is unchanged with a moderate level of concern. Risk analysis was performed. Laboratory testing was performed according to the following standards:
IEC 60601-1-2:2007 Medical Electrical Equipment-Part 1-2: General Requirements for Safety – 2. Collateral Standard-Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3:2008 (Second Edition) for use with IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
IEC 60601-1-6:2010 (Third Edition) for use in conjunction with IEC 60601-1: 2005 (Third Edition)Medical electrical equipment Part 1-6: General requirements for safety – Collateral Standard: Usability
IEC 60601-2-28:2010 (Second Edition) for use in conjunction with IEC 60601-1: 2005 (Third edition) Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-54 (First Edition): 2009 Medical electrical equipment Part 2: Particular requirements for
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the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 62304:2006 (First Edition) Medical device software: Software life-cycle processes
IEC 62366: 2007 (First Edition) + A1: 2014 Medical devices - Application of usability engineering to medical devices.
The test results showed compliance with the above standards. We also confirmed overall operation by taking and reviewing test images.
Battery performance testing: A 3rd Party Testing Lab was engaged to do safety performance testing on the rechargeable lithium-ion battery pack, done according to the United Nations "Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria." The following testing was successfully performed: Altitude simulation, Thermal test, Vibration, Shock, External short circuit, Impact, Overcharge, and Forced discharge. In addition, battery life testing was performed to establish how many x-ray exposures can be made on one battery charge. The AC/DC adapter used with the battery charger is medical grade UL Listed (E356265).
During the design process, we took the following FDA guidance into account: Guidance for Industry and FDA Staff Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use; Document issued on December 24, 2008. This involved employing extra shielding and precautionary information in the labeling. Meets the US Performance standard on leakage.
-
- Summary of clinical testing: A limited clinical test was performed to demonstrate that the device could image anatomy other than extremities. A Board Certified Radiologist performed a successful review.
-
- Conclusion: After analyzing bench and clinical testing, it is the conclusion of MinXray Inc. that the TR90BH Portable X-Ray Equipment is as safe and effective as the predicate device, has few technological differences, and has similar indications for use, thus rendering it substantially equivalent to the predicate device.
§ 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.