(62 days)
The iQFlex M/iQFlex MD Mobile X-ray System is a medical 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). This device is not intended for mammography.
This Mobile X-ray System (Model: i9Flex M/iºFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (linepowered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iºFlex MD. In addition, this unit has preset memory keys to store and select kV/mAs, The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector. The image detectors (a necessary component of a fully-functional diagnostic system) are not part of this submission. This device is a mains-powered mobile X-ray system, designed and manufactured by First Source Inc. Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation. The major components of the X-ray main unit include: handle, enclosure, control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the system control board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. 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 highvoltage tank to generate high-voltage to excite the X-ray tube inside to emit Xrays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. The iQFlex M/iºFlex MD is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This mobile X-ray system is designed for handheld or stand-mounted imaging. Model i®Flex MD can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device. The cybersecurity risks of the i9Flex M/iºFlex MD have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
The provided text is a 510(k) Summary for the iQFlex M/iQFlex MD Mobile X-ray System. It describes the device, its indications for use, comparison to a predicate device, and performance data. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way you've outlined.
Specifically, it states "Clinical Studies: Not applicable. Clinical testing was not deemed to be required to show substantial equivalence. We relied on non-clinical testing and compliance with standards." This means:
- No clinical study was performed to evaluate the device's performance in a clinical setting against specific acceptance criteria related to diagnostic accuracy or clinical outcomes.
- The entire submission relies on non-clinical (bench) testing and compliance with recognized standards (electrical safety, EMC, software, cybersecurity) to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot populate the requested table and information, as the study as described in your prompt (especially regarding human readers, ground truth, and clinical performance metrics) was not conducted or reported in this document.
For completeness, here's what could be inferred about "acceptance criteria" from the provided text, but it's not in the format you requested, nor does it address clinical performance:
Summary of "Acceptance Criteria" (based on non-clinical testing and standards compliance):
| Acceptance Criteria Category | Reported Device Performance (as per non-clinical testing and standards compliance) |
|---|---|
| Electrical Safety | Conforms to IEC 60601-1:2005/AMD1:2012, EN 60601-1:2006/A1:2013 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2:2014 / EN60601-1-2:2015 |
| Radiation Protection | Conforms to EN 60601-1-3:2008/A11:2016 |
| X-ray Equipment Basic Safety & Essential Performance | Conforms to IEC 60601-2-54:2015/EN 60601-2-54:2015 |
| Software Life-Cycle Processes | Conforms to IEC 62304:2006/AMD1:2015. Software verification and validation conducted (considered "moderate" level of concern). |
| Usability Engineering | Conforms to IEC 62366-1:2015/EN 62366:2008 AMD1:2015 and IEC 60601-1-6:2010+A1:2013 |
| Risk Management | Conforms to ISO 14971:2012 |
| Cybersecurity | Management of cybersecurity implemented as per FDA guidance (Oct 2, 2014); risks addressed to assure no new or increased risks. |
| Overall Performance & Functionality | "Intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements" were evaluated in non-clinical (bench) testing. Predefined acceptance criteria were met. |
| Substantial Equivalence | Device is as safe and effective as the predicate device (MinXray HF120/60HPowerPlus™), has the same indications for use, and technological differences are addressed through performance testing and standards compliance. |
Since no clinical study was performed, the following information cannot be provided from the text:
- Sample size used for the test set and data provenance: Not applicable, no clinical test set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of improvement with AI vs without AI assistance: Not applicable, no clinical study or AI component mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm performance study was mentioned.
- The type of ground truth used: Not applicable, no clinical ground truth established.
- The sample size for the training set: Not applicable, no machine learning training details provided.
- How the ground truth for the training set was established: Not applicable.
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June 13, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
First Source Inc. % Mr. Woo Sung Park Consultant MEDMONTS Co., Ltd. Life officetel 320, 40, 63-ro, Youngdeungpo-gu Seoul, 07345 REPUBLIC OF KOREA
Re: K221081
Trade/Device Name: iQFlex M, iQFlex MD Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: February 28, 2022 Received: April 27, 2022
Dear Mr. Park:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221081
Device Name iQFlex M/iQFlex MD Mobile X-Ray System
Indications for Use (Describe)
The iQFlex M/iQFlex MD Mobile X-ray System is a medical 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).
This device is not intended for mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the text 'K221081' in a simple, sans-serif font. The text is presented in a horizontal arrangement, with each character clearly legible. The overall impression is clean and straightforward, with the focus solely on the alphanumeric sequence.
| Image: Logo | 005_510(k) Summary | Page: | 005-1 |
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005 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
SUBMITTER I.
First Source Inc.
Address: 3495 Winton Place, Building E, Suite #1, Rochester, NY 14623 Phone: 585.272.1690, Toll Free: 800.349.5980, Fax: 585.272.7678 https://1stsourceimaging.com
Email: sales@fsimed.com
Person: Ronald Viola
Position: President
Date Prepared: Feb.28, 2022
II. DEVICE
Name of Device: i9Flex M/i9Flex MD Mobile X-ray System
Requlation Name: Mobile X-ray system
Regulation Number: 892.1720
Regulatory Class: II
Product Code: IZL
III. PREDICATE DEVICE
MinXray HF120/60HPowerPlus™, K040046
Name of Device: Min Xray, MODEL HF120/60H PowerPlus™
Regulation Name: Mobile X-ray system
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K221081
| 17SOURCE |
|---|
| -------------- |
Page:
Regulation Number: 892.1720
Regulatory Class: II
Primary Product Code: IZL
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
This Mobile X-ray System (Model: i9Flex M/iºFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (linepowered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iºFlex MD. In addition, this unit has preset memory keys to store and select kV/mAs, The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector. The image detectors (a necessary component of a fully-functional diagnostic system) are not part of this submission.
This device is a mains-powered mobile X-ray system, designed and manufactured by First Source Inc.
Compared with traditional X-ray products, this device has exquisite structure, compact design, light weight and easy operation.
The major components of the X-ray main unit include: handle, enclosure, control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the system control board.
The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. 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 highvoltage tank to generate high-voltage to excite the X-ray tube inside to emit Xrays, control the switch of the collimator indicator, and monitor the working status of the device, and control the display of the status indicators.
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Page:
The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites.
The iQFlex M/iºFlex MD is not intended for mammography.
The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This mobile X-ray system is designed for handheld or stand-mounted imaging. Model i®Flex MD can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.
The cybersecurity risks of the i9Flex M/iºFlex MD have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
V. INDICATIONS FOR USE
The iPFlex M/iPFlex MD Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician forthe 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). This device is not intended for mammography.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison between the overall specifications of predicate device (MinXray HF120/60HPowerPlus™) and the subject device (i9Flex M/i9Flex MD mobile X-ray system) is shown in Table 1.
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| Image: logo | 005_510(k) Summary | Page: | 005-4 |
|---|---|---|---|
| ------------- | -------------------- | ------- | ------- |
| Item | Predicate Device | Subject Device |
|---|---|---|
| MinXray HF120/60HPowerPlus TM (K040046) | ioFlex M/ioFlex MD (without digital imaging) | |
| Indications for use | This radiographic system is intended for use by aqualified/trained physician or technician on bothadult and pediatric subjects for taking diagnosticx-rays. Not for mammographic use. | The ioFlex M/ioFlex MD Mobile X-ray System is amedical device intended for use by aqualified/trained physician or technician for thepurpose of acquiring X-ray images of the desiredparts of patient's anatomy (including head, cervicalspine, chest, abdomen, lumbar spine, pelvis andextremities).The device may be used for handheld diagnosticimaging of body extremities. This device is notintended for mammography. |
| Weight | 17.94 kg | X-ray Generator: 11.0 kg(24.25lbs)Mobile Cart: 38.1kg (84lbs) |
| Size | 453292224 mm | X-ray Generator:- ioFlex M : 365(L) x 240(W) x 230(H) (mm)- ioFlex MD : 365(L) x 240(W) x 185(H) (mm)Mobile Cart with X-ray Generator0.74m x 1.36m(2.41ft. x 4.47ft.);with maximum height positioning: 1m x 2m(3.27ft. x 6.56ft.) |
| Output | 60 mA(0.01-0.1sec), 42 mA (0.11 – 5.0sec) @40 - 50 kVDC50 mA(0.01-0.1sec), 35 mA (0.11 – 5.0sec) @52 - 60 kVDC | 40kV ~ 60kV, 30mA, 0.4mAs ~ 120mAs61kV ~ 70kV, 35mA, 0.4mAs ~ 63mAs61kV ~ 70kV, 30mA, 80mAs ~ 100mAs71kV ~ 80kV, 30mA, 0.4mAs ~ 50mAs |
| Predicate Device | Subject Device | |
| MinXray HF120/60HPowerPlus™ (K040046) | iQFlex M/iQFlex MD (without digital imaging) | |
| 45 mA(0.01-0.1sec), 31.5 mA (0.11 – 5.0sec) @ | 71kV ~ 80kV, 25mA, 63mAs ~ 80mAs | |
| 62 - 70 kVDC | 81kV ~ 90kV, 25mA, 0.4mAs ~ 40mAs | |
| 38 mA(0.01-0.1sec), 26.6 mA (0.11 – 5.0sec) @ | 81kV ~ 90kV, 20mA, 50mAs ~ 100mAs | |
| 72 - 80 kVDC | 91kV ~ 100kV, 25mA, 0.4mAs ~ 32mAs | |
| 33 mA(0.01-0.1sec), 23.1 mA (0.11 – 5.0sec) @ | 91kV ~ 100kV, 20mA, 40mAs ~ 80mAs | |
| 82 - 90 kVDC | ||
| 30 mA(0.01-0.1sec), 21 mA (0.11 – 5.0sec) @ | ||
| 92 - 100 kVDC | ||
| 20 mA(0.01-0.1sec), 14 mA (0.11 – 5.0sec) @ | ||
| 102 - 120 kVDC | ||
| Up-Down pushbuttons for kVp selections and | Up/Down pushbuttons for kV/exposure time(mAs) | |
| exposure time selections with LED indicators | selections and LED indicators for selected | |
| mAs indicator | kV/exposure time(mAs) | |
| (0.01-0.2sec) in 0.01sec. Step | 0.010~6.000sec. | |
| (0.2-0.4sec) in 0.02sec. Step | 0.010, 0.013, 0.014, 0.016, 0.017, 0.020, 0.024. | |
| Item | Predicate Device | Subject Device |
| MinXray HF120/60HPowerPlus™ (K040046) | i9Flex M/i9Flex MD (without digital imaging) | |
| 1.142, 1.250, 1.280, 1.333, 1.428, 1.600, 1.666,1.800, 2.000, 2.100, 2.285, 2.500, 2.520, 2.666,2.857, 3.150, 3.200, 3.333, 3.428, 4.000, 4.800,5.000, 6.000 (86 Steps)(0.4~120mAs) | ||
| MemorySettings(technique) | 5 memories | 5 memories |
| HF Generator | 85 kHz | 50 kHz |
| kW | 2.4 kW peak -> 3.15 | 2.5 kW |
| kVp | 40-120 kVp | 40-100 kV |
| X-ray Tube | Superior X-ray Tube Company SXR-130 1.2 mm, 65 kHU | OX/125-1.2(CEI) 1.2mm, 35kHU |
| Collimator | Advantech -> Collimare | Manual Type, Double Slit |
| Flat-paneldetector | None | PIXXGEN PRUDENT 1212/1417/1717 declared inK211108DRTECH EVS 4343W/WP, 3643W/WP declared inK193017VIEWORKS VIVIX-S 1717V declared in K181003or alternatives U.S. 510(k) cleared |
| Flat-paneldetector | None | PRUDENT 1212 : 140µm, 2,048 x 2,048 pixels, a-Si/IGZO |
| Item | Predicate DeviceMinXray HF120/60HPowerPlus™ (K040046) | Subject DeviceioFlex M/ioFlex MD (without digital imaging) |
| specifications | PRUDENT 1417 : 140µm, 2,560 x 3,072 pixels, a-Si/IGZOPRUDENT 1717 : 140µm, 3,072 x 3,072 pixels, a-Si/IGZOEVS 4343W/WP: 140µm, 3,072 x 3,072 pixels, IGZOEVS 3643W/WP: 140µm, 2,560 x 3,072 pixels, IGZOVIVIX-S 1717V: 140µm, 3,072 x 3,072 pixels, a-Si | |
| Photo | Image: MinXray HF120/60HPowerPlus | Image: iFlex MImage: iFlex MD |
Table 1 Comparison of Technology Characteristics
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Image /page/7/Picture/6 description: The image shows the logo for 1st Source. The logo features the number "1st" in black, stacked on top of the word "SOURCE" in a larger, also black font. Behind the text is a teal crescent shape that curves around the right side of the text, creating a semi-circular frame. The logo is simple and modern, using a clean font and a limited color palette.
Use Interface
Exposure time
(0.4-1.0sec) in 0.05sec Step
(1.0-5.0sec) in 0.1sec Step
ltem
0.180, 0.200, 0.210, 0.228, 0.250, 0.252, 0.266, 0.285, 0.315, 0.320, 0.333, 0.371, 0.400, 0.433,
0.025, 0.028, 0.030, 0.033, 0.037, 0.040, 0.043,
0.045, 0.050, 0.052, 0.053, 0.057, 0.064, 0.065, 0.066, 0.071, 0.080, 0.083, 0.091, 0.100, 0.106, 0.114, 0.125, 0.128, 0.133, 0.142, 0.160, 0.166,
0.457, 0.500, 0.520, 0.533, 0.571, 0.640, 0.650, 0.666, 0.714, 0.800, 0.833, 0.914, 1.000, 1.066,
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Image /page/8/Picture/0 description: The image shows the logo for 1st Source. The logo features the text "1st SOURCE" in a stylized font. The "1st" is smaller and positioned above the word "SOURCE". A teal crescent shape partially surrounds the text, adding a visual element to the design. The logo is simple and professional, likely representing a financial institution or related service.
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Image /page/9/Picture/0 description: The image contains the logo for 1st Source. The logo features the number "1st" stacked on top of the word "SOURCE". The text is positioned inside of a teal crescent shape. The background of the image is white.
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Image /page/10/Picture/0 description: The image shows the logo for 1st Source. The logo features the text "1st SOURCE" in bold, black letters. Above the text is a teal, crescent-shaped graphic that partially encircles the "1st" part of the text. The overall design is simple and professional.
PERFORMANCE DATA VII.
Performance Testing:
The iQFlex M/i9Flex MD conforms to the following standards:
| ISO 14971:2012 | Medical device - application of risk management tomedical device |
|---|---|
| IEC 60601-1:2005/AMD1:2012EN 60601-1:2006/A1:2013 | Medical electrical equipment -- Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-2:2014 /EN60601-1-2:2015 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticdisturbances - Requirements and tests |
| EN 60601-1-3:2008/A11:2016 | Medical electrical equipment - Part 1-3: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment (IEC60601-1-3:2008) |
| IEC 60601-2-54:2015/EN 60601-2-54:2015 | Medical electrical equipment -- Part 2-54: Particularrequirements for the basic safety and essentialperformance of X ray equipment for radiography andradioscopy |
| IEC62304:2006/AMD1:2015 | Medical device software - Software life-cycleprocesses |
| IEC 62366-1:2015/EN 62366:2008 AMD1:2015 | Medical devices - Application of usabilityengineering to medical devices |
| IEC 60601-1-6:2010+A1:2013 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
Discussion of Testing
The performance characteristics and operation / usability of the i9Flex MD were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, shipping performance, verification and validation of requirements for intended use, and reliability of the system including both software and hardware requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and test results have
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demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
The following performance data were provided in support of the substantial equivalence
determination:
· Electrical safety and electromaqnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the i9Flex M/19Flex MD Mobile X-ray System in compliance to IEC 60601-1-2:2014 - Medical electrical equipment Part 1-2, Electromagnetic Compatibility.
· Software Verification and Validation Testing Software verification and validation testing was conducted and documentation has been provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to present a "moderate" level of concern. This is based on the fact that a malfunction of or latent design flaw in the software component could lead to an erroneous diagnosis, or to a delay in delivery of appropriate medical care that may lead to a minor injury.
· Management of Cybersecurity
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 2, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device.
Clinical Studies
Not applicable. Clinical testing was not deemed to be required to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
VIII. CONCLUSIONS
After analyzing bench tests, it is the conclusion of First Source Inc. that the i®Flex M/i9Flex MD Mobile X-ray System is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.
§ 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.