NOMAD MD 75K V HANDHELD X-RAY SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a wing-like shape above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 19, 2014 Aribex, Inc. % Mr. Sanjay Ahuja Director, Regulatory Affairs 744 South 400 East OREM UT 84097 Re: K140723 Trade/Device Name: Nomad MD Handheld X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: June 5, 2014 Received: July 21, 2014 Dear Mr. Ahuja: 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. {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 yours. Smh. 7) for Janine M. Morris 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) K140723 Device Name NOMAD MD Handheld X-ray System #### Indications for Use (Describe) The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (LVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Form Approved: OMB No. 0910-0120 {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {4}------------------------------------------------ # 510(k) Summary # NOMAD MD Handheld X-ray System #### Submitter: Aribex, Inc. 744 South 400 East Orem, UT 84097 Phone No: 801-226-5522 FAX No: ## Date of Summary: March 14, 2014 ## Contact Person: Christopher Dodge, Senior Regulatory Affairs Specialist or Sanjay Ahuja, Ph.D., Director, Regulatory Affairs #### Device Name: ● - Trade Name: NOMAD MD Handheld X-ray System ● - . Common Name: - Nomad MD - Classification Name: Mobile X-ray system 21CFR 892.1720 - Regulation: - Product Code: . IZL # Predicate Device for Which Substantial Equivalence is Claimed: MinXray HF 100H+ Portable X-ray Unit (K052721) #### Device Description: The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery, a Charging Cradle, and an AC-to-DC Power Supply. Consideration was given to three FDA guidance documents, "Pediatric Information for X-ray Imaging Device Premarket Notifications" issued on May 10, {5}------------------------------------------------ 2012, "Radiation Safety Considerations for X-Ray Equipment for Hand-Held Use," issued on December 24, 2008, and "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices," dated August 6,1999. Aribex determined that the solid state quidance did not apply to the NOMAD MD because it is an X-ray emitter and the quidance document is written for X-ray image recording systems, not for X-ray emitters. #### Indications for Use/Intended Use: The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types. #### Summary of Technological Characteristics: The NOMAD MD has been demonstrated to be substantially equivalent to the predicate device, the MinXray HF 100H+ Portable X-ray Unit (cleared under K052721). The proposed device has been verified and validated to satisfy the requirements derived from the indications for use and the substantial equivalence table. NOMAD MD shares many of the same components and features as the predicate device including: - Portable X-ray source - . Collimation of X-ray - Two stage triggering mechanism . - Source to skin guard to limit distance between X-ray source and patient . - Constant potential waveform - Similar user interface with tactile membrane pad with up-down push ● buttons for making selections - . Similar alerts and alarms that indicate equipment state of readiness to use The MinXray operator instructions require that the operator "stand as far as possible from the X-ray unit while holding the exposure switch and pressing the button" in order to avoid being exposed to excess leakage and backscatter radiation. The following is a comparison between Nomad MD (proposed) and the predicate device, the MinXray HF 100H+ Portable X-ray Unit (cleared under K052721). {6}------------------------------------------------ | | MinXray HF100H+<br>(K052721) | Nomad MD<br>X-ray System (K140723) | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | | | | Regulation No. | 21 CFR 892.1720 | 21 CFR 892.1720 | | Regulation Class | II | II | | Product Code | IZL | IZL | | Indications for<br>Use/Intended Use: | Intended for use by a<br>qualified/trained physician or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic x-rays. | The NOMAD MD is a<br>handheld and portable<br>general purpose X-ray<br>system. The device uses a<br>fixed tube current and<br>voltage (kVp) and,<br>therefore, is limited to<br>taking diagnostic X-rays of<br>extremities. | | | | It is intended to be used by<br>a qualified and trained<br>clinician on both adult and<br>pediatric patients. It is not<br>intended to replace a<br>radiographic system with<br>variable tube current and<br>voltage (kVp) which may be<br>required for full optimization<br>of image quality and<br>radiation exposure for<br>different exam types. | | Principle of Operation | General Purpose Diagnostic X-<br>Ray | General Purpose<br>Diagnostic X-Ray | | TECHNOLOGICAL: | | | | Size: Body | 8.75"Hx9.5"Wx15.35"L<br>excluding skin guards | 9.5"H x 5.25"Wx10"L<br>(excluding Source Skin<br>guard) | | Weight | 40.9 lbs. | 11.0 lbs. | | Source to skin distance | 30 cm | 30 cm | | Focal Spot | 1.2 mm | 0.4 mm | | Collimator | Four manually and steplessly<br>adjustable shutters with light<br>beam type central x-ray<br>indicator (Advantech R72) | Four manually and<br>steplessly adjustable<br>shutters with LED Light<br>Field Center Indicator | | Triggering Mechanism | Two stage triggering | Two stage triggering | | User Interface | Up-down push buttons for kVp<br>selections and exposure time<br>selections with LED indicators<br>and mAs indicators. | Up-down buttons for<br>exposure time selection,<br>with timer display. | | Energy Source | 100-140 VAC 50/60 Hz | Rechargeable 14.4 V DC<br>NiCd battery pack | | Exposure Time | 0.03-0.2 sec (in 0.01 sec Steps)<br>0.2-0.4 sec (in 0.02 sec Steps)<br>0.4-1.0 sec (in 0.05 sec Steps) | 0.02 - 0.99 seconds in 0.01<br>increments | | Feature | MinXray HF100H+<br>(K052721) | Nomad MD<br>X-ray System (K140723) | | | 1.0-4.0 sec (in 0.1 sec Steps) | | | mA | 30 mA @ 40-60 kV<br>25 mA @ 62-80 kV<br>20 mA @ 82-100 kV | 2.0 mA fixed | | kVp | 40-100kVp | 75 kVp fixed | | Waveform | Constant Potential | Constant Potential | | Alerts and Alarms | As least two specific alerts and<br>alarms indicate equipment state<br>of readiness to use | Seven specific alerts and<br>alarms indicating<br>equipment's state of<br>readiness to use | | Class II Laser | Not a feature on this unit | Used to indicate the<br>distance from the x-ray<br>source to the target to be<br>diagnosed. | | User Interface Ease | Tactile membrane pad with<br>audible signals indicates<br>settings.<br>Large illuminated digital<br>exposure setting screen. | Tactile membrane pad with<br>audible signals indicates<br>settings.<br>Large illuminated digital<br>exposure setting screen. | | Safety | Exposure switch button<br>illuminates if unit misfires. The<br>unit will lock up and needs to<br>be restarted from the off<br>position<br>During the exposure an audible<br>signal and the X-ray indicator<br>illuminates. | Locked upon powering on<br>with LC indicator, along with<br>elongated audible signal.<br>Unit will power down after<br>2.5 minutes of inactivity.<br>After 10 seconds of being<br>enabled, the unit will lock if<br>exposure does not occur.<br>Continuous audible signal is<br>emitted along with indicator<br>lights indicating that<br>exposure is completed. | | Low Battery Indicator<br>and Audible Signal | Not a feature on this unit<br>because it is AC/DC powered. | LED illuminates and flashes<br>when battery charge is<br>needs or needs recharging<br>Audible signal indicates low<br>battery signal | | Electrical Safety<br>Standards | UL 2601, IEC60601 | IEC60601-1, EN60601-2 | | Performance Standard | 21 CFR 1020.30 | 21 CFR 1020.30, 1020.31<br>IEC60601-3 | {7}------------------------------------------------ Per the recommendations of the FDA Guidance document on "Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use," Aribex has incorporated internal shielding into the design of the NOMAD MD. This shielding, made from a proprietary bismuth blend, encapsulates the X-ray source assembly and prevents the operator of the device from being exposed to any appreciable amounts of leakage radiation. Test results indicate that the level of exposure is {8}------------------------------------------------ well below the requirements of 21 CFR 1020.30(k). Evidence of the effectiveness of this internal shielding can be found in Section 19 NOMAD MD Performance Testing - Bench. Specifically, TP-0223, Test Case Scatter Radiation NOMAD MD, identifies the operator exposure dose within the significant zone of occupancy. See also QR-0200 Risk Analysis. NOMAD MD - Risk ID R009. R017. Since the NOMAD MD, unlike its dental predecessor, is held on average 28 inches from the patient, it was not considered practical to incorporate an external backscatter shield into the design of the device. The effective size of the backscatter shield would need to be about three feet in diameter. For this reason, Aribex recommends in its operator manual (MP-0221, Section 3.3, Section 4.7[6], and Section 7.5) the use of a lead apron and thyroid collar when operating the NOMAD MD. Also see QR-0200 Risk Analysis, NOMAD MD - Risk ID R061. As evidenced through Design Verification and Validation, NOMAD MD can produce diagnostic images of adult and pediatric extremities and they are of equivalent diagnostic quality as the MinXray device. An extremity is generally defined as the distal or terminal portion of any bodily limb, or any portion of bodily limbs such as arms and legs. The NOMAD MD has been validated (see Section 19, TP-0302, Extremity Thickness Performance, NOMAD MD) to capture diagnostic quality images of body part extremities, such as fingers (from 1.5cm) and thighs (up to 21cm). Based upon an analysis of the technological differences, and the substantiation through design verification and validation. Aribex determines that the safety and effectiveness of the proposed NOMAD MD is substantially equivalent to the MinXray predicate device and does not raise any new concerns. #### Non-Clinical Test Data: Performance bench testing was conducted as part of design control to ensure the safety and effectiveness of the NOMAD MD is equivalent to the predicate device. The safety and effectiveness of NOMAD MD for the proposed indications for use is substantiated through verification and validation testing on diagnostic images. An image comparison study was also conducted by taking radiographic images of foot, knee, elbow, and hand phantoms using both the NOMAD MD and the predicate device. The images were then reviewed by a board-certified radiologist who determined that images from both devices were of diagnostic quality and, therefore, substantially equivalent. Software documentation has been provided in Section 17 according to the FDA's requirement for software that meets the moderate level of concern. {9}------------------------------------------------ EMC and Electrical Safety testing on the NOMAD MD was performed and found to meet all the requirements in standards IEC 60601-1: 2005, IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 60601-2-28:2010, IEC 60601-2-54:2009, IEC 60825:2007, IEC 62366:2007, and IEC 60601-1-2:2007. #### Clinical Test Data: Clinical testing was deemed not required to support the indications for use and therefore, it has not been conducted on the Nomad MD proposed product. ## Conclusion: Based on the comparison of the indications for use/intended use, the technological characteristics, and the operation of the device, Aribex concludes that NOMAD MD is substantially equivalent to the predicate device. In addition, based upon the review of the performance, standards analysis, and labeling, the differences between NOMAD MD device and the MinXray predicate device do not raise new concerns on safety and effectiveness for the proposed indications of use.