(90 days)
No
The summary describes standard digital X-ray technology with features like automatic alignment and radiation dose calculation, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
Explanation: The device is described as providing "radiographic, multiradiographic and fluoroscopic imaging" for "guidance and visualization during diagnostic radiographic, surgery, and interventional procedures." This indicates its primary function is for imaging/diagnosis, not directly for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "radiographic, multiradiographic and fluoroscopic imaging" and is used for "guidance and visualization during diagnostic radiographic, surgery, and interventional procedures." This directly indicates its role in diagnosis.
No
The device description explicitly lists multiple hardware components including an x-ray source, digital imaging system with a flat panel detector, computer, monitor, and a mobile cart. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "radiographic, multiradiographic and fluoroscopic imaging" and is used for "guidance and visualization during diagnostic radiographic, surgery, and interventional procedures." This describes an imaging device used to visualize structures within the body, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details components like an X-ray source, digital imaging system, and mobile cart. These are all characteristic of an X-ray imaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical imaging device used for diagnostic and interventional procedures by visualizing internal structures using X-rays. This falls under the category of medical devices, but specifically imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pedian the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, OXO
Device Description
The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic, fluoroscopic
Anatomical Site
skull, spinal column, chest, abdomen, extremities
Indicated Patient Age Range
all patients except pediatrics
Intended User / Care Setting
qualified/trained medical professionals, healthcare facilities both inside and outside of hospital
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)
Study Type: Bench testing
Key Results: Electrical safety and EMC testing was performed on the unit and found to be acceptable. Software has been written and validated according to the FDA Software Guidance. Cybersecurity concerns have been addressed. The x-ray generator modification for fluoroscopic exposures (cooling fans, pulsed mode) showed acceptable internal temperature rise. No clinical data was necessary as the digital panels received previous 510(k) clearances.
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.
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.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Portavision Medical LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES, FL 34114
Re: K191503
Trade/Device Name: MobileRay Pulse SE Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: Mav 29, 2019 Received: June 6, 2019
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/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
1
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 M. Burk, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191503
Device Name MobileRay Pulse SE Digital Imaging System
Indications for Use (Describe)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pedian the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
| 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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3
510(K) Summary, K191503
Image /page/3/Picture/1 description: The image shows the logo for PortaVision Medical. The logo consists of three blue circles with the letters P, V, and M in white. Below the circles, the words "PortaVision Medical" are written in a simple, sans-serif font.
PortaVision Medical LLC 800 Central Avenue Jefferson, Louisiana 70121 Phone: 866-783-4133 email: info@pvmed.net www.portavisionmedical.com Contact: Terry Ancar, Predsident Date Prepared: August 3, 2019
1. Identification of the Device:
Trade/Device Names: MobileRay Pulse SE Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Codes: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System
2. Equivalent legally marketed device: K160279
Trade/Device Name: AnyView 500R Fluoroscopic Mobile X-ray System Manufacturer: EcoTron Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System
-
- Reference Devices: (Used with this device, customer picks one of the units below. They differ only in size)
K161942
Trade/Device Name: XRpad2 3025 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB K161966 Trade/Device Name: XRpad2 4336 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
4
-
- Indications for Use Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides radiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, and extremities. The device may be used for other imaging applications on all patients except pediatrics within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
-
- Description of the Device: The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the
X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.
-
- Safety and Effectiveness, comparison to predicate device. This device has similar indications for use and similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels. The chief differences are: The predicate uses a fixed Source to Image distance dictated by a "C-Arm," and uses image intensifier technology whereas the proposed new device uses a unique source to image receptor location technology and the image receptor is a digital panel. Otherwise the two systems have the same functionality and uses.
7. Substantial Equivalence Chart: (Next Page)
5
| Characteristic | EcoTron Anyview 500R K160279 | MobileRay Pulse SE Digital Imaging
System |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use: | Anyview-500R mobile C arm, fluoroscopic x-
ray system, is radiation medical equipment
only used by professional radiologists. This
product is designed to provide fluoroscopic
and spot film images of the patient during
diagnostic and interventional procedures.
This system can be applied in emergency
room, operation room, cast room or etc. of
hospital | Intended for use by a qualified/trained
medical professionals, who have full
understanding of the safety information and
emergency procedures as well of capabilities
and function of the device. The device
provides radiographic, multiradiographic and
fluoroscopic imaging and is used for guidance
and visualization during diagnostic
radiographic, surgery, and interventional
procedures. The device is to be used in
healthcare facilities both inside and outside
of hospital, in a variety of procedures of the
skull, spinal column, chest, abdomen, and
extremities. The device may be used for
other imaging applications on all patients
except pediatrics within the limits of the
device. Applications can be performed with
the patient sitting, standing, or lying in the
prone or supine position. The system is not
intended for mammography applications |
| Energy Source | 220V-230V, Single 50-60 Hz | 110V-120V, Single 50-60Hz (4 kW) or
220-230V Single 50-60Hz (8 kW) |
| System
Weight and
Size | 200 lbs.
35.75" x 28" x 72.5" | 136 lbs.
65" x 26" x 87" |
| Generator
Type | High frequency Inverter type | High frequency Inverter type |
| Output Power | 5KW | 4 kW (120v) or 8KW (220v) |
| Fluoroscopy | | |
| Pulse | 0.5 – 20 mA | 0.5 – 16mA |
| Boost | 0.5 - 30 mA | N/A |
| Radiography | | |
| KV range | 40 – 125 KV | 40 – 125 KV |
| mA range | 20 – 100 mA | 20 - 100 mA |
| mAs range | 0.8 – 200 mAs | 0.8 – 200mAs |
| Pulse width | N/A | 10 ms |
| Pulse rate | 8, 15, 30 | 1 - 7.5 fps but see key advantage
immediately below: |
| Weight | 552 lbs (Fairly heavy) | 139 lbs. Much lighter and easier to
maneuver. |
| X-ray Tube | Rotating anode | Stationary anode |
| Characteristic | EcoTron Anyview 500R K160279 | MobileRay Pulse SE Digital Imaging
System |
| Indicators | Display on workstation monitor | Same as predicate |
| Collimator | Multi-leaf adjustable motorized | Multi-leaf adjustable motorized |
| Digital Panel
Specification | N/A, not digital | XRpad2 3025 100 μ, 3004 x 2508 pixels
XRpad2 4336 100 μ, 4288 x 3524 pixels |
| Pixel Pitch | N/A not digital | 100 μ |
| Pixel Matrix | N/A not digital | 3004 x 2508 or 4288 x 3524 |
| AD
Conversion | N/A not digital | 16 bits |
| DQE | N/A | 75% (@ 0 lp/mm) |
| MTF | N/A | 70% (1 lp/mm) |
| Image
acquisition | Image Intensifier 9/6/4.5 in
E5830SD-P4A (TOSHIBA) | Amorphous Silicon Direct deposition
Csl:TI |
| Connection | Ethernet or Wi-Fi | Same as predicate |
| DICOM | Yes | Same as predicate |
| Electrical
Safety | IEC60601-1:2005 + A1 (2012)
IEC60601-1-2:2007 | Same as predicate, See bench test
information below. |
| Photo | Image: EcoTron Anyview 500R K160279 | Image: MobileRay Pulse SE Digital Imaging System |
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The following table compares The MobileRay Pulse SE software to the predicate software.
| Feature | Predicate Device
EcoTron Anyview K160279 | Proposed Device
MobileRay Pulse SE |
|-------------------------------|---------------------------------------------|---------------------------------------|
| Acquiring image from detector | Yes | Yes |
| Viewing image | Yes | Yes |
| Change window/level | Yes | Yes |
| Invert | Yes | Yes |
| Lookup Table | Yes | Yes |
| Zoom | Yes | Yes |
7
| Feature | Predicate Device
EcoTron Anyview K160279 | Proposed Device
MobileRay Pulse SE |
|-------------------------|---------------------------------------------|---------------------------------------|
| Pan | Yes | Yes |
| Noise Reduction | Yes | Yes |
| Patient Information | Yes | Yes |
| Annotation | Yes | Yes |
| Image rotation | Yes | Yes |
| X-Ray generator control | Yes | Yes |
| DICOM worklist and Send | Yes | Yes |
-
- Summary of non-clinical testing: Bench testing was performed to assess the device safety and effectiveness. Electrical safety and EMC testing was performed on the unit. The standards employed were: EN 60601-1-2 (2015): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests EN 301 489-1 V2.2.0 (2017): Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements & EN 301 489-17 V3.2.0 (2017): Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems AND: IEC 60601-1: 2005 + Corr.1: 2006 + A1: 2012 EN 60601-1: 2006 + A11: 2011 + A1: 2013 + AC:2014 + A12:2014 UNE-EN 60601-1: 2008 + Corr.: 2010 + A11: 2010 + A11: 2012 + AC:2014 + A12:2015 POSE000 14 (General procedure of Safety Lab) EMC and Electrical Safety performance for the digital receptor panels had previously been submitted to FDA in K161942 and in K161966. Software has been written and validated according to the FDA Software Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005 Cybersecurity concerns have been addressed in accordance with: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014). In order to be able to perform fluoroscopic exposures the x-ray generator (cleared in K121410) was modified to include cooling fans and to allow for repetitive exposures, i.e. fluoro/pulsed mode. The internal temperature rise in the generator was measured during operation and found to be acceptable.
-
- Summary of clinical testing: No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. The digital panels both received previous 510(k) clearances
-
- Conclusion: After analyzing software integration validation, safety testing data, and bench test images, it is the conclusion of PortaVision Medical LLC that the MobileRay Pulse SE Digital Imaging System is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.