K Number
K141885
Device Name
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
Manufacturer
Date Cleared
2014-09-18

(69 days)

Product Code
Regulation Number
892.1720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
Device Description
This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Toshiba flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.
More Information

No
The description focuses on the hardware components (generator, panel) and standard software for image capture and display (dicomPACS®). There is no mention of AI/ML in the device description, intended use, or performance studies. The performance studies rely on phantom images evaluated by a radiologist for comparable diagnostic quality, not on algorithmic performance metrics.

No.

This device is intended for diagnostic x-rays, which is a diagnostic purpose, not a therapeutic one. Therapeutic devices are used for treatment, while this system's "Intended Use / Indications for Use" explicitly states it's for "taking diagnostic x-rays."

Yes

This device is a digital radiographic system intended for "taking diagnostic x-rays" and for "capturing high quality diagnostic images for routine diagnosis."

No

The device description clearly states it is a "digital radiographic system" which is a combination of hardware (MinXray HF120/60H PowerPlus™ generator, Toshiba Solid State Imager) and software (dicomPACS® software package). It is not solely software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for taking diagnostic x-rays on adult and pediatric subjects. This is an in vivo diagnostic procedure, meaning it's performed on a living organism.
  • Device Description: The description details a digital radiographic system, which is used to capture images of the inside of the body using X-rays. This is consistent with in vivo imaging.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on samples outside of the body, which are hallmarks of IVD devices.

Therefore, this device falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

Product codes

IZL, MQB, LLZ

Device Description

This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Toshiba flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

both adult and pediatric subjects

Intended User / Care Setting

qualified/trained physician or technician

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)

Summary of non-clinical testing: A prototype system was assembled and tested. First the dicomPAC® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. Next, the synchronization circuit was connected between the Mikasa HF portable generator and the Toshiba panel. The Ethernet cable was then connected between the Toshiba panel and the Dell laptop. The panel was connected to the AC power source and turned on. Then the Mikasa HF portable generator was turned on. The Mikasa generator was set to generate an exposure. The generator was aimed at the Toshiba panel, and a radiographic phantom was placed on the panel. Several test exposures showed that the system was operating properly. No modifications were necessary to any of the hardware or software other than changing the digital panel. The complies with DHHS radiation safety standards currently in effect, i.e. 21 CFR 1020.30 and 21 CFR 1020.31 and has undergone testing for compliance with UL 60601-1 (Electrical medical device safety), IEC 60601-1-2 (Electromagnetic Compatibility). The software was tested to and complies with the NEMA PS 3.1-3.20(DICOM) standard. The Toshiba detector has been previously cleared under K131211.
Summary of clinical testing: Because this same Toshiba panel/software combination has been cleared by FDA before, a full clinical trial per the FDA guidance document on solid state imaging devices was deemed to be unnecessary, per the FDA "Least Burdensome" guidance. Instead we employed "Supertech" lung/chest phantom and other phantoms to obtain images from both the predicate and the new digital panel. The images were evaluated by a board certified radiologist and found to be of comparable diagnostic quality.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100449

Reference Device(s)

K040046, K131211

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2014

MinXray, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K141885

Trade/Device Name: CMDR-2ST & CMDR-2SLWT Digital Portable X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB, LLZ Dated: August 15, 2014 Received: August 19, 2014

Dear Mr. 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. 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.

Sm. 77)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141885

Device Name CMDR-2ST & CMDR-2SLWT

Indications for Use (Describe)

This digital radiographic system is intended for use by a qualified/trained physician or both adult and pediatric subjects for taking diagnostic x-rays. (Not for mammographic use).

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)

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510(k) Summary: 510(k) Number K141885 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Tel. 1-847-564-0323 Fax 1-847-564-9040 Date Prepared: August 15, 2014 Keith Kretchmer, President Contact:

  • Identification of the Device: 1. Proprietary-Trade Name: CMDR-2ST & CMDR-2SLWT Digital Portable X-ray System
    1. Classification Name: Mobile x-ray system, Product Code 90 IZL and Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Picture Archiving and Communications System 90 LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System Regulation Number: 21 CFR 892.1720
    1. Equivalent legally marketed device: MinXray CMDR-2S, K100449
    1. Indications for Use (intended use): This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
    1. Description of the Device: This represents the straightforward interconnection of three devices: The MinXray HF120/60H PowerPlus™ (K040046), the Toshiba Solid State Imager, and the dicomPACS® software package. MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60° AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features the Toshiba flat panel technology in a sleek and compact unit. The portable panel provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography. The only difference between this modified device and our predicate device is the supplier of the digital x-ray receptor panel. The previous supplier was Varian. The two model numbers differ only in the configuration and weight of the mounting hardware.
    1. 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 devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination.

| Characteristic | MinXray CMDR-2S Digital Diagnostic X-Ray
System K100449 | CMDR-2ST & CMDR-2SLWT |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Intended Use: | Intended for use by a qualified/trained
physician or technician on both adult and
pediatric subjects for taking
diagnostic x-rays. Not for mammography | SAME |
| Configuration | Mobile System | SAME |
| Computer | Dell laptop | SAME |

7. Substantial Equivalence Chart

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| Characteristic | MinXray CMDR-2S Digital Diagnostic X-Ray
System K100449 | CMDR-2ST & CMDR-2SLWT |
|------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------|
| Generator | High Frequency HF120/60H PowerPlus™ | SAME |
| Digital X-ray Panel Supplier | Varian 4336R | Toshiba FDX3543RP |
| Panel Performance | Pixel size 139 x 139 μm
Matrix size 2,560 x 3,072
Size 14" x 17" | Pixel size 143 x 143μm
Matrix size 2448×2984
Size 14" x 17" |
| Panel Interface | Ethernet | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | Uses high frequency generator made by
Mikasa X-Ray in Japan. 80 khz. | SAME generator |
| PACS software | dicomPACS® | dicomPACS® |
| Power Source | 120 V 50/60 Hz AC 20 amp | SAME |
| Digital Panel | Image: Digital Panel | Image: Digital Panel |

    1. Summary of non-clinical testing: A prototype system was assembled and tested. First the dicomPAC® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. Next, the synchronization circuit was connected between the Mikasa HF portable generator and the Toshiba panel. The Ethernet cable was then connected between the Toshiba panel and the Dell laptop. The panel was connected to the AC power source and turned on. Then the Mikasa HF portable generator was turned on. The Mikasa generator was set to generate an exposure. The generator was aimed at the Toshiba panel, and a radiographic phantom was placed on the panel. Several test exposures showed that the system was operating properly. No modifications were necessary to any of the hardware or software other than changing the digital panel. The complies with DHHS radiation safety standards currently in effect, i.e. 21 CFR 1020.30 and 21 CFR 1020.31 and has undergone testing for compliance with UL 60601-1 (Electrical medical device safety), IEC 60601-1-2 (Electromagnetic Compatibility). The software was tested to and complies with the NEMA PS 3.1-3.20(DICOM) standard. The Toshiba detector has been previously cleared under K131211.
    1. Summary of clinical testing: Because this same Toshiba panel/software combination has been cleared by FDA before, a full clinical trial per the FDA guidance document on solid state imaging devices was deemed to be unnecessary, per the FDA "Least Burdensome" guidance. Instead we employed "Supertech" lung/chest phantom and other phantoms to obtain images from both the predicate and the new digital panel. The images were evaluated by a board certified radiologist and found to be of comparable diagnostic quality.
    1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of MinXray Inc. that the CMDR-2ST & CMDR-2SLWT Digital Diagnostic X-Ray System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.