(33 days)
No
The device description focuses on the combination of existing, cleared components (X-ray generators, digital panel, and software) and explicitly states that the only difference from the predicate is the supplier of the digital panel. There is no mention of AI, ML, or advanced image processing beyond standard digital radiography.
No
This device is for taking diagnostic X-rays, which means it aids in diagnosis rather than providing therapy.
Yes
The device is described as "taking diagnostic x-rays" and explicitly states that it captures "high quality diagnostic images for routine diagnosis."
No
The device description explicitly states it is a combination of three hardware devices (X-ray generators and a digital X-ray receptor panel) and a software package. The testing also includes hardware verification.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "taking diagnostic x-rays" on patients (adult and pediatric subjects). This involves imaging the internal structures of the body using radiation.
- Device Description: The device is described as a combination of an X-ray generator, a digital X-ray receptor panel, and software for processing the images. This is consistent with an in vivo imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on specimens outside of the body, which are the defining characteristics of an IVD.
The device is clearly designed for in vivo diagnostic imaging, not in vitro diagnostic testing.
N/A
Intended Use / Indications for 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."
Product codes
IZL, MQB, LLZ
Device Description
"This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators:
a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR
b) HF100H+ cleared in K052721 OR
c) HF1202 PowerPlus cleared in K153059.
Plus: A 510(k) cleared (K150929) Digital X-Ray Receptor Panel CareView 1500Cw X-ray Flat Panel Detector.
e) PLUS: the dicomPACS® software package (Same as our predicate).
The x-ray generators are portable units which operate from 120/240V 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 Careray 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 devices is the supplier of the digital x-ray receptor panel."
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric
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
"We employed the i.b.a. Test Device DIGI-13, a device for quality tests at CR and DR systems (e.g. for acceptance tests according to DIN V 6868-58 and constancy tests according to DIN 6868-13) to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Prototype systems covering all generator/panel combinations were assembled and tested. First the dicomPACS® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. A Wi-Fi connection was confirmed between the PerkinElmer panel and the Dell laptop. The panel was confirmed to be charged and turned on. Then the MinXray HF portable generator was turned on. The MinXray portable X-ray generator was set to generate an exposure. The generator was aimed at the PerkinElmer 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 comples with DHHS radiation safety standards currently in effect, and has undergone testing for compliance with UL 60601-1 (2005) [Electrical medical device safety), IEC 60601-1-2 (2007) (Electromagnetic Compatibility). Additionally, the HF1202H PowerPlus generator meets IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. The other generators were designed and cleared prior to the issuance of this standard. We verified software compatibility with the new CareView Cw digital panel. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
We employed the i.b.a. Test Device DIGI-13, a device for quality tests at CR and DR systems (e.g. for acceptance tests according to DIN V 6868-58 and constancy tests according to DIN 6868-13) to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested. The images were evaluated and found to be of diagnostic quality."
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.
K150929, K040046, K141885, K052721, K153059, K143257, K140551, K141440
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2019
MinXray, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K191451
Trade/Device Name: CMDR 2CW (Multiple Models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB, LLZ Dated: May 28, 2019 Received: May 31, 2019
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. 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 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
1
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
For
Thalia T. Mills, Ph.D. 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) K191451
Device Name CMDR 2CW (Multiple Models)
Indications for Use (Describe)
Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(k) Summary: 510(k) Number K191451 MinXray, Inc. 3611 Commercial Avenue Northbrook. Illinois 60062. USA Toll Free 1-800-221-2245 (USA & Canada) Date Prepared: June 17, 2019 Contact: Keith Kretchmer, President
- Identification of the Device: 1) Trade/Device Name: CMDR 2CW (Multiple Models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Equivalent legally marketed device: K171353 Trade/Device Name: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Reference device (We employ these cleared devices without modification): Trade/Device Name: K150929 CareView 1500Cw X-ray Flat Panel Detector made by CareRay. Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
- Indications for Use (intended use): These digital radiographic systems are intended for use by a qualified/trained 4) physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
-
- Description of the Device: This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators:
- a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR
- b) HF100H+ cleared in K052721 OR
- c) HF1202 PowerPlus cleared in K153059.
- Plus: A 510(k) cleared (K150929) Digital X-Ray Receptor Panel CareView 1500Cw X-ray Flat Panel Detector. d)
- e) PLUS: the dicomPACS® software package (Same as our predicate).
The x-ray generators are portable units which operate from 120/240V 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 Careray 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 devices is the supplier of the digital x-ray receptor panel.
4
6) Substantial Equivalence Chart
| Characteristic | Predicate: K171353 CMDR 2ST (Multiple
Models) CMDR 2SPE (Multiple Models) | CMDR 2CW (Multiple Models) |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 with digital x-ray panel and
image acquisition computer | SAME |
| Computer | Dell Precision M3510 or Dell Latitude 14 | Dell Precision M3530 or Dell Latitude 7424
(ruggedized) |
| X-ray
Generator(s)
(All made by
Mikasa X-Ray) | HF120/60H PowerPlus (K040046) or
HF100H+ (K052721) or
HF1202H PowerPlus (K153059) | SAME |
| Basic
Generator
Characteristics | 120 VAC Line operated:
HF120/60H PowerPlus™ produces up to 120
kVP and 2.4 kW peak
HF100H+: up to 100 kVp and 2 kW peak
HF1202H PowerPlus: up to 120 kVp up to 3.0
kW peak | SAME |
| Collimator | Collimare LED Collimator | Collimare LED Collimator |
| Generator
Photo(s)
The same
generators will
be used for the
modified device | Image: HF120/60HPPWV | HF100H+
HF1202 H |
| Digital X-ray
Panel
Supplied | Toshiba FDX3543RPW. Note: this panel was
cleared in K143257 OR PerkinElmer XRpad
4336 (Cleared in K140551) | K150929 CareView 1500Cw X-ray Flat Panel
Detector manufactured by CareRay |
| Panel
Performance | Pixel Pitch 140 μm
Pixel Matrix 2466 (H) x 3040 (V)
Size 14" x 17" OR
Pixel Pitch 100 x 100μm
Matrix size 3556 × 4320
Size 14" x 17" (Cleared in K140551) | Pixel Pitch 154 μm
2304 × 2816 pixels
Size 14" x 17"
(Cleared in K150929) |
| Panel Power
Source | DC Adapter or Lithium Ion rechargeable
battery | DC Adapter or Lithium Ion rechargeable
battery |
| Characteristic | Predicate: K171353 CMDR 2ST (Multiple
Models) CMDR 2SPE (Multiple Models) | CMDR 2CW (Multiple Models) |
| Meets US
Performance
Standard | YES | YES |
| PACS software | dicomPACS® (Cleared with the Toshiba panels
in K141440) | SAME |
| Power Source | 120 V 50/60 Hz AC 20 amp | SAME |
| Digital Panel
Power Source | 120 V 50/60 Hz AC or Lithium Ion Rechargeable
Battery. | SAME |
| Digital Panel | Image: Digital Panel | Image: Digital Panel |
| Model Details | (All models use O&R Imaging Software, and
either a wired or wireless Toshiba panel) (Five
Models) | (All models use O&R Imaging Software with the
Careray Digital Panel and a Dell Laptop) (Five
Models) Model Details: |
| | HF120/60HPPWV Generator with Toshiba
FDX3543RP
CMDR 2ST 100+/ DP for Dell Precision or a /DL for
Dell Latitude Computer: Uses HF100H+ Generator
with Toshiba FDX3543RP
CMDR 2STW 100H+/DP for Dell Precision or a /DL
for Dell Latitude Computer: Uses HF100H+
Generator with Toshiba FDX3543RPW
CMDR 2STW 1202/DP for Dell Precision or a /DL for
Dell Latitude Computer: Uses HF1202 Generator
with Toshiba FDX3543RPW
CMDR 2STW-MIL (Uses Dell Latitude 14 with the
HF120/60HPPWV Generator with Toshiba
FDX3543RPW | CMDR.CW.120.60.S for Dell Precision or
CMDR.CW.120.60.R for Dell Latitude Laptop or
equivalent Uses HF120/60HPPWV Generator with
CareView 1500Cw and O&R Imaging Software
CMDR.CW.100.S for Dell Precision or
CMDR.CW.100.Rfor Dell Latitude Laptop or
equivalent Uses HF100H+ Generator with CareView
1500Cw and O&R Imaging Software.
CMDR.CW.1202.S for Dell Precision Laptop or
equivalent or
CMDR.CW.1202.R for Dell Latitude Laptop or
equivalent Uses HF1202 Generator with CareView
1500Cw and O&R Imaging Software
CMDR 2CW-MIL (Uses Dell Latitude 7424 or
equivalent with the HF120/60HPPWV Generator |
5
6
-
- The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new devices are 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. NO HARDWARE OR SOFTWARE MODIFICATIONS TO ALREADY CLEARED DEVICES WERE REQUIRED TO CREATE THESE NEW MODELS. The main difference from the predicate device is the addition of the CareView 1500 CW flat-panel detector, that replaces the Toshiba and Perkin-Elmer digital imagers used with the predicate system.
-
- Summary of non-clinical testing: Prototype systems covering all generator/panel combinations were assembled and tested. First the dicomPACS® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. A Wi-Fi connection was confirmed between the PerkinElmer panel and the Dell laptop. The panel was confirmed to be charged and turned on. Then the MinXray HF portable generator was turned on. The MinXray portable X-ray generator was set to generate an exposure. The generator was aimed at the PerkinElmer 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 comples with DHHS radiation safety standards currently in effect, and has undergone testing for compliance with UL 60601-1 (2005) [Electrical medical device safety), IEC 60601-1-2 (2007) (Electromagnetic Compatibility). Additionally, the HF1202H PowerPlus generator meets IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. The other generators were designed and cleared prior to the issuance of this standard. We verified software compatibility with the new CareView Cw digital panel. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
We employed the i.b.a. Test Device DIGI-13, a device for quality tests at CR and DR systems (e.g. for acceptance tests according to DIN V 6868-58 and constancy tests according to DIN 6868-13) to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested. The images were evaluated and found to be of diagnostic quality.
In recognition of the FDA Guidance on Cybersecurity, we added Cybersecurity precautions to our labeling and obtained Cybersecurity information from our DICOM software supplier Oehm Und Rehbein.
-
- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
-
- Conclusion: After analyzing bench and clinical tests, it is the conclusion of MinXray Inc. that the modified Digital Diagnostic X-Ray Systems are 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.