Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components (X-ray generators, digital panels) and standard image acquisition/viewing software (dicomPACS®). There is no mention of AI, ML, or advanced image processing features that would typically indicate the presence of such technology. The testing described is focused on hardware compatibility and image quality, not the performance of an AI/ML algorithm.

Therapeutic

No
The device is used for taking diagnostic x-rays, which falls under diagnostic imaging rather than a therapeutic purpose.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for taking diagnostic x-rays," and the "Device Description" mentions that the portable panels "provide digital X-ray image capture for a wide range of applications" and are used to "capture high quality diagnostic images for routine diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a combination of three devices, including X-ray generators and digital X-ray receptor panels, which are hardware components. While software is mentioned, it is part of a larger system that includes hardware.

IVD (In Vitro Diagnostic)

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 patients (adult and pediatric). This is an in-vivo diagnostic procedure, meaning it's performed on a living organism.
Device Description: The device is a combination of an X-ray generator and a digital X-ray receptor panel. These components are used to produce and capture images of the inside of the body, not to analyze samples taken from the body.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.

Therefore, this device falls under the category of medical imaging devices, specifically X-ray equipment, rather than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended for use by a qualified trained physician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Product codes (comma separated list FDA assigned to the subject device)

IZL, MQB, LLZ

Device Description

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: HF120/60H PowerPlus cleared in K040046, (and in K141885) OR HF100H+ cleared in K052721 OR HF1202 PowerPlus cleared in K153059. One of three cleared digital X-ray receptor panels: Toshiba FDX3543RP OR the Toshiba FDX3543RPW cleared in K162687 (and others) OR the PerkinElmer Solid State Imager, (K140551) PLUS: the dicomPACS® software package (K141885) (Same as our predicate). The X-ray generators are portable units which operate 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 formerly used Toshiba panels or PerkinElmer flat panel technology in a sleek and compact unit. The portable panels provide 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 digital x-ray receptor panel.

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

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

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 completed system complies 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 isuance of this standard. The software supplier Oehm Und Rehbein GmbH verified compatibility with the new PerkinElmer digital panel and supplied us with a test report. 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing indicates that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. The modified combination of components worked properly and produced diagnostic quality images as good as the predicate generator/panel combination.

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.

K141885

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.

K140551, K141440

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles stacked on top of each other.

Public Health Service

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

June 7, 2017

MinXray, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

Re: 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 Code: IZL, MQB, LLZ Dated: May 3, 2017 Received: May 9, 2017

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

1

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.

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/ResourcesforYou/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.

Sincerely,

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171353

Device Name

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

Indications for Use (Describe)

Intended for use by a qualified trained physician 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)

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510(k) Summary: 510(k) Number K171353 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Date Prepared: May 27, 2017 Contact: Keith Kretchmer, President

1. Identification of the Device: 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
1. Equivalent legally marketed device: 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 Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
1. Reference devices (We employ these cleared devices without modification):
- a) Trade/Device Name: K140551 Perkinelmer, XRpad 4336 MED Flat Panel Detector Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
- b) Trade/Device Name: K141440; Oehm Und Rehbein Gmbh, DicomPACS® DX-R with flat panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: Class II Product Code: MQB
1. Indications for Use (intended use): These digital radiographic systems are 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.

Description of the Device: This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: HF120/60H PowerPlus cleared in K040046, (and in K141885) OR HF100H+ cleared in K052721 OR HF1202 PowerPlus cleared in K153059. One of three cleared digital X-ray receptor panels: Toshiba FDX3543RP OR the Toshiba FDX3543RPW cleared in K162687 (and others) OR the PerkinElmer Solid State Imager, (K140551) PLUS: the dicomPACS® software package (K141885) (Same as our predicate). The X-ray generators are portable units which operate 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 formerly used Toshiba panels or PerkinElmer flat panel technology in a sleek and compact unit. The portable panels provide 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 digital x-ray receptor panel. .

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6) Substantial Equivalence Chart

| Characteristic | Predicate:
CMDR-2ST & CMDR-2SLWT
Digital X-Ray System
K141885 | CMDR 2ST (Multiple Models) | CMDR 2SPE (Multiple Models) | Integris |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | SAME | SAME |
| Configuration | Mobile System with digital x-
ray panel and image
acquisition computer | SAME | SAME | SAME |
| Computer | Dell laptop | Dell Precision M3510 or Dell
Latitude 14 (ruggedized) | Dell Precision M3510 or Dell
Latitude 14 (ruggedized) | Beckhoff C6920/C6925 |
| X-ray
Generator(s)
(All made by
Mikasa X-Ray) | HF120/60H PowerPlus
(K040046) | SAME OR
HF100H+ (K052721)
HF1202H PowerPlus (K153059) | SAME OR
HF100H+ (K052721)
HF1202H PowerPlus (K153059) | HF1202H PowerPlus (K153059) |
| Basic
Generator
Character-
istics | 120 VAC Line operated
HF120/60H PowerPlus™
produces up to 120 kVP and
2.4 kW peak | SAME OR
HF100H+: up to 100 kVp and 2
kW peak
HF1202H PowerPlus: up to 120
kVp up to 3.0 kW peak | SAME OR
HF100H+: up to 100 kVp and 2 kW
peak
HF1202H PowerPlus: up to 120 kVp
up to 3.0 kW peak | HF1202H PowerPlus: up to 120
kVp up to 3.0 kW peak |
| Collimator | Collimare LED Collimator | Collimare LED Collimator | Collimare LED Collimator | Collimare LED Collimator |
| Characteristic | Predicate:
CMDR-2ST & CMDR-2SLWT
Digital X-Ray System
K141885 | CMDR 2ST (Multiple Models) | CMDR 2SPE (Multiple Models) | Integris |
| Generator
Photo(s) | HF120/60HPPWV PowerPlus
Image: HF120/60HPPWV PowerPlus generator | HF120/60HPPWV PowerPlus
Image: HF120/60HPPWV PowerPlus generator
OR: HF100H+
Image: HF100H+ generator
OR: HF1202H PowerPlus
Image: HF1202H PowerPlus generator | CMDR 2SPE 120/60 PP
Image: CMDR 2SPE 120/60 PP generator
OR: HF100H+
Image: HF100H+ generator
OR: HF1202H PowerPlus
Image: HF1202H PowerPlus generator | HF1202H PowerPlus
Image: HF1202H PowerPlus generator |
| Digital X-ray
Panel
Supplied | Toshiba FDX3543RP | Toshiba FDX3543RPW. Note:
this panel was cleared in
K143257 | PerkinElmer XRpad 4336 (Cleared in
K140551) | PerkinElmer XRpad 4336 (Cleared
in K140551) |
| Characteristic | Predicate:
CMDR-2ST & CMDR-2SLWT
Digital X-Ray System
K141885 | CMDR 2ST (Multiple Models) | CMDR 2SPE (Multiple Models) | Integris |
| Panel
Performance | Pixel size 143 x 143μm
Matrix size 2448x2984
Size 14" x 17" | Pixel Pitch 140 μ m
Pixel Matrix 2466 (H) x 3040 (V)
Size 14" x 17" | Pixel size 100 x 100μm
Matrix size 3556 × 4320
Size 14" x 17" (Cleared in K140551) | Pixel size 100 x 100μm
Matrix size 3556 × 4320
Size 14" x 17" (Cleared in
K140551) |
| Panel Power
Source | DC Adapter | DC Adapter or Lithium Ion
rechargeable battery | DC Adapter or Lithium Ion
rechargeable battery | DC Adapter or Lithium Ion
rechargeable battery |
| Panel
Interface | Ethernet | Ethernet or Wi-Fi wireless, panel
cleared in | Ethernet or Wi-Fi wireless, panel
cleared in K140551 | Ethernet or Wi-Fi wireless, panel
cleared in K140551 |
| Performance
Standard | 21 CFR 1020.30 | SAME | SAME | SAME |
| PACS
software | dicomPACS® (Cleared in
K141440) | dicomPACS® (Cleared with the
Toshiba panels in K141440) | dicomPACS® (Cleared with the
PerkinElmer panel in K141440) | dicomPACS® (Cleared with the
PerkinElmer panel in K141440) |
| Power Source | 120 V 50/60 Hz AC 20 amp | SAME | SAME | SAME |
| Digital Panel
Power Source | 120 V 50/60 Hz AC | 120 V 50/60 Hz AC or Lithium
Ion Rechargeable Battery. | 120 V 50/60 Hz AC or Lithium Ion
Rechargeable Battery. | 120 V 50/60 Hz AC or Lithium Ion
Rechargeable Battery. |
| Digital Panel | Image: Digital Panel | Image: Digital Panel | Image: Digital Panel | Image: Digital Panel |
| Characteristic | Predicate:
CMDR-2ST & CMDR-2SLWT
Digital X-Ray System
K141885 | CMDR 2ST (Multiple Models) | CMDR 2SPE (Multiple Models) | Integris |
| Model Details | HF120/60HPPWV Generator
with Toshiba FDX3543RP and
O&R Imaging Software | CMDR 2ST 100+/ DP for Dell
Precision or a /DL for Dell
Latitude Computer
Uses HF100H+ Generator with
Toshiba FDX3543RP and O&R
Imaging Software
CMDR 2STW 100H+/DP for Dell
Precision or a /DL for Dell
Latitude Computer
Uses HF100H+ Generator with
Toshiba FDX3543RPW and O&R
Imaging Software
CMDR 2STW 1202/DP for Dell
Precision or a /DL for Dell
Latitude Computer
Uses HF1202 Generator with
Toshiba FDX3543RPW and O&R
Imaging Software
CMDR 2STW-MIL (Uses Dell
Latitude 14 with the
HF120/60HPPWV Generator
with Toshiba FDX3543RPW and
O&R Imaging Software | CMDR 2SPE 120/60 PP
CMDR 2SPE 100H+
CMDR 2SPE 1202
(The suffix is the generator model
number)
Add a /DP for Dell Precision
Computer or a /DL for Dell Latitude
Computer
All use the PerkinElmer XRpad 4336
and O&R Imaging Software | Integris.
Panel: Perkin Elmer Wireless
XRpad 4336 and O&R Imaging
Software
Computer: Beckhoff
C6920/C6925
Generator: HF1202H PowerPlus |

5

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1. 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 indicates 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.
1. 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 completed system complies 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 isuance of this standard. The software supplier Oehm Und Rehbein GmbH verified compatibility with the new PerkinElmer digital panel and supplied us with a test report. 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.
1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
1. 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.