Who is the manufacturer of CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

Minxray, Inc. filed the 510(k) submission for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (K171353).

What is the FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

IZL. It is classified under 21 CFR 892.1720 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

510(k) clearance (submission type: Special).

What are the predicate devices for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

CMDR-2ST & CMDR-2SLWT Digital Portable X-ray System (K141885).

Who can help prepare an FDA 510(k) submission like CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K171353 · Minxray, Inc. · IZL · Jun 7, 2017 · Radiology

Device Facts

Record ID	K171353
Device Name	CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
Applicant	Minxray, Inc.
Product Code	IZL · Radiology
Decision Date	Jun 7, 2017
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1720
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

Mobile digital x-ray system; captures diagnostic images using portable high-frequency x-ray generators and digital receptor panels. System components include MinXray portable generators (HF120/60H, HF100H+, or HF1202H), digital flat panel detectors (Toshiba FDX3543RP/RPW or PerkinElmer XRpad 4336), and dicomPACS software on a laptop or industrial computer. Operated by physicians or technicians in clinical or bedside settings. X-ray generator produces ionizing radiation; digital panel converts x-rays to digital signals; software processes, displays, and manages images. Output used by clinicians for diagnostic assessment of patient anatomy. Benefits include streamlined digital radiography, portability for trauma/bedside exams, and high-quality diagnostic imaging.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing. System performance verified using i.b.a. Test Device DIGI-13 for quality tests (DIN V 6868-58, DIN 6868-13). Images evaluated for diagnostic quality across all generator/panel combinations. Compliance with electrical safety (UL 60601-1) and electromagnetic compatibility (IEC 60601-1-2) confirmed.

Technological Characteristics

Mobile x-ray system; high-frequency inverter generators (120 VAC); digital flat panel detectors (Toshiba/PerkinElmer); laptop/industrial PC. Connectivity via Ethernet or Wi-Fi. Standards: 21 CFR 1020.30, UL 60601-1 (2005), IEC 60601-1-2 (2007), IEC 60601-2-54. Software: dicomPACS.

Indications for Use

Indicated for use by qualified/trained physicians or technicians on adult and pediatric patients for diagnostic x-ray imaging. Contraindicated for mammography.

Regulatory Classification

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.

Predicate Devices

CMDR-2ST & CMDR-2SLWT Digital Portable X-ray System (K141885)

Reference Devices

Perkinelmer, XRpad 4336 MED Flat Panel Detector (K140551)
Oehm Und Rehbein Gmbh, DicomPACS® DX-R with flat panel (K141440)

Related Devices

K100449 — MINXRAY MODEL CMDR-2S · Minxray, Inc. · Apr 23, 2010
K082627 — MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL · Minxray, Inc. · Nov 7, 2008
K201575 — CMDR 2C (Multiple Models) · Minxray, Inc. · Jul 8, 2020
K101517 — SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY · Sedecal., Sa. · Aug 5, 2011
K191451 — CMDR 2CW (Multiple models) · Minxray, Inc. · Jul 3, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### 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 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 - 2) 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 - 3) 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 - 4) 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. 5) 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. . {4}------------------------------------------------ ## 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}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ - 7) 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. - 8) 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. - 9) Summary of clinical testing: Clinical testing was not required to establish substantial equivalence. - 10) 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.