(32 days)
Not Found
No
The summary describes a standard radiographic X-ray system and does not mention any AI or ML capabilities, image processing features, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a "radiographic system used for producing X-ray images" and "diagnostic imaging," indicating its purpose is for diagnosis, not therapy.
Yes
Explanation: The "Device Description" section explicitly states that the MRH ALFA, MRH II & MRH IIE Radiographic Systems are "used for diagnostic imaging (analog radiology)".
No
The device description explicitly states it is a "general purpose, computed radiography (CR) X-ray systems" and mentions testing to hardware standards like IEC 60601-1 and IEC 60601-2-54, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The MRH ALFA, MRH II, and MRH IIE systems are described as radiographic systems that produce X-ray images of the human body. This is an in vivo imaging technique, meaning it examines the body directly, not through a specimen.
- Intended Use: The intended use clearly states the system is for producing X-ray images of various anatomical regions of the human body.
The description and intended use align with a medical imaging device used for diagnostic purposes through direct imaging of the patient, not through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system.
The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system.
The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system.
The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
The MRH ALFA, MRH II & MRH IIE Radiographic Systems designed and manufactured by CMR are general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The devices are designed to meet the requirements of basic radiology procedures and produces a low radiation dose to the patient, while acquiring its images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. Full body.
Indicated Patient Age Range
Adults and pediatric patients:
- Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
Intended User / Care Setting
Not Found
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)
As part of demonstrating substantial equivalence of the MRH II & MRH IIE Radiographic Systems to the predicate device, CMR submitted a final finished device for testing to the following voluntary standards:
- IEC 60601-1 (+ ES60601-1), Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance (passed required testing)
- IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (passed required testing)
- IEC 60601-1-3, Medical Electrical Equipment - Part. 1: General Requirements for Safety 3. Collateral Standard: General Requirements for Radiation (passed required testing)
- IEC 60601-1-6, Medical electrical equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability (passed required testing)
- IEC 60601-2-54, Medical Electrical Equipment - Part 2- 54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radioscopy (passed required testing)
- ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 10993-5 (cytotoxicity) (passed required testing)
- ISO 10993-10 (irritation) (passed required testing)
- ISO 10993-10 (sensitization) (passed required testing)
Additionally, CMR also performed the following internal quality control measures during the design, development and manufacturing stages of their MRH ALFA, MRH IIE Radiographic Systems:
- Risk Analysis (FMEA) per ISO 14971, Medical Devices - Application of Risk Management to Medical Devices
- Compliance to 21 CFR Part 1020.30 Diagnostic x-ray systems and their major components and 21 CFR Part 1020.31 Radiographic equipment.
- Compliance to the following FDA guidance documents:
- Medical Devices and Radiation-Emitting Products, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
- Pediatric Information for X-ray Imaging Device Premarket Notifications
Clinical testing on the subject devices have not been performed. These types of devices, including the predicate device, have been on the market for many years with proven safety and effectiveness. The nonclinical testing detailed in this submission supports the substantial equivalence of the subject devices.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Compania Mexicana De Radiologia CGR, S.A. DE C.V. % Mr. Stuart R. Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 AUSTIN TX 78746
January 28, 2020
Re: K193637
Trade/Device Name: MRH ALFA, MRH II & MRH IIE Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: December 19, 2019 Received: December 27, 2019
Dear Mr. Goldman:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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
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Indications for Use
510(k) Number (if known) K193637
Device Name
MRH ALFA, MRH II & MRH IIE Radiographic Systems
Indications for Use (Describe)
- The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system.
The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
- The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system.
The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
- The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system.
The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
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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Special 510(k) Summary MRH ALFA, MRH II & MRH IIE Radiographic Systems
1. Submission Sponsor
Compañía Mexicana de Radiología CGR S.A. de C.V. Fraccionamiento Industrial la Noria s/n El Marqués, Querétaro C.P. 76240 México Phone: (55) 54821300 Contact: Tonatiuh Monroy Soberón Title: Design Engineer, Regulatory Specialist
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Stuart R. Goldman Title: Sr. Consultant RA/QA
3. Date Prepared
December 19, 2019
4. Purpose of the Submission
In this Special 510(k) Compañía Mexicana de Radiología (CMR) is making several minor technological modifications to certain components of their previously cleared ARiX RAD Radiographic System (K182134), the predicate device, that will result in the creation of their new MRH ALFA, MRH IIE Radiographic Systems.
5. Device Identification
| Trade Name: | MRH ALFA, MRH II & MRH IIE Radiographic Systems |
|---|---|
| Common Name: | Radiographic System |
| Classification Name: | Stationary X-ray System |
| Regulation Number: | 892.1680 |
| Product Code: | KPR, System, X-Ray, Stationary |
| Class: | Class 2 |
| Classification Panel: | Radiology |
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6. Legally Marketed Predicate Device
| Device name: | ARiX RAD Radiographic System |
|---|---|
| 510(k) No.: | K182134 |
| Manufacturer: | Compañía Mexicana de Radiología CRG S.A. de C.V. |
7. Indications for Use
The indications for use on subject devices are identical to the predicate device, the ARiX RAD Radiographic System, as shown below.
The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system.
The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography.
The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follows:
- . Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system.
The MRH II system is not intended for use in mammography, fluoroscopy or angiography.
The MRH II system is intended for adults and pediatric patients. The pediatric population is as follows:
- . Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system.
The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography.
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The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follows:
- Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
8. Device Description
The MRH ALFA, MRH II & MRH IIE Radiographic Systems designed and manufactured by CMR are general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The devices are designed to meet the requirements of basic radiology procedures and produces a low radiation dose to the patient, while acquiring its images.
9. Device Modifications
The following minor technological modifications have been made to the ARiX RAD Radiographic System (K182134), the predicate device. The minor modifications are being made to several main components of the predicate device to create the subject devices. The minor modifications are: 1) removal of the touch screen functionality from the Control Panel, 2) change the dimensions, load capacity and motorized movement feature of the Powered Table Top, 3) change the height, longitudinal displacement and vertical displacement of the X-ray Tube Stand and 4) change the casing material for the Wall Bucky. In addition, the name of the device is also being changed from the ARiX RAD Radiographic System to the MRH ALFA, MRH II & MRH IIE Radiographic Systems to reflect these different changes for marketing purposes.
10. Substantial Equivalence Comparison
Table 5-1 compares the MRH ALFA, MRH IIE Radiographic Systems subject devices to the predicate device ARiX RAD Radiographic System with respect to indications for use, principles of operation, technological characteristics, components/materials, and performance testing. The comparison of the subject devices to the predicate device provides detailed information regarding the basis for the determination of substantial equivalence. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
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| Attributes | Subject Devices | Predicate Device | Comparison |
|---|---|---|---|
| Device Name | MRH ALFA, MRH II & MRH IIE Radiographic Systems | ARIX RAD Radiographic System | - |
| Manufacturer | Compañía Mexicana de Radiología (CMR) | Compañía Mexicana de Radiología (CMR) | Same |
| 510(k) # | Pending | K182134 | - |
| Regulatory Information | |||
| Product Code | KPR | KPR | Identical |
| Regulation | CFR 892.1680 | CFR 892.1680 | Identical |
| Regulation Name | Stationary x-ray system | Stationary x-ray system | Identical |
| Class | II | II | Identical |
| Review Panel | Radiology | Radiology | Identical |
| Intended Use | Radiographic system used for producing X-ray images of | Radiographic system used for producing X-ray images of | Identical |
| the human body. | the human body. | ||
| Indications for Use | The MRH ALFA system is a radiographic system used for | ||
| producing X-ray images of the human body, including all | |||
| anatomical regions such as the head, thorax, column, | |||
| abdomen, extremities and internal organs. The system is | |||
| designed to be used with conventional film or CR systems | |||
| and can be interfaced with a digital detector, but neither | |||
| the X-Ray detector nor the image acquisition system are | |||
| part of the MRH ALFA radiographic system. The | |||
| acquisition system comes as a separate system. | |||
| The MRH ALFA system is not intended for use in | |||
| mammography, fluoroscopy or angiography. | |||
| The MRH ALFA system is intended for adults and | |||
| pediatric patients. The pediatric population is as follows: | |||
| • Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 | |||
| kg (114 lb.) | |||
| • Adolescent (12-21 yrs.), approximately 51 kg (114 | |||
| lb.) to 80 kg (176 lb.) | |||
| The MRH II system is a radiographic system used for | The ARIX RAD system is a radiographic system used for | ||
| producing X-ray images of the human body, including all | |||
| anatomical regions such as the head, thorax, column, | |||
| abdomen, extremities and internal organs. The system | |||
| is designed to be used with conventional film or CR | |||
| systems and can be interfaced with a digital detector, | |||
| but neither the X-Ray detector nor the image acquisition | |||
| system are part of the ARIX RAD radiographic system. | |||
| The acquisition system comes as a separate system. | |||
| The ARIX RAD system is not intended for use in | |||
| mammography, fluoroscopy or angiography. | |||
| The ARIX RAD system is intended for adults and | |||
| pediatric patients. The pediatric population is as follows: | |||
| • Child (3-12 yrs.), approximately 12kg (26 lb.) to | |||
| 51 kg (114 lb.) | |||
| • Adolescent (12-21 yrs.), approximately 51kg (114 | |||
| lb.) to 80kg (176 lb.) | Identical | ||
| Attributes | Subject Devices | Predicate Device | Comparison |
| anatomical regions such as the head, thorax, column, | |||
| abdomen, extremities and internal organs. The system is | |||
| designed to be used with conventional film or CR systems | |||
| and can be interfaced with a digital detector, but neither | |||
| the X-Ray detector nor the image acquisition system are | |||
| part of the MRH II radiographic system. The acquisition | |||
| system comes as a separate system. | |||
| The MRH II system is not intended for use in | |||
| mammography, fluoroscopy or angiography. | |||
| The MRH II system is intended for adults and pediatric | |||
| patients. The pediatric population is as follows: | |||
| Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 | |||
| kg (114 lb.) | |||
| Adolescent (12-21 yrs.), approximately 51 kg (114 | |||
| lb.) to 80 kg (176 lb.) | |||
| The MRH IIE system is a radiographic system used for | |||
| producing X-ray images of the human body, including all | |||
| anatomical regions such as the head, thorax, column, | |||
| abdomen, extremities and internal organs. The system is | |||
| designed to be used with conventional film or CR systems | |||
| and can be interfaced with a digital detector, but neither | |||
| the X-Ray detector nor the image acquisition system are | |||
| part of the MRH IIE radiographic system. The acquisition | |||
| system comes as a separate system. | |||
| The MRH IIE system is not intended for use in | |||
| mammography, fluoroscopy or angiography. | |||
| The MRH IIE system is intended for adults and pediatric | |||
| patients. The pediatric population is as follows: | |||
| Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 | |||
| kg (114 lb.) | |||
| Attributes | Subject Devices | Predicate Device | Comparison |
| Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.) | |||
| Technology Overview | General diagnostic X-ray system consisting of a tube-head and collimator assembly, with a generator, generator control, and an X-ray table. | General diagnostic X-ray system consisting of a tube-head and collimator assembly, with a generator, generator control, and an X-ray table. | Identical |
| Mechanism of Action | X-ray tube | ||
| (Dual Focal Spot) | X-ray tube | ||
| (Dual Focal Spot) | Identical | ||
| Configuration | Column mount | Column mount | Identical |
| Positioning Controls | Enhanced | Enhanced | Identical |
| Collimator | Manual | ||
| (made by Ralco) | Manual | ||
| (made by Ralco) | Identical | ||
| Anatomical Location | Full body | Full body | Identical |
| Power Supply | 220 VCA | 220 VCA | Identical |
| Generator | High frequency: 32, 50, 60 and 80 kW | ||
| (made by CMR) | High frequency: 32, 50, 60 and 80 kW | ||
| (made by CMR) | Identical | ||
| Exposure Voltage Ranges for Available Generators | 40 - 125 kVp or 40 - 150 kVp | 40 - 125 kVp or 40 - 150 kV | Identical |
| X-ray Current for Available Generators | 400 – 800 mA | 400 – 800 mA | Identical |
| X-ray Exposure Times | 0.001 - 10 s | 0.001 - 10 s | Identical |
| Software Controlled | Yes | Yes | Identical |
| Safety and Performance Testing Applied | |||
| Design and Performance | 21 CFR 1020.30 | ||
| 21 CFR 1020.31 | 21 CFR 1020.30 | ||
| 21 CFR 1020.31 | Identical | ||
| Attributes | Subject Devices | Predicate Device | Comparison |
| Electrical Safety | |||
| and EMC | IEC 60601-1 | IEC 60601-1 | Identical |
| IEC 60601-1-2 | IEC 60601-1-2 | ||
| IEC 60601-1-3 | IEC 60601-1-3 | ||
| IEC 60601-1-6 | IEC 60601-1-6 | ||
| IEC 60601-2-54 | IEC 60601-2-54 | ||
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Identical |
| ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-10 |
Table 5-1 – Substantial Equivalence Comparison of MRH II & MRH IIE Radiographic Systems vs. ARiX RAD Radiographic System (K182134)
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11. Summary of Safety and Performance Testing
As part of demonstrating substantial equivalence of the MRH II & MRH IIE Radiographic Systems to the predicate device, CMR submitted a final finished device for testing to the following voluntary standards:
- . IEC 60601-1 (+ ES60601-1), Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance (passed required testing)
- . IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (passed required testing)
- IEC 60601-1-3, Medical Electrical Equipment - Part. 1: General Requirements for Safety 3. Collateral Standard: General Requirements for Radiation (passed required testing)
- . IEC 60601-1-6, Medical electrical equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability (passed required testing)
- . IEC 60601-2-54, Medical Electrical Equipment - Part 2- 54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radioscopy (passed required testing)
- ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- ISO 10993-5 (cytotoxicity) (passed required testing) O
- O ISO 10993-10 (irritation) (passed required testing)
- ISO 10993-10 (sensitization) (passed required testing) O
Additionally, CMR also performed the following internal quality control measures during the design, development and manufacturing stages of their MRH ALFA, MRH IIE Radiographic Systems:
- Risk Analysis (FMEA) per ISO 14971, Medical Devices - Application of Risk Management to Medical Devices
- Compliance to 21 CFR Part 1020.30 Diagnostic x-ray systems and their major components and 21 CFR Part 1020.31 Radiographic equipment.
- . Compliance to the following FDA guidance documents:
- Medical Devices and Radiation-Emitting Products, Guidance for the Content of Premarket O Submissions for Software Contained in Medical Devices
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices O
- O Pediatric Information for X-ray Imaging Device Premarket Notifications
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12. Clinical Testing
Clinical testing on the subject devices have not been performed. These types of devices, including the predicate device, have been on the market for many years with proven safety and effectiveness. The nonclinical testing detailed in this submission supports the substantial equivalence of the subject devices.
13. Statement of Substantial Equivalence
The MRH ALFA, MRH II & MRH IIE Radiographic Systems have the same intended use and indications for use as the predicate device. The comparison of the mode of operation, technological characteristics and safety and performance testing between the subject devices and the and predicate device demonstrates that the subject devices are as safe and effective as the predicate device. Therefore, the MRH ALFA, MRH II & MRH IIE Radiographic Systems as designed and manufactured by Compañía Mexicana de Radiología are determined to be substantially equivalent to its ARiX RAD Radiographic System (K182134).