(28 days)
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment.
This looks like a 510(k) summary for a medical device called "Micro C Medical Imaging System, M01". The summary primarily focuses on establishing substantial equivalence to a predicate device and discussing technical characteristics and compliance with various standards.
There is no information provided regarding acceptance criteria nor a typical clinical study with patient data that would involve the following:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for image quality or diagnostic performance, nor does it report device performance against such metrics.
- Sample size used for the test set and the data provenance: There is no mention of a test set with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no clinical test set, there's no mention of experts or ground truth establishment.
- Adjudication method for the test set: Not applicable as there's no patient test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as there's no patient test set or reader study mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes an X-ray imaging system, not an AI algorithm. Therefore, this is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as there's no clinical test set.
- The sample size for the training set: Not applicable as there's no AI algorithm with a training set discussed.
- How the ground truth for the training set was established: Not applicable as there's no AI algorithm with a training set discussed.
What the document does provide:
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Technological Characteristics Comparison (Table 5-2 and 5-3): This table compares the subject device (Micro C Medical Imaging System, M01) with a predicate mobile X-ray system (Nomad MD 75kV Handheld X-Ray System, K140723) and reference devices (KDR™ AU-DDR System, K193225 and Faxitron VisionCT, K173309). It details various technical specifications like product code, regulation, classification, indication for use, age of device use, principle of operation, image type, detector characteristics (for the detector incorporated), collimator, weight, dimensions, triggering mechanism, SSD, SID, light field, energy source, exposure time, mA, kVp, ingress protection, image processing, connectivity options, DICOM compliance, and device package contents.
- Non-Clinical Performance Data: The document states that testing was performed successfully according to a list of international standards (e.g., ISO, IEC) and FDA regulations. These standards cover aspects like risk management, diagnostic X-ray system requirements, electrical safety, electromagnetic compatibility, usability, X-ray tube assemblies, software product lifecycle, biocompatibility, labeling, and laser safety.
- Additional Non-Clinical Performance Testing: This includes Functional Testing, an Image Quality Study, Usability Testing, and a Cleaning Study. However, no specific details, criteria, or results from these studies are provided in this summary.
Conclusion from the document:
The summary concludes that the Micro C Medical Imaging System, M01 is similar to the legally marketed predicate device (Nomad MD 75kV Handheld X-Ray System) in intended use, similar technologies, and performance data, and therefore does not raise different questions of safety and effectiveness, thus supporting its substantial equivalence claim.
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January 12, 2021
% Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL, MINNESOTA 55114
Re: K203658
Trade/Device Name: Micro C Medical Imaging System, M01 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 14, 2020 Received: December 15, 2020
Dear Prithul Bom:
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
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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) Unknown K203658
Device Name Micro C Medical Imaging System, M01
Indications for Use (Describe)
The Micro C Medical Imaging System. M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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Image /page/3/Picture/2 description: The image shows the logo for OXOS Medical. The logo consists of four symbols: a circle with two gaps, an X, a circle with two gaps, and an S. Below the symbols, the word "MEDICAL" is written in a sans-serif font.
Section 5 510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Micro C Medical Imaging System, M01 Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Submitter: | OXOS Medical, Inc1230 Peachtree St NE SuiteSuite #300Atlanta, GA 30309Tel: 1-800-SEE-XRAY |
|---|---|
| Submission Contact: | Mo KhosravanipourDirector of Program ManagementOXOS Medical, Inc.Email: Mo@oxos.com |
| Grace Powers, MS, MBA, RAC | |
| Founder/Principal Consultant | |
| Powers Regulatory Consulting | |
| Email: grace@powersregulatory.com | |
| Submission Date: | November 16, 2019 |
| Subject Device: | Trade Name: Micro C Medical Imaging System, M01Common Name: Mobile X-Ray System |
| Regulation: 21 CFR § 892.1720 | |
| Regulatory Classification: 2 | |
| Product Code: IZL | |
| Classification Panel: Radiology | |
| Predicate Device: | Legally marketed device to which substantial equivalence is claimed:Nomad MD 75kV Handheld X-Ray System (K140723) |
| Reference Devices: | KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography andKDR™ AU System Advanced U-Arm with Static Digital Radiography (K193225)Faxitron VisionCT (K173309) |
Device Description:
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C
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Section 5 510(k) Summary
Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment. A description of the three major sub-systems is listed below.
- Emitter: This component contains the operator control panel, X-ray tube, and computer vision camera. The control panel allows the operator to control the major functions of the device, including the technique factors. This component is controlled and held in the operator's hand.
- Cassette: This component contains the X-ray detector that collects the X-ray energy and provides a digital representation to the control unit for eventual display. This component also contains status lights and IR lights to assist in X-ray field positioning. The patient anatomy of interest is placed on top of this module.
- Control Unit: This component contains the High Voltage generator, computing power, monitor and keyboard inputs, and other electronics required for the functioning of the device. This module is typically placed on a shelf, cart, counter, or other flat surface convenient to the operator and environment.
The system is intended to work in conjunction with a DICOM monitor, keyboard and a mouse and the mains power outlet.
The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs, and transfer radiographs to a PACS server or flash drive.
Image /page/4/Picture/8 description: The image shows a white box connected to a white device with two cables. The white box has several ports on its side, and two cables are plugged into it. One cable is light blue and the other is gray. The light blue cable connects the box to a white device, and the gray cable connects the box to a different port on the white device.
Figure 5-1: Subject Device - Micro C Medical Imaging System, M01
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Image /page/5/Figure/2 description: The image shows a computer setup with a monitor, keyboard, and mouse connected to a device. The monitor is connected to the device via a cable, and the keyboard and mouse are also connected to the device. The device is connected to a power outlet via a power cord. The image shows the connections between the different components of the computer setup.
Intended Use:
The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities.
Indications for Use:
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities.
The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
Technological Characteristics
The Micro C Medical Imaging System, M01 has similar technological characteristics as the predicate device, Nomad MD 75kV Handheld X-Ray System cleared via K140723. The Micro C Medical Imaging System, M01 also includes a detector. The detector is identical to the Faxitron VisionCT (K173309). The Micro C Medical Imaging System, M01 also includes serial radiography similar to the reference device KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography cleared via K193225. The table below compares the subject, predicate and reference device. A comparison of the detectors is in the second table below.
| Subject Device:Micro C Medical ImagingSystem, M01 | Predicate Device:Nomad MD 75kVHandheld X-Ray SystemK140723 | Reference Device:KDRTM AU-DDR SystemAdvanced U-ArmK193225 | |
|---|---|---|---|
| Product Code | IZL (Mobile X-RaySystem) | IZL (Mobile X-RaySystem) | KPR (System, X-Ray,Stationary), MQB (Solid StateX-Ray Imager (FlatPanel/Digital Imager) |
| Regulation | 21 CFR 892.1720 | 21 CFR 892.1720 | 21 CFR 892.1680 |
| ClassificationName | Mobile X-Ray System | Mobile X-Ray System | Stationary X-ray System |
| Classification | Class 2 | Class 2 | Class 2 |
| Indication for Use | The Micro C MedicalImaging System, M01 is ahandheld and portablegeneral purpose X-raysystem that is indicatedfor use byqualified/trainedclinicians on adultpatients for takingdiagnostic static andserial radiographicexposures of extremities.The device is notintended to replace aradiographic system thathas both variable tubecurrent and voltages(kVp) in the range thatmay be required for fulloptimization of imagequality and radiationexposure for differentexam types. | The NOMAD MD is ahandheld and portablegeneral purpose X-raysystem. The device usesa fixed tube current andvoltage (kVp) and,therefore, is limited totaking diagnostic X-raysof extremities.It is intended to be usedby a qualified andtrained clinician on bothadult and pediatricpatients. It is notintended to replace aradiographic systemwith variable tubecurrent and voltage(kVp) which may berequired for fulloptimization of imagequality and radiationexposure for differentexam types. | The KDRTM AU-DDR SystemAdvanced U-Arm withDynamic Digital Radiographyand KDRTM AU SystemAdvanced U-Arm with StaticDigital Radiography isindicated for use byqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic static and serialradiographic exposures of theskull, spinal column, chest,abdomen, extremities, andother body parts.Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position(not for mammography). |
| Age of DeviceUse | Adults | Adults and Children | Adults and Children |
| Principle ofOperation | General purposediagnostic X-ray | General purposediagnostic X-ray | General purpose diagnostic X-ray |
| Image typeproduced | Static, serial radiographicand photographic imagesfor convenience. | Static images only | Static or serial radiographicimages |
| Detector | 6 x 6" digital detector | No detector provided. | 16.7 x 16.7" digital detector |
| Collimator | The removable fixedcollimators (referred toas pucks) | Four manually andsteplessly adjustableshutters with LED LightField Center Indicator tolimit the X-ray. | Six pairs of motorizedautomatic collimation withmanual override possible,light field Indicator and twoLasers and Camera. |
| Weight | Emitter: 2.86kg (6.3lbs)Cassette: 6.5kg (14.3lbs)Control Unit: 8.6kg(19.0lbs) | 11.0lbs | Stationary device |
| Dimension/Size | Emitter: 9.3"H x 3.5"W x8.3"L (excluding SSDCone)Cassette: 15.5"H x15.5"W x 2.8"L | 9.5"H x 5.25"W x 10"L(excluding Source Skinguard) | Stationary device with U-Mount arm and X-ray table |
| Control Unit: 16.4"H x 12.9"W x 5.5"L | |||
| TriggeringMechanism | Two stage triggering | Two stage triggering | Start button on the userinterface after set up. |
| MinimumSource toskin distance(SSD) | 20 cm SSD Cone ensuresminimum SSD of 20 cm | 30 cm Source SkinGuard ensuresminimum SSD of 30 cm | Unknown |
| Source toDetectordistance | 20 - 45 cm | Not limited | 100 - 200 cm |
| Light Field | Virtual light field onMonitor UI. No projectedlight field. | Projected light field | Projected light field |
| EnergySource | 120 VAC / 60 Hz (norechargeable battery) | Rechargeable 14.4V DCNiCd battery pack (alsocontains an AC to DCpower supply) | 480 VAC/ 60Hz (generator) |
| ExposureTime | 33ms, 66ms and 99ms | 20 – 990ms in 10msincrements | 1-1000 ms in variousincrements |
| mA | 1.0 mA fixed | 2.0 mA fixed | 100-1000 mA in variousincrements |
| kVp | 40kVp, 50kVp, and 60kVp | 75 kVp fixed | 40-150 kVp in variousincrements |
| IngressProtectionRating | IPOO | IP0; do not operateunder wet conditions | Unknown |
| ImageProcessing | User Interface can beused to drag, zoom,rotate and also adjustbrightness, contrast, andsharpness. | Not applicable | User interface has optionalpost-processing functionssuch as brightness, sharpness,annotations, stitching andother functions. |
| ConnectivityOptions | WiFi, Ethernet, Four USB2.0 ports | Not applicable | Ethernet, USB ports |
| DICOM | Yes- DICOM 3.0Compliant | Not applicable | Yes- DICOM 3.0 Compliant |
| DevicePackageContents | Cassette Control Unit Emitter Collimation Pucks SSD Cone Cassette Power Cable Cassette Data Cable Control Unit Power Cable Connector Covers | Nomad MD device Spare Battery Charging Cradle AC-to-DC Power Supply | A floor and wall-mounted Positioner (also referred to as a stand) Generator Off-the-shelf computer with proprietary software (also referred to as an acquisition workstation) |
| Instructions for Use Case |
Table 5-2: Device Comparison
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Section 5 510(k) Summary
Faxitron VisionCT cleared under K173309 contains the identical detector (Xineos-1515 manufactured by Teledyne DALSA) as the subject device. The Faxitron VisionCT is a stationary X-ray but is used for specimen radiography.
| Subject Device:Micro C Medical ImagingSystem, M01 | Reference Device:Faxitron VisionCT(K173309). | Reference Device:KDR TM AU-DDR SystemAdvanced U-ArmK193225 | |
|---|---|---|---|
| Scintillator | Cesium Iodide (CsI) | Cesium Iodide (CsI) | Cesium Iodide (CsI) |
| Resolution/ Pixelsize | 99 μm | 99 μm | 100 μm |
| DQE @ 0Lp/mm | 70% | 70% | 72% |
| MTF @ 1 Lp/mm,RQA5 | 60% | 60% | Unknown |
Table 5-3: Detector Comparison
Note: The predicate device does not have a detector.
Non-Clinical Performance Data
Testing was performed successfully according to the following standards and CFR:
- . ISO 14971 Edition 2 2007 Application of risk management to medical devices (FR Recognition number 5-40)
- 21 CFR 1020.30 Diagnostic X-ray systems and their major components (met via conformity to IEC 60601-1-3 and 60601-2-54, and 21 CFR 1020.30 parts (a), (b), (d), (e),(g), (j), and (q))
- 21 CFR 1020.31 Radiographic equipment (met via conformity to IEC 60601-1-3 and 60601-2-54)
- IEC 60601-1 Edition 3.1 2005 Requirements for Medical Electrical Equipment (FR Recognition number 19-4)
- . IEC 60601-1-2 Edition 4 2014 Requirements for Medical Equipment (FR Recognition number 19-8)
- IEC 60601-1-3 Edition 2.1 2013 Requirements for Medical Electrical Equipment (FR Recognition number 12-269)
- IEC 60601-1-6 Edition 3.1 2013 Requirements for Medical Electrical Equipment, and IEC 62366-1 Edition 1.0 2015 Application of usability engineering to medical devices (FR Recognition number 5-89)
- . IEC 60601-2-28 Edition 3.0 2017 Requirements for X-ray Tube Assemblies (FR Recognition number 12-309)
- . IEC 60601-2-54 Edition 1.1 2015 Requirements for Medical electrical equipment for radiography (FR Recognition number 12-296)
- IEC 62304 Edition 1.1 2015 for all software product lifecycle development (FR Recognition number 13-79)
- ISO 10993-1 Edition 5 2018 (FR Recognition number 2-258)
- 21 CFR 801: Labeling
- IEC 60825 Edition 3.0 2014 requirements for Lasers (FR Recognition number 12-273)
- DICOM Standard when interfacing with PACS
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Additional Non-Clinical performance testing conducted includes:
- Various Functional Testing
- Image Quality Study ●
- Usability Testing
- Cleaning Study
The following specific guidance document was utilized in the device development to ensure the safety of this device for both the operators and patients:
- Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
- . Radiation Safety Considerations for X-ray Equipment Designed for Hand-held Use
Conclusion
The Micro C Medical Imaging System, M01 is similar to the legally marketed predicate device as demonstrated by the same intended use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.
§ 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.