Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard X-ray system with basic image manipulation features and a computer vision positioning system, but there is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as an X-ray system indicated for taking diagnostic radiographic exposures, and its intended use is for "point of care visualization through diagnostic X-rays." This indicates a diagnostic purpose rather than a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities" and "designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of three major hardware subsystems: The Emitter, Cassette, and Control Unit. It also describes the device as a "handheld X-ray system," which is a hardware device. While it includes software components for control and image processing, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Micro C Medical Imaging System, M01 is an X-ray system that takes images of the extremities. It uses external radiation to create images, not analysis of biological samples.
Intended Use: The intended use is for taking diagnostic radiographic exposures of extremities, which is a form of medical imaging, not in vitro testing.

The description clearly indicates it's a medical imaging device that uses X-rays to visualize internal structures, which falls outside the scope of in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 and pediatric 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.

Product codes

IZL

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 Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to 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. These are accessories are not included in the submission. 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. The device software is based on the predicate device and no changes to the software were performed for this submission.

Mentions image processing

User Interface can be used to drag, zoom, rotate and also adjust brightness, contrast, and sharpness.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

extremities

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

qualified/trained clinicians

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)

Non-Clinical Performance Data
Testing specific to the use in surgery was performed and includes:

Usability testing for use in surgery
Cleaning and Disinfection Studies ●
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
Pediatric Information for X-ray Imaging Device Premarket Notifications

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Micro C Medical Imaging System, M01 (K203658)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

June 4, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

OXOS Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K211473

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: May 11, 2021 Received: May 12, 2021

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

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K211473

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 and pediatric 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 GER 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, another circle with two gaps, and the letter S. Below the symbols, the word "MEDICAL" is written in a smaller font.

Section 5 510(k) Summary K211473

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, Inc
1230 Peachtree St NE
Suite #300
Atlanta, GA 30309
Tel: 1-855-SEE-XRAY |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Mo Khosravanipour
Director of Program Management
OXOS Medical, Inc.
Email: Mo@oxos.com |
| | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
Email: grace@powersregulatory.com |
| Submission Date: | April 16, 2021 |
| Subject Device: | Trade Name: Micro C Medical Imaging System, M01
Common Name: System, X-Ray, Mobile
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:
Micro C Medical Imaging System, M01 (K203658)
Common Name: System, X-Ray, Mobile
Regulation: 21 CFR § 892.1720
Regulatory Classification: 2
Product Code: IZL
Classification Panel: Radiology |

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Section 5 510(k) Summary

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 Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to 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. These are accessories are not included in the submission.

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. The device software is based on the predicate device and no changes to the software were performed for this submission.

Image /page/4/Figure/9 description: The image shows a white box connected to a white handheld device and a white square device via cables. Two blue cables connect the box to the handheld device and the square device. A gray cable connects the box to the square device.

Figure 5-1: Subject Device - Micro C Medical Imaging System, M01

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Image /page/5/Picture/2 description: The image shows a computer setup with a monitor, keyboard, mouse, and a white box-shaped device. The monitor is connected to the white box, which also has connections for the keyboard, mouse, and an Ethernet cable. The power cords for the monitor and the white box are plugged into wall outlets.

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 and pediatric 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 is identical to the predicate device cleared via K203658. The purpose of this submission is to add the pediatric population to the indication and to allow use in surgery.

The table below compares the subject and predicate device.

		Comparison
Subject Device:
Micro C Medical Imaging
System, M01	Predicate Device: Micro
C Medical Imaging
System, M01 (K203658)
Product Code

                                      | IZL (Mobile X-Ray

Table 5-2: Device Comparison

6

7

8

Non-Clinical Performance Data

Testing specific to the use in surgery was performed and includes:

Usability testing for use in surgery
Cleaning and Disinfection Studies ●

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
Pediatric Information for X-ray Imaging Device Premarket Notifications

Conclusion

The Micro C Medical Imaging System, M01 is identical in design to the legally marketed predicate device. The updated indication and contraindication are acceptable as demonstrated by the performance data and does not raise different questions of safety and effectiveness.