(189 days)
No
The summary describes a portable X-ray system with various safety interlocks and imaging modes. It mentions image processing capabilities like zoom and contrast adjustment, but there is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, interpretation, or system control beyond basic sensor data processing.
No.
The device is an X-ray system indicated for diagnostic imaging purposes, not for therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed to aid clinicians with point-of-care visualization through diagnostic X-rays of extremities." The "Device Description" also explicitly mentions "diagnostic X-rays." Additionally, the performance studies involve radiologists clinically evaluating image quality, which implies the images are used for diagnostic purposes.
No
The device description clearly states that the MC2 Portable X-ray System consists of two major system components: the emitter and the cassette, which are hardware components. It also mentions accessories like a clinical cart and a wireless foot pedal. While it interfaces with software (OXOS Device App), the core device is a hardware system.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The MC2 Portable X-ray System is an imaging device that uses X-rays to visualize internal structures of the body (specifically extremities). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities." This involves direct imaging of the patient, not analysis of samples.
Therefore, the MC2 Portable X-ray System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.
The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
The device is not intended to be used in environments with the following characteristics:
- Aseptic or sterile fields, such as in surgery
- Home or residential settings or other settings where qualified operators are not present ●
- Vehicular and moving environments ●
- Environments under direct sunlight ●
- Oxygen-rich environments, such as near an operating oxygenation concentrator ●
Product codes
OWB, IZL, OXO
Device Description
The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of extremities distal to the shoulders and distal to the knees. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.
The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs. Single radiography acquisitions may be performed handheld, while serial radiography and fluoroscopy require the emitter to be in a stand-mounted configuration.
The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.
The source-to-image distance interlock uses the Tracking System to disallow X-ray acquisition when the device is outside the bounds of source-to-image distance (SID). This acts concurrently with the source-to-skin distance (SSD) interlock which uses the LIDAR system to disallow X-ray acquisition below 30cm source-to-skin distance. Both conditions must be met for X-ray acquisition to be allowed. The active area interlock uses the Tracking System to prevent the X-ray field from extending beyond the bounds of the active area. The stand-mounted interlock prevents handheld X-ray acquisition in serial radiography and fluoroscopy modes.
In addition to the components listed above, the MC2 includes accessories, such as a clinical cart and a wireless foot pedal should be used for stand-mounted imaging when initiating single, serial or fluoroscopic acquisitions remotely. The clinical cart supports the MC2 for stand-mounted operation and allows the user to position anatomy easily. An accessory stand such as the clinical cart is required to facilitate stand-mounted imaging modes. Radiography and Photo modes may be used without a stand.
Mentions image processing
User Interface can drag, zoom, rotate, adjust brightness, contrast, and sharpness.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
extremities distal to the shoulders and distal to the knees
Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified/trained medical professionals; healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
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)
Comparison: The subject device's display is similar to that of other devices, including the reference devices, in that it can be displayed on monitors or tablets.
Comparison: The subject and predicate devices have detectors with equivalent technological characteristics.
Comparison: The subject device has a similar MTF compared to the predicate device.
Comparison: The subject device has a similar DQE compared to the predicate device.
Pixel Pitch: Similar.
Scintillator: Identical.
Collimator: The subject device has a collimation design similar to the predicate device. Both devices use device tracking information to confine the X-ray field to the active area.
Source to Skin Distance (SSD): Identical.
Field Visualization: The subject device has a Viewfinder on the emitter to aid patient positioning. The predicate device uses a similar technique to display the x-ray field with respect to the patient in real-time.
Laser: The subject and reference device b similarly utilize lasers for patient positioning.
Focal Spot (IEC): The subject device's focal spot is similar to the predicate and reference devices.
Exposure Time / Pulse Duration: The subject device exposure times are similar to the predicate and reference device's exposure time.
mA: The subject device's mA is identical to the predicate device.
kVp: The kVps of all devices are similar.
Software: All predicate and reference devices have software that supports the device.
Image Processing: Similar.
Connectivity Options: The predicate and reference devices all have various connectivity options.
DICOM: Identical.
Electrical Safety: Identical.
A comprehensive, task-based image quality study was conducted to assess the clinical adequacy of the device's imaging performance. This study collected radiographic images, radiographic series, and fluoroscopic series for all relevant anatomical indications stated in the Indications for Use. Images were acquired for static radiography, serial radiography, and fluoroscopic modes. Radiologic technologists acquired images in all acquisition modes with appropriately selected techniques, and five radiologists clinically evaluated the image quality.
OXOS performed nonclinical bench testing on the MC2 Portable X-ray System to demonstrate the system performance met required design inputs and user needs and is safe for its intended use. The testing included the verification and validation of: the design and software per OXOS specifications, the adequacy of image quality for the MC2 intended use, the conformance to voluntary standards evaluating device safety and performance, and the usability of the device, demonstrating that MC2 is safe and effective for its intended users.
The MC2 Portable X-ray System met bench testing acceptance criteria as defined in the test protocols. This testing supports substantial equivalence of the MC2 technological characteristics and performance compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K211191 Virtual C DRF Digital Imaging System
Reference Device(s)
K182207 MinXray, Inc. TR90BH, K193225 KDR U-ARM, K221714 Flat Panel Detector, K150150 Rayence 1717SCN
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2024
Oxos Medical, Inc. % Dhruv Vishwakarma Director of Regulatory Affairs Powers Regulatory Consulting 1100 Peachtree St NE Suite 700 ATLANTA, GA 30309
Re: K241567
Trade/Device Name: MC2 Portable X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, IZL, OXO Dated: November 5, 2024 Received: November 7, 2024
Dear Dhruv Vishwakarma:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241567
Device Name MC2 Portable X-ray System
Indications for Use (Describe)
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.
The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
The device is not intended to be used in environments with the following characteristics:
-Aseptic or sterile fields, such as in surgery
-
-Home or residential settings or other settings where qualified operators are not present
-Vehicular and moving environments -
-Environments under direct sunlight
-Oxygen-rich environments, such as near an operating oxygenation concentrator
| 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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4
Image /page/4/Picture/0 description: The image shows the letters OXOS in a stylized font. The O's are circles with small gaps at the top, bottom, left, and right. The X is formed by two diagonal lines that intersect in the middle, and the S is a curved letter.
Contact Details
| Applicant Information | Correspondent Information | |
|---|---|---|
| Name | OXOS Medical, Inc. | OXOS Medical, Inc. |
| Address | 1100 Peachtree St NE | |
| Suite 700 | ||
| Atlanta, GA 30309 | 1100 Peachtree St NE | |
| Suite 700 | ||
| Atlanta, GA 30309 | ||
| Contact | Mr. Dhruv Vishwakarma | Mr. Dhruv Vishwakarma |
| Phone | 770-375-7840 | 770-375-7840 |
| dhruv.vishwakarma@oxos.com | dhruv.vishwakarma@oxos.com |
Device Information
| Device Information | |
|---|---|
| Trade Name | MC2 Portable X-ray System |
| Common Name | Interventional fluoroscopic x-ray system |
| Classification Name | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Regulation Number: 892.1650 | |
| Product Codes | OWB, OXO, IZL |
Legally Marketed Predicate Devices
| Type | K-Number | Trade Name | Product Code |
|---|---|---|---|
| Predicate | K211191 | Virtual C DRF Digital Imaging System | OWB |
| Reference | K182207 | MinXray, Inc. TR90BH | IZL |
| Reference | K193225 | KDR U-ARM | KPR |
| Reference | K221714 | Flat Panel Detector | MQB |
| Reference | K150150 | Rayence 1717SCN | MQB |
5
Device Description Summary
The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of extremities distal to the shoulders and distal to the knees. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.
The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs. Single radiography acquisitions may be performed handheld, while serial radiography and fluoroscopy require the emitter to be in a stand-mounted configuration.
The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.
The source-to-image distance interlock uses the Tracking System to disallow X-ray acquisition when the device is outside the bounds of source-to-image distance (SID). This acts concurrently with the source-to-skin distance (SSD) interlock which uses the LIDAR system to disallow X-ray acquisition below 30cm source-to-skin distance. Both conditions must be met for X-ray acquisition to be allowed. The active area interlock uses the Tracking System to prevent the X-ray field from extending beyond the bounds of the active area. The stand-mounted interlock prevents handheld X-ray acquisition in serial radiography and fluoroscopy modes.
In addition to the components listed above, the MC2 includes accessories, such as a clinical cart and a wireless foot pedal should be used for stand-mounted imaging when initiating single, serial or fluoroscopic acquisitions remotely. The clinical cart supports the MC2 for stand-mounted operation and allows the user to position anatomy easily. An accessory stand such as the clinical cart is required to facilitate stand-mounted imaging modes. Radiography and Photo modes may be used without a stand.
6
Intended Use/Indications for Use
Intended Use:
The MC2 Portable X-ray System is designed to aid clinicians with point-of-care visualization and guidance during X-rays of distal extremities. It is intended for use in clinical environments and is not intended for surgical applications.
Indications for Use:
The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.
The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).
The device is not intended to be used in environments with the following characteristics:
- Aseptic or sterile fields, such as in surgery
- Home or residential settings or other settings where qualified operators are not present ●
- Vehicular and moving environments ●
- Environments under direct sunlight ●
- Oxygen-rich environments, such as near an operating oxygenation concentrator ●
Contraindications
The MC2 System is contraindicated as follows:
- The MC2 System is NOT intended for bariatric patients. ●
- The MC2 System is NOT intended for mammography. ●
- The MC2 System is NOT intended for dental applications. ●
- The MC2 System is NOT intended to come in contact with non-intact skin.
- The MC2 System is NOT intended for cardiac applications. ●
- The MC2 System is not intended for use in proximity to pacemakers or implantable . cardioverter-defibrillators (ICDs).
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Indications for Use Comparison
The MC2 Portable X-ray System and the predicate device are both intended for use by qualified/trained medical professionals on adult patients for diagnostic radiographic and interventional fluoroscopic procedures. The MC2 Portable X-ray System has a narrower anatomical, procedural, and environmental scope than the Virtual C DRF Digital Imaging System. The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.
Technological Comparison
The MC2 Portable X-ray System shares most technological characteristics with the primary predicate device, the Virtual C DRF Digital Imaging System, including principles of operation and design features; however, there are some differences in detailed technological characteristics. Both devices offer single radiographic and fluoroscopic imaging. The MC2 device has longer exposure time capabilities. The MC2 features a higher resolution (pixel pitch) detector and a slightly larger focal spot. MTF and DQE values differ slightly between the two devices. The subject device and the primary predicate both utilize LIDAR to provide the means to maintain a safe source-to-skin distance.
The MinXray, Inc. TR90BH is used as a reference device due to its handheld nature. It is used for performing static radiographic imaging for similar anatomical indications.
The Konica Minolta KDR U-Arm features serial radiographic (DDR) capabilities similar to those of the subject MC2 device. The DDR functionality in the MC2 includes various mitigations to disallow use for guidance. These include a 2 second delay from image acquisition to display of each preview frame, a low-resolution preview display, a lower frame rate during image preview, and a salient disclaimer informing the user that the mode is not to be used for fluoroscopy.
The iRay Venu1717X is an FDA-cleared detector that is very similar in design and technological features to the detector found in the subject MC2 device. The X-ray detection technology is identical in both detectors, with similar DQE and MTF. The reference device has a large 17 x 17" active area.
The Rayence 1717SCN reference device is an FDA-cleared X-ray detector similar to the iRay Mercu0909X found in the subject device.
8
The following table provides a comparison of the technological characteristics of the MC2 with the predicate and reference devices:
| | Subject Device:
OXOS MC2 (K241567) | Predicate Device:
Virtual C DRF
(K211191) | Relevant Reference
Device | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display | The MC2 system interfaces via
the OXOS Device App with a
tablet or monitor. An
off-the-shelf tablet is optionally
supplied with the MC2 or can
be supplied by the user. | Display on
workstation monitor. | | The subject device's display is similar
to that of other devices, including the
reference devices, in that it can be
displayed on monitors or tablets. |
| Detector | iRay Mercu0909X
Active Area: 9 x 9 inches
Frame rate: 5 fps @ 1×1 | Vivix-D1212G
Active Area: 12" x
12"
Frame rate: 20 FPS
@ 1x1 | Konica Minolta KDR
U-Arm:
348.8 x 425.6 mm
(13.7 x 16.8 in)
15 FPS
Rayence 1717SCN:
43.18cm x 43.18 cm
(17 in x 17 in) | The subject and predicate devices
have detectors with equivalent
technological characteristics. |
| MTF | MTF @ 1 Lp/mm, RQA5: 55%
MTF @ 2 Lp/mm, RQA5: 23% | MTF @ 2.0 Lp/mm:
30% | Rayence 1717SCN:
MTF @ 1 Lp/mm:
59%
MTF @ 2 Lp/mm:
26% | The subject device has a similar MTF
compared to the predicate device. |
| DQE | DQE @ 0 Lp/mm: 72%
DQE @ 1 Lp/mm: 51%
DQE @ 2 Lp/mm: 31%
RQA5 | DQE @ 1 Lp/mm:
56% | Konica Minolta KDR
U-Arm:
DQE @ 0 Lp/mm:
72%
RQA5
Rayence 1717SCN:
DQE @ 0 Lp/mm:
61%
DQE @ 1 Lp/mm:
53%
DQE @ 2 Lp/mm:
28%
RQA5 | The subject device has a similar DQE
compared to the predicate device. |
| Pixel
Pitch | 139µm | 145µm | Rayence 1717SCN:
127µm | Similar. |
| Scintillator | Cesium lodide (Csl) | Cesium lodide (Csl) | Cesium lodide (Csl) | Identical. |
| Collimator | Removable fixed collimators
(pucks) and an automatic
collimator with manual stepped
adjustment capability for fine
adjustments. | Machine-Vision
Collimator
(Accession
2010848-000) | | The subject device has a collimation
design similar to the predicate device.
Both devices use device tracking
information to confine the X-ray field to
the active area. |
| Source to
Skin
Distance
(SSD) | LIDAR | LIDAR | | Identical. |
| Field
Visualizati
on | Viewfinder on emitter screen
UI. | A visual display
provides real time
video images of the
patient, and a | | The subject device has a Viewfinder
on the emitter to aid patient
positioning. The predicate device uses
a similar technique to display the x-ray |
| | Subject Device:
OXOS MC2 (K241567) | Predicate Device:
Virtual C DRF
(K211191) | Relevant Reference
Device | Comparison |
| | | the video images
represents the
location and size of
the radiation beam
with respect to the
patient. | | field with respect to the patient in
real-time. |
| Laser | Class 1 laser device compliant
with IEC 60825-1:2014 -3rd
edition used for Light Detection
and Ranging (LIDAR) to
indicate the distance from the
x-ray source to the target to be
diagnosed.
Class 1 laser devices compliant
with IEC 60825-1:2014 - 3rd
edition display a red crosshair
used to align patient anatomy. | Unknown. | MinXray TR90BH:
Two lasers:
Class II; laser diode;
max output ≤1.0 mW,
wavelength 635 nm | The subject and reference device b
similarly utilize lasers for patient
positioning. |
| Focal
Spot
(IEC) | 0.8 | SB-80-2K-LD: 0.6 | MinXray TR90BH: 0.8 | The subject device's focal spot is
similar to the predicate and reference
devices. |
| Exposure
Time /
Pulse
Duration | 40-200 ms | 10 ms | MinXray TR90BH:
0.01-0.3 sec (10-300
ms).
0.01 sec (10 ms) Step | The subject device exposure times are
similar to the predicate and reference
device's exposure time. |
| mA | 1.0-2.0 mA | 0.1-2.0 mA | MinXray TR90BH:
15 mA @ 82-90
kVDC. (2 kVP steps) | The subject device's mA is identical to
the predicate device. |
| kVp | 40–80 kVp | 30–80 kVp | MinXray TR90BH:
40-90kVp | The kVps of all devices are similar. |
| Software | Custom software is embedded
within the emitter, cassette, and
foot pedal to operate the
device. The OXOS Device App
(non-embedded) is for image
viewing, study management,
collimation control, image
processing for DICOM 3.14
greyscale calibration, and
display of messages and alerts. | Virtual C DRF
software | N/A | All predicate and reference devices
have software that supports the
device. |
| Ingress
Protection
Rating | IP00 (E1 Emitter, C1 Cassette,
H1 Wired Charger) IPX8 (F1
Foot Pedal)
IP67 (P1 Case) | Unknown | N/A | N/A. |
| Image
Processin
g | User Interface can drag, zoom,
rotate, adjust brightness,
contrast, and sharpness. | Includes software
for image capture
and analysis. | All include software
for image capture and
analysis. | Similar. |
| Connectiv
ity
Options | WiFi, USB-C ports | Ethernet or Wi-Fi | MinXray TR90BH:
RJ45 port for DR
interface | The predicate and reference devices
all have various connectivity options. |
| DICOM | DICOM 3.0 compliant | DICOM | All are DICOM 3.0
compliant | Identical. |
| Electrical
Safety | IEC60601-1:2005 + A2 (2020)
IEC60601-1-2:2020 | IEC60601-1:2005 +
A1 (2012) | - | Identical. |
| Subject Device:
OXOS MC2 (K241567) | Predicate Device:
Virtual C DRF
(K211191) | Relevant Reference
Device | Comparison | |
| IEC60601-1-3:2008 + A2 | IEC60601-1-3:2008 | | | |
| (2021) | IEC60601-2-28:201 | | | |
| IEC60601-2-28:2017 | 0 | | | |
| IEC60601-2-43:2022 | IEC60601-2-43:201 | | | |
| IEC60601-2-54:2022 | 0 | | | |
| NEMA PS 3.1-3.20 | IEC60601-2-54:200 | | | |
| | 9 | | | |
| | NEMA PS 3.1-3.20 | | | |
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Cybersecurity
Following the FDA guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2023), the MC2 was risk assessed for security threats separately from device risk assessment using the methodology prescribed in the quidance.
Threat modeling was performed in accordance with the STRIDE methodology. Security controls were implemented in the following categories:
- Authentication controls ●
- Authorization controls ●
- . Cryptography controls
- Code, data, and execution integrity controls ●
- . Confidentiality controls
- Event detection and logging controls ●
- Resiliency and recovery controls
- Firmware and software update controls ●
Security controls were verified and demonstrated adequacy within the MC2's usage environments. Additionally, fuzz testing of vulnerable interfaces and robust third-party penetration testing of the entire system were performed, demonstrating the MC2's security.
Performance Testing
All components of the MC2, including software, were verified and validated to demonstrate compliance with the appropriate regulations and in accordance with the risk profile analysis. A third-party testing laboratory performed performance testing of the MC2 in accordance with the applicable standards. The third-party testing laboratory and formal internal testing also tested all safety interlocks. All forms of testing showed the MC2 to be compliant with the relevant standards and safe and effective in the procedures and scenarios outlined in the Indications for Use.
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A comprehensive, task-based image quality study was conducted to assess the clinical adequacy of the device's imaging performance. This study collected radiographic images, radiographic series, and fluoroscopic series for all relevant anatomical indications stated in the Indications for Use. Images were acquired for static radiography, serial radiography, and fluoroscopic modes. Radiologic technologists acquired images in all acquisition modes with appropriately selected techniques, and five radiologists clinically evaluated the image quality.
Non-Clinical and Clinical Tests Summary and Conclusions
OXOS performed nonclinical bench testing on the MC2 Portable X-ray System to demonstrate the system performance met required design inputs and user needs and is safe for its intended use. The testing included the verification and validation of: the design and software per OXOS specifications, the adequacy of image quality for the MC2 intended use, the conformance to voluntary standards evaluating device safety and performance, and the usability of the device, demonstrating that MC2 is safe and effective for its intended users.
The MC2 Portable X-ray System met bench testing acceptance criteria as defined in the test protocols. This testing supports substantial equivalence of the MC2 technological characteristics and performance compared to the predicate device.
Standards
| Regulation or Standard | K241567 - 510(k) Summary |
|---|---|
| 21 CFR 801 | Labeling |
| 21 CFR 1020.30(a), (b), (d), (e), (g), (j), and (q) Sections (c), (h), (k), (l), (m), (n), and (o) met via conformity to IEC 60601-1-3 and 60601-2-54 | Diagnostic X-ray systems and their major components |
| 21 CFR 1020.31 met via conformity to IEC 60601-1-3 and IEC 60601-2-54 | Radiographic equipment |
| 21 CFR 1020.32(d)(3)(v), and (g) Sections (a), (b), (c), (d)(1), (d)(2), (d)(3)(i) – (iv), (d)(4), (f), (h), (i), (j), and (k) met via conformity to IEC 60601-1-3, IEC 60601-2-54, and IEC 60601-2-43 | Fluoroscopic equipment |
| 47 CFR 18 | Telecommunication |
| ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk |
| management to medical devices | |
| IEC 60601-1 Edition 3.2 2020-08 | |
| CONSOLIDATED VERSION | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential | |
| performance | |
| 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED | |
| VERSION | Medical electrical equipment - Part 1-2: General |
| requirements for basic safety and essential | |
| performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements | |
| and tests | |
| 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED | |
| VERSION | Medical electrical equipment - Part 1-3: General |
| requirements for basic safety and essential | |
| performance - Collateral Standard: Radiation | |
| protection in diagnostic X-ray equipment | |
| 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED | |
| VERSION | Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential | |
| performance - Collateral standard: Usability | |
| IEC 60601-2-28 Edition 3.0 2017-06 | Medical electrical equipment - Part 2-28: |
| Particular requirements for the basic safety and | |
| essential performance of X-ray tube assemblies | |
| for medical diagnosis | |
| IEC 60601-2-43 Edition 2.2 2019-10 | |
| CONSOLIDATED VERSION | Medical electrical equipment - |
| Part 2-43: Particular requirements for the basic | |
| safety and essential performance of X-ray | |
| equipment for interventional procedures | |
| IEC 60601-2-54 Edition 2.0 2022-09 | Medical electrical equipment - Part 2-54: |
| Particular requirements for the basic safety and | |
| essential performance of X-ray equipment for | |
| radiography and radioscopy | |
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATED | |
| VERSION | Medical device software - Software life cycle |
| processes | |
| ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices - Part 1: |
| Evaluation and testing within a risk management | |
| process | |
| NEMA PS 3.1 - 3.20 2022d | |
| Digital Imaging and Communications in Medicine | |
| (DICOM) Set | Digital Imaging and Communications in Medicine |
| (DICOM) Set | |
| IEC 62563-1 Edition 1.2 2021-07 | |
| CONSOLIDATED VERSION | Medical electrical equipment - Medical image |
| display systems - Part 1: Evaluation methods | |
| IEC 61910-1 Edition 1.0 2014-09 | Medical electrical equipment - Radiation dose |
| documentation - Part 1: Radiation dose | |
| structured reports for radiography and | |
| radioscopy | |
| IEEE ANSI USEMCSC C63.27-2021 | American National Standard for Evaluation of |
| Wireless Coexistence | |
| AAMI TIR69:2017/(R2020) | Technical Information Report Risk management |
| of radio-frequency wireless coexistence for | |
| medical devices and systems. | |
| IEC 62366-1 Edition 1.1 2020-06 | |
| CONSOLIDATED VERSION | Medical devices - Part 1: Application of usability |
| engineering to medical devices | |
| IEC 62133-2 Edition 1.0 2017-02 | Secondary cells and batteries containing alkaline |
| or other non-acid electrolytes - Safety | |
| requirements for portable sealed secondary | |
| cells, and for batteries made from them, for use | |
| in portable applications - Part 2: Lithium systems | |
| Section 38.3 of the UN Manual of Tests and | |
| Criteria | Lithium metal and lithium ion batteries |
The MC2 complies with the following standards, as applicable:
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The MC2 complies with 21 CFR Subchapter J, including 21 CFR 1020.30 to 1020.32, partially by conforming with IEC 60601-1-3 Edition 2.2 (2021), IEC 60601-2-54 Edition 2.0 (2022), and IEC 60601-2-43 Edition 2.2 (2019), in accordance with section 14(c)(1)(A) of the FD&C Act as outlined in "Medical X-Ray Imaging Devices: Conformance with IEC Standards," dated February 21, 2023.
O