(138 days)
Unknown
While the predicate device is named "Soteria.AI", the description of the proposed device (Soteria E-View) does not explicitly mention AI or ML capabilities. The description focuses on standard X-ray system components and functions like image processing and post-processing, which are not inherently AI/ML. Without further information specifically detailing AI/ML features in the Soteria E-View, it's unclear if the technology is incorporated.
No
The device is described as an interventional fluoroscopic X-ray system used for diagnostic and interventional imaging, which provides information to the physician but does not directly treat the patient.
Yes
The Intended Use / Indications for Use section explicitly states that "The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging." This clearly indicates its role in diagnostic procedures.
No
The device description explicitly lists hardware components such as a patient table, C-arm, X-ray source, flat panel detector, X-ray generator, image processor, collimator, X-ray Tube, and Positioner. This indicates it is a hardware system with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging." This describes an imaging system used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details an X-ray system with components like a patient table, C-arm, X-ray source, flat panel detector, and image processing capabilities. This aligns with the description of an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the Soteria E-View system is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.
Product codes (comma separated list FDA assigned to the subject device)
JAA, OWB
Device Description
The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of:
- The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes, and the flat panel detector can be lifted vertically. The tabletop can be shifted from side to side and move forward/backward by an operator.
- Real-time image visualization of patient anatomy during procedures.
- Imaging techniques and tools to assist interventional procedures.
- . Post-processing functions after interventional procedures.
- Storage of reference/control images for patient records.
- Compatibility to images of other modalities via DICOM.
- . Built-in radiation safety controls-with the already FDA cleared CA-100S /FluoroShield (K182834).
This array of functions provides the physician with the imaging information required to achieve minimally invasive interventional procedures.
The Soteria E-View system is available as a Model GI-100 configuration. It is similar to the currently marketed predicate Soteria.Al consisting of an X-ray generator, image processor, collimator, X-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K212336).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
General and Pediatric Populations
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)
Non-clinical and Sample clinical images were used to validate image performance. This testing has been performed on the Soteria E-View system to demonstrate substantial equivalence to the predicate device.
-
- IEC 62304 Medical device software Software life cycle processes. FDA/CDRH recognition number 13-79.
-
- ISO 14971 Medical devices Application of risk management to medical devices
-
- IEC 60601-2-54 Particular requirements for basic safety and essential performance of X-ray Safety.
-
- IEC60601-2-43 - Particular requirements for the basic safety and essential performance of x-ray equipment for interventional procedures.
-
- Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Device Software function. June 2023
- "Guidance for Industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in 6. Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
-
- Guidance for industry and FDA staff Electronic Submission Template for Medical Device 510(k) submissions. Oct. 2023
Software verification testing of the functional requirements, as well as performance, reliability, and safety, have been performed to verify that all conditions of System requirements Specifications, as well as the safety risk control measures from the detailed Risk management and security requirements, have been implemented. Results demonstrated that the executed verification test was passed.
Non- clinical and Sample clinical images were used for validation testing of the Soteria E-View system to demonstrate conformance to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.
The Soteria E-View was demonstrated with the following attributes:
- Indication for use.
- Technological characteristics.
- Non-clinical and Sample clinical image performance testing.
- Safety and effectiveness.
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.
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
§ 892.1650 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.
0
January 6, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.
Omega Medical Imaging, LLC % Matthew Anderson Director of RA/OA 3400 St. Johns Parkway, Suite 1020 SANFORD, FL 32771
Re: K242488
Trade/Device Name: Soteria E-View Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: JAA, OWB Dated: August 15, 2024 Received: December 11, 2024
Dear Matthew Anderson:
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.
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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
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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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
K242488
Device Name
Soteria E-View
Indications for Use (Describe)
The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image contains the logo for Omega Medical Imaging. The logo consists of a blue stylized omega symbol on the left, followed by the text "OMEGA" in a bold, blue sans-serif font. Below the word "OMEGA" is the text "Medical Imaging" in a smaller, light gray sans-serif font. The overall design is clean and professional, suggesting a company in the medical field.
Traditional 510(k) SUMMARY K242488
| Company Name: | Omega Medical Imaging, LLC |
|---|---|
| Address: | 3400 St. Johns Parkway, Suite 1020, Sanford, FI 32771 |
| Telephone No: | 407-323-9400 |
| Registration No: | 1052701 |
| Contact person: | Matthew Anderson, Director RA/QA |
| Date Prepared: | 06/04/2024 |
| Device (trade) name: | Soteria E-View |
| Common/usual name: | Fluoroscopic/Radiographic X-ray system |
| Classification Name: | Image-intensified Fluoroscopic X-ray system |
| Classification Panel: | Radiology |
| CFR section: | 892.1650 |
| Device Class: | Class II |
| Primary Product code: | JAA |
| Secondary product code: | OWB |
Predicate Device K212336
| Company Name: | Omega Medical Imaging, LLC | |
|---|---|---|
| Address: | 3400 St. Johns Parkway, Suite 1020, Sanford, FI 3277 | |
| Telephone No: | 407-323-9400 | |
| Registration No: | 1052701 | |
| Contact person: | John Newman | |
| Date Prepared: | 08/19/2021 | |
| Device (trade) name: | Soteria.AI | |
| Common/usual name: | Fluoroscopic/Radiographic X-ray system | |
| Classification Name: | Image-intensified Fluoroscopic X-ray system | |
| Classification Panel: | Radiology | |
| CFR section: | 892.1650 | |
| Device Class: | Class II | |
| Primary Product code: | JAA | |
| Secondary Product code: | OWB |
5
Indications for use:
The System is intended for use in Radiographic/fluoroscopic applications including general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General and Pediatric Populations.
Device Description:
The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of:
- The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes, and the flat panel detector can be lifted vertically. The tabletop can be shifted from side to side and move forward/backward by an operator.
- Real-time image visualization of patient anatomy during procedures.
- Imaging techniques and tools to assist interventional procedures.
- . Post-processing functions after interventional procedures.
- Storage of reference/control images for patient records.
- Compatibility to images of other modalities via DICOM.
- . Built-in radiation safety controls-with the already FDA cleared CA-100S /FluoroShield (K182834).
This array of functions provides the physician with the imaging information required to achieve minimally invasive interventional procedures.
The Soteria E-View system is available as a Model GI-100 configuration. It is similar to the currently marketed predicate Soteria.Al consisting of an X-ray generator, image processor, collimator, X-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K212336).
Patient Population:
General and Pediatric Population, special concerns must be taken for pediatric use.
Based on the information provided above, the Soteria E-View system is considered substantially equivalent to the current marketed predicate device Soteria. Al (K212336). Both share Indications for use.
(Note: Cardiac and Vascular application removed from the Soteria E-View indications for use)
6
Technological characteristics and Summary of Critical Improvements:
The Soteria E-View system has similar technological characteristics compared to the predicate device with some changes to it. Below is a summary of the changes between the new Soteria E-View system and the predicate device. FluoroShield was integrated with the Varex Azure 3131Z CXP Flat Panel Detector.
- Replace 80KV high voltage generator with GI Epsilon Generator (E-view), X-ray generator is certified . separately.
- . The positioner changed from L/C to I/C configuration.
- Updated 12 and 24V Power supplies in electronics cabinet with newer more available UL compliant units.
- Added fluoro, spot and save buttons to positioner controls.
- Upgrade actuators to support Linak instead of SKF.
- . Shorter GI patient table that supports an 800-pound patient, as this is a more suitable table configuration for Gastrointestinal interventional procedures.
- . The Nyquist image processor is now configured with a Varex 3131x CXP detector, as Indium Gallium Zinc Oxide technology has a high quantum efficiency and lower dose than traditional CMOS detectors.
- . Replaced Powertronix IsoStation Transformer and Ametek UPS combination with a single Astrodyne TDI UL certified PowerBridge which combines the isolation transformer and UPS into a single unit.
The difference between the Soteria E-View system and the predicate device does not raise any new safety or effectiveness. Based on the information provided in this 510K submission, Soteria E-View is considered substantially equivalent to the current marketed predicate Soteria. Al (K212336)
Clinically:
- . Legacy E-view (K062647) and Soteria E-view (GI-100) are virtually identical in terms of the Positioner and Table movements and capabilities.
- Same Tube ●
- Same Generator
- Same Table Size
Summary of Non- Clinical Performance
Non-clinical and Sample clinical images were used to validate image performance. This testing has been performed on the Soteria E-View system to demonstrate substantial equivalence to the predicate device.
-
- IEC 62304 Medical device software Software life cycle processes. FDA/CDRH recognition number 13-79.
-
- ISO 14971 Medical devices Application of risk management to medical devices
-
- IEC 60601-2-54 Particular requirements for basic safety and essential performance of X-ray Safety.
7
-
- IEC60601-2-43 - Particular requirements for the basic safety and essential performance of x-ray equipment for interventional procedures.
-
- Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Device Software function. June 2023
- "Guidance for Industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in 6. Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
-
- Guidance for industry and FDA staff Electronic Submission Template for Medical Device 510(k) submissions. Oct. 2023
Software verification testing of the functional requirements, as well as performance, reliability, and safety, have been performed to verify that all conditions of System requirements Specifications, as well as the safety risk control measures from the detailed Risk management and security requirements, have been implemented. Results demonstrated that the executed verification test was passed.
Non- clinical and Sample clinical images were used for validation testing of the Soteria E-View system to demonstrate conformance to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.
The Soteria E-View was demonstrated with the following attributes:
- Indication for use.
- Technological characteristics.
- Non-clinical and Sample clinical image performance testing.
- Safety and effectiveness.
Substantial equivalence Conclusion:
The Soteria E-View system is substantially equivalent to the currently marketed predicate device Soteria.Al regarding indications for use, technological characteristics, safety, and effectiveness.
Therefore, Soteria E-View is as safe and effective as its predicate device and does not raise any new safety and effectiveness concerns.
8
Comparison with Predicate Devices:
| Indications for use comparison: | ||
|---|---|---|
| 510(k) | ||
| Number and | ||
| Device Name | K212336 (Predicate Device) | |
| Soteria.Al, Model Al-100 | K242488 (This Submission) | |
| Soteria E-View, Model GI-100 | ||
| Intended Use | The Omega Medical Imaging, LLC AI-100, | |
| Soteria.AI (SSXI) systems with FluoroShield / CA- | ||
| 100S device to provide an automated Region of | ||
| interest that reduces exposure to the patient and | ||
| operator. The System is intended for use in | ||
| Radiographic/fluoroscopic applications, including | ||
| cardiac, vascular, general | ||
| radiographic/fluoroscopic diagnostic, and | ||
| interventional x-ray imaging for General and | ||
| Pediatric Populations. | The Omega Medical Imaging, LLC GI-100, | |
| Soteria E-View (SSXI) systems with | ||
| FluoroShield / CA-100S device to provide an | ||
| automated Region of interest that reduces | ||
| exposure to the patient and operator. The | ||
| System is intended for use in | ||
| Radiographic/fluoroscopic applications, including | ||
| gastrointestinal, ERCP, general | ||
| radiographic/fluoroscopic diagnostic, and | ||
| interventional x-ray imaging for General and | ||
| Pediatric Populations. | ||
| Classification | ||
| Name: | Image-intensified Fluoroscopic X-ray system | Image-intensified Fluoroscopic X-ray system |
| CFR | ||
| Regulation #: | 892.1650 | 892.1650 |
| Device Class | Class II | Class II |
| Classification | ||
| Product Code: | JAA, OWB | JAA, OWB |
PRODUCT OVERVIEW
Substantial Equivalence:
| 1. Flat Panel Detectors | ||
|---|---|---|
| 510(k) Cleared (Predicate | ||
| Device) K212336 | This Submission Soteria E-View | |
| Detector Name: | Teledyne Dalsa Xineos-3030HS | Varex Azure 3131Z CXP Detector |
| 1.1 Receptor Type | CMOS | IGZO (indium gallium zinc oxide) |
| 1.2 Conversion Screen | Cesium Iodide | Cesium Iodide |
| 1.3 Pixel Area - Active | 29.6 cm x 29.6 cm | 30.7 cm x 30.7 cm |
| 1.4 Pixel Matrix - Active | 1952 x 1952 | 2048 x 2048 |
| 1.5 Pixel Pitch | 151.8 μm | 150 μm |
| 1.6 Limiting Resolution | 3.15 lp/mm | 3.3 lp/mm |
| 1.7 MTF, X-ray | 58% @ (1.0 lp/mm at RQA5 1x1) | 60% @ (1.0 lp/mm) |
| 1.8 Energy Range | 40 - 125 kV | 40-125 kV |
| 1.9 Fill Factor | 83% | 66% |
| 1.10 Dynamic Range | 77 dB | 65 dB |
| 1.11 A/D Conversion | 16-bits | 16-bits |
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| 2. Acquisition is the same for all Flat Panel Detectors | ||
|---|---|---|
| 2.1 Modes | Pulsed Fluoro, Spot, Cine, Roadmaping (Subtration Fluoroscopy) and DSA | Pulsed Fluoro and Spot |
| 2.2 Pulsed Fluoro Rates | 3.75, 7.5, and 14 pps | 3, 6, and 12.5 pps |
| 2.3 Spot Rates | 1, 2, 3,4, and 6 fps | 1, 2, 3,4, and 6 fps |
| 2.4 Cine Rates | 7.5, 15, and 30 fps | No Cine |
| 2.5 Polarity | Positive & Negative | Positive & Negative |
| 2.6 Edge Enhancement | 5 levels | 5 levels |
| 2.7 Noise Reduction | 5 levels | 5 levels |
| 2.8 Last Image Hold | Yes | Yes |
| 2.9 Fluoro Loops | Yes | Yes |
| 2.10 Horizontal & | ||
| Vertical Flip | Yes | Yes |
| 3. Acquisition Workstation | ||
| 3.1 Workstation Model | Nyquist | Nyquist |
| 3.2 Monitor, size | 2 x 21.3 inch, Medical Grade | |
| Color, High Contrast | 2 x 21.3 inch, Medical Grade | |
| Color, High Contrast | ||
| 3.3 Grey Levels | 10-bit, Display Port | 10-bit, Display Port |
| 3.4 Review (Fluoro | ||
| Loops/Cine) | Forward, Reverse, Pause, and | |
| Play | Forward, Reverse, Pause, and | |
| Play | ||
| 3.5 Window/Level Adjust | Yes | Yes |
| 3.6 Annotation | Yes | Yes |
| 3.7 Image Invert | Yes | Yes |
| 3.8 Horizontal & Vertical | ||
| Flip | Yes | Yes |
| 3.9 Zoom & Roam | Yes (2x) | Yes (2x) |
| 3.10 Image Storage | Minimum: 225,000 images | Minimum: 225,000 images |
| 3.11 Networking | ||
| Capabilities | Gigabit ethernet | |
| 10/100/1000 | Gigabit ethernet 10/100/1000 | |
| 3.12 DICOM Worklist | ||
| 3.13 DICOM Storage | Yes | Yes |
| 3.14 DICOM Storage to DVD/CD | With Embedded Viewer | With Embedded Viewer |
| 4. Reference Monitor Identifiers [Review Station] | ||
| 4.1 Patient Name | Yes | Yes |
| 4.2 Patient I.D. | Yes | Yes |
| 4.3 Date | No | No |
| 4.4 Time | No | No |
| 4.5 Window/Level | No | No |
| 4.6 Hospital Name | No | No |
| 4.7 Physician Name | Yes | Yes |
| 4.8 Study I.D. | Yes | Yes |
| 4.9 Series/Image | Yes | Yes |
| 4.10 Acquisition Mode | Yes | Yes |
| 4.11 Image Orientation | Yes | Yes |
| 4.12 Radiation | No | No |
| 14.13 Image I.D. | Yes | Yes |
| 5. Live Monitor Identifiers [Image Area] | ||
| 5.1 Patient Name | Yes | Yes |
| 5.2 Patient I.D. | Yes | Yes |
| 5.3 Date | Yes | Yes |
| 5.4 Time | Yes | Yes |
| 5.5 Window/Level | No | No |
| 5.6 Hospital Name | Yes | Yes |
| 5.7 Physician Name | No | No |
| 5.8 Study I.D. | Yes | Yes |
| 5.9 Series/Image | Only Image Number | Only Image Number |
| 5.10 Image Orientation | Yes | Yes |
| 5.11 Radiation Symbol | Radiation symbol during Live | Radiation symbol during Live |
| 5.12 Image I.D. | e.g., FL LIH, FL Loops, Spot | |
| Replay, or Cine Replay | e.g., FL LIH, FL Loops, Spot | |
| Replay, or Cine Replay | ||
| 5.13 Detector Status | Ready/Not Ready | Ready/Not Ready |
| 5.14 Magnification Mode | Normal, MAG 1, MAG 2 | Normal, MAG 1, MAG 2 |
| 5.15 Loop Replay | Play, Forward, Reverse, Play, | |
| & Pause | Play, Forward, Reverse, Play, & | |
| Pause | ||
| GUI [Graphic User Interface on Reference Monitor] | ||
| Patient/Exam Entry | ||
| 5.16 Directory | Opens 'Patient Directory' | |
| screen | Opens 'Patient Directory' | |
| screen | ||
| 5.17 New | Opens 'Patient Data Entry' | |
| screen | Opens 'Patient Data Entry' | |
| screen | ||
| 5.18 Close | Closes active patient | Closes active patient |
| Acquisition | ||
| 5.19 NR Hi / NR Lo | Selects Noise Reduction Level | Selects Noise Reduction Level |
| 5.20 L -> R | Live to Reference (monitor) | |
| transfer | Live to Reference (monitor) | |
| transfer | ||
| 5.21 Fluoro Pulse Rates: | Pulse Rates: [14 f/s default, | |
| 7.5, & 3.75 f/s] | Pulse Rates: [12.5 f/s default, | |
| 6, & 3 f/s] | ||
| Note: Image Orientation available for Acquisition Mode [from Review] | ||
| Review | ||
| 5.22 Edge | ||
| [enhancement] | Increments from 1 - 5 | Increments from 1 - 5 |
| 5.23 Win./Lev. | Window/Level adjustment | Window/Level adjustment |
| 5.24 Split | Invokes 4 on 1 image display, | |
| No | Invokes 4 on 1 image display, | |
| No | ||
| 5.25 Reference - Live | Toggles image between the | |
| Reference and Live monitors | Toggles image between the | |
| Reference and Live monitors | ||
| 5.26 Zoom | Up to 2X zoom with panning | Up to 2X zoom with panning |
| 5.27 Polarity | Video white on black or black | |
| on white | Video white on black or black | |
| on white | ||
| 5.29 R [image | ||
| orientation] | Toggles thru 1 of 4 positions | Toggles thru 1 of 4 positions |
| Additional Functions | ||
| 5.30 Send | Opens 'DICOM server node | |
| selection' | Opens 'DICOM server node | |
| selection' | ||
| 5.31 Print | Sends image to a Windows | |
| compatible printer (No) | Sends image to a Windows | |
| compatible printer (No) | ||
| 5.32 Save | Saves current image to Hard | |
| Drive | Saves current image to Hard | |
| Drive | ||
| 5.33Text | Invokes the Annotation and | |
| Measurement function | Invokes the Annotation and | |
| Measurement function | ||
| C-Arm & Operator Controls | ||
| C-ARM Specifications: | 510(k) Cleared (Predicate | |
| Device) K212336 | This Submission Soteria E-View.AI | |
| C-Angulation | Head $\pm$ 110° $\pm$ 2°, | |
| Side $\pm$ 45° $\pm$ 2°, | $\pm$ 90°, $\pm$ 2° | |
| C-Roll | Head $\pm$ 45° $\pm$ 2°, | |
| Side $\pm$ 90° $\pm$ 2°, | + 90°, $\pm$ 2°, -75°, $\pm$ 2° | |
| Iso-Rotation | $\pm$ 90°, $\pm$ 2° | No |
| Collimator - Longitude | Opens to full field, closes fully | Opens to full field, closes fully |
| Collimator - | ||
| Latitude | Opens to full field, closes fully | Opens to full field, closes fully |
| Cardio Filter - | ||
| Open Close | Opens to full field, closes fully | |
| (vascular), closes to mid field | ||
| (lung) | No Filter | |
| Cardio Filter - | ||
| Rotate | Rotates cardio filter(s) 360° | No Filter |
| Variable SID | 13", $\pm$ 1" | 13", $\pm$ 1" |
| Operator Controls | ||
| Fluoro Enable | Enables/disables Fluoro function | Enables/disables Fluoro function |
| Fluoro Timer Reset | Resets 5-minute alarm on high | |
| voltage generator | Resets 5-minute alarm on high | |
| voltage generator | ||
| Emergency Stop | Disables motion actuators and | |
| high voltage generator | Disables motion actuators and | |
| high voltage generator | ||
| Magnification mode | Selects field sizes: Normal, Mag | |
| 1, and Mag 2 | Selects field sizes: Normal, Mag 1, | |
| and Mag 2 | ||
| Controls select | Requests active control is 2 | |
| controllers are installed | Requests active control is 2 | |
| controllers are installed | ||
| 5th Axis Rotate | ± 90°, ± 2° | No |
| Cardio filter select | Lung or vascular | No |
| DAP meter reset | Resets DAP meter outputs to 0 | Resets DAP meter outputs to 0 |
| Pediatric Filter Select | Selects none, 0.1, 0.2, or 0.3 mm | |
| Cu filters | No | |
| Parking Control | Controls parking actuator | No |
| Fluoro | Enables X-ray fluoro | Enables X-ray fluoro |
| Fluoro loops | Enables X-ray fluoro loops | Enables X-ray fluoro loops |
| Cine | Enables X-ray cine mode | No |
| Miscellaneous Functions: | ||
| System Digital Display | Miscellaneous System Status | Miscellaneous System Status |
| Collision Sensing on FPD | Bump stop. | Bump stop. |
| Collimator Functions: | ||
| Collimator: Maximum Size | ||
| and Tracking | Yes | Yes |
| Collimator: Minimum Size | Yes | Yes |
| X-Ray Specifications | ||
| Half Value Layer | Minimum value = 3.6 mm Al | |
| equiv. @ 100 kV | ||
| Maximum value = 4.0 mm Al | ||
| Equiv. @ 100 kV | Minimum value = 3.6 mm Al | |
| equiv. @ 100 kV | ||
| Maximum value = 4.0 mm Al | ||
| Equiv. @ 100 kV | ||
| Tabletop Aluminum | ||
| Equivalence | Rejection Limit: 2.00 mm Al max. | Rejection Limit: 1.6 mm Al max. |
| Dose Calibration: Maximum | ||
| Input Dose Rate | 80 to 85 mGy/minute | 80 to 85 mGy/minute |
| Dose Calibration: Max Input | ||
| Dose Rate | 2.3 to 2.9 µR/frame | 2.3 to 2.9 µR/frame |
| Dose Calibration: Flat Panel | ||
| Input Dose rate | 0.8 µGy/sec. | 0.8 µGy/sec. |
| Generator Function: Pulsed | ||
| Fluoro Function | Yes | Yes |
| Generator Function: ABC | ||
| Function | Yes | Yes |
| Image Quality: Resolution | Up to 3.15 lp/mm | Up to 3.15 lp/mm |
| Last Image Hold | Yes | Yes |
| Table Specifications: | 510(k) Cleared (Predicate | |
| Device) K212336 | This Submission Soteria E-View | |
| Table Lock Manual Disable | ||
| Controls | Unlocks table rotate, latitude | |
| and longitude. | No | |
| Table Trendelenburg | ± 15°, ± 1° | ± 12°, ± 1° |
| Table height | 33" to 45" | Same |
| Table cradle (LAO/RAO) | ± 15°, ± 1° | ± 12°, ± 1° |
| Table Rotation | 0° to 90° | No |
| X-RAY TUBE Specifications: | ||
| X-RAY Tube | ||
| Specifications: | 510(k) Cleared (Predicate | |
| Device) K212336 | This Submission Soteria E-View | |
| Tube Model: | G-2090 | G-1092 |
| Heat Exchanger | HE-280 | HE-100 |
| Focal Spot sizes | 0.6 - 1.0 mm | 0.6 – 1.2mm |
| Heat Unit rating | 2.0 MHU | 1.0 MHU |
| Housing Model: | B-240H | B-160 |
| High Voltage Generator | ||
| H.V. Generator | ||
| Specifications: | 510(k) Cleared (Predicate | |
| Device) K212336 | This Submission Soteria E-View | |
| Model: | EMD Technologies EPS High | |
| Voltage Generator series | EMD Technologies EPS High | |
| Voltage Generator series | ||
| Mains Input Power: | 480 Vac +/- 10% 50/60 Hz (3 | |
| phases) | 480 Vac +/- 10% 50/60 Hz (3 | |
| phases) | ||
| kV range: | 40 kV - 125 kV | 40 kV - 125 kV |
| mA range: | Min: 5mA to Max: 1000mA | Min: 5mA to Max: 1000mA |
| CA-100S / FluoroShield | ||
| ROI: 'ON' ,'OFF', | ||
| 'ERROR', or | ||
| 'BYPASS' | Yes | Yes |
| 'AUTO' or | ||
| 'MANUAL' ROI | Yes | Yes |
| 'HIGH' or 'LOW' | ||
| reduction | Yes | Yes |
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Safety information:
- The Omega Soteria E-View systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega Soteria E-View systems comply with the international safety standards EN 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-2-54, IEC 60601-2-54, IEC 60601-2-43, EN ISO 15223-1, and EN ISO 14971.
- The Omega Soteria E-View systems comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90.
- The device is designed and manufactured under the Quality System Regulations outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with applicable parts of the IEC60601-1 standards and its collateral standards. All Federal Diagnostic Equipment Standard requirements, as outlined in 21 CFR § 1020, that apply to this device will be met and reported in this initial report.
- . This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
Safety is assured through a risk management process, and manufacturing complies with the Quality System Regulations.
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Referenced Guidance Documents:
- · Guidance for this submission of 510/k) for Indications of use as provided in Pediatric Information for X-ray Imaging Device Premarket Notifications (Document issued on November 28, 2017) Guidance for Industry and Food and Drug Administration Staff.
- · Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. (Document issued September 2023)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices . (Document issued June 2023)
- · Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically powered Medical Devices. (Document issued June 2022)
- Guidance for this submission of 510(k) for (SSXID) Solid State X-ray Imaging Devices issued on: September 1, 2016, was used to establish substantial equivalence.
- · Guidance for industry and FDA Staff User Fees and Refunds for Premarket Notification Submissions 510(k)s, (Document issued October 2022)
- Guidance for industry and FDA Staff Refuse to Accept Policy for 510(k) (Document issued April 2022)
- Guidance for industry and FDA Staff -Format for Traditional and Abbreviated 510(k)s (Document issued on September 2019)
- · Guidance for industry and FDA Staff Deciding when to submit a 510(k) for a change to an existing device. (Document issued on October 25, 2017)
- Guidance for industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Document Issued on July 28, 2014)
- · Guidance for industry and FDA Staff Guidance for Off-The-Shelf Software Use in Medical Devices (Document issued August 2023)
- · Guidance for industry and FDA Staff Guidance for the Content of Premarket Submission for Software in Medical Devices. (Document issued June 2023)
- Guidance for industry and Food and Drug Administration Staff Policy Clarification for Certain . Fluoroscopic Equipment Requirements (Document issued on May 8, 2019)
- · Guidance for Industry and FDA Staff Medical X-Ray Imaging Devices Conformance with IEC Standards. (Document issued February 2023)
- Guidance for Industry and FDA Staff Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment. (Document issued on December 17, 2018)
- · Guidance for Industry and FDA Administration Staff Pediatric Information for X-ray Imaging Device Premarket Notifications (Document issued on November 28, 2017)