(113 days)
Yes
The device name "Soteria.AI" explicitly includes "AI", strongly suggesting the incorporation of artificial intelligence technology.
No
This device is an X-ray imaging system intended for diagnostic and interventional imaging, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "general radiographic/fluoroscopic diagnostic and interventional x-ray imaging".
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. While it includes software components and potentially AI, it is not solely software.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Soteria.AI system is an X-ray imaging system used for radiographic/fluoroscopic applications. It generates images of the inside of the body using X-rays.
- Intended Use: The intended use is for "Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic and interventional x-ray imaging." This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details components like an X-ray source, detector, patient table, and C-arm, all related to generating and capturing X-ray images of the patient.
- Lack of Sample Analysis: There is no mention of analyzing biological samples or performing tests on specimens outside of the body.
While the system includes image processing and potentially AI for image analysis (like the optional VVA software), the core function and intended use are focused on in-vivo imaging, not in-vitro diagnostic testing.
No
The letter does not state that the FDA has reviewed and cleared a PCCP for this specific device.
Intended Use / Indications for Use
The System is intended for use in Radiographic/fluoroscopic applications including cardiac, 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.Al system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria.AI 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, lifted vertically, shifted to the side, and moved 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 the imaging information required to achieve minimally invasive interventional procedures.
The Soteria.Al system is available as a Model Al-100 configuration. It is similar to the currently marketed predicate consisting of an X-ray generator, Image processor, collimator, x-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K182834).
Additionally, Soteria.Al can be equipped with an optional X-ray VVA (Vessel and Ventricular Analysis) image analysis (FDA-Cleared) software, (K112807).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Radiographic/fluoroscopic X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
General and Pediatric Population
Intended User / Care Setting
Physician / 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 performance testing has been performed on the Soteria.Al system and demonstrated compliance with the following International and FDA approved consensus standard and FDA guidance documents:
-
- IEC 62304 Medical device software Software life cycle processes. FDA/CDRH recognition number 13-79.
-
- I SO 14971 Medical devices Application of risk management to medical devices
-
- IEC 60601-2-54 Particular requirements for the basic safety and essential performance of X-ray Safety.
-
- Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
-
- Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
Software verification testing of the functional and non-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 the privacy and security requirements, have been implemented. Results demonstrated that executed verification test was passed.
Non- clinical validation testing has been performed to validate that the Soteria. Al system conforms to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.
The Soteria.AI did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP was demonstrated with the following attributes:
- Indication for use.
- Technological characteristics.
- Non-clinical performance testing; and
- 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
December 14, 2021
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Omega Medical Imaging, LLC John Newman Regulatory Specialist 3400 St. Johns Parkway, Suite 1020 Sanford, Florida 32771
Re: K212336
Trade/Device Name: Soteria.AI Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OWB
Dear John Newman:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 17, 2021. Specifically, FDA is updating this SE Letter to include the updated IFU statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health, Thalia.Mills@fda.hhs.gov.
Sincerely.
Michael D. O'Hara
For
Thalia Mills, Ph.D. Division 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
1
November 17, 2021
Image /page/1/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Omega Medical Imaging, LLC % Mr. John Newman Regulatory Specialist 3400 St. Johns Parkway, Suite 1020 SANFORD FL 32771
Re: K212336
Trade/Device Name: Soteria.AI Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OWB Dated: August 17, 2021 Received: August 19, 2021
Dear Mr. Newman:
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
2
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,
Digitally signed by Laurel M. Burk -S Laurel M. Burk -S
Date: 2021.11.17 12:15:41 -05'00' . 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
3
Indications for Use
510(k) Number (if known) K212336
Device Name Soteria.AI
Indications for Use (Describe)
The System is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic and interventional x-ray imaging for General and Pediations
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 eye-like symbol on the left, followed by the word "OMEGA" in blue, bold, uppercase letters. Below the word "OMEGA" is the phrase "Medical Imaging" in a smaller, lighter font, suggesting the company's focus on medical imaging technology.
Traditional 510(k) SUMMARY
| 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: | John Newman (Regulatory Affairs Specialist) |
| Date Prepared: | 07/16/2021 |
| Device (trade) name: | Soteria.Al |
| 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 |
| Performance Standard: | This device conforms to applicable Performance Standards for lonizing |
| Radiation Emitting Products (21 CFR Subchapter J, Federal Diagnostic | |
| X-ray Equipment Standard) | |
| Predicate Device K182834 | |
| Company Name: | Omega Medical Imaging, LLC |
| Address: | 675 Hickman Circle, Sanford, Florida 32771 |
| Telephone No: | 407-323-9400 |
| Registration No: | 1052701 |
| Contact person: | John Newman |
| Date Prepared: | 02/13/2019 |
| Device (trade) name: | CS-series-FP with Optional CA-100S ROI Accessory |
| 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 cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General and Pediatric Populations.
Device description:
The Soteria.Al system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria.AI 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, lifted vertically, shifted to the side, and moved 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 the imaging information required to achieve minimally invasive interventional procedures.
The Soteria.Al system is available as a Model Al-100 configuration. It is similar to the currently marketed predicate consisting of an X-ray generator, Image processor, collimator, x-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K182834).
Additionally, Soteria.Al can be equipped with an optional X-ray VVA (Vessel and Ventricular Analysis) image analysis (FDA-Cleared) software, (K112807).
Patient Population:
General and Pediatric Population, special concerns must be taken for pediatric use. (See Operator Manual for specific instructions)
Based on the information provided above, the Soteria.Al system is considered substantially equivalent to the current marketed predicate device CS- series-FP with the Optional CA-100S / FluoroShield (K182834). Both share the same Indications for use.
6
Technological characteristics and Summary of Critical Improvements
The Soteria.Al system has similar technological characteristics compared to the predicate device with some improvements to it. Below is a summary of the critical improvements between the new Soteria.Al system and the predicate device. FluoroShield was integrated with the Teledyne Zineos 3030HS Flat Panel Detector and the Nyquist.IQ Image Processor, Verification and Validation is included in this submission.
- Modified C-arm with the additional rotational axis (Fifth Axis).
- New motion control software for patient and X-ray beam positioning, giving an improved roll scan time.
- Improved collimator, new tube model with higher heat capacity.
- More consistent collision prevention.
- New Image Processor called Nyquist. IQ
- Integration of a New Flat Panel Detector (Teledyne Xineos 3030HS CMOS x-ray detector previously cleared K192182) with the already FDA-cleared CA-100S / FluoroShield (K182834).
- . FluoroShield software was revised to accommodate Frame Rate and resolution requirements for the Teledyne Xineos 3030HS CMOS FPD and Nyquist Image Processor.
- Operator TouchPad interface.
- Operator programable presets for the position of the C-arm and Table.
The difference between the Soteria.Al system and the predicate device does not raise any new safety or effectiveness. Based on the information provided in this 510K submission, Soteria.Al is considered substantially equivalent to the current marketed predicate CS-series-FP with the Optional CA-100S / FluoroShield in terms of fundamental technology.
Summary of Non- Clinical Performance
Non-clinical performance testing has been performed on the Soteria.Al system and demonstrated compliance with the following International and FDA approved consensus standard and FDA guidance documents:
-
- IEC 62304 Medical device software Software life cycle processes. FDA/CDRH recognition number 13-79.
-
- I SO 14971 Medical devices Application of risk management to medical devices
-
- IEC 60601-2-54 Particular requirements for the basic safety and essential performance of X-ray Safety.
-
- Guidance for Industry and FDA Staff Guidance for the Content of premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
-
- Premarket Notifications [510(k)]", July 28, 2014 (document number 1766).
7
Software verification testing of the functional and non-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 the privacy and security requirements, have been implemented. Results demonstrated that executed verification test was passed.
Non- clinical validation testing has been performed to validate that the Soteria. Al system conforms to the intended use, claims, user, and service needs, effectively satisfying measures and instruction for use.
The Soteria.AI did not require clinical study data since substantial equivalence to the currently marketed predicate device Omega CS-series-FP was demonstrated with the following attributes:
- Indication for use.
- Technological characteristics.
- Non-clinical performance testing; and
- Safety and effectiveness.
Substantial equivalence Conclusion:
The Soteria.Al system is substantially equivalent to the currently marketed predicate device CS- series- with the Optional CA-100S (ROI Assembly) regarding indications for use, technological characteristics, safety, and effectiveness.
The Soteria.Al system is within the controls and predetermined specifications. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in these 510(k) premarket notifications. These tests demonstrate that the Soteria.Al system complies with the user need requirements and the requirements specified in the FDA-recognized consensus standards and guidance documents.
Therefore, Soteria.AI is as safe and effective as its predicate device and does not raise any new safety and effectiveness concerns.
Comparison with Predicate Devices:
| Indications for use comparison: | ||
|---|---|---|
| 510(k) | ||
| Number and | ||
| Device Name | K182834 (Predicate Device) | |
| CS-series-FP with optional CA-100S | (This Submission) | |
| Soteria Al, Model Al-100 | ||
| Intended Use | The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification 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 Populations. | 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 Populations. | ||
| Classification | ||
| Name: | Image-intensified Fluoroscopic X-ray system | Image-intensified Fluoroscopic X-ray system |
8
| CFR
| Regulation #: | 892.1650 | 892.1650 |
|---|---|---|
| Device Class | Class II | Class II |
| Classification | ||
| Product Code: | JAA, OWB | JAA, OWB |
PRODUCT OVERVIEW
Substantial Equivalence:
It is detailed in the Bench testing section of this submission.
Safety information:
- The Omega Soteria.Al systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega Soteria.Al systems comply with the international safety standards EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-2-54, EN ISO 15223-1, and EN ISO 14971.
- The Omega Soteria.Al 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.
9
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 on October 2018)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices . (Document issued on May 11, 2005)
- · Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-powered Medical Devices. (Document issued on July 11, 2016)
- 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 on October 2, 2017)
- Guidance for industry and FDA Staff Refuse to Accept Policy for 510(k) (Document issued on September 2019)
- 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 on September 2019)
- · Guidance for industry and FDA Staff Guidance for the Content of Premarket Submission for Software in Medical Devices. (Document issued May 11, 2005)
- · 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 on May 8, 2019)
- 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)