(180 days)
Not Found
No
The device description explicitly states the use of "OCR software" to analyze the digital input video. While OCR can sometimes incorporate ML techniques, the description does not mention any AI or ML-specific terms, training data, or performance metrics typically associated with AI/ML models. The focus is on standard OCR and rule-based dose checking according to a NEMA standard.
No
Explanation: The device is intended to monitor and alert operators about potentially high radiation doses from CT scanners, thus preventing over-exposure. It does not directly treat or alleviate a medical condition.
No
The device is designed to provide a dose check feature for CT scanners, acting as an alert system for high radiation doses to ensure patient safety according to NEMA XR-25 and XR-29 standards. It does not provide medical diagnoses for patients.
No
The device description explicitly states that the SafeCT-29 is a "software and hardware system which includes Computer, dedicated display and controls." It also describes hardware components like a video splitter and video grabber.
Based on the provided information, the SafeCT-29 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SafeCT-29 Function: The SafeCT-29's function is to monitor and alert CT operators about estimated radiation dose levels prior to a scan. It does this by analyzing the video output of the CT console display using OCR.
- No Specimen Analysis: The device does not interact with or analyze any biological specimens from a patient. Its input is the video signal from the CT scanner's console.
- Focus on Equipment Operation: The intended use and device description clearly indicate that the SafeCT-29 is focused on providing a safety feature related to the operation of the CT equipment and the radiation dose delivered, not on analyzing patient samples for diagnostic purposes.
Therefore, the SafeCT-29 falls under the category of a medical device, but specifically one related to imaging equipment and radiation safety, not an IVD.
N/A
Intended Use / Indications for Use
The SafeCT-29 is intended for provided Tomography Dose Check feature to Computed Tomography X-ray systems.
The SafeCT-29 is specifically indicated for providing the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds, for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Medic Vision's SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer's internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
*The SafeCT-29 does not provide all the features specified in the NEMA XR-29 standard. The only provided feature is the Dose Check.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional personnel
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
An Off-The Shelf (OTS) OCR software which is embedded in the SafeCT-29 software has been verified by testing its performances following the requirements of the "Guidance on Offthe-Shelf Software Use in Medical Devices". As required by the guidance the OTS performance was tested prior to mitigation and after embedding it into the SafeCT-29 software and taking mitigation means. Before the test, 1800 screen images were captured from various CT scanners. These images included more than 6000 numeric and alphanumeric text images. These data were input into the device and the dose levels and protocols were calculated based on the software analysis and recognition of the numeric and alphanumeric text images. The results were compared to the original CT screens' data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification: The device software has been verified by testing the software following predefined software test plan, which confirmed that the software output meets the input as defined by the Software Requirements Specifications (SRS). The SRS encompasses Dose Check features as specified by NEMA XR-25 standard, display & operation controls and applicable risk mitigations. The test results were recorded and traceability control was established to ensure the all the SRS requirement were met.
An Off-The Shelf (OTS) OCR software which is embedded in the SafeCT-29 software has been verified by testing its performances following the requirements of the "Guidance on Offthe-Shelf Software Use in Medical Devices". As required by the guidance the OTS performance was tested prior to mitigation and after embedding it into the SafeCT-29 software and taking mitigation means. Before the test, 1800 screen images were captured from various CT scanners. These images included more than 6000 numeric and alphanumeric text images. These data were input into the device and the dose levels and protocols were calculated based on the software analysis and recognition of the numeric and alphanumeric text images. The results were compared to the original CT screens' data. The resulted specificity in detecting the correct input data (protocol and dose data) was better than 99.4%. These test results confirmed that, after mitigation, the OTS performance meets the system software requirements.
The performance of the SafeCT-29 system has been verified by simulation methods. Sequence of data, which were recorded from various CT scanners, served as the SafeCT-29 input. The data was processed by the device and its Dose Check functionality was tested. The results of process confirmed that device meets its performance specifications. Additionally, the usability and reliability of the SafeCT-29 system was verified in user environment at 4 imaging centers, using 4 different CT scanner models, by end-users and Medic Vision engineers.
Design Validation: This testing was performed at end-user operating conditions in five medical centers with five different CT scanner models. The tests included the device installation, operation, functionality processes and features. The test results confirmed that the SafeCT-29 meets the defined user needs and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The SafeCT-29 specificity in detecting the correct input data (protocol and dose data) is 99%.
The resulted specificity in detecting the correct input data (protocol and dose data) was better than 99.4%.
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.
Not Found
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Medic Vision Imaging Solutions Ltd. % Mr. Dan Laor O&R Advisor 6 Sireni St. Haifa, 32972 ISRAEL
Re: K153331 Trade/Device Name: SafeCT-29 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 11, 2016 Received: April 19, 2016
Dear Mr. Laor:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K 153331
Device Name SafeCT-29
Indications for Use (Describe)
The SafeCT-29 is intended for provided Tomography Dose Check feature to Computed Tomography X-ray systems.
The SafeCT-29 is specifically indicated for providing the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds, for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
| 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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3
510(k) Summary
Submitter details
Medic Vision Imaging Solutions Ltd. 3 Yozma St, Tirat Carmel 39032, Israel
Submission Contact: Dan Laor Preparation Date: March 16, 2016
Details of the submitted Device
| Proprietary Name: | SafeCT-29 |
|---|---|
| Regulation Number | 892.1750 |
| Product Code: | JAK |
| Committee/Panel: | Radiology |
| Device Class: | 2 |
Reason for 510(k) Submission:
New Device
Identification of the Legally Marketed Predicate Device
Proprietary Name: Regulation Number Product Code: Committee/Panel: Device Class:
syngo ® V A48 (SOMARIS/7 V A48) 892.1750 JAK Radiology 2
Telephone +972.73.7262226
6 Sireni St., Haifa, 32972, Israel.
Device Description
Medic Vision's SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer's internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
*The SafeCT-29 does not provide all the features specified in the NEMA XR-29 standard. The only provided feature is the Dose Check.
4
Intended use and indications for Use
The SafeCT-29 is intended for providing Computed Tomography Dose Check feature to Computed Tomography X-ray systems.
The SafeCT-29 is specifically indicated for providing the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds, for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
Substantial Equivalence information
Reference guidance documents
- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11 2005
- "Guidance on Off-the-Shelf Software Use in Medical Devices" September 9, 1999. ●
Comparison with the predicate device
Intended Use: As the predicate device, the SafeCT-29 is intended to provide Computed Tomography Dose Check feature to Computed Tomography X-ray systems.
Indications for Use: As the predicate device, the safeCT-29 is indicated for use by authorized personnel to provide the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds.
| Category | Predicate Device
Syngo® VA48 | Subject Device
SafeCT-29 |
|------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data inputs | Host CT Digital Data
directly interfaced by
the device software. | The SafeCT-29 uses its own input separate
hardware: The device is interfaced to the CT
screen via a video splitter that provides a copy
of the CT screen in real-time. The CT screen
data is captured by grabbing and digitizing the
video signal.
The captured data is interpreted by OCR
software. |
| Scan Controls | Software | Software & hardware |
| Accumulates
values for the
total CTDIvol | Designed to fulfill the
requirements of the
NEMA XR-25 Standard
section 2.2.2 | The software extracts accumulated CTDIvol
per Z axis location from the CT screen
whenever such information is displayed by
the scanner.
For scanners that do not present such
information, the accumulated CTDIvol is
calculated by the SafeCT-29 software. The
calculation follows the AAPM guidelines and
assumes "worst case scenario" (i.e. calculated |
Differences in Technological Characteristics
5
| CTDIvol may be higher than the actual value) in order to prevent over-the-limit scans. The SafeCT-29 assumes that each z-axis position gets the displayed maximum CTDIvol value, and calculates the accumulated CTDIvol accordingly. | ||
|---|---|---|
| Display | Host CT Screen | The SafeCT-29 has its own display separate hardware: a dedicated monitor. SafeCT-29 generates an audio alert to ensure the user is aware of notifications and warnings displayed on its display. |
| Man machine | ||
| interface | Host CT keyboard & | |
| mouse | Dedicated keyboard & mouse | |
| Record Data | ||
| output | Not known | Data is saved in the Device's internal memory and can be exported with a USB memory stick |
| Processor | ||
| hardware | Host CT Processor | Dedicated Off-the-shelf processor and controls |
The effects of the difference in Data inputs
- (a) The SafeCT-29 specificity in detecting the correct input data (protocol and dose data) is 99% *.
-
- This value was obtained by the OTS verification process see Design Verification below.
- (b) The SafeCT-29 delay in detecting the correct input data is less than 300ms, which is negligible in terms of man machine interface time.
Verification and Validation
Design Verification: In conformance to the requirements of 21CFR 820.30 (f), Medic Vision established and maintains procedures, which confirm that the design output meets the design input requirements. The design verification testing details, including identification of the design and methods are as follows:
The device software has been verified by testing the software following predefined software test plan, which confirmed that the software output meets the input as defined by the Software Requirements Specifications (SRS). The SRS encompasses Dose Check features as specified by NEMA XR-25 standard, display & operation controls and applicable risk mitigations. The test results were recorded and traceability control was established to ensure the all the SRS requirement were met.
An Off-The Shelf (OTS) OCR software which is embedded in the SafeCT-29 software has been verified by testing its performances following the requirements of the "Guidance on Offthe-Shelf Software Use in Medical Devices". As required by the guidance the OTS performance was tested prior to mitigation and after embedding it into the SafeCT-29 software and taking mitigation means. Before the test, 1800 screen images were captured from various CT scanners. These images included more than 6000 numeric and alphanumeric text images.
6
These data were input into the device and the dose levels and protocols were calculated based on the software analysis and recognition of the numeric and alphanumeric text images. The results were compared to the original CT screens' data. The resulted specificity in detecting the correct input data (protocol and dose data) was better than 99.4%. These test results confirmed that, after mitigation, the OTS performance meets the system software requirements.
The performance of the SafeCT-29 system has been verified by simulation methods. Sequence of data, which were recorded from various CT scanners, served as the SafeCT-29 input. The data was processed by the device and its Dose Check functionality was tested. The results of process confirmed that device meets its performance specifications. Additionally, the usability and reliability of the SafeCT-29 system was verified in user environment at 4 imaging centers, using 4 different CT scanner models, by end-users and Medic Vision engineers.
Design Validation: In conformance to the requirements of 21CFR 820.30 (g), Medic Vision established and maintains procedures, which ensure that devices conform to defined user needs and intended uses. The validation process included testing of production units. This testing was performed at end-user operating conditions in five medical centers with five different CT scanner models. The tests included the device installation, operation, functionality processes and features. The test results confirmed that the SafeCT-29 meets the defined user needs and intended uses.
The above verification and validation testing methods adhered to state-of-art standards and procedures.
Clinical Data:
Clinical data is not included (not applicable).
Risk Management
The device risks were managed and controlled following the requirements of ISO 14971standard. The device hazards were identified, their risk levels were evaluated and mitigation measures were taken to reduce the risk levels. In Medic Vision opinion the benefits of providing the Dose Check feature to CT scanners not equipped with this function, overweight the device residual risks.
The SafeCT-29 is designed to fulfill the requirements of the following standards:
- IEC60601-1:2005+CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment . - Part 1: General requirements for basic safety and essential performance.
- EN 60601-1-2 :2007 Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests