(170 days)
No
The summary describes a standard CT scanner with a sliding gantry mechanism. While it mentions postprocessing applications, there is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development. The performance studies focus on the mechanical and image quality equivalence to the predicate device, not on the performance of any AI/ML algorithms.
No
The device is an imaging system designed to produce cross-sectional images of the body using x-ray transmission data for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The device is intended to produce cross-sectional images of the body using X-ray transmission data, which is a process used for diagnosis in healthcare.
No
The device description clearly details hardware components including a CT gantry, ceiling mounted suspension and drive mechanism, and mentions leveraging components from a previously cleared CT scanner (SOMATOM Definition, Model AS/AS+). While it mentions software (syngo platform and applications), it is integrated with and controls significant hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The iCT device described is an X-ray computed tomography (CT) scanner. Its function is to produce cross-sectional images of the body using X-rays. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use clearly states it's for producing images of the body by computer reconstruction of x-ray transmission data. This aligns with the function of a CT scanner, not an IVD.
- Device Description: The description details the physical components of a CT scanner (gantry, X-ray tube, detectors, etc.) and how it operates to create images. There is no mention of handling or analyzing biological specimens.
The information provided consistently describes a medical imaging device, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The iCT device with sliding gantry is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).
Product codes
JAK
Device Description
iCT is a whole body x-ray computed tomography (CT) scanner. It combines a standard CT gantry with a ceiling mounted suspension and drive mechanism to move the gantry horizontally during image acquisition. The standard CT gantry features a continuously rotating tub-detector system and functions according to the fan beam principle. The ceiling mounted suspension and drive mechanism allows iCT to be moved along rails for storage or to share the iCT between multiple rooms. The ceiling mounted system also provides precise horizontal movement that is integrated with the CT scan control. During image acquisition, the iCT drive mechanism translates the CT gantry while the patient table remains stationary. Moving the gantry allows the patient to remain stationary instead of translating the patient relative to the gantry as is required with fixed gantry systems. iCT may be used with commercially available patient tables, including surgical tables, that meet the appropriate size and x-ray transmission characteristic requirements.
iCT leverages the previously cleared SOMATOM Definition, Model AS/AS+ (K081022) gantry, power supply and operator console components, including the syngo software platform and compatible syngo applications. iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.
Mentions image processing
iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
body
Indicated Patient Age Range
Not Found
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)
iCT performance has been evaluated in verification and validation to ensure the ceiling railing system maintains the performance of the contained SOMATOM Definition, Model AS/AS+ system components. Risk Management has been applied to identify, mitigate and test the distinctions between iCT and the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. Image quality testing based on high precision phantoms was provided in this submission to demonstrate substantial equivalence with the predicate. iCT has been tested to perform to the same image quality, z-axis accuracy and gantry stability specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. iCT has also been tested to conform to applicable product safety standards. iCT meets the applicable requirements of the Federal performance standards for ionizing radiation emitting products defined in 21 CFR §§1020.30 and 1020.33 for CT systems. It conforms to the applicable International Electrotechnical Commission (IEC) 60601 family of standards, including applicable collateral and particulars, for medical devices and CT systems. iCT complies with NEMA XR-25, Computed Tomography Dose Check.
The iCT system uses a previously cleared CT system with cleared moving gantry option as a base, and the major modification to the predicate is the integrate hardware that allow for the system to be mounted on the ceiling instead of the floor. Because the major software components in the imaging chain are unmodified from the predicate, sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies.
iCT verification and validation results support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and words. The text includes "K130224", "page 1 of 3", and "iCT". The handwriting is cursive and somewhat stylized, with some characters connected and others distinct. The overall impression is that of a page number or identification code within a larger document.
510{k) Premarket Notification
IMRIS O
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
| Submitter: | IMRIS Inc.
1370 Sony Place
Winnipeg, MB R3T 1N5
Canada
Establishment Registration Number: 3003807210 | | | JUL 1 8 2013 |
|---------------------------|------------------------------------------------------------------------------------------------------------------|--|--|--------------|
| Contact Person: | Daniel Biank, JD, MEng, PE, RAC
Director, Regulatory Affairs | | | |
| Telephone: | 763.203.6310 | | | |
| Fax: | 204.480.7071 | | | |
| Email: | dbiank@imris.com | | | |
| Alternate Contact Person: | Sanjay Shah, P.Eng
Manager, Regulatory Affairs | | | |
| Telephone: | 204.480.7054 | | | |
| Fax: | 204.480.7071 | | | |
| Email: | sshah@imris.com | | | |
| Date Prepared: | May 15, 2013 | | | |
| Device Name | | | | |
| Trade Name: | iCT | | | |
| Common Name: | System, X-ray, Tomography, Computed (JAK) | | | |
| Classification Name: | Computed Tomography X-ray System (21 CFR §892.1750) | | | |
Predicate Devices:
| 510(k) | Decision Date | Device Name | Manufacturer |
|---|---|---|---|
| K081022 | Jun 2, 2008 | SOMATOM Definition, Model AS/AS+ | Siemens Medical Solutions USA, Inc. |
| K032475 | Nov 10, 2003 | SOMATON Computed Tomography X- | |
| Ray Systems Sliding Gantry Option | Siemens Medical Solutions USA, Inc. |
Device Description:
iCT is a whole body x-ray computed tomography (CT) scanner. It combines a standard CT gantry with a ceiling mounted suspension and drive mechanism to move the gantry horizontally during image acquisition. The standard CT gantry features a continuously rotating tub-detector system and functions according to the fan beam principle. The ceiling mounted suspension and drive mechanism allows iCT to be moved along rails for storage or to share the iCT between multiple rooms. The ceiling mounted system also provides precise horizontal movement that is integrated with the CT scan control. During image acquisition, the iCT drive mechanism translates the CT gantry while the patient table remains stationary. Moving the gantry allows the patient to remain stationary instead of translating the patient relative to the gantry as is required with fixed gantry systems. iCT may be used with commercially available patient tables, including surgical tables, that meet the appropriate size and x-ray transmission characteristic requirements.
1
Image /page/1/Picture/0 description: The image shows a handwritten note with the text "K130224 Page 2 of 3 iCT". The text is written in black ink on a white background. The handwriting is somewhat stylized, with the "K" and "P" being particularly prominent.
IMBIS O
510(k) Premarket Notification
iCT leverages the previously cleared SOMATOM Definition, Model AS/AS+ (K081022) gantry, power supply and operator console components, including the syngo software platform and compatible syngo applications. iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.
Intended Use:
The iCT device with sliding gantry is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).
Comparison with Predicate Devices:
iCT is substantially equivalent to the currently cleared and marketed SOMATOM Definition, Model AS/AS+ (K081022) when used with the optional sliding gantry package cleared earlier under SOMATON Computed Tomography X-Ray Systems Sliding Gantry Option (K032475) by Siemens Medical Solutions USA, Inc. The predicate SOMATOM Definition, Model AS/AS+ is a standard CT system. As a SOMATOM family CT scanner it can be used with the SOMATON Computed Tomography X-Ray Systems Sliding Gantry Option.
The SOMATOM Definition, Model AS/AS+ with Sliding Gantry Option provides a fully functional CT scanner that moves the CT gantry along rails mounted in the floor. This allows the patient to remain stationary on a fixed table as the gantry moves horizontally during image acquisition.
iCT provides a fully functional CT scanner that moves the CT gantry suspended from rails mounted in the ceiling. It also uses the horizontal motion of the gantry while the patient remains stationary on a table during image acquisition.
iCT uses the SOMATOM Definition, Model AS/AS+ gantry, power supply and operator workspace components. Therefore, the x-ray characteristics and scan interfaces are the same. It acquires images using the same method for incorporating gantry translation into scan control movement as the cleared Sliding Gantry Option. The primary difference between the predicates and iCT is that iCT travels on ceiling rails instead of floor rails. These differences have been identified and assessed in risk management and are addressed by recognized standards and the included testing.
Summary of Studies:
iCT performance has been evaluated in verification and validation to ensure the ceiling railing system maintains the performance of the contained SOMATOM Definition, Model AS/AS+ system components. Risk Management has been applied to identify, mitigate and test the distinctions between iCT and the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. Image quality testing based on high precision phantoms was provided in this submission to demonstrate substantial equivalence with the predicate. iCT has been tested to perform to the same image quality, z-axis accuracy and gantry stability specifications as the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. iCT has also been tested to conform to applicable product safety standards. iCT meets the applicable
2
IMBIS O
510(k) Premarket Notification
requirements of the Federal performance standards for ionizing radiation emitting products defined in 21 CFR §§1020.30 and 1020.33 for CT systems. It conforms to the applicable International Electrotechnical Commission (IEC) 60601 family of standards, including applicable collateral and particulars, for medical devices and CT systems. iCT complies with NEMA XR-25, Computed Tomography Dose Check.
The iCT system uses a previously cleared CT system with cleared moving gantry option as a base, and the major modification to the predicate is the integrate hardware that allow for the system to be mounted on the ceiling instead of the floor. Because the major software components in the imaging chain are unmodified from the predicate, sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies.
iCT verification and validation results support a determination of substantial equivalence.
Additional Information:
Substantial equivalence was evaluated based on software documentation for a Moderate Level of Concern device.
Conclusion:
iCT is substantially equivalent to the currently cleared and marketed SOMATOM Definition, Model AS/AS+ (K081022) when used with the optional sliding gantry package, SOMATON Computed Tomography X-Ray Systems Sliding Gantry Option (K032475). iCT has been successfully tested to operate within the same performance and image quality specifications as the currently cleared and marketed SOMATOM Definition, Model AS/AS+. iCT has been evaluated to conform to applicable product safety standards that have been recognized to address known CT risks. iCT is substantially equivalent to the predicate based on the included studies and analysis.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing three smaller figures. The symbol is rendered in black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Godge Silver Spring, MD 20993-0002
July 18, 2013
IMRIS, Inc. % Mr. Daniel Biank Director. Regulatory Affairs 100-1370 Sony Place Winnipeg, Manitoba R3T 1N5 CANADA
Re: K130224
Trade/Device Name: iCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 16, 2013 Received: May 20, 2013
Dear Mr. Biank:
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. Ilisting 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 11 (Special Controls) or class 11) (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 (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
Page 2 - Mr. Biank
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/RcportaProblem/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 Small Manufacturers, International and Consumer Assistance 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 vours.
Smh.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130224
Device Name: iCT
Indications for Use:
The iCT device with sliding gantry is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130224 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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