(196 days)
Not Found
No
The description focuses on hardware and software for scan initiation, termination, and real-time image display, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as a CT scanner option used for real-time monitoring of interventional procedures, not for therapeutic purposes. It assists in guiding procedures and monitoring images, which are diagnostic and procedural guidance functions, not therapeutic interventions.
Yes
Explanation: The device is a CT scanner, which is used to generate images for diagnostic purposes, specifically for whole-body computed tomography applications and interventional procedures.
No
The device description explicitly states it comprises both hardware and software components, including pedals, a monitor, and a handle.
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 description clearly states that this device is an addition to CT scanners and is used for whole body Computed Tomography applications and interventional procedures. It involves hardware and software for controlling the scanning process, monitoring images, and assisting with needle insertion during procedures.
- No Sample Analysis: There is no mention of analyzing biological samples or performing tests on specimens taken from the patient. The device is used for imaging and guiding procedures directly on the patient's body.
Therefore, the CT Scope option is a medical device used for imaging and procedural guidance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The option is used for whole body computed tomography applications and specifically for interventional procedures that are performed on the CT table.
Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
- The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included.
- The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.
Mentions image processing
Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography
Anatomical Site
whole 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)
Not Found
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.
K945512, K930090, K950972, K970606
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.
0
m
JUN 3 10008
Summary of Safety and Effectiveness
1. Device Name
CT Scope option for CT scanners
2. Submitter
Elscint Inc., 505 Main Str. Hackensack, NJ 07601
3. Intended Use Of Device and its Main Features
The option is used for whole body computed tomography applications and specifically for interventional procedures that are performed on the CT table.
- The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included.
- The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.
4. Predicate Devices
- CT-Twin flash submitted in "HRSW Option for CT-Twin Flash" K945512.
- ◆ HeliCAT CT scanner, K930090
- Precise Biopsy Localization by Computed Tomography, . Radiology 118:603-607, March 1976
- Toshiba America Medical Systems Inc., Real time Reconstruction system option . for Xpress/SX CT System, K950972, cleared on April 15, 1996.
- GE-YMS CT ProSpeed Family of CT Systems with ProSpeed Renaissance . Options, K970606, cleared on April 4, 1997.
1
5. Safety and Effectiveness
The safety of the option is assured by adherence to GMP practices and to International Standards. Potential hazards are identified in a hazard analysis and controlled in the following manner:
Software safety of the option is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.
Electrical and Mechanical safety is assured by adherence to IEC 601-1 standards.
Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.
The CT Scope option enables initiation and termination of the scan process and on-line monitoring of the resulting images in the gantry room, in addition to the Operator of the LaserGuide during the CT Scope procedure may reduce the X-ray exposure to the interventionist by enabling the initial needle insertion under Laser Guide, leaving only the final needle approach to the continuous scanning phase.
6. Substantial Equivalency Statement
Based on the above considerations, it is Elscint's opinion that scanners incorporating the CT Scope and LaserGuide options are substantially equivalent in safety and effectiveness to the predicate devices, CT Twin flash, K945512 and HeliCAT, K930090,
In our opinion they are also substantially equivalent to the interventional procedures using CT that predate the 1976 Medical Device Amendments an example of which is the article "Precise Biopsy Localization by Computed Tomography", Radiology 118:603-607, March 1976.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or a bird in flight, rendered in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 JUN
Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint . Inc. Corporate Headquarters 505 Main Street Hackensack, NJ 07601
Re: K974344
CT Scope option for CT Scanners Dated: March 10, 1998 Received: March 11, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Kay:
We have reviewed your Section 510/2) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major resulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): _ 17 4344
Device Name: CT Scope option for CT Scanners.
Indications For Use:
ಿನ
Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.
(Please do not write below this line-continue on another page if needed)
(Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-counter use
Daniel C. Skyman
OR
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number