(78 days)
No
The summary describes an upgrade to a CT scanner that uses ECG signals for timing, but there is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is a CT scanner, which is an imaging device used for diagnosis, not therapy. Its function is to produce images of the human body using x-ray transmission data.
Yes
The device is described as producing "cross-sectional images of a human body," which are used for diagnostic purposes by healthcare professionals to identify and analyze medical conditions.
No
The device is described as an "upgrade" to a previously cleared CT scanner, which is a hardware device. The upgrade specifically enables ECG-gating signals to trigger scans, implying integration with and control of the existing hardware. While software is undoubtedly involved in processing the ECG signals and controlling the scanner, the device's function is intrinsically tied to the operation of the CT scanner hardware.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device produces cross-sectional images of a human body by reconstructing x-ray transmission data. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Input Data: The input is "x-ray transmission data," which is generated by passing x-rays through the body, not from a sample taken from the body.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial turnors, blood clots in the brain, eye trauma, soft tissue lesions in the extremittes, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared device already found in the marketplace.
Product codes
90JAK
Device Description
The ECG-Gating System is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265, K990134]. This upgrade will allow scans to be triggered by ECG-gating signals.
Mentions image processing
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial turnors, blood clots in the brain, eye trauma, soft tissue lesions in the extremittes, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared device already found in the marketplace.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission data
Anatomical Site
human 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)
Reference Device(s)
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
AUG 10 1999
510(k) Summary
| Date: | 13 May 1999 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | ECG-Gating System for Aquilion CT Scanner, TSX-101A |
| Common Name: | Scanner, Computed Tomography, X-Ray |
| [Fed. Reg. No. 892.1750, Pro. Code: 90JAK] | |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard: | 21 CFR Subchapter J, |
| Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | Toshiba TSX-101A, Aquilion [K982265, K990134] |
| Other Similar Devices: | Siemens SOMATOM Plus 4 with Volume Zoom [K982349] |
| GE LightSpeed QXi [K980176] | |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The ECG-Gating System is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265, K990134]. This upgrade will allow scans to be triggered by ECG-gating signals.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial turnors, blood clots in the brain, eye trauma, soft tissue lesions in the extremittes, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared device already found in the marketplace.
1
Technological Characteristics:
This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. This device produces two dimensional, black and white image that can be filmed or electronically stored for future review.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.
Substantial Equivalence:
Based upon the above considerations TAMS believes that this upgrade package, ECG-Gating System CHEG-001A, is substantially equivalent to the Aquilion CT scanner.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Paul Biggens Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, California 92781-2068
Re:
Aquilion CT Scanner TSX-101A with ECG-Gating System (CHEG-001A) Dated: May 13, 1999 Received: May 24, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Biggens:
We have reviewed your Section 510(k) 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 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). 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 III (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 (QS) 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 requlatory 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CART Daniel O. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting 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): K991766
Device Name: Aquilion CT Scanner TSX-101A with ECG-Gating System (CHEG-001A)
Indications for Use:
This device is indicated to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. This specific model employs the use of ECG signals to specify the timing of the x-ray transmission commencement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991766 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109)
| (Optional Format 1-2-96) | OR | Over-The-Counter Use |
|---|---|---|
| ---------------------------------------------------------------------- | ---- | ---------------------- |